Background The objective of our study was to investigate the association of adverse clinical musculoskeletal and neurological events in healthy postpartum women with live attenuated (RA27/3 strain) rubella-virus vaccine, and to assess the frequency of acute and recurrent arthralgia and arthritis and associations with acute and recurrent muscle pain (myalgia) and neurological manifestations (paraesthesias).
Methods We used a randomised placebo-controlled, double-blind design in a community setting. 636 women were enrolled and, after 90 women dropped out, 546 healthy women aged 18-41 years, who were rubella seronegative on routine screening were immunised parenterally with either monovalent live attenuated (RA27/3 strain) rubella vaccine (n=270) or saline placebo (n=276) in the postpartum period.
Outcome measures were the occurrence of acute and persistent or recurrent joint manifestations (arthralgia or arthritis) at 1,3,6,9, and 12 months after immunisation.
Occurrence of muscle pain (myalgia), and neurological symptoms (paraesthesia) was also assessed at the same times.
Findings 543 women completed 1-month follow-up.
456 women completed the 12-month assessment.
There were no differences at the time of immunisation between rubella vaccine and placebo groups in distribution of age, ethnic origin, parity, time between delivery and immunisation, breastfeeding history, or histories of earlier rubella vaccination or joint complaints. (...)
Mots-clés Pascal : Rubéole, Virose, Infection, Postpartum, Vaccination, Effet secondaire, Randomisation, Etude double insu, Séronégativité, Femelle, Homme, Symptomatologie, Immunopathologie, Immunoprophylaxie
Mots-clés Pascal anglais : Rubella, Viral disease, Infection, Puerperium, Vaccination, Secondary effect, Randomization, Double blind study, Seronegativity, Female, Human, Symptomatology, Immunopathology, Immunoprophylaxis
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0299366
Code Inist : 002B05A02. Création : 15/07/1997.