Preventive vaccination in healthy subjects aged 3 to 17 years against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)
Conditions
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of Informed Consent Form signed by the subject's the parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 6 to 11 years, and of Informed Consent Form signed by subjects =12 years. 2) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures 3) Aged 3 to 17 years on the day of inclusion 4) For a female of childbearing potential, 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 At V05 (M8), for antibody persistence assessment (amendment 2) 5) Having received two injections of the 15 µg HA vaccine or of the 3.8 µg HA + AF03 vaccine 6) Addendum 1 to Informed Consent Form has been signed by the subject's parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 1 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 1 to Informed Consent Form signed by subjects =12 years At V06, for subjects eligible for the Ab persistence evaluation who will receive the TIV (amendment 3): 7) Addendum 2 to Informed Consent Form has been signed by the subject and/or subject’s parent(s)/guardian(s) (and by an independent witness if required by local regulations). In addition, provision of addendum 2 to Assent Form signed by subjects aged 6 to 11 years, and of addendum 2 to Informed Consent Form signed by subjects =12 years Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination 2) Planned participation in another clinical trial during the present trial period 3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination 4) Planned receipt of any vaccine prior to the Day 42 blood sample 5) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 6) 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) 7) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C as reported by parents/legal representative 8) 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 9) Thrombocytopenia, contraindicating IM vaccination as reported by parents/legal representative 10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 11) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 12) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 13) 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 14) Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain 15) Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009 16) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment 17) 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) 18) Known pregnancy, or a positive urine pregnancy test 19) Currently breastfeeding a child 20) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures At V05 (M8), for antibody persistence assessment (amendment 2) 21) Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the immune response of each candidate vaccine 21 days after each vaccination by HAI and SN testing in all subjects. • To describe the safety profiles (injection site reactions, and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all subjects • To describe the antibody persistence eight months (M8) after the first vaccine administration using HAI method, in a subset of subjects who received two injections of either the 15 µg HA or 3.8 µg HA + AF03 vaccine (amendment 2) • To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of subjects who received two injections of either the 15 µg HA or 3.8 µg HA + AF03 vaccine for primary vaccination series (amendment 3);Secondary Objective: Not applicable;Primary end point(s): A) Immunogenicity * Primary Vaccination Series and Ab Persistence: HAI antibody (Ab) titers against the swine origin A/H1N1 strain measured with HAI method will be expressed as described below: • HAI Ab titers will be obtained on D0, D21, and D42. The following endpoints will be derived: • Individual titers ratios D21/D0, D42/D0, and D42/D21 • Subjects with HAI Ab titer =40 (1/dilution [dil]) on D0, D21, and D42 • Subjects with seroconversion or significant increase in HAI Ab titer, from D0 to D21 and from D0 to D42: - Seroconversion for subjects with a pre-vaccination titer 38°C (pyrexia) for 24 hours or more in the 3 days following each injection - Malaise in the 3 days following each injection - Shivering (chills) in the 3 days following each injection • Occurrence of SAEs including AESIs within the 21 days following each/any (for primary series only) vaccination, and up to the end of the trial. • Occurrence of biochemical or hematological test results of a | — |
Countries
Finland
Outcome results
None listed