title: Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women.
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 pregnant Chinese women who received the influenza A(H1N1) vaccine and 104 pregnant women who did not receive any vaccine (serving as controls) were observed. The results indicated that the seroconversion rate in the vaccinated group was 90.4% (95% confidence interval [CI], 82.6% to 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 in the vaccinated group and the unvaccinated group were 0.8% and 1.9%, respectively (exact probability test, P = 0.470), the prolonged-pregnancy rates were 8.2% and 4.8%, respectively (χ(2) = 1.041, P = 0.308), the low-birth-weight rates were 1.6% and 0.95%, respectively (exact probability test, P = 1.000), and the spontaneous-labor rates were 70.5% and 75%, respectively (χ(2) = 0.573, P = 0.449). All newborns who have an Apgar score of ≥7 are considered healthy; Apgar scores of ≥9 were observed in 38.5% and 57.7% of newborns in the vaccinated group and the unvaccinated group, respectively (χ(2) = 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. (This study has been registered at ClinicalTrials.gov under registration no. NCT01842997.).
authors.affiliation: Department of Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China jsepi_ma@163.com.
authors.forename: Fubao
authors.initials: F
authors.lastname: Ma
authors.affiliation: Department of Disease Control and Prevention, Xiangshui County Center for Disease Control and Prevention, Xiangshui, Jiangsu Province, China.
authors.forename: Longhua
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Expanded Program on Immunization, Yancheng Municipal Center for Disease Control and Prevention, Xiangshui, Jiangsu Province, China.
authors.forename: Renjie
authors.initials: R
authors.lastname: Jiang
authors.affiliation: Department of Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.
authors.forename: Jinlin
authors.initials: J
authors.lastname: Zhang
authors.affiliation: National Immunization Program, Chinese Center for Disease Control and Prevention, Beijing, China.
authors.forename: Huaqing
authors.initials: H
authors.lastname: Wang
authors.affiliation: Department of Disease Control and Prevention, Xiangshui County Center for Disease Control and Prevention, Xiangshui, Jiangsu Province, China.
authors.forename: Xiaozhi
authors.initials: X
authors.lastname: Gao
authors.affiliation: Department of Disease Control and Prevention, Xiangshui County Center for Disease Control and Prevention, Xiangshui, Jiangsu Province, China.
authors.forename: Xiuhong
authors.initials: X
authors.lastname: Li
authors.affiliation: Department of Expanded Program on Immunization, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu Province, China.
authors.forename: Yuanbao
authors.initials: Y
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000328:Adult; D044466:Asian People; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control* / Q000821:virology; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines