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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03205371 | Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers | PHASE3 | COMPLETED | 1,183 | — | — | Nov 7, 2016 | Jul 19, 2018 | Apr 5, 2022 | 37 | Mexico, Russia +2 |
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination titers \<1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers \>=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
| Arm | Type | Description |
|---|---|---|
| South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. |
| South Korea (Group 2): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| South Korea (Group 3): MMR + Varicella Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. |
| Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. |
| Thailand (Group 11):MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Thailand (Group 12): MMR + Varicella Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0. |
| Mexico (Group 5): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0. |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0. |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Russian Federation (Group 9): PCV13 Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0. |
| Name | Type | Description |
|---|---|---|
| MenACYW conjugate vaccine | BIOLOGICAL | Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular |
| MMR | BIOLOGICAL | Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous |
| Varicella | BIOLOGICAL | Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous |
| DTaP-IPV-HB-Hib | BIOLOGICAL | Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular |
| PCV13 | BIOLOGICAL | Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular |
Inclusion Criteria: * For South Korea: Korean males and females aged 12 to 23 months on the day of the first study visit. * For Mexico: Males and females aged 12 to 23 months on the day of the first study visit. * For the Russian Federation: Males and females aged 12 to 14 months or 16 to 23 months...