Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007
| Autor: | Hans L. Bock, D.V. Thiem, D.D. Anh, Celia C. Carlos, H.H. Han, P.V. Suryakiran, Igor Smolenov, Yanee Hutagalung, S. Gatchalian |
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| Rok vydání: | 2010 |
| Předmět: |
Male
medicine.medical_specialty Philippines medicine.disease_cause Antibodies Viral Vaccines Attenuated Rotavirus Infections Double-Blind Method Rotavirus Internal medicine medicine Humans Hepatitis B Vaccines Seroconversion Diphtheria-Tetanus-Pertussis Vaccine Immunization Schedule Reactogenicity General Veterinary General Immunology and Microbiology business.industry Immunization Programs Immunogenicity Public Health Environmental and Occupational Health Rotavirus Vaccines Infant Hepatitis B medicine.disease Rotavirus vaccine Immunoglobulin A Vaccination Poliovirus Vaccines Infectious Diseases Immunization Vietnam Immunology Molecular Medicine Female business |
| Zdroj: | Vaccine. 29(11) |
| ISSN: | 1873-2518 |
| Popis: | Evaluation of immunogenicity and safety of a 2-dose liquid formulation of human rotavirus vaccine, RIX4414 following WHO's Expanded Program on Immunization (EPI) schedule (0, 1, and 2 months; Month 0 indicates day of enrollment) in Vietnam and the Philippines. Infants aged 6-10 (mean=8.7 ± 1.07 weeks Vietnam) and 5-10 weeks (mean=6.6 ± 1.03 weeks Philippines) received two doses of RIX4414 vaccine (V) and one dose of placebo (PL) or three placebo doses concomitantly with commercially available diphtheria-tetanus-whole-cell pertussis, hepatitis B and oral poliovirus vaccines. The vaccination schedules were: V-V-PL, V-PL-V and PL-PL-PL (Vietnam); PL-V-V, V-PL-V and PL-PL-PL (Philippines). Anti-rotavirus seroconversion rate was assessed pre-vaccination and post-vaccination (ELISA cut-off=20 U/ml). 375 infants were enrolled in each country. Seroconversion rates at one month post-Dose 2 of RIX4414 were Vietnam 63.3% (95% CI: 54.3-71.6) in V-V-PL group and 81.5% (95% CI: 73.4-88) in V-PL-V group; Philippines 70% (95% CI: 61-78) in PL-V-V group and 59.2% (95% CI: 49.8-68) in V-PL-V group. Frequencies of solicited (8-day post-each dose) and unsolicited symptoms (31-day post-each dose) were similar. Two-doses of rotavirus vaccine administered within the WHO EPI offer flexibility in existing schedule, though both schedules provides good immune responses. |
| Databáze: | OpenAIRE |
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