drugset / Trial / NCT00127855
Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
RandomizedParallel-groupTriple-blindPrevention
Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.
Timeline
- Start
- 2003-03-01
- Primary completion
- 2004-02-01
- Completion
- 2004-02-12
Publications
- Background Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
- Background Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. doi: 10.1016/j.vaccine.2007.10.013. Epub 2007 Oct 25.
- Background T Nolan et al. A novel Haemophilus influenzae type b - meningococcal serogroups C and Y conjugate (Hib-MenCY-TT) vaccine induces persistent immune responses and immune memory. Abstract presented at Pediatric Academic Societies' (PAS) Annual meeting. San Francisco, California, US, 29 April to 2 May 2006.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ActHIB | Vaccine | — | Intramuscular |
| Subject | Hib-MenCY-TT vaccine | Vaccine | — | Intramuscular |
| Subject | Mencevax™ ACWY | Vaccine | — | Intramuscular |
| Comparator | Meningitec | Vaccine | — | Intramuscular |
| Subject | PRP (Polyribosyl Ribitol Phosphate) | Unknown | 10 ug | Intramuscular |
| Background | Pediarix | Vaccine | — | Intramuscular |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |