A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Condition: Meningococcal Immunization
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).; Meningococcal Group C-CRM197 Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM); Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)
Other intervention name(s): 395; Menjugate®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment