NCT06165276

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. 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. 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®).
  3. 3.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.
  4. 4.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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2008

Completed
15.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

December 1, 2023

Last Update Submit

December 1, 2023

Conditions

Meningococcal Immunization

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (8)

Group 1

EXPERIMENTAL

Adults receiving Low Dose TetraMen-T with adjuvant

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

Group 2

EXPERIMENTAL

Adults receiving High Dose TetraMen-T without adjuvant

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

Group 3

EXPERIMENTAL

Toddlers receiving Low Dose TetraMen-T with adjuvant

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

Group 4

EXPERIMENTAL

Toddlers receiving High Dose TetraMen-T without adjuvant

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

Group 5

EXPERIMENTAL

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).

Group 6

EXPERIMENTAL

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).

Group 7

EXPERIMENTAL

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).

Group 8

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: 395
Group 1Group 2Group 3Group 4Group 5Group 6Group 7
Meningococcal Group C-CRM197 Conjugate VaccineBIOLOGICAL

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

Also known as: Menjugate®
Group 8

Eligibility Criteria

Age60 Days - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

July 25, 2006

Primary Completion

August 27, 2008

Study Completion

August 27, 2008

Last Updated

December 11, 2023

Record last verified: 2023-11