Immunogenicity and Safety of a Vaccine Against Influenza (2010-2011 Northern Hemisphere Season, Intramuscular Route)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Influenza virus vaccine (split virion, inactivated)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01121822

2009-017690-38 (EudraCT Number)

GRT90

UTN: U1111-1112-8285 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to evaluate the new formulation of the influenza vaccine for the 2010-2011 Northern Hemisphere (NH) season in terms of immunogenicity and safety in the corresponding population and to check its compliance with the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96

Objectives:

To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups
To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups

Full description

Each participant will receive a dose of vaccine on Day 0 and will be followed up for 21 days post-vaccination.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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 vaccination until at least 4 weeks after vaccination
Entitled to national social security.

Exclusion Criteria :

Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
History of pandemic H1N1 influenza vaccination
History of clinically or laboratory confirmed pandemic H1N1 influenza infection
History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine)
Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months
Known or suspected congenital or acquired immunodeficiency, resulting for example from:
- End-stage renal disease requiring dialysis
- Active neoplastic disease or active hematologic malignancy
- Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: 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)
History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
History of thrombocytopenia, contraindicating intramuscular (IM) vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine in the 3 weeks following the trial vaccination
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
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
Identified as employees 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.