NCT06165276

A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study

Phase I Study of the Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine in Adults, Toddlers, and Infants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 60 Days – 40 Years
• Healthy volunteers: Accepted

Summary

The study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. The secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of TetraMen-T. Primary objectives: 1. To describe the safety profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®). 2. To describe the immunogenicity profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®). Secondary objectives: 1. To describe the safety profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age. 2. To describe the immunogenicity profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.

Detailed description

Up to 24 months

Conditions

• Meningococcal Immunization

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).	Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
BIOLOGICAL	Meningococcal Group C-CRM197 Conjugate Vaccine	Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Timeline

• Start date: 2006-07-25
• Primary completion: 2008-08-27
• Completion: 2008-08-27
• First posted: 2023-12-11
• Last updated: 2023-12-11

Regulatory

• FDA-regulated drug study