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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00954798
• Date of registration: 03/08/2009
• Prospective Registration: No
• Primary sponsor: Sanofi Pasteur, a Sanofi Company
• Public title: A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy European Adults and the Elderly
• Scientific 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
• Date of first enrolment: August 2009
• Target sample size: 450
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00954798
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Medical Monitor
• Affiliation: Sanofi Pasteur Inc.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Swine-origin A/H1N1 Influenza

Intervention(s)

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

Primary Outcome(s)

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]

To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine [Time Frame: 21 days post-vaccination]

Secondary ID(s)

UTN: U1111-1111-4918

GPF07

2009-013344-37

Source(s) of Monetary Support

Please refer to primary and secondary sponsors