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Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

NCT03673462 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2797

Last updated 2023-12-14

Study results available
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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.

Conditions

  • Healthy Volunteers (Meningococcal Infection)

Interventions

BIOLOGICAL

Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)

Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)

Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine

Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Rotavirus Vaccine

Pharmaceutical form: Oral solution Route of administration: Oral

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine

Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

BIOLOGICAL

Varicella Virus Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2023-03-16
Completion
2023-03-16
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673462 on ClinicalTrials.gov