Safety of H1N1 Influenza Vaccination in Pregnant Women

Study Overview
=================
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.

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

Conditions
-----------------
Virus Diseases, Respiratory Tract Infections, Influenza, Orthomyxoviridae Infections

Intervention / Treatment
-----------------
* Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of influenza-like illness |  | 0-6months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flu, non-adjuvanted H1N1 vaccine, Safety, pregnant women