Immunogenicity and safety of the human rotavirus vaccine Rotarix™ co-administered with routine infant vaccines following the vaccination schedules in Europe

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• 作者：Timo Vesikari ; Aino Karvonen ; Roman Prymula ; Volker Schuster ; Juan C. Tejedor ; Franck Thollot ; Pilar Garcia-Corbeira ; Silvia Damaso ; Htay-Htay Han ; Alain Bouckenooghe
• 关键词：Rotavirus ; Vaccination ; Immune response ; Safety ; Concomitant administration
• 刊名：Vaccine
• 出版年：2010
• 出版时间：19 July 2010
• 年：2010
• 卷：28
• 期：32
• 页码：5272-5279
• 全文大小：316 K

文摘

This study assessed the immunogenicity and safety of a human rotavirus vaccine RIX4414; the effect of co-administration of childhood vaccines on the immune responses was also assessed.

Healthy infants aged 6–14 weeks received two doses of RIX4414/placebo concomitantly with the primary childhood vaccination (Infanrix hexa™, Infanrix quinta™, Meningitec™ and/or Prevnar™), respecting the vaccination schedule of each country. Anti-rotavirus IgA seroconversion rate (ELISA cut-off 20 U/ml) was measured pre-vaccination and 1–2 months post-Dose 2. Immune response against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, inactivated polio virus, pneumococcal polysaccharide conjugate (France and Germany) and meningococcal group C conjugate vaccines (Spain) were measured approximately 1-month post-Dose 3.

An overall anti-rotavirus IgA seroconversion rate of 86.5 % (95 % CI: 83.9–88.8) was observed in the RIX4414 group 1-month post-Dose 2. The seroconversion rate in Finland and Italy (3 and 5-month schedule) was 94.6 % (95 % CI: 90.0–97.5) and 92.3 % (95 % CI: 64.0–99.8), respectively. Immune response to the childhood vaccines was unaffected following co-administration with RIX4414. Reactogenicity profile was similar for RIX4414 and placebo groups.

RIX4414 was immunogenic and well tolerated in European infants and the co-administration of routine childhood vaccines with RIX4414 did not negatively impact the immune responses to these vaccines.