Safety of H1N1 Influenza Vaccination in Pregnant Women

Sponsor

Jiangsu Province Centers for Disease Control and Prevention (Other)

Overall Status

Completed

CT.gov ID

NCT01842997

Collaborator

(none)

122

Enrollment

Location

Arm

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Virus Diseases Respiratory Tract Infections Influenza Orthomyxoviridae Infections	Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Stratified and Controlled Clinical Trial With Split-virion, Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Pregnant Women

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg 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 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.

Arm

Intervention/Treatment

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

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

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.

Outcome Measures

Primary Outcome Measures

Adverse Pregnancy Outcomes [0-28 days postpartum]
include the following indicators： incidence of spontaneous abortion, incidence of induced abortion，incidence of Preterm, incidence of post-term pregnancy, proportion of underweight-Babies

Secondary Outcome Measures

incidence of influenza-like illness [0-6months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
Psychiatric condition that precludes compliance with the protocol
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent