Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: GSK Biologicals' GSK2340274A (two different formulations); Biological: GSK Biologicals' - GSK2340272A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01161160

114495

Details and patient eligibility

About

This study is designed to characterize the safety and immunogenicity of pandemic influenza (H1N1) candidate vaccines GSK2340274A and GSK234072A in children 3 to less than 10 years old.

Enrollment: 209 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or pre-menarchal female children 3 to < 10 years of age at the time of the study vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of the study 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.
• Subjects and/or parent(s)/LAR who the investigator believes can and will comply with the requirements of the protocol as documented by signature on the informed consent document (and, if appropriate, the informed assent document).

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 vaccination.
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment (day of study vaccination), 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.
• Administration of any licensed live-attenuated vaccine within 30 days before study vaccination or any licensed inactivated vaccine within 15 days before study vaccination.
• Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 21 phlebotomy.
• Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 21. 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 study vaccination, or planned use during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines; 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 (A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 3 patient groups

AREPANRIX 1/2 GROUP

Experimental group

Description:

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: GSK Biologicals' GSK2340274A (two different formulations)

PANDEMRIX 1/2 GROUP

Experimental group

Description:

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: GSK Biologicals' - GSK2340272A

AREPANRIX GROUP

Experimental group

Description:

Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

Treatment:

Biological: GSK Biologicals' GSK2340274A (two different formulations)