Safety of H1N1 Influenza Vaccination in Pregnant Women

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01842997
Study type	Interventional
Source	Jiangsu Province Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	Phase 4
Start date	October 2009
Completion date	December 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05523089` - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults	Phase 2
Completed	`NCT05009251` - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake	N/A
Completed	`NCT03282240` - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US	Phase 3
Completed	`NCT00968526` - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00968539` - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00971425` - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)	Phase 3
Completed	`NCT05525494` - Patient Portal Flu Vaccine Reminders (5)	N/A
Completed	`NCT04074928` - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects	Phase 3
Completed	`NCT04695717` - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam	Phase 3
Completed	`NCT05012163` - Lottery Incentive Nudges to Increase Influenza Vaccinations	N/A
Completed	`NCT04109222` - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively	Phase 4
Completed	`NCT03888989` - Response to Influenza Vaccine During Pregnancy	Phase 1
Completed	`NCT02587221` - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age	Phase 3
Completed	`NCT03453801` - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection	Phase 1
Completed	`NCT01440387` - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older	Phase 3
Terminated	`NCT01195779` - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children	Phase 2
Completed	`NCT03321968` - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults	Phase 3
Completed	`NCT00972517` - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children	Phase 3
Completed	`NCT04570904` - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting	`NCT03331991` - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel	N/A