Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Summary
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: * To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Timeline
- Start
- 2018-10-04
- Primary completion
- 2023-10-20
- Completion
- 2023-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | MenACWY-DT | Vaccine | 0.5 ml | Intramuscular |
| Subject | MenACYW-TT | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Menveo | Vaccine | 0.5 ml | Intramuscular |
| Background | Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Background | Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Background | Haemophilus b Conjugate Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Background | Hepatitis B vaccine | Vaccine | 0.5 ml | Intramuscular |
| Background | Measles, Mumps, and Rubella Virus Vaccine Live | Vaccine | 0.5 ml | Subcutaneous |
| Background | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |
| Background | Rotarix | Vaccine | 2 ml | Oral |
| Background | Varivax | Vaccine | 0.5 ml | Subcutaneous |
Indications
No indication recorded.