NCT01049035

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 580 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 365 Days
• Healthy volunteers: Accepted

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.

Detailed description

Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending on the assigned schedule in their randomized groups. All participants underwent safety and immunogenicity assessments according to the schedule for their assigned group.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-12-16
• Primary completion: 2012-02-13
• Completion: 2012-02-13
• First posted: 2010-01-14
• Last updated: 2022-03-28
• Results posted: 2020-06-09

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study