Clinical trial NCT06165276: A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Meningococcal Immunization
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 285
Sex: ALL
Minimum age (years): 60
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 7 days after injection
measure: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
timeFrame: Up to 28 days after injection
measure: Presence of serious adverse events (SAEs) throughout the trial.
timeFrame: From baseline up to 24 months
measure: Incidence of treatment-emergent antibodies responses
timeFrame: From baseline up to 24 months
Secondary outcomes:
measure: 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
timeFrame: Up to 7 days after injection
measure: After booster dose of TetraMen-T: Presence of any unsolicited systemic adverse events (AEs) reported up to 28 days after injection
timeFrame: Up to 28 days after injection
measure: After booster dose of TetraMen-T: Presence of serious adverse events (SAEs) throughout the trial.
timeFrame: From baseline up to 24 months
measure: After booster dose of TetraMen-T: Incidence of treatment-emergent antibodies responses
timeFrame: From baseline up to 24 months
Other outcomes:
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