Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05794230 | Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa | PHASE3 | COMPLETED | 1,528 | — | — | Mar 27, 2023 | Nov 15, 2025 | Jan 21, 2026 | 15 | India, South Africa |
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...