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A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

NCT01049035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2022-03-28

Study results available
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Summary

The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease.

Objectives:

* To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
* To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
* To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.

Conditions

Interventions

BIOLOGICAL

Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate

0.5 milliliter (mL), Intramuscular (IM) injection

BIOLOGICAL

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)

0.5 mL, IM injection

BIOLOGICAL

M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live

0.5 mL, Subcutaneous (SC) injection

BIOLOGICAL

Varicella Virus Vaccine Live

0.5 mL, SC injection

BIOLOGICAL

Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

0.5 mL, IM injection

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

0.5 mL, IM injection

BIOLOGICAL

Rotavirus Vaccine

oral

BIOLOGICAL

Hepatitis B Vaccine

0.5 mL, IM injection

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-12-16
Primary Completion
2012-02-13
Completion
2012-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01049035 on ClinicalTrials.gov