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

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 enrolment) in Vietnam and the Philippines. Infants aged 6–10 (mean=8.7±1.07 we...

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Veröffentlicht in:Vaccine 2011-03, Vol.29 (11), p.2029-2036
Hauptverfasser: Anh, D.D, Carlos, C.C, Thiem, D.V, Hutagalung, Y, Gatchalian, S, Bock, H.L, Smolenov, I, Suryakiran, P.V, Han, H.H
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Sprache:eng
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Zusammenfassung: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 enrolment) 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=20U/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.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2011.01.018