A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00954798
First received: August 3, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Primary objectives:

  • To describe the immune response to study vaccine 21 days after each vaccination.
  • To describe the antibody persistence 8 months after the first vaccine administration using hemagglutination inhibition (HAI) method in a randomized subset of adult subjects who received two injections.
  • To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 Northern Hemisphere (NH) seasonal trivalent influenza vaccine (TIV) administered 13 months after the first vaccination in a subset subjects who received the A/H1N1 influenza vaccine and in subjects naïve to the swine origin A/H1N1 strain.
  • To describe the safety profiles of study vaccines in all participants.

Condition Intervention Phase
Influenza
Swine-origin A/H1N1 Influenza
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine [ Time Frame: 21 days post-vaccination ] [ Designated as safety issue: No ]
  • To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine [ Time Frame: 0 to7 days post-vaccination and entire study duration ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: August 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A/H1N1 Vaccine Group 1
All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)
Experimental: A/H1N1 Vaccine Group 2
All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13.
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).
Experimental: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and Day 21

Detailed Description:

All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.

  Eligibility

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

Inclusion Criteria :

  • Aged 18 years or over on the day of inclusion
  • Informed Consent Form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination
  • Entitled to national social security

At Visit 05, for antibody persistence assessment:

  • Addendum 1 to Informed Consent Form has been signed and dated
  • Having received two vaccinations with the vaccine formulation 1 or 2.

At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine:

- Addendum 2 to Informed Consent Form has been signed and dated

Exclusion Criteria :

  • Known pregnancy, or a positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • 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)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • 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
  • Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
  • 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
  • Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • 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)

At Month 8, for antibody persistence assessment:

- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.

Additional criteria for subset to receive only the TIV:

  • History of pandemic A/H1N1 influenza vaccination
  • History of clinically or laboratory confirmed pandemic A/H1N1 influenza infection
  • Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
  • Planned receipt of any vaccine during the present trial period.
  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: NCT00954798

Locations
France
Angers, France, 49000
Chateau Gontier, France, 53200
Cherbourg, France, 50100
Equeurdreville, France, 50120
Laval, France, 53000
Tierce, France, 49125
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00954798     History of Changes
Other Study ID Numbers: GPF07, UTN: U1111-1111-4918, 2009-013344-37
Study First Received: August 3, 2009
Last Updated: January 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sanofi:
Influenza
Pandemic Flu
Swine-origin Influenza
Inactivated split-virion vaccine
Adjuvant
Adult

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

ClinicalTrials.gov processed this record on September 29, 2014