Phase 3
Completed N=2,797
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Healthy Volunteers (Meningococcal Infection)
Source: ClinicalTrials.gov NCT03673462 ↗
Enrolled (actual)
2,797
Serious AEs
4.7%
Results posted
Oct 2023
Primary outcomePrimary: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) — 7; 2 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) |
7; 2 | — |
| PRIMARY Number of Participants With Solicited Injection Site Reactions |
1501; 499; 826; 257; 557; 170 | — |
| PRIMARY Number of Participants With Solicited Systemic Reactions |
724; 219; 542; 163; 1437; 478 | — |
| PRIMARY Number of Participants With Unsolicited Adverse Events |
1352; 437 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs) |
108; 21; 19; 1 | — |
| PRIMARY Number of Participants With Medically Attended Adverse Event (MAAEs) |
1581; 526 | — |
Eligibility Criteria
Inclusion criteria
- Aged >= 42 to = 38 degree Celsius [>= 100.4-degree Fahrenheit]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT03673462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.