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

NCT03537508 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2627

Last updated 2024-10-15

Study results available
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Summary

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Conditions

  • Healthy Volunteers (Meningococcal Infection)

Interventions

BIOLOGICAL

MenACYW conjugate vaccine

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

BIOLOGICAL

MenACYW-135 conjugate vaccine

Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular

BIOLOGICAL

DTaP-IPV//Hib vaccine

DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular

BIOLOGICAL

Pneumococcal 13-valent conjugate vaccine

Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular

BIOLOGICAL

Pentavalent rotavirus vaccine

Rotavirus vaccine at 2, 4, and 6 months of age, oral solution

BIOLOGICAL

Hepatitis B vaccine

Hepatitis B vaccine at 2 and 6 months of age, Intramuscular

BIOLOGICAL

Measles, mumps, rubella (MMR) vaccine

MMR vaccine at 12 months of age, Subcutaneous

BIOLOGICAL

Varicella vaccine

Varicella vaccine at 12 months of age

BIOLOGICAL

Hepatitis A vaccine

Hepatitis A vaccine at 15 to 18 months of age

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · 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
2018-04-25
Primary Completion
2023-09-22
Completion
2023-09-22
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 NCT03537508 on ClinicalTrials.gov