Comparison · NCT03673462-85ef2752
Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
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®: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs). Trial comparisons, record NCT03673462-85ef2752. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03673462-85ef2752
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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 | 0.00337 | 0.00163 | 0.00693 | wilson | |
| Risk in group 2 | 0.00287 | 0.000787 | 0.0104 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000496 | -0.00723 | 0.00462 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.244 | 5.63 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.243 | 5.66 | log | |
| Number needed to treat, for one more participant with the outcome on Group 1: MenACYW Conjugate Vaccine than on Group 2: MENVEO® | 2,020 | 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 | Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; 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; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age. | 7 | 2,080 | OG000 |
| Group 2 | Group 2: MENVEO® | Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 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; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age. | 2 | 697 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
- Description
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol.
- Time frame
- Within 30 minutes post-any vaccination
- Population
- Analysis was performed on SafAS that included all participants who had received at least one dose of the study vaccines and had any safety data available.
Source ClinicalTrials.gov
Trial
- Title
- Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
- NCT number
- NCT03673462
- Phases
- PHASE3
- Conditions
- Healthy Volunteers (Meningococcal Infection)
- Interventions
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine, Pneumococcal 13-valent Conjugate Vaccine, Rotavirus Vaccine, Hepatitis B Vaccine, Measles, Mumps, and Rubella Virus Vaccine, Varicella Virus Vaccine
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Results first posted
- 2023-10-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03673462?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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