Trial · NCT03537508
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508, Phase 3, Completed, Sanofi Pasteur, a Sanofi Company; results first posted 2024-10-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US. Trials, record NCT03537508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03537508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
- NCT number
- NCT03537508
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,627 participants, actual
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Conditions
- Healthy Volunteers (Meningococcal Infection)
- Interventions
MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine, Pneumococcal 13-valent conjugate vaccine, Pentavalent rotavirus vaccine, Hepatitis B vaccine, Measles, mumps, rubella (MMR) vaccine, Varicella vaccine, Hepatitis A vaccine
- First posted
- 2018-05-25
- Last updated
- 2024-10-15
- Other registries' IDs
- eudract:2018-001473-24
- Results first posted
- 2024-10-15
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place. |
| Primary | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
| Secondary | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer \>=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place. |
| Secondary | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer \>=0.15 mcg/mL and \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place. |
| Secondary | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 were assessed. |
| Secondary | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations \>=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place. |
| Secondary | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA. |
| Secondary | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-pertussis antibodies (pertussis toxoid \[PT\], filamentous hemagglutinin adhesin \[FHA\], pertactin \[PRN\] and fimbriae types 2 and 3 \[FIM\]) were measured by electrochemiluminescent (ECL) assay. |
| Secondary | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibodies in human serum. |
| Secondary | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Vaccine response against anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay and anti-mumps antibodies were assessed by ELISA. Percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion are reported: measles: \>=255 mIU/mL; mumps: \>=10 antibody units per milliliter and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Per-Protocol Analysis Set 3 (PPAS3) (for 2nd year of life vaccination). PPAS3 included participants of Full Analysis set 3 (FAS3: a subset of all randomized participants who received \>=1 dose of the study vaccine in the 2nd year of life \[\>=12 months of age\] and had a valid post-vaccination serology result in the 2nd year of life) with no relevant protocol deviations. Only those participants with data collected for each specific serogroup are reported. | percentage of participants | NUMBER |
| PRIMARY | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | PPAS1 (for infant vaccination). PPAS1 included participants of FAS1 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[\<12 months of age\] and had a valid post-vaccination serology result in infancy) with no relevant protocol deviations during infancy. Only those participants with data collected for each specific serogroup are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | Units/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | ELISA units/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified serotype are reported. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Serogroup A | 79.4 | 95% Confidence Interval 75.6 to 82.9 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 2a: MENVEO (Post 12-month Vaccination) | Serogroup A | 77.6 | 95% Confidence Interval 71.5 to 82.9 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Serogroup C | 97.0 | 95% Confidence Interval 95.1 to 98.3 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 2a: MENVEO (Post 12-month Vaccination) | Serogroup C | 88.2 | 95% Confidence Interval 83.4 to 92.0 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Serogroup Y | 96.4 | 95% Confidence Interval 94.4 to 97.8 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 2a: MENVEO (Post 12-month Vaccination) | Serogroup Y | 92.3 | 95% Confidence Interval 88.1 to 95.4 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Serogroup W | 97.6 | 95% Confidence Interval 95.9 to 98.7 | percentage of participants |
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Group 2a: MENVEO (Post 12-month Vaccination) | Serogroup W | 96.4 | 95% Confidence Interval 93.3 to 98.3 | percentage of participants |
| Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Group 1: MenACYW Conjugate Vaccine | Serogroup A | 77.9 | 95% Confidence Interval 75.0 to 80.7 | percentage of participants |
| Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Group 2: MENVEO | Serogroup A | 67.7 | 95% Confidence Interval 63.0 to 72.2 | percentage of participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: MenACYW Conjugate Vaccine | 1,746 | |
| Overall Study | STARTED | Group 2: MENVEO | 881 | |
| Overall Study | Safety Analysis Set (SafAS) | Group 1: MenACYW Conjugate Vaccine | 1,727 | |
| Overall Study | Safety Analysis Set (SafAS) | Group 2: MENVEO | 867 | |
| Overall Study | Vaccinated at 2 Months | Group 1: MenACYW Conjugate Vaccine | 1,727 | |
| Overall Study | Vaccinated at 2 Months | Group 2: MENVEO | 869 | |
| Overall Study | Vaccinated at 4 Months | Group 1: MenACYW Conjugate Vaccine | 1,619 | |
| Overall Study | Vaccinated at 4 Months | Group 2: MENVEO | 828 | |
| Overall Study | Vaccinated at 6 Months | Group 1: MenACYW Conjugate Vaccine | 1,543 | |
| Overall Study | Vaccinated at 6 Months | Group 2: MENVEO | 793 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events186
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Group 1: MenACYW Conjugate Vaccine | 975 | 1,727 | 2,319 |
| other | Somnolence | Nervous system disorders | Group 2: MENVEO | 507 | 867 | 1,273 |
| other | Teething | Gastrointestinal disorders | Group 1: MenACYW Conjugate Vaccine | 106 | 1,727 | 124 |
| other | Teething | Gastrointestinal disorders | Group 2: MENVEO | 62 | 867 | 73 |
| other | Vomiting | Gastrointestinal disorders | Group 1: MenACYW Conjugate Vaccine | 417 | 1,727 | 607 |
| other | Vomiting | Gastrointestinal disorders | Group 2: MENVEO | 196 | 867 | 276 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Group 1: MenACYW Conjugate Vaccine | 704 | 1,727 | 1,246 |
| other | Decreased Appetite | Metabolism and nutrition disorders | Group 2: MENVEO | 388 | 867 | 732 |
| other | Nasopharyngitis | Infections and infestations | Group 1: MenACYW Conjugate Vaccine | 96 | 1,727 | 105 |
| other | Nasopharyngitis | Infections and infestations | Group 2: MENVEO | 50 | 867 | 62 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: MenACYW Conjugate Vaccine | 1 | 1,727 |
| Total, all-cause mortality | Group 2: MENVEO | 0 | 867 |
| Total, other adverse events | Group 1: MenACYW Conjugate Vaccine | 1,471 | 1,727 |
| Total, other adverse events | Group 2: MENVEO | 746 | 867 |
| Total, serious adverse events | Group 1: MenACYW Conjugate Vaccine | 99 | 1,727 |
| Total, serious adverse events | Group 2: MENVEO | 38 | 867 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41337697 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO: deaths from any cause | Trial comparisons |
| Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03537508
GET https://conductscience.org/api/trials/v1/NCT03537508/results?page=2