clinical trial · NCT03673462
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Sanofi Pasteur, a Sanofi Company·phase3·completed·n = 2,797
Healthy Volunteers (Meningococcal Infection)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 VaccinePneumococcal 13-valent Conjugate VaccineRotavirus VaccineHepatitis B VaccineMeasles, Mumps, and Rubella Virus VaccineVaricella Virus Vaccine
brief 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.
started
Sep 17, 2018
primary completion
Mar 16, 2023
completion
Mar 16, 2023
last updated
Dec 14, 2023
detailed description
Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.
official title
A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol