Comparison · NCT03673462-fe08e0a4
Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: Number of Participants With Unsolicited Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Group 1: MenACYW Conjugate Vaccine vs Group 2: MENVEO®: Number of Participants With Unsolicited Adverse Events. Trial comparisons, record NCT03673462-fe08e0a4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03673462-fe08e0a4
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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 | 0.65 | 0.629 | 0.67 | wilson | |
| Risk in group 2 | 0.627 | 0.59 | 0.662 | wilson | |
| Risk difference, group 1 minus group 2 | 0.023 | -0.0178 | 0.0648 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.971 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 1.1 | 0.925 | 1.32 | log | |
| Number needed to treat, for one more participant with the outcome on Group 1: MenACYW Conjugate Vaccine than on Group 2: MENVEO® | 43.4 | 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) 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. | 1,352 | 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) 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. | 437 | 697 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Unsolicited Adverse Events
- Description
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
- Time frame
- Within 30 days post any vaccination
- Population
- Analysis was performed on SafAS.
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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