Phase 3
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)
Bottom Line
View on ClinicalTrials.gov: NCT03673462 ↗Enrolled (actual)
2,797
Serious AEs
4.7%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) — 7; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Biological); Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) (Biological); Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine (Biological); Pneumococcal 13-valent Conjugate Vaccine (Biological); Rotavirus Vaccine (Biological); Hepatitis B Vaccine (Biological); Measles, Mumps, and Rubella Virus Vaccine (Biological); Varicella Virus Vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Mar 2023
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 | — |
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.
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.