Safety of H1N1 Influenza Vaccination in Pregnant Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
fubaoma, Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01842997
First received: April 24, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Adverse Pregnancy Outcomes [ Time Frame: 0-28 days postpartum ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0-6months ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Cases, cured cases and close contact of influenza A (H1N1) virus
  2. 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
  3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  4. Autoimmune disease or immunodeficiency
  5. 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
  6. Diabetes mellitus (type I or II), with the exception of gestational diabetes
  7. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  8. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  9. 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
  10. 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)
  11. History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
  12. Administration of any other investigational research agents within 30 days before the dosing
  13. Administration of any live attenuated vaccine within 30 days before the dosing
  14. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  15. Axillary temperature > 37.0 centigrade at the time of dosing
  16. Psychiatric condition that precludes compliance with the protocol
  17. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842997

Locations
China, Jiangsu
Xiangshui Center for Disease Control and Prevention
Xiangshui, Jiangsu, China, 224600
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: Fubao Ma Jiangsu Province Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: fubaoma, prof., Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01842997     History of Changes
Other Study ID Numbers: JSEPI-001
Study First Received: April 24, 2013
Last Updated: April 25, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Flu
non-adjuvanted H1N1 vaccine
Safety
pregnant women

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Infections
Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on April 15, 2014