Comparison · NCT03537508-sae
Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO: serious adverse events. Trial comparisons, record NCT03537508-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03537508-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0573 | 0.0473 | 0.0693 | wilson | |
| Risk in group 2 | 0.0438 | 0.0321 | 0.0596 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0135 | -0.00517 | 0.0303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.908 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.904 | 1.95 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Group 1: MenACYW Conjugate Vaccine than on Group 2: MENVEO | 74.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Group 1: MenACYW Conjugate Vaccine | Participants received MenACYW conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age as a part of the study.~Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. | 99 | 1,727 | EG000 |
| Group 2 | Group 2: MENVEO | Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age.~Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. | 38 | 867 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- 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
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2024-10-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03537508?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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