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Pneumoccocal Vaccine · 1 trial · 2 indications
Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age (\[Group 1 + Group 3\] versus \[Group 2 + Group 4\]) The following threshold values will be considered: ≥ 1:8
Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7) The following threshold values will be considered: ≥ 1:8
| Arm | Type | Description |
|---|---|---|
| Groups 1a, 1b and 1c Cohort Ia (India) | EXPERIMENTAL | 2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines |
| Group 2 Cohort Ia (India) | ACTIVE_COMPARATOR | 2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines |
| Groups 3 Cohort Ib (RSA) | EXPERIMENTAL | 2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines |
| Group 4 Cohort Ib (RSA) | ACTIVE_COMPARATOR | 2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines |
| Groups 5a and 5b Cohort IIa (India) | EXPERIMENTAL | 3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines |
| Group 6 Cohort IIa (India) | OTHER | routine pediatric vaccines only |
| Group 7 Cohort IIb (RSA) | EXPERIMENTAL | 3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines |
| Group 8 Cohort IIb (RSA) | OTHER | routine pediatric vaccines only |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) | BIOLOGICAL | Oral suspension - oral |
| Pneumoccocal Vaccine | BIOLOGICAL | Suspension for injection - intramuscular |
| Measles, Mumps, and Rubella Vaccine live (MMR) | BIOLOGICAL | Lyophilized powder for injection - subcutaneous |
| DTwP-HepB-Hib-IPV vaccine | BIOLOGICAL | Suspension - intramuscular |
| DTaP-IPV-Hib-HepB vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Hepatitis A vaccine | BIOLOGICAL | Lyophilized powder for injection - subcutaneous |
| Rotavirus vaccine | BIOLOGICAL | Oral solution - oral |
| Typhoid conjugate vaccine (TCV) | BIOLOGICAL | Suspension for injection - intramuscular |
| Measles vaccine | BIOLOGICAL | Freeze-dried powder for reconstitution and injection - subcutaneous |
| Varicella vaccine live | BIOLOGICAL | Sterile powder and diluent for injection - subcutaneous |
Inclusion Criteria: * Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit * Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit * Healthy infants as determined by medical history, physical examination, and judgment of the Investi...
Pneumococcal Vaccine is being studied for meningococcal immunisation in healthy infants and toddlers. It is an investigational quadrivalent meningococcal conjugate vaccine, also referred to as MenACYW conjugate vaccine, and is currently in Phase 3 clinical development.
Pneumococcal Vaccine targets meningococcal bacteria, specifically serogroups A, C, Y, and W, as it is a quadrivalent conjugate vaccine. It is designed to elicit an immune response against these four serogroups to provide protection against meningococcal disease.
Pneumococcal Vaccine is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY.
Pneumococcal Vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to support potential regulatory submissions.
Pneumococcal Vaccine has one completed Phase 3 trial, identified as NCT05794230. This study evaluated the vaccine given with routine pediatric vaccines in healthy infants and toddlers in India and South Africa, enrolling 1528 participants aged 6 weeks and older.
Yes, Pneumococcal Vaccine is also known as the MenACYW conjugate vaccine. The clinical trial NCT05794230 refers to it as a quadrivalent meningococcal conjugate vaccine, and it is being developed by Sanofi for meningococcal immunisation.