Study of Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Bridging Study on Safety and Immunogenicity of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Non-Adjuvanted Vaccine in Healthy Adults in India

The purpose of this study is to assess the safety and immunogenicity of one dose of A/H1N1 non-adjuvanted pandemic vaccine to support registration of the vaccine in India.

Primary Objective:

  • To describe the safety profile (injection site reactions and systemic events) of the vaccine within 21 days following vaccination, and serious adverse events throughout the study in all subjects

Secondary Objectives:

  • To describe the immune response to the vaccine 21 days after vaccination by hemagglutination inhibition (HAI) testing in all subjects
  • To describe the antibody persistence 6 months after vaccination by HAI testing in all subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each study participant will receive one dose of the study vaccine on Day 0, provide pre- and post-vaccination blood samples at 21 and 180 days for immunogenicity testing and undergo safety follow-up for 6 months post-vaccination.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
      • New Delhi, India, 110001
      • Pune, India, 411043

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria :

  • 18 years of age and above on the day of inclusion
  • Provision of informed consent form signed by the participant. If the participant is illiterate, an independent witness is required to sign the consent form.
  • Participant able to attend all scheduled visits and comply with all trial procedures
  • For a female, if sexually active, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine during the study period (except 6 months follow up)
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C as reported by the participant / parent or legal representative and/or based on medical history
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Known thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
  • Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
  • History of influenza infection in 2009-2010
  • Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
  • Known pregnancy, or a positive urine pregnancy
  • Currently breastfeeding a child
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

Temporary contraindication to be resolved before vaccination:

- Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Participants aged 18 years and older at enrollment.
Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)
0.5 mL, Intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the safety profile in terms of solicited injection site reactions, systemic events, and serious adverse events after administration of A/H1N1 pandemic influenza vaccine.
Time Frame: 7 days post-vaccination and entire study duration
7 days post-vaccination and entire study duration

Secondary Outcome Measures

Outcome Measure
Time Frame
To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine.
Time Frame: 21 days post-vaccination
21 days post-vaccination
To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine.
Time Frame: 6 months post-vaccination
6 months post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPF14
  • UTN: U1111-1111-6149 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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