Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study.
Am J Obstet Gynecol
; 207(3): 177.e1-8, 2012 Sep.
Article
en En
| MEDLINE
| ID: mdl-22939717
ABSTRACT
OBJECTIVE:
The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy. STUDYDESIGN:
This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates.RESULTS:
No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters.CONCLUSION:
There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Polisorbatos
/
Complicaciones Infecciosas del Embarazo
/
Escualeno
/
Vacunas contra la Influenza
/
Adyuvantes Inmunológicos
/
Gripe Humana
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Risk_factors_studies
Límite:
Adolescent
/
Adult
/
Female
/
Humans
/
Middle aged
/
Pregnancy
Idioma:
En
Año:
2012
Tipo del documento:
Article