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Safety of H1N1 Influenza Vaccination in Pregnant Women

Primary Purpose

Virus Diseases, Respiratory Tract Infections, Influenza

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Virus Diseases focused on measuring Flu, non-adjuvanted H1N1 vaccine, Safety, pregnant women

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Xiangshui Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

incidence of influenza-like illness

Full Information

NCT ID

NCT01842997

First Posted

April 24, 2013

Last Updated

April 25, 2013

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01842997

Brief Title

Safety of H1N1 Influenza Vaccination in Pregnant Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Virus Diseases, Respiratory Tract Infections, Influenza, Orthomyxoviridae Infections

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Adverse Pregnancy Outcomes

Description

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

Secondary Outcome Measure Information:

Title

incidence of influenza-like illness

Time Frame

0-6months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fubao Ma

Organizational Affiliation

Jiangsu Province Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xiangshui Center for Disease Control and Prevention

City

Xiangshui

State/Province

Jiangsu

ZIP/Postal Code

224600

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

24990911

Citation

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.

Results Reference

derived

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Safety of H1N1 Influenza Vaccination in Pregnant Women

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