Since October 2009, H1N1 influenza vaccine has developed and approved of immunization in population in China. However, there was little epidemiological evidence of safety when vaccinated in healthy pregnant women. The main objective of this study is to assess the safety of split-virion inactivated H1N1 vaccine without adjuvant when administered in healthy pregnant women. It is a stratified and controlled clinical trial in healthy pregnant women. And participants were included up to 226 healthy pregnant women aged 18 -35 years old who have no history of novel influenza H1N1 infection or novel influenza H1N1 vaccination. The pregnancy week ranged from 5 weeks to 32 weeks. Subjects were divided into 2 groups: vaccinated group(122) and unvaccinated group(104). Subjects in the vaccinated group were administered one dose of 15μg H1N1 vaccine. Subjects in the unvaccinated group received no vaccine as controls. Safety will be measured by assessment of pregnancy outcomes. And observation time for pregnancy outcomes was lasting for 28 days postpartum since vaccinated; and protective effect was observed for six months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
122
122 participants (19 at 5-9 weeks pregnant,36 at 10-19 weeks pregnant,13 at 20-29 weeks pregnant,54 at more than 30 weeks pregnant) received split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
Xiangshui Center for Disease Control and Prevention
Xiangshui, Jiangsu, China
Adverse Pregnancy Outcomes
include the following indicators: incidence of spontaneous abortion, incidence of induced abortion,incidence of Preterm, incidence of post-term pregnancy, proportion of underweight-Babies
Time frame: 0-28 days postpartum
incidence of influenza-like illness
Time frame: 0-6months
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