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

Phase 1

Completed

• Conditions: Meningococcal Immunization

• Registration Number: NCT06165276
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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

Study Timeline

• Study Start: 2006-07-25
• Primary Completion: 2008-08-27
• Study Completion: 2008-08-27
• Status Verified: 2023-11
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

-Subject is healthy, as determined by medical history and physical assessment.

-At the time of vaccination on Day 0, subject was the following age: Adults: aged ≥18 to < 40 years Toddlers: aged ≥12 to < 19 months Infants: aged 2 months + 28 days (60 to 88 days)

• Institutional Review Board (IRB)-approved informed consent form signed by the subject or the subject's parent/legal guardian.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection	Up to 28 days after injection
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection	Up to 7 days after injection
Presence of serious adverse events (SAEs) throughout the trial.	From baseline up to 24 months
Incidence of treatment-emergent antibodies responses	From baseline up to 24 months

Secondary Outcome Measures

Name	Time	Method
After booster dose of TetraMen-T: Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection	Up to 7 days after injection
After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection	Up to 28 days after injection
After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses	From baseline up to 24 months
After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.	From baseline up to 24 months