Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Summary
The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to \[\>=\] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone. The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.
Timeline
- Start
- 2018-10-10
- Primary completion
- 2022-12-05
- Completion
- 2022-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bexsero | Vaccine | 0.5 ml | Intramuscular |
| Subject | MenACYW conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |
| Background | Infanrix hexa | Vaccine | 0.5 ml | Intramuscular |
| Background | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |
| Background | Rotarix | Vaccine | 1.5 ml | Oral |
Indications
No indication recorded.