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 Subjects Aged 6 to 35 Months - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine

• Conditions: Preventive vaccination in healthy subjects aged 6 to 35 months against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)

• Registration Number: EUCTR2009-013858-32-FI
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects
1) Aged 6 to 35 months on the day of inclusion
2) Informed consent form has been signed and dated by the parent(s) or other legally
acceptable representative
3) Subject and parent/legal representative are able to attend all scheduled visits and
to comply with all trial procedures
4) Completion of vaccination according to the national immunization schedule
Subjects =6 to <24 months of age
5) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg

At V05 (M8) for antibody persistence assessment (amendment 2)
6) Having received two half doses of the 15 µg HA vaccine or of the
3.8 µg HA + AF03 vaccine
7) Addendum 1 to Informed Consent Form has been signed and dated by the
parent(s) or other legally acceptable representative

At V06, for subjects eligible for the Ab persistence evaluation who will receive the TIV (amendment 3):
8)Addendum 2 to Informed Consent Form has been signed by the subject’s parents/legal representative.
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

All subjects
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 antigen, 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) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
12) Family members of the Investigator or of the employees of the study center
13) Previous participation in a trial investigating a vaccine with the swine-origin
A/H1N1 influenza strain
14) Confirmed infection with the swine-origin A/H1N1 influenza strain (different
from the seasonal strain) in 2009
15) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection
on the day of vaccination, according to Investigator judgment
16) 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)
Subjects =6 to <24 months of age
17) History of seizures
At V05 (M8), for antibody persistence assessment (amendment 2)
18) Subjects who received, in the context of a pandemic immunization program,
another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal
Products

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified