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Haemophilus b Conjugate Vaccine · 1 trial · 1 indication
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase from baseline for participant with pre-vaccination hSBA titer \>= 1:8.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age |
| Group 2 | ACTIVE_COMPARATOR | MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age |
| Group 3 | EXPERIMENTAL | MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age |
| Group 4 | ACTIVE_COMPARATOR | Menactra® at 17 to 19 months of age and 20 to 23 months of age |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL |
| Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL |
| Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL |
| Haemophilus b Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL |
| Pneumococcal 13-valent Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL |
| Rotavirus Vaccine, Live, Oral, Pentavalent | BIOLOGICAL | Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL |
| Hepatitis B Vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL |
| Measles, Mumps, and Rubella Virus Vaccine Live | BIOLOGICAL | Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL |
| Varicella Virus Vaccine Live | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL |
Inclusion criteria : * Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit * Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations * Subject and parent/guardian are able to ...
Haemophilus b Conjugate Vaccine is being studied for use in healthy volunteers in the context of meningococcal infection prevention. It is an investigational vaccine evaluated in a Phase 3 clinical trial to assess its immunogenicity and safety when administered with routine pediatric vaccines in healthy infants and toddlers.
Haemophilus b Conjugate Vaccine is developed by Sanofi, a company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this vaccine to evaluate its potential use in preventing meningococcal infection in healthy pediatric populations.
Haemophilus b Conjugate Vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development and potential regulatory submissions.
Haemophilus b Conjugate Vaccine is associated with one completed Phase 3 clinical trial, identified as NCT03691610. This study evaluated the immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine administered concomitantly with routine pediatric vaccines in healthy infants and toddlers, enrolling 950 participants in the United States and Puerto Rico.
The clinical trial NCT03691610 evaluates a quadrivalent meningococcal conjugate vaccine, which is the vaccine under investigation. Haemophilus b Conjugate Vaccine is the drug name used in this context, referring to the same investigational vaccine being studied for its immunogenicity and safety in healthy infants and toddlers.