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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01053143
First received: January 19, 2010
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Influenza
Pandemic Influenza
Influenza A Virus, H1N1 Subtype
Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the immune response to A/H1N1 pandemic influenza vaccine. [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning antibody persistence 6 months after vaccination with A/H1N1 pandemic influenza vaccine. [ Time Frame: 6 months post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Participants aged 18 years and older at enrollment.
Biological: A/H1N1 pandemic influenza vaccine (non- adjuvanted)
0.5 mL, Intramuscular

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053143

Locations
India
Chandigarh, India, 160012
New Delhi, India, 110001
Pune, India, 411043
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01053143     History of Changes
Other Study ID Numbers: GPF14, UTN: U1111-1111-6149
Study First Received: January 19, 2010
Last Updated: January 10, 2014
Health Authority: India: Ministry of Health

Keywords provided by Sanofi:
Influenza
Pandemic Influenza
Swine-Origin Influenza A/H1N1 Non-adjuvanted Vaccine
Influenza A Virus, H1N1 subtype
Adults

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

ClinicalTrials.gov processed this record on October 22, 2014