Safety of H1N1 Influenza Vaccination in Pregnant Women

NCT01842997 | Completed Phase 4 DMC

• 1 other identifier: JSEPI-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Virus Diseases; Respiratory Tract Infections; Influenza; Orthomyxoviridae Infections

Keywords

Flu; non-adjuvanted H1N1 vaccine; Safety; pregnant women

Outcome Measures

Primary Outcomes (1)

• 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

  0-28 days postpartum

Secondary Outcomes (1)

• incidence of influenza-like illness

  0-6months

Study Arms (1)

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

EXPERIMENTAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg made by Shanghai Institute of Biological Products lot number: 200909008

Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg

Interventions

split-virion, non-adjuvanted H1N1 vaccine of 15 μg BIOLOGICAL

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.

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women
• Be able to show legal identity card for the sake of recruitment
• Be able to understand and sign the informed consent

You may not qualify if:

• Cases, cured cases and close contact of influenza A (H1N1) virus
• Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency
• Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• History of thyroidectomy or thyroid disease that required medication within the past 12 months
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
• Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
• History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
• Administration of any other investigational research agents within 30 days before the dosing
• Administration of any live attenuated vaccine within 30 days before the dosing
• Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
• Axillary temperature \> 37.0 centigrade at the time of dosing

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Xiangshui Center for Disease Control and Prevention

Xiangshui, Jiangsu, 224600, China

Location

Related Publications (1)

• Ma F, Zhang L, Jiang R, Zhang J, Wang H, Gao X, Li X, Liu Y. Prospective cohort study of the safety of an influenza A(H1N1) vaccine in pregnant Chinese women. Clin Vaccine Immunol. 2014 Sep;21(9):1282-7. doi: 10.1128/CVI.00375-14. Epub 2014 Jul 2.

  PMID: 24990911 DERIVED

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; RNA Virus Infections

Study Officials

• Fubao Ma

  Jiangsu Province Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 30, 2013
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

CN (1)