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OpenTrials
Completed

NCT Number: NCT06165276

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

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.

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Key information

Conditions

Meningococcal Immunization

Age range

60 day–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Up to 24 months

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: 395

Meningococcal Group C-CRM197 Conjugate Vaccine

Biological

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

Other names: Menjugate®

Primary outcomes

  1. 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

    Time frame: Up to 7 days after injection

  2. Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection

    Time frame: Up to 28 days after injection

  3. Presence of serious adverse events (SAEs) throughout the trial.

    Time frame: From baseline up to 24 months

  4. Incidence of treatment-emergent antibodies responses

    Time frame: From baseline up to 24 months

Secondary outcomes

  1. 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

    Time frame: Up to 7 days after injection

  2. After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection

    Time frame: Up to 28 days after injection

  3. After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.

    Time frame: From baseline up to 24 months

  4. After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses

    Time frame: From baseline up to 24 months

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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