Meningococcal VaccinePhase 2NCT04645966

A Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants

A Phase 2 study testing MenABCWY, Bivalent rLP2086 (60-µg Dose) and Bivalent rLP2086 (120-µg Dose) in people with Meningococcal Vaccine, run by Pfizer at 21 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age. Read more about this study

Who is it for?: Ages 2 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Vaccine
What is being tested?: MenABCWY, Bivalent rLP2086 (60-µg Dose) and Bivalent rLP2086 (120-µg Dose)
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: 21 sitesin 3 countries
Study dates: 26 Nov 2020to 15 Sep 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization.
Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.
Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
Body weight ≥4 kg for participants 2 months of age at the time of randomization.
Participants whose parent(s)/legal guardian are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Who cannot join

Prior adverse reaction to paracetamol use, including allergic reactions.
Participant was born prematurely (<37 weeks of gestation).
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the SRM for additional details.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.

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Significant neurological disorder or history of seizure (including simple febrile seizure).
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Previous vaccination with any meningococcal vaccine. Written vaccination history must be obtained prior to randomization.
For participants 2 months of age, prior vaccination with any of the following licensed or investigational vaccines: pneumococcal vaccine and hexavalent DTPa-HBV-IPV-Hib or its component, except for the birth dose of hepatitis B vaccine.
Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
Receipt of any blood products, including immunoglobulin, before the first study vaccination.
Current chronic use of systemic antibiotics.
Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

Spain17 sites

Hospital Vithas Virgen del Mar
Almería, 04120
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Centro de Salud L'Eliana
L'Eliana, Valencia, 46183
Hospital General Universitario Gregorio Marañón
Madrid, 28009
Hospital Universitario Clinico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Grupo Pediatrico Uncibay
Málaga, 29015
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, 28938
Centro de Salud de Paiporta
Paiporta, Valencia, 46200
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, 15706
Instituto Hispalense de Pediatria
Seville, 41012
Hospital Universitario Virgen Del Rocio
Seville, 41013
FISABIO
Valencia, 46020
Centro de Salud la Serreria II
Valencia, 46022
Centro de Salud Nazaret
Valencia, 46024

Other trials in Spain

Greece3 sites

P. & A. Kyriakou Children's Hospital
Athens, 11527
University General Hospital "ATTIKON"
Athens, 12462
"Ippokratio" General Hospital of Thessaloniki
Thessaloniki, 54642

Other trials in Greece

Germany1 site

Dr. med Falko Panzer Praxis fuer Kinder und Jugendliche
Mannheim, 68161

Other trials in Germany

About this study

Official title: A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Conditions: Meningococcal Vaccine
Being tested: MenABCWY, Bivalent rLP2086 (60-µg Dose), Bivalent rLP2086 (120-µg Dose), Bexsero, Prophylactic Liquid Paracetamol (PLP)
Keywords: Meningococcal Vaccine, Invasive Meningococcal Disease, Meningococcal Serogroups A, B, C W and Y, MenABCWY Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MenABCWYBiological
Neisseria meningitis groups A, B, C W, and Y vaccine
Bivalent rLP2086 (60-µg Dose)Biological
Trumenba (half dose) - Meningococcal Group B vaccine
Bivalent rLP2086 (120-µg Dose)Biological
Trumenba - Meningococcal Group B vaccine
BexseroBiological
Bexsero - Meningococcal Group B vaccine
Prophylactic Liquid Paracetamol (PLP)Drug
PLP administration during primary vaccinations 1 and 2
NimenrixBiological
Nimenrix - Meningococcal Group A, C, W and Y vaccine
PlaceboOther
Normal Saline
Scheduled Liquid Paracetamol (SLP)Drug
SLP administration after primary vaccinations 1 and 2.
Therapeutic Liquid Paracetamol (TLP)Drug
TLP administration after primary vaccinations 1 and 2

Study groups in NCT04645966
Study group	Role	What they receive
MenABCWY with PLP - 6 months of age	Experimental	Group 1 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations. Receives: Biological: MenABCWY; Drug: Prophylactic Liquid Paracetamol (PLP)
MenABCWY - 6 months of age	Experimental	Group 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule Receives: Biological: MenABCWY
Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age	Experimental	Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations. Receives: Biological: Bivalent rLP2086 (60-µg Dose); Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix; Drug: Scheduled Liquid Paracetamol (SLP)
Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age	Experimental	Group 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule Receives: Biological: Bivalent rLP2086 (60-µg Dose); Biological: Nimenrix
Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age	Experimental	Group 5 - Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations. Receives: Biological: Bivalent rLP2086 (120-µg Dose); Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix
MenABCWY with SLP - 2 months of age	Experimental	Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations. Receives: Biological: MenABCWY; Drug: Scheduled Liquid Paracetamol (SLP)
Bexsero and Nimenrix with PLP - 2 months of age	Experimental	Group 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations Receives: Biological: Bexsero; Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix
Bexsero and Nimenrix - 2 months of age	Experimental	Group 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule Receives: Biological: Bexsero; Biological: Nimenrix
MenABCWY with TLP - 2 months of age	Experimental	Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations. Receives: Biological: MenABCWY; Drug: Therapeutic Liquid Paracetamol (TLP)
Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age	Experimental	Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations. Receives: Biological: MenABCWY; Other: Placebo; Drug: Scheduled Liquid Paracetamol (SLP); Drug: Therapeutic Liquid Paracetamol (TLP)
Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age	Experimental	Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations. Receives: Biological: Bexsero; Drug: Prophylactic Liquid Paracetamol (PLP); Biological: Nimenrix; Drug: Therapeutic Liquid Paracetamol (TLP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer greater than or equal to (>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Measured: 1 month after primary vaccination 2
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer >= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Measured: 1 month after booster vaccination
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Measured: 1 month After primary vaccination 2
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.
Measured: 1 month after primary vaccination 2
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Measured: 1 Month after booster vaccination
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
Percentage of participants achieving hSBA titer >= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.
Measured: 1 Month after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after primary vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 Days after primary Vaccination 2
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method
Measured: Within 7 Days after primary Vaccination 1
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after primary vaccination 2
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after primary vaccination 1
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after primary vaccination 2
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after any primary vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after primary vaccination 2 up to booster vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Measured: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes After primary vaccination 1
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes After primary vaccination 2
Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.
Measured: Within 7 Days after booster vaccination
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Measured: Within 7 days after booster vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From date of booster vaccination through 1 month after booster vaccination
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)

Secondary outcomes (5)

hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
GMTs were calculated by exponentiating mean logarithm of titers and CIs were calculated by exponentiating confidence limits based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 Month after primary Vaccination 2
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
GMTs were calculated by exponentiating the mean logarithm of the titers and CIs were calculated by exponentiating the confidence limits based on the Student t distribution for the mean logarithm of the titers. No serum samples were collected after booster dose for groups 4 and 5 due to study termination.
Measured: 1 month after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Local reactions included pain at injection site, redness and swelling and were recorded by participant's in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site on left arm were reported in this outcome measure.
Measured: Within 7 Days after primary Vaccination(Vac) 1 and 2
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Exact 2-sided CI was based on the Clopper and Pearson method. Decreased appetite was categorized as Grade 1:decreased interest in eating, Grade 2:decreased oral intake, Grade3: refusal to feed. Drowsiness: Grade 1 Increased or prolonged sleeping bouts,Grade2: Slightly subdued interfering with daily activity, Grade3; Disabling, not interested in usual daily activity. Irritability; Grade1: Easily consolable, Grade2: requiring increased attention, Grade 3: Inconsolable; crying could not be comforted.
Measured: Within 7 Days after primary Vaccination 1 and 2
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Measured: Within 30 days after any vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 202015 Sep 2022

First posted27 Nov 2020
Study start26 Nov 2020
Primary completion15 Sep 2022
Study completion15 Sep 2022

Why it stopped: The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meningococcal VaccineStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04645966
Sponsor's protocol ID: C3511002
Other IDs: 2020-000948-60
Status last verified: Sep 2023
First submitted: 20 Nov 2020
Last updated: 25 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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See locations

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Meningococcal Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE
ClinicalTrials.gov ID: NCT04645966
Acronym / sponsor ID: C3511002
Conditions: Meningococcal Vaccine
Keywords: Meningococcal Vaccine, Invasive Meningococcal Disease, Meningococcal Serogroups A, B, C W and Y, MenABCWY Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.
Enrolment: 326 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 26 Nov 2020 (actual)
Primary completion: 15 Sep 2022 (actual)
Study completion: 15 Sep 2022 (actual)
First posted: 27 Nov 2020 (actual)
Results: Posted 25 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study is to describe the safety, tolerability, and immunogenicity of MenABCWY in healthy infants 2 and 6 months of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (care provider, investigator)
Number of arms: 11

Arm	Type	Receives
MenABCWY with PLP - 6 months of age	Experimental	Biological: MenABCWY, Drug: Prophylactic Liquid Paracetamol (PLP)Group 1 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 (2 primary vaccinations and a booster dose) schedule, and given Prophylactic Liquid Paracetamol (PLP) during primary vaccinations.
MenABCWY - 6 months of age	Experimental	Biological: MenABCWYGroup 2 - Participants 6 months of age vaccinated with MenABCWY on a 2+1 schedule
Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age	Experimental	Biological: Bivalent rLP2086 (60-µg Dose), Drug: Prophylactic Liquid Paracetamol (PLP), Biological: Nimenrix, Drug: Scheduled Liquid Paracetamol (SLP)Group 3 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-µg Dose) and Nimenrix on a 2+1 schedule, with PLP or Scheduled Liquid Pracetamol (SLP) during primary vaccinations.
Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age	Experimental	Biological: Bivalent rLP2086 (60-µg Dose), Biological: NimenrixGroup 4 - Participants 2 months of age vaccinated with Bivalent rLP2086 (60-mcg Dose) and Nimenrix on a 2+1 schedule
Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age	Experimental	Biological: Bivalent rLP2086 (120-µg Dose), Drug: Prophylactic Liquid Paracetamol (PLP), Biological: NimenrixGroup 5 - Participants 2 months of age vaccinated with Bivalent rLP2086 (120-µg Dose) and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations.
MenABCWY with SLP - 2 months of age	Experimental	Biological: MenABCWY, Drug: Scheduled Liquid Paracetamol (SLP)Group 7 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, and given SLP during primary vaccinations.
Bexsero and Nimenrix with PLP - 2 months of age	Experimental	Biological: Bexsero, Drug: Prophylactic Liquid Paracetamol (PLP), Biological: NimenrixGroup 8 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule, and given PLP during primary vaccinations
Bexsero and Nimenrix - 2 months of age	Experimental	Biological: Bexsero, Biological: NimenrixGroup 10 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule
MenABCWY with TLP - 2 months of age	Experimental	Biological: MenABCWY, Drug: Therapeutic Liquid Paracetamol (TLP)Group 11 - Participants 2 months of age vaccinated with MenABCWY on a 2+1 schedule, with Therapeutic Liquid Paracetamol (TLP) during primary vaccinations.
Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age	Experimental	Biological: MenABCWY, Other: Placebo, Drug: Scheduled Liquid Paracetamol (SLP), Drug: Therapeutic Liquid Paracetamol (TLP)Group 13 - Participants 2 months of age vaccinated with MenABCWY and placebo on a 2+1 schedule, with a determined ratio of participants given SLP or TLP during primary vaccinations.
Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age	Experimental	Biological: Bexsero, Drug: Prophylactic Liquid Paracetamol (PLP), Biological: Nimenrix, Drug: Therapeutic Liquid Paracetamol (TLP)Group 14 - Participants 2 months of age vaccinated with Bexsero and Nimenrix on a 2+1 schedule with a determined ratio of participants given PLP or TLP during primary vaccinations.

Who may qualify

Ages: 2 to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Male and female participants, 2 months of age (≥60 to ≤98 days) or 6 months of age (≥150 to ≤210 days) at the time of randomization.
Participant's parent(s)/legal guardian who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Participant is available for the entire study period and the participant's parent(s)/legal guardian can be reached by telephone.
Healthy participant as determined by medical history, physical examination, and judgment of the investigator.
Body weight ≥4 kg for participants 2 months of age at the time of randomization.

Key exclusion criteria (15 listed)

Prior adverse reaction to paracetamol use, including allergic reactions.
Participant was born prematurely (<37 weeks of gestation).
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Please refer to the SRM for additional details.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MenABCWYNeisseria meningitis groups A, B, C W, and Y vaccine	Biological	Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age, MenABCWY - 6 months of age, MenABCWY with PLP - 6 months of age, MenABCWY with SLP - 2 months of age, MenABCWY with TLP - 2 months of age
Bivalent rLP2086 (60-µg Dose)Trumenba (half dose) - Meningococcal Group B vaccine	Biological	Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age, Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age
Bivalent rLP2086 (120-µg Dose)Trumenba - Meningococcal Group B vaccine	Biological	Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age
BexseroBexsero - Meningococcal Group B vaccine	Biological	Bexsero and Nimenrix - 2 months of age, Bexsero and Nimenrix with PLP - 2 months of age, Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age
Prophylactic Liquid Paracetamol (PLP)PLP administration during primary vaccinations 1 and 2	Drug	Bexsero and Nimenrix with PLP - 2 months of age, Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age, Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age, Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age, MenABCWY with PLP - 6 months of age
NimenrixNimenrix - Meningococcal Group A, C, W and Y vaccine	Biological	Bexsero and Nimenrix - 2 months of age, Bexsero and Nimenrix with PLP - 2 months of age, Bivalent rLP2086 (120-µg Dose) and Nimenrix, with PLP - 2 months of age, Bivalent rLP2086 (60-µg Dose) and Nimenrix - 2 months of age, Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age, Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age
PlaceboNormal Saline	Other	Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age
Scheduled Liquid Paracetamol (SLP)SLP administration after primary vaccinations 1 and 2.	Drug	Bivalent rLP2086 (60-µg Dose) and Nimerix, with PLP or SLP - 2 months of age, Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age, MenABCWY with SLP - 2 months of age
Therapeutic Liquid Paracetamol (TLP)TLP administration after primary vaccinations 1 and 2	Drug	Blinded: Bexsero and Nimenrix with PLP or TLP - 2 months of age, Blinded: MenABCWY and placebo with SLP or TLP - 2 months of age, MenABCWY with TLP - 2 months of age

Primary outcome

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: 1 month after primary vaccination 2
Percentage of participants achieving hSBA titer greater than or equal to (>=) lower limit of quantitation (LLOQ) (i.e.,1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided confidence interval (CI) using the Clopper and Pearson method was presented. Analysis was performed on Post-primary vaccination 2 (post-PV2) evaluable immunogenicity population (EIP). No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: 1 month after booster vaccination
Percentage of participants achieving hSBA titer >= LLOQ (1:8) for each MenA, MenC, MenW and MenY test strains were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: 1 month After primary vaccination 2
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No serum samples collected after vaccination 2 for participants in Group 11 as participants were not administered PV 2 due to study termination.
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5
Time frame: 1 month after primary vaccination 2
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain(1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented.
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: 1 Month after booster vaccination
Percentage of participants achieving hSBA titer>= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. No participants in Group 7 and Group 11 received booster vaccination due to study termination.
Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenB Test Strain 1 Month After Booster Vaccination: Groups 3, 4 and 5
Time frame: 1 Month after booster vaccination
Percentage of participants achieving hSBA titer >= LLOQ for each MenB test strain (1:16 for strain A22 and 1:8 for strain B44) is reported in this outcome measure. Exact 2-sided CI using Clopper and Pearson method is presented. Groups 4 and 5 had no serum samples collected post-booster for serology testing due to study termination.
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 7 days after primary vaccination 1
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Local Reactions Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Time frame: Within 7 Days after primary Vaccination 2
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 7 Days after primary Vaccination 1
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius(C) and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Time frame: Within 7 days after primary vaccination 2
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C and was categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was categorized as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness was graded as Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Primary Vaccination 1: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 30 days after primary vaccination 1
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Medically attended adverse event (MAE) was defined as a nonserious AE that resulted in an evaluation at a medical facility. Newly diagnosed chronic medical condition (NDCMC) was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs,MAEs and NDCMC Within 30 Days After Primary Vaccination 2: Group 7 Versus Group 8 and 10 Combined
Time frame: Within 30 days after primary vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that wasis expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Within 30 Days After Any Primary Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 30 days after any primary vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that is was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Primary Series Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: From day of primary vaccination 1 at Day 1 up to 1 month after primary vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With SAEs, MAEs and NDCMC During Primary Series Follow-up Phase: Group 7 Versus Group 8 and 10 Combined
Time frame: From 1 month after primary vaccination 2 up to booster vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Primary Series Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: From the date of primary vaccination 1 up to 8 months after primary vaccination 2 (maximum up to 9 months)
Infant participants aged 2 months were administered single IM injection of 0.5mL of Bexsero into left thigh, 0.5mL of Nimenrix into right thigh at Day 1(primary vaccination 1), Month 2 (primary vaccination 2) and approximately 10 months after vaccination 1 (booster vaccination). Participants in Group 8 were administered PLP orally with 3 required doses, first dose starting 30 minutes before vaccination at Day1 and Month 2. All participants received single IM injection of Prevenar 13 and Vaxelis into right thigh at 2 and 4 months of age.
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 1: Groups 7 and 11 Combined Versus Groups 8 and 10 Combined
Time frame: Within 30 minutes After primary vaccination 1
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With Immediate AEs Within 30 Minutes After Primary Vaccination 2: Group 7 Versus Groups 8 and 10 Combined
Time frame: Within 30 minutes After primary vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With Immediate AEs After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 30 minutes after booster vaccination
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 7 Days after booster vaccination
Local reactions included tenderness at injection site, redness and swelling and were recorded by participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: 0.5 to 2.0 cm, moderate: >2.0 to 7.0 cm and severe: >7.0 cm. Tenderness at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched with crying and severe: caused limitation of limb movement.
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: Within 7 days after booster vaccination
Systemic events were recorded by participant's parents/legal guardians in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as Mild: decreased interest in eating, Moderate: decreased oral intake, Severe: refusal to feed. Drowsiness: Mild: Increased or prolonged sleeping bouts, Moderate: Slightly subdued interfering with daily activity, Severe; Disabling, not interested in usual daily activity. Irritability; Mild: Easily consolable, Moderate: required increased attention, Severe: Inconsolable; crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Vaccination Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: From date of booster vaccination through 1 month after booster vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC During Booster Follow-up Phase: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 5 months)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With AEs, SAEs, MAEs and NDCMC Throughout Booster Stage: Group 7 and 11 Combined Versus Group 8 and 10 Combined
Time frame: From 1 month after booster vaccination up to 6 months after booster vaccination (maximum up to 6 months)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

5 secondary outcomes

hSBA Geometric Mean Titers (GMTs) for Each of the MenB Test Strains: 1 Month After Primary Vaccination 2 in Group 3 and 4 Combined Versus Group 5
Time frame: 1 Month after primary Vaccination 2
hSBA GMTs for Each of the MenB Test Strains: 1 Month After Booster Vaccination in Groups 3, 4 and 5
Time frame: 1 month after booster vaccination
Percentage of Participants With Local Reactions Within 7 Days After Each Primary Vaccination: Group 3, 4 and 5
Time frame: Within 7 Days after primary Vaccination(Vac) 1 and 2
Percentage of Participants With Systemic Events and Antipyretic Use Within 7 Days After Each Primary Vaccination: Group 3,4 and 5
Time frame: Within 7 Days after primary Vaccination 1 and 2
Percentage of Participants With AEs, SAEs, MAEs and NDCMC: Groups 3, 4 and 5
Time frame: Within 30 days after any vaccination

Results and safety

Results posted to the registry on 25 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (MenABCWY +PLP)	23	22
Group 2 (MenABCWY)	25	25
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)	36	20
Group 4 (60 mcg rLP2086 +Nimenrix)	16	0
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)	53	2
Group 7 (MenABCWY +SLP)	50	0
Group 8 (Bexsero +Nimenrix +PLP)	55	25
Group 10 (Bexsero +Nimenrix)	55	22
Group 11 (MenABCWY +TLP)	12	0

Primary outcome: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined

Time frame: 1 month after primary vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 7 and 11 Combined n = 16	Group 8 and 10 Combined n = 92
MenA	100.0 (79.4 to 100.0)	100.0 (96.0 to 100.0)
MenC	100.0 (79.4 to 100.0)	100.0 (96.0 to 100.0)
MenW	100.0 (79.4 to 100.0)	100.0 (96.0 to 100.0)
MenY	100.0 (79.4 to 100.0)	100.0 (96.1 to 100.0)

Population analysed: Post-PV 2 EIP: participants randomized,eligible through Visit(V)4;received vaccine at V1,V3;blood drawn for assay test within required timeframes at V4;had at least 1 valid, determinate MenA,C,W,Y,or B assay result at V4;received no prohibited vaccines/treatment,no protocol deviation through V4.''N''=participants evaluable for outcome measure; ''n''=participants evaluable for specific rows.

Primary outcome: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each MenACWY MenA, MenC, MenW and MenY Test Strains 1 Month After Booster Vaccination: Group 7 and 11 Combined Versus Group 8 and 10 Combined

Time frame: 1 month after booster vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 7 and 11 Combined n = 0	Group 8 and 10 Combined n = 42
MenA	–	100.0 (91.4 to 100.0)
MenC	–	100.0 (91.4 to 100.0)
MenW	–	100.0 (91.6 to 100.0)
MenY	–	100.0 (91.4 to 100.0)

Population analysed: Post-booster vaccination EIP: randomized participants eligible through V6;received vaccine at V1, V3, V5;blood drawn for assay testing within required timeframes at V6; had at least 1 valid, determinate MenA, MenC, MenW, MenY, or MenB assay result at V6; received no prohibited vaccines/treatment and had no protocol deviations through V6. Here, ''N''=participants evaluable for the outcome measure and ''n''=participants evaluable for specific rows.

Primary outcome: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined

Time frame: 1 month After primary vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 7 and 11 Combined n = 18	Group 8 and 10 Combined n = 95
PMB80 (A22)	44.4 (21.5 to 69.2)	9.6 (4.5 to 17.4)
PMB2707 (B44)	88.9 (65.3 to 98.6)	29.5 (20.6 to 39.7)

Primary outcome: Percentage of Participants Achieving hSBA Titer >= LLOQ for Each Neisseria Meningitidis Group B (MenB) Test Strain 1 Month After Primary Vaccination 2: Group 3 and 4 Combined Versus Group 5

Time frame: 1 month after primary vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 3 and 4 Combined n = 35	Group 5 (120 mcg rLP2086 +Nimenrix +PLP) n = 45
PMB80 (A22)	46.7 (28.3 to 65.7)	47.7 (32.5 to 63.3)
PMB2707 (B44)	82.9 (66.4 to 93.4)	97.8 (88.2 to 99.9)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Systematic assessment(SA): local reactions/systemic events within 7 days after vaccination 1, 2 and booster vaccination; Non-systematic assessment: SAEs and other AEs from Day 1 up to 196 days after last study vaccination (up to 12 months for Group1 and 2; up to 16 months for Group 3,4,5,7,8,10,11). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (MenABCWY +PLP)	0 of 23 (0%)	23 of 23 (100%)	0 of 23
Group 2 (MenABCWY)	1 of 25 (4%)	25 of 25 (100%)	0 of 25
Group 3 (60 mcg rLP2086 +Nimenrix +PLP/SLP)	1 of 36 (2.8%)	36 of 36 (100%)	0 of 36
Group 4 (60 mcg rLP2086 +Nimenrix)	1 of 16 (6.3%)	16 of 16 (100%)	0 of 16
Group 5 (120 mcg rLP2086 +Nimenrix +PLP)	11 of 53 (20.8%)	53 of 53 (100%)	0 of 53
Group 7 (MenABCWY +SLP)	5 of 50 (10%)	50 of 50 (100%)	1 of 50
Group 8 (Bexsero +Nimenrix +PLP)	1 of 55 (1.8%)	54 of 55 (98.2%)	0 of 55
Group 10 (Bexsero +Nimenrix)	6 of 55 (10.9%)	55 of 55 (100%)	0 of 55
Group 11 (MenABCWY +TLP)	1 of 12 (8.3%)	12 of 12 (100%)	0 of 12

Limitations and caveats (from the sponsor): Study was terminated based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenABCWY, Bivalent rLP2086 (60-µg Dose) and Bivalent rLP2086 (120-µg Dose) in people with Meningococcal Vaccine, run by Pfizer at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain, Greece, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=LLOQ for Each MenA, MenC, MenW and MenY Test Strains 1 Month After Primary Vaccination 2: Group 7 and 11 Combined Versus Group 8 and 10 Combined (time frame: 1 month after primary vaccination 2). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04645966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.