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

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.

Study Overview

• Status: Completed
• Conditions: Meningococcal Immunization
• Intervention / Treatment: Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).; Biological: Meningococcal Group C-CRM197 Conjugate Vaccine

Detailed Description

Up to 24 months

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Adults receiving Low Dose TetraMen-T with adjuvant	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); Other Names: 395
Experimental: Group 2; Adults receiving High Dose TetraMen-T without adjuvant	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); Other Names: 395
Experimental: Group 3; Toddlers receiving Low Dose TetraMen-T with adjuvant	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); Other Names: 395
Experimental: Group 4; Toddlers receiving High Dose TetraMen-T without adjuvant	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); Other Names: 395
Experimental: Group 5; Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months	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); Other Names: 395
Experimental: Group 6; Infants receiving Low Dose TetraMen-T with adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months	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); Other Names: 395
Experimental: Group 7; Infants receiving High Dose TetraMen-T without adjuvant. Subjects were to receive a booster dose of the same formulation at age 13 months	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); Other Names: 395
Active Comparator: Group 8; Infants receiving Menjugate ®. Subjects were to receive a booster dose of low-dose adjuvanted TetraMen-T at age 13 months. Routine vaccines were deferred.	Biological: Meningococcal Group C-CRM197 Conjugate Vaccine; Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM); Other Names: Menjugate®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 any unsolicited systemic adverse events (AEs) reported up to 28 days after injection	Up to 28 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

Outcome Measure	Time Frame
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: Presence of serious adverse events (SAEs) throughout the trial.	From baseline up to 24 months
After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses	From baseline up to 24 months

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2006
• Primary Completion (Actual): August 27, 2008
• Study Completion (Actual): August 27, 2008

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MET28

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No