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  4. Safety, Reactogenicity and Immunogenicity of the Human Rotavirus Vaccine in Pre-Term European Infants: A Randomized Phase IIIb Study

Safety, Reactogenicity and Immunogenicity of the Human Rotavirus Vaccine in Pre-Term European Infants: A Randomized Phase IIIb StudyArchived

ECDC comment

​Results of this study demonstrated that the RIX4414 vaccine was well tolerated and immunogenic in pre-term European infants: more than 75% of infants had seroconverted 30-83 days after dose 2. This is a reassuring notion, considering that rotavirus disease is more severe in pre-term infants than in full-term infants.

Omenaca F, Sarlangue J, Szenborn L, Nogueira M, Suryakiran PV, Smolenov IV, Han HH; Rota-054 Study Group. Pediatr Infect Dis J. 2012 Jan 5. [Epub ahead of print]

Based on the results of this trial – and in line with the recommendations of the WHO and the European Society for Paediatric Infectious Diseases – medically stable, healthy pre-term infants may receive rotavirus vaccine at the chronologic age similar to full-term infants.