Meningococcal InfectionsPhase 3NCT03476135

Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children

A Phase 3 study testing MenACYW conjugate vaccine in people with Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Finland.

Completed

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

Official record

Search all trials

Trial summary

This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years… Read more about this study

Who is it for?: Ages 46 to 61 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Infections
What is being tested?: MenACYW conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 8 sitesFinland
Study dates: 27 Feb 2018to 10 Sep 2018
Phase: Phase 3
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 46 to 61 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participated in and completed (attended Visit 2) study MET54.
Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations).
Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
Covered by health insurance where applicable.

Who cannot join

Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2.
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
History of meningococcal infection, confirmed either clinically, serologically, or microbiologically

Show all 16Show fewer

At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
Personal history of Guillain-Barré syndrome.
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.
Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Finland8 sites

Sanofi Pasteur Investigational Site 2460005
Espoo, 02230
Sanofi Pasteur Investigational Site 2460006
Helsinki, 00100
Sanofi Pasteur Investigational Site 2460002
Helsinki, 00930
Sanofi Pasteur Investigational Site 2460007
Jarvenpaa, 04400
Sanofi Pasteur Investigational Site 2460008
Oulu, 90220
Sanofi Pasteur Investigational Site 2460001
Pori, 28100
Sanofi Pasteur Investigational Site 2460003
Tampere, 33100
Sanofi Pasteur Investigational Site 2460004
Turku, 20520

Other trials in Finland

About this study

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

The objectives were:

To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.

Read the detailed description

Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30 days after vaccination. Safety was assessed throughout the study period, and included solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring throughout the trial.

Conditions: Meningococcal Infections
Being tested: MenACYW conjugate vaccine
Keywords: Meningococcal Meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal

What participants receive

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

MenACYW conjugate vaccineBiological
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

Study groups in NCT03476135
Study group	Role	What they receive
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)	Experimental	Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). Receives: Biological: MenACYW conjugate vaccine
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)	Experimental	Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). Receives: Biological: MenACYW conjugate vaccine

What is being measured

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

Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Measured: Day 0 (pre-vaccination)
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Measured: Day 30 (post-booster vaccination)
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Measured: Day 0 (pre-vaccination)
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Measured: Day 30 (post-booster vaccination)
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Measured: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Measured: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.
Measured: Day 0 (pre-vaccination)
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Anti-tetanus antibodies were measured by ECL assay.
Measured: Day 30 (post-booster vaccination)
Number of Participants With Immediate Adverse Event After Vaccination in MET62
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Measured: Within 30 minutes after vaccination
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.
Measured: Within 7 days after vaccination
Number of Participants With Unsolicited Adverse Event After Vaccination in MET62
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
Measured: Within 30 days after vaccination
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.
Measured: Within 30 days after vaccination

Timeline

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

27 Feb 201810 Sep 2018

First posted23 Mar 2018
Study start27 Feb 2018
Primary completion10 Sep 2018
Study completion10 Sep 2018

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 InfectionsStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03476135
Sponsor's protocol ID: MET62
Other IDs: 2017-001993-40, U1111-1183-5988, 2017
Status last verified: Mar 2022
First submitted: 19 Mar 2018
Last updated: 6 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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

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 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
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 Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers
ClinicalTrials.gov ID: NCT03476135
Acronym / sponsor ID: MET62
Conditions: Meningococcal Infections
Keywords: Meningococcal Meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 27 Feb 2018 (actual)
Primary completion: 10 Sep 2018 (actual)
Study completion: 10 Sep 2018 (actual)
First posted: 23 Mar 2018 (actual)
Results: Posted 5 Jun 2020

Clinical summary

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

The objectives were:

To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)	Experimental	Biological: MenACYW conjugate vaccineParticipants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)	Experimental	Biological: MenACYW conjugate vaccineParticipants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62).

Who may qualify

Ages: 46 to 61 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Participated in and completed (attended Visit 2) study MET54.
Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations).
Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
Covered by health insurance where applicable.

Key exclusion criteria (16 listed)

Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2.
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

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
MenACYW conjugate vaccineMeningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular	Biological	Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW), Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)

Primary outcome

Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 30 (post-booster vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 30 (post-booster vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 0 (pre-vaccination)
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Time frame: Day 30 (post-booster vaccination)
Anti-tetanus antibodies were measured by ECL assay.
Number of Participants With Immediate Adverse Event After Vaccination in MET62
Time frame: Within 30 minutes after vaccination
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
Time frame: Within 7 days after vaccination
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.
Number of Participants With Unsolicited Adverse Event After Vaccination in MET62
Time frame: Within 30 days after vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62
Time frame: Within 30 days after vaccination
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.

Results and safety

Results posted to the registry on 5 Jun 2020, 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:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)	42	42
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)	49	49

Primary outcome: Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

Time frame: Day 0 (pre-vaccination). Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) n = 40	Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) n = 44
Serogroup A	12.1 (8.15 to 18.1)	16.5 (11.9 to 22.9)
Serogroup C	106 (73.2 to 153)	11.7 (7.03 to 19.4)
Serogroup Y	30.9 (24.2 to 39.5)	17.6 (13.1 to 23.7)
Serogroup W	48.5 (34.4 to 68.4)	21.9 (14.7 to 32.7)

Population analysed: Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all participants who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample result and had no certain protocol deviations.

Primary outcome: Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

Time frame: Day 30 (post-booster vaccination). Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) n = 40	Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) n = 44
Serogroup A	763 (521 to 1117)	659 (427 to 1017)
Serogroup C	5894 (4325 to 8031)	1592 (1165 to 2174)
Serogroup Y	2013 (1451 to 2792)	2806 (2066 to 3813)
Serogroup W	2656 (1601 to 4406)	3444 (2387 to 4970)

Population analysed: Analysis was performed on PPAS.

Primary outcome: Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62

Time frame: Day 0 (pre-vaccination). Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) n = 39	Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) n = 44
Serogroup A	135 (58.0 to 314)	281 (131 to 606)
Serogroup C	102 (60.9 to 169)	11.9 (6.14 to 22.9)
Serogroup Y	119 (65.0 to 219)	126 (69.1 to 230)
Serogroup W	113 (54.6 to 234)	126 (63.6 to 250)

Population analysed: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62

Time frame: Day 30 (post-booster vaccination). Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) n = 40	Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) n = 44
Serogroup A	4240 (3352 to 5365)	5702 (4575 to 7107)
Serogroup C	8629 (6573 to 11328)	4871 (3750 to 6327)
Serogroup Y	5499 (4502 to 6717)	7814 (6465 to 9445)
Serogroup W	16103 (12691 to 20431)	19793 (15538 to 25214)

Population analysed: Analysis was performed on PPAS.

Adverse events

Time frame: SR were collected up to Day 7 after each vaccination, non-serious unsolicited AEs were collected up to Day 30 after each vaccination. SAEs were collected throughout the trial (up to 30 days after vaccination).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW)	0 of 42 (0%)	36 of 42 (85.7%)	0 of 42
Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix)	0 of 49 (0%)	43 of 49 (87.8%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Related trials for Meningococcal Infections

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 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
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

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.

Medical Director study director

Sanofi Pasteur, a Sanofi Company

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACYW conjugate vaccine in people with Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Finland.

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 4 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Jun 2020). 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?

Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 (time frame: Day 0 (pre-vaccination)). The study lists 12 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 NCT03476135.

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 6 Apr 2022.