A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years. - FLU Q-PAN H1N1-031

• Conditions: Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza

• Registration Number: EUCTR2009-016268-35-SK
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-18
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

Male or female children 10 to less than 18 years of age at the time of the first vaccination. Less than 18 years of age” implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
Written informed consent obtained from the subject’s parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
Good general health as established by medical history and clinical examination before entering into the study.
Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to bring the study subject to scheduled visits) as documented by signature on the informed consent document (and, if appropriate, the informed assent document).

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

Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
Presence of a temperature = 38.0ºC by any route or method, or acute symptoms greater than mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
Diagnosed with cancer, or treatment for cancer, within 3 years. NOTE: Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Receipt of systemic glucocorticoids (e.g., prednisone greater than or equal to 0.5 mg/kg/day, or greater than or equal to 10 mg/day [whichever is less] for more than 14 consecutive days) within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Child in care.

Study & Design

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