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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03630705 | Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico | PHASE3 | COMPLETED | 525 | — | — | Oct 17, 2018 | Feb 18, 2022 | Oct 19, 2023 | 11 | Mexico, Russia |
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine (Mexico) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12. |
| Group 2: Menveo® (Mexico) | ACTIVE_COMPARATOR | Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12. |
| Group 3: MenACYW Conjugate Vaccine (Russian Federation) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12. |
| Group 4: Routine Pediatric Vaccines (Russian Federation) | OTHER | Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12. |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Liquid solution Route of administration : Intramuscular |
| Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular |
| Measles, Mumps, and Rubella Virus Vaccine Live | BIOLOGICAL | Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous |
| Pneumococcal 13-valent Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular |
| Hepatitis B Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Rotavirus Vaccine, Live, Pentavalent | BIOLOGICAL | Pharmaceutical form: Oral solution Route of administration: Oral |
| Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: * Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.\* * Born after a full-term pregnancy, with an estimated gestation age \>= 37 weeks and a ...