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

Study Overview
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Brief Summary
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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: 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®). 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: 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. 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
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Up to 24 months

Official Title
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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

Conditions
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Meningococcal Immunization

Intervention / Treatment
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* Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).
* Biological: Meningococcal Group C-CRM197 Conjugate Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Adults receiving Low Dose TetraMen-T with adjuvant | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 2<br>Adults receiving High Dose TetraMen-T without adjuvant | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 3<br>Toddlers receiving Low Dose TetraMen-T with adjuvant | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 4<br>Toddlers receiving High Dose TetraMen-T without adjuvant | Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Tetanus Protein Conjugate Vaccine (TetraMen-T).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 5<br>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).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 6<br>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).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Experimental: Group 7<br>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).<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: 395;|
| Active Comparator: Group 8<br>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<br>* Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM)<br>* Other names: Menjugate®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |