Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
This study is ongoing, but not recruiting participants.
First Received: August 3, 2009   Last Updated: August 25, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00954798
  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 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 II

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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-Aventis:

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 of Swine A/H1N1 influenza vaccine [ Time Frame: 0 to7 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A/H1N1 Vaccine Group 1: Experimental
Participants will receive A/H1N1 vaccine formulation 1
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21
A/H1N1 Vaccine Group 2: Experimental
Participants will receive A/H1N1 vaccine formulation 2
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21
A/H1N1 Vaccine Group 3: Experimental
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.

  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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954798

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

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: GPF07, UTN: U1111-1111-4918
Study First Received: August 3, 2009
Last Updated: August 25, 2009
ClinicalTrials.gov Identifier: NCT00954798     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

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

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Adjuvants, Immunologic
Influenza, Human
Healthy
Orthomyxoviridae Infections

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

ClinicalTrials.gov processed this record on September 11, 2009