MedDataX Logo

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

NCT ID: NCT06165276

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-25

Study Completion Date

2008-08-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Up to 24 months

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningococcal Immunization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Adults receiving Low Dose TetraMen-T with adjuvant

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Group 2

Adults receiving High Dose TetraMen-T without adjuvant

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Group 3

Toddlers receiving Low Dose TetraMen-T with adjuvant

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Group 4

Toddlers receiving High Dose TetraMen-T without adjuvant

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

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

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

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

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

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

Group Type EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

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.

Group Type ACTIVE_COMPARATOR

Meningococcal Group C-CRM197 Conjugate Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type BIOLOGICAL

Meningococcal Group C-CRM197 Conjugate Vaccine

Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

395 Menjugate®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

-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)

Exclusion Criteria

* 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.
Minimum Eligible Age

60 Days

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MET28

Identifier Type: -

Identifier Source: org_study_id