Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Secondary objectives:
Up to 24 months
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Adults receiving Low Dose TetraMen-T with adjuvant |
|
| Group 2 | Experimental | Adults receiving High Dose TetraMen-T without adjuvant |
|
| Group 3 | Experimental | Toddlers receiving Low Dose TetraMen-T with adjuvant |
|
| Group 4 | Experimental | Toddlers receiving High Dose TetraMen-T without adjuvant |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
| 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 |
Not provided
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)
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
|
| 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. |
|
|
| Meningococcal Group C-CRM197 Conjugate Vaccine | Biological | Pharmaceutical form:suspension for injection-Route of administration:Intramuscular (IM) |
|
|
| 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 |