drugset / Trial / NCT01978093
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.
Timeline
- Start
- 2014-02-01
- Primary completion
- 2016-03-18
- Completion
- 2016-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN | Vaccine | — | Intramuscular |
| Subject | Hib-MenCY-TT | Vaccine | — | Intramuscular |
| Background | Havrix | Vaccine | — | Intramuscular |
| Background | Pediarix | Vaccine | — | Intramuscular |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Oral |