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Clin Vaccine Immunol. 2014 Jul 2. pii: CVI.00375-14. [Epub ahead of print]
Safety of the influenza A (H1N1) vaccine in Chinese pregnant women: A prospective cohort study.
Ma F1, Zhang L2, Jiang R3, Zhang J4, Wang H5, Gao X2, Li X2, Liu Y4.
Author information
Abstract
To monitor and evaluate the safety of the influenza A (H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 Chinese pregnant women who received the influenza A (H1N1) vaccine and 104 pregnant women who did not receive any vaccine as control were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95%CI: 82.6-95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A (H1N1) vaccine was 3.3%. The spontaneous abortion rates of the vaccinated group and unvaccinated group were 0.8% and 1.9%, respectively (exact probability test, p= 0.470); prolonged pregnancy rates were 8.2% and 4.8%, respectively (χ2=1.041, p=0.308); low birth weight rates were 1.6% and 0.95%, respectively (exact probability test, p = 1.000); and spontaneous labor rates were 70.5% and 75%, respectively (χ2= 0.573, р=0.449). All newborns that received an Apgar score of 7 or more are healthy. Apgar scores of 9 and above were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ2= 8.274, p=0.004). From these results, we conclude that the influenza A (H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. CLINICALTRIALS.GOV Identifier: NCT01842997.
Copyright ? 2014, American Society for Microbiology. All Rights Reserved.
PMID:
24990911
[PubMed - as supplied by publisher]
Safety of the influenza A (H1N1) vaccine in Chinese pregnant women: A prospective cohort study.
Ma F1, Zhang L2, Jiang R3, Zhang J4, Wang H5, Gao X2, Li X2, Liu Y4.
Author information
Abstract
To monitor and evaluate the safety of the influenza A (H1N1) vaccine in pregnant women and its influence on the fetus and neonate, we performed a prospective study in which 122 Chinese pregnant women who received the influenza A (H1N1) vaccine and 104 pregnant women who did not receive any vaccine as control were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95%CI: 82.6-95.5%). The rate of adverse events following immunization in the pregnant women who received the influenza A (H1N1) vaccine was 3.3%. The spontaneous abortion rates of the vaccinated group and unvaccinated group were 0.8% and 1.9%, respectively (exact probability test, p= 0.470); prolonged pregnancy rates were 8.2% and 4.8%, respectively (χ2=1.041, p=0.308); low birth weight rates were 1.6% and 0.95%, respectively (exact probability test, p = 1.000); and spontaneous labor rates were 70.5% and 75%, respectively (χ2= 0.573, р=0.449). All newborns that received an Apgar score of 7 or more are healthy. Apgar scores of 9 and above were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ2= 8.274, p=0.004). From these results, we conclude that the influenza A (H1N1) vaccine is safe for pregnant women and has no observed adverse effects on fetal growth. CLINICALTRIALS.GOV Identifier: NCT01842997.
Copyright ? 2014, American Society for Microbiology. All Rights Reserved.
PMID:
24990911
[PubMed - as supplied by publisher]
