MENINGOCOCCAL INFECTIONPhase 2NCT02531698

A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

A Phase 2 study testing Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine and Normal Saline in people with MENINGOCOCCAL INFECTION, run by Pfizer at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young children. The study will also look at the safety of the new vaccine as well as how it is tolerated. Read more about this study

Who is it for?: Ages 24 months to 10 yearsHealthy volunteers can take part
Conditions the study is for: MENINGOCOCCAL INFECTION
What is being tested?: Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine and Normal Saline
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 15 sitesin 2 countries
Study dates: Aug 2015to Mar 2017
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 24 months to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
Male or female subjects aged ≥24 months and <10 years at time of randomization, stratified equally by age (≥24 months to <4 years or ≥4 years to <10 years).
Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Subject must have received all vaccinations in the relevant national immunization program (NIP) for their age group.
Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
Negative urine pregnancy test for all female subjects who are biologically capable of having children.

Who cannot join

Previous vaccination with any meningococcal serogroup B vaccine.
Subjects who have received prior HAV vaccination.
Contraindication to vaccination with any HAV vaccine or known latex allergy.
Subjects receiving any allergen immunotherapy with a nonlicensed product or subjects receiving allergen immunotherapy with a licensed product and who are not on stable maintenance doses.
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.

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A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects with terminal complement deficiency may be included. Additional details will be provided in the study reference manual (SRM).
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
Current chronic use of systemic antibiotics.
Participation in other studies involving investigational product(s)/device(s) (Phases 1-4) within 28 days before administration of the first study vaccination. Participation in purely observational studies is acceptable.
Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Pregnant female subjects, breastfeeding female subjects, male subjects with partners who are currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
Subjects who are children of investigational site staff members directly involved in the conduct of the study and their family members, subjects who are children of site staff members otherwise supervised by the investigator, or subjects who are children of Pfizer employees directly involved in the conduct of the study.

Trial locations and contacts

15 sites in 2 countries.

Country

City, postcode or hospital

15 sites in 2 countries

Poland8 sites

Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek
Dębica, 39-200
Praktyka Lekarza Rodzinnego-Slawin Sp. z o.o.
Kiełczów, 55-093
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31- 202
Hanna Czajka - Indywidualna Specjalistyczna Praktyka Lekarska
Krakow, 31-302
Niepubliczny Zaklad Opieki Zdrowotnej Salmed S. C.
Łęczna, 21-010
Specjalistyczna Przychodnia Medycyny Wieku Rozwojowego
Poznan, 61-709
Niepubliczny Zaklad Lecznictwa Ambulatoryjnego "Michalkowice"Jarosz i Partnerzy Spolka Lekarska
Siemianowice Śląskie, 41-103
Samodzielny Publiczny Szpital Kliniczny Nr 1 We Wroclawiu
Wroclaw, 50-368

Other trials in Poland

Finland7 sites

Espoo Vaccine Research Clinic
Espoo, 02230
Helsinki South Vaccine Research Clinic
Helsinki, 00100
Oulu Vaccine Research Clinic
Oulu, 90220
Pori Vaccine Research Clinic
Pori, 28100
Tampere Vaccine Research Clinic
Tampere, 33100
Turku Vaccine Research Center
Turku, 20520
Turku Vaccine Research Clinic
Turku, 20520

Other trials in Finland

About this study

Official title: A Phase 2, Randomized, Controlled, Observer-blinded Study To Describe The Immunogenicity, Safety, And Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent Rlp2086) In Healthy Subjects Aged >/= 24 Months To <10 Years

Conditions: MENINGOCOCCAL INFECTION
Being tested: Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine, Normal Saline
Medical subject headings: Meningococcal Infections

What participants receive

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

Bivalent rLP2086 VaccineBiological
1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.
Licensed pediatric hepatits A vaccineBiological
1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.
Normal SalineOther
Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.

Study groups in NCT02531698
Study group	Role	What they receive
Bivalent rLP2086	Experimental	Bivalent rLP2086 (containing 60 μg each of a purified subfamily A and subfamily B rLP2086 protein, adsorbed to aluminum in a sterile buffered isotonic suspension) in a 0.5-mL dose for injection. Receives: Biological: Bivalent rLP2086 Vaccine
Licensed pediatric hepatitis A vaccine	Other	Not described Receives: Biological: Licensed pediatric hepatits A vaccine; Other: Normal Saline

What is being measured

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

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Measured: 1 month after Vaccination 3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: Within 7 Days after Vaccination 1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: Within 7 Days after Vaccination 2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Measured: Within 7 Days after Vaccination 3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Measured: Within 7 Days after Vaccination 1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Measured: Within 7 Days after Vaccination 2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Measured: Within 7 Days after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1
SAE was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: Within 30 Days after any vaccination
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: From the Vaccination 1 up to 1 month after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Measured: From Vaccination 1 up to 6 months after Vaccination 3
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: Within 30 Days after any vaccination
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: From the Vaccination 1 up to 1 month after the Vaccination 3
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Measured: From the Vaccination 1 up to 6 months after the Vaccination 3
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 Days after any vaccination
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From the Vaccination 1 up to 1 month after the Vaccination 3
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Measured: From the Vaccination 1 up to 6 months after the Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 1
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 2
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Within 30 Days after Vaccination 3
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: Within 30 Days after any vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: From the Vaccination 1 up to 1 month after the Vaccination 3
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes after Vaccination 1
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes after Vaccination 2
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Measured: Within 30 minutes after Vaccination 3
Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase
Measured: From the Vaccination 1 up to 1 month after the Vaccination 3

Secondary outcomes (4)

Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Measured: 1 month after Vaccination 3
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).
Measured: 1 month after Vaccination 2 and 6 months after Vaccination 3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains
Measured: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
Measured: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3

Timeline

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

Aug 2015Mar 2017

First posted24 Aug 2015 (estimated)
Study startAug 2015
Primary completionMar 2017
Study completionMar 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MENINGOCOCCAL INFECTIONStudies 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02531698
Sponsor's protocol ID: B1971017
Other IDs: 2014-000933-21, 6108K2-3012, 2014
Status last verified: Oct 2020
First submitted: 20 Aug 2015
Last updated: 26 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7.
PubMed 36087588

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All MENINGOCOCCAL INFECTION trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Controlled, Observer-blinded Study To Describe The Immunogenicity, Safety, And Tolerability Of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent Rlp2086) In Healthy Subjects Aged >/= 24 Months To <10 Years
ClinicalTrials.gov ID: NCT02531698
Acronym / sponsor ID: B1971017
Conditions: MENINGOCOCCAL INFECTION
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Aug 2015 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 24 Aug 2015 (estimated)
Results: Posted 27 Mar 2018

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Bivalent rLP2086	Experimental	Biological: Bivalent rLP2086 VaccineBivalent rLP2086 (containing 60 μg each of a purified subfamily A and subfamily B rLP2086 protein, adsorbed to aluminum in a sterile buffered isotonic suspension) in a 0.5-mL dose for injection.
Licensed pediatric hepatitis A vaccine	Other	Biological: Licensed pediatric hepatits A vaccine, Other: Normal Saline

Who may qualify

Ages: 24 months to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject's parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Parent(s)/legal guardian and subject who are willing and able to comply with scheduled visits, vaccine regimen, laboratory tests, and other study procedures.
Male or female subjects aged ≥24 months and <10 years at time of randomization, stratified equally by age (≥24 months to <4 years or ≥4 years to <10 years).
Subject is available for the entire study period and subject's parent(s)/legal guardian can be reached by telephone.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (16 listed)

Previous vaccination with any meningococcal serogroup B vaccine.
Subjects who have received prior HAV vaccination.
Contraindication to vaccination with any HAV vaccine or known latex allergy.
Subjects receiving any allergen immunotherapy with a nonlicensed product or subjects receiving allergen immunotherapy with a licensed product and who are not on stable maintenance doses.
A previous anaphylactic reaction to any vaccine or vaccine-related component.

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
Bivalent rLP2086 Vaccine1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.	Biological	Bivalent rLP2086
Licensed pediatric hepatits A vaccine1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.	Biological	Licensed pediatric hepatitis A vaccine
Normal SalineSterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.	Other	Licensed pediatric hepatitis A vaccine

Primary outcome

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1
Time frame: Within 7 Days after Vaccination 1
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2
Time frame: Within 7 Days after Vaccination 2
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3
Time frame: Within 7 Days after Vaccination 3
Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1
Time frame: Within 7 Days after Vaccination 1
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2
Time frame: Within 7 Days after Vaccination 2
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3
Time frame: Within 7 Days after Vaccination 3
Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1
Time frame: Within 30 Days after Vaccination 1
SAE was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2
Time frame: Within 30 Days after Vaccination 2
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3
Time frame: Within 30 Days after Vaccination 3
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination
Time frame: Within 30 Days after any vaccination
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after Vaccination 3
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase
Time frame: From 1 month after Vaccination 3 up to 6 months after Vaccination 3
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study
Time frame: From Vaccination 1 up to 6 months after Vaccination 3
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1
Time frame: Within 30 Days after Vaccination 1
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2
Time frame: Within 30 Days after Vaccination 2
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3
Time frame: Within 30 Days after Vaccination 3
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination
Time frame: Within 30 Days after any vaccination
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after the Vaccination 3
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase
Time frame: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study
Time frame: From the Vaccination 1 up to 6 months after the Vaccination 3
A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1
Time frame: Within 30 Days after Vaccination 1
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2
Time frame: Within 30 Days after Vaccination 2
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3
Time frame: Within 30 Days after Vaccination 3
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination
Time frame: Within 30 Days after any vaccination
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after the Vaccination 3
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase
Time frame: From 1 month after Vaccination 3 up to 6 months after the Vaccination 3
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study
Time frame: From the Vaccination 1 up to 6 months after the Vaccination 3
A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1
Time frame: Within 30 Days after Vaccination 1
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2
Time frame: Within 30 Days after Vaccination 2
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3
Time frame: Within 30 Days after Vaccination 3
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Time frame: Within 30 Days after any vaccination
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after the Vaccination 3
AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1
Time frame: Within 30 minutes after Vaccination 1
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2
Time frame: Within 30 minutes after Vaccination 2
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3
Time frame: Within 30 minutes after Vaccination 3
Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.
Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase
Time frame: From the Vaccination 1 up to 1 month after the Vaccination 3

4 secondary outcomes

Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3
Time frame: 1 month after Vaccination 3
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3
Time frame: 1 month after Vaccination 2 and 6 months after Vaccination 3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains
Time frame: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains
Time frame: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3

Results and safety

Results posted to the registry on 27 Mar 2018, 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 Bivalent rLP2086 (>=24 Months to <10 Years)	294	283
Group 2 HAV/Saline (>=24 Months to <10 Years)	106	104

Primary outcome: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3

Time frame: 1 month after Vaccination 3. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n = 136	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n = 138	Group 2 HAV/Saline (>=24 Months to <4 Years) n = 52	Group 2 HAV/Saline (>=4 Years to <10 Years) n = 45
PMB80 [A22]	83.8 (72.9 to 91.6)	91.0 (81.5 to 96.6)	4.0 (0.1 to 20.4)	10.0 (1.2 to 31.7)
PMB2001 [A56]	100.0 (94.7 to 100.0)	100.0 (94.9 to 100.0)	4.2 (0.1 to 21.1)	42.1 (20.3 to 66.5)
PMB2948 [B24]	85.7 (74.6 to 93.3)	92.1 (82.4 to 97.4)	7.7 (0.9 to 25.1)	0.0 (0.0 to 16.8)
PMB2707 [B44]	80.0 (68.2 to 88.9)	78.3 (66.7 to 87.3)	0.0 (0.0 to 13.2)	0.0 (0.0 to 14.2)

Population analysed: Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1

Time frame: Within 7 Days after Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n = 294	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n = 145	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n = 149	Group 2 HAV/Saline (>=24 Months to <10 Years) n = 106	Group 2 HAV/Saline (>=24 Months to <4 Years) n = 55	Group 2 HAV/Saline (>=4 Years to <10 Years) n = 51
Pain at injection site: Any	66.0 (60.3 to 71.4)	51.7 (43.3 to 60.1)	79.9 (72.5 to 86.0)	22.6 (15.1 to 31.8)	10.9 (4.1 to 22.2)	35.3 (22.4 to 49.9)
Pain at injection site: Mild	32.3 (27.0 to 38.0)	24.1 (17.4 to 31.9)	40.3 (32.3 to 48.6)	17.9 (11.2 to 26.6)	9.1 (3.0 to 20.0)	27.5 (15.9 to 41.7)
Pain at injection site: Moderate	30.3 (25.1 to 35.9)	24.8 (18.0 to 32.7)	35.6 (27.9 to 43.8)	4.7 (1.5 to 10.7)	1.8 (0.0 to 9.7)	7.8 (2.2 to 18.9)
Pain at injection site: Severe	3.4 (1.6 to 6.2)	2.8 (0.8 to 6.9)	4.0 (1.5 to 8.6)	0.0 (0.0 to 3.4)	0.0 (0.0 to 6.5)	0.0 (0.0 to 7.0)
Redness: Any	40.8 (35.1 to 46.7)	42.1 (33.9 to 50.5)	39.6 (31.7 to 47.9)	9.4 (4.6 to 16.7)	10.9 (4.1 to 22.2)	7.8 (2.2 to 18.9)
Redness: Mild	17.7 (13.5 to 22.5)	22.1 (15.6 to 29.7)	13.4 (8.4 to 20.0)	5.7 (2.1 to 11.9)	7.3 (2.0 to 17.6)	3.9 (0.5 to 13.5)
Redness: Moderate	18.7 (14.4 to 23.6)	18.6 (12.6 to 25.9)	18.8 (12.9 to 26.0)	3.8 (1.0 to 9.4)	3.6 (0.4 to 12.5)	3.9 (0.5 to 13.5)
Redness: Severe	4.4 (2.4 to 7.4)	1.4 (0.2 to 4.9)	7.4 (3.7 to 12.8)	0.0 (0.0 to 3.4)	0.0 (0.0 to 6.5)	0.0 (0.0 to 7.0)

Population analysed: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2

Time frame: Within 7 Days after Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n = 291	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n = 143	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n = 148	Group 2 HAV/Saline (>=24 Months to <10 Years) n = 103	Group 2 HAV/Saline (>=24 Months to <4 Years) n = 54	Group 2 HAV/Saline (>=4 Years to <10 Years) n = 49
Pain at injection site: Any	70.8 (65.2 to 76.0)	63.6 (55.2 to 71.5)	77.7 (70.1 to 84.1)	12.6 (6.9 to 20.6)	5.6 (1.2 to 15.4)	20.4 (10.2 to 34.3)
Pain at injection site: Mild	40.2 (34.5 to 46.1)	40.6 (32.4 to 49.1)	39.9 (31.9 to 48.2)	9.7 (4.8 to 17.1)	5.6 (1.2 to 15.4)	14.3 (5.9 to 27.2)
Pain at injection site: Moderate	28.5 (23.4 to 34.1)	20.3 (14.0 to 27.8)	36.5 (28.7 to 44.8)	2.9 (0.6 to 8.3)	0.0 (0.0 to 6.6)	6.1 (1.3 to 16.9)
Pain at injection site: Severe	2.1 (0.8 to 4.4)	2.8 (0.8 to 7.0)	1.4 (0.2 to 4.8)	0.0 (0.0 to 3.5)	0.0 (0.0 to 6.6)	0.0 (0.0 to 7.3)
Redness: Any	37.1 (31.5 to 42.9)	36.4 (28.5 to 44.8)	37.8 (30.0 to 46.2)	5.8 (2.2 to 12.2)	5.6 (1.2 to 15.4)	6.1 (1.3 to 16.9)
Redness: Mild	16.5 (12.4 to 21.3)	15.4 (9.9 to 22.4)	17.6 (11.8 to 24.7)	5.8 (2.2 to 12.2)	5.6 (1.2 to 15.4)	6.1 (1.3 to 16.9)
Redness: Moderate	18.2 (14.0 to 23.1)	20.3 (14.0 to 27.8)	16.2 (10.7 to 23.2)	0.0 (0.0 to 3.5)	0.0 (0.0 to 6.6)	0.0 (0.0 to 7.3)
Redness: Severe	2.4 (1.0 to 4.9)	0.7 (0.0 to 3.8)	4.1 (1.5 to 8.6)

Primary outcome: Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3

Time frame: Within 7 Days after Vaccination 3. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n = 285	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n = 139	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n = 146	Group 2 HAV/Saline (>=24 Months to <10 Years) n = 104	Group 2 HAV/Saline (>=24 Months to <4 Years) n = 54	Group 2 HAV/Saline (>=4 Years to <10 Years) n = 50
Pain at injection site: Any	68.4 (62.7 to 73.8)	54.7 (46.0 to 63.1)	81.5 (74.2 to 87.4)	15.4 (9.1 to 23.8)	9.3 (3.1 to 20.3)	22.0 (11.5 to 36.0)
Pain at injection site: Mild	38.2 (32.6 to 44.2)	26.6 (19.5 to 34.8)	49.3 (41.0 to 57.7)	10.6 (5.4 to 18.1)	7.4 (2.1 to 17.9)	14.0 (5.8 to 26.7)
Pain at injection site: Moderate	27.0 (21.9 to 32.6)	25.2 (18.2 to 33.2)	28.8 (21.6 to 36.8)	4.8 (1.6 to 10.9)	1.9 (0.0 to 9.9)	8.0 (2.2 to 19.2)
Pain at injection site: Severe	3.2 (1.5 to 5.9)	2.9 (0.8 to 7.2)	3.4 (1.1 to 7.8)	0.0 (0.0 to 3.5)	0.0 (0.0 to 6.6)	0.0 (0.0 to 7.1)
Redness: Any	35.1 (29.6 to 40.9)	34.5 (26.7 to 43.1)	35.6 (27.9 to 44.0)	9.6 (4.7 to 17.0)	9.3 (3.1 to 20.3)	10.0 (3.3 to 21.8)
Redness: Mild	16.5 (12.4 to 21.3)	15.8 (10.2 to 23.0)	17.1 (11.4 to 24.2)	8.7 (4.0 to 15.8)	7.4 (2.1 to 17.9)	10.0 (3.3 to 21.8)
Redness: Moderate	14.7 (10.8 to 19.4)	17.3 (11.4 to 24.6)	12.3 (7.5 to 18.8)	1.0 (0.0 to 5.2)	1.9 (0.0 to 9.9)	0.0 (0.0 to 7.1)
Redness: Severe	3.9 (1.9 to 6.8)	1.4 (0.2 to 5.1)	6.2 (2.9 to 11.4)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)	5 of 294 (1.7%)	281 of 294 (95.6%)	0 of 294
Group 2 HAV/Saline (>=24 Months to <10 Years)	1 of 106 (0.9%)	87 of 106 (82.1%)	0 of 106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36087588Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

15 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bivalent rLP2086 Vaccine, Licensed pediatric hepatits A vaccine and Normal Saline in people with MENINGOCOCCAL INFECTION, run by Pfizer at 15 sites in 2 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Poland, Finland. 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 27 Mar 2018). 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 With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 (time frame: 1 month after Vaccination 3). The study lists 37 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 NCT02531698, which also lists 1 linked publication.

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 26 Oct 2020.