CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 580 enrolled
Drug / intervention
Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate +7 morebiological
Likely dose
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 mLfrom record
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Search/NCT01049035
NCT01049035Phase 2Completed
CompareCT.gov

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Infants and Toddlers

Sanofi Pasteur, a Sanofi Company·interventional·Posted Jan 14, 2010·Updated Mar 28, 2022

In Brief

A Phase 2 clinical trial evaluating Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined), and 6 other interventions for Meningitis and Meningococcal Infection. Completed, enrolled 580 participants across 25 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartDec 16, 2009
Primary CompletionFeb 13, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.5 years ago

Interventions

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

0.5 milliliter (mL), Intramuscular (IM) injection

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

0.5 mL, IM injection

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

0.5 mL, Subcutaneous (SC) injection

Varicella Virus Vaccine Livebiological

0.5 mL, SC injection

Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)biological

0.5 mL, IM injection

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)biological

0.5 mL, IM injection

Rotavirus Vaccinebiological

oral

Hepatitis B Vaccinebiological

0.5 mL, IM injection