Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations); Biological: Placebo; Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01051661

114000

Details and patient eligibility

About

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

Enrollment: 6,154 patients

Sex: All

Ages: 6 months to 9 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female children 6 months to less than 10 years of age at the time of the first 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 first vaccine dose under this protocol.
• Written informed consent obtained from the subject's parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements).
• Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment.
• Parent(s)/LAR(s) available and accessible for active surveillance contacts.
• Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document.
• Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

Exclusion criteria

• Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.
• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
• 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 (≥ 100.4ºF) 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.
• 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 (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 live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination.
• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. 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.
• Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period.
• Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6,154 participants in 6 patient groups

Arepanrix 2D 6M-3Y Group

Experimental group

Description:

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Arepanrix 2D 3Y-10Y Group

Experimental group

Description:

Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the Arepanrix™ vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Arepanrix 1D 6M-3Y Group

Experimental group

Description:

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Biological: Placebo

Arepanrix 1D 3Y-10Y Group

Experimental group

Description:

Subjects, male and female, aged 3 years (Y) to 10 years, received 1 dose (D) of the Arepanrix™ vaccine followed by 1 dose of saline placebo at a 21-day interval at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Biological: Placebo

GSK2340273A 6M-3Y Group

Experimental group

Description:

Subjects, male and female, aged 6 months (M) to 3 years (Y), received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified) or, for children \<12 months of age, in the left anterolateral thigh. Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm) or, for, children \<12 months of age, in the right anterolateral thigh.

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)

GSK2340273A 3Y-10Y Group

Experimental group

Description:

Subjects, male and female, aged 3 years (Y) to 10 years, received 2 doses (D) of the GSK2340273A vaccine at a 21-day interval (Days 0 and 21). First doses were administered in the deltoid region of the non-dominant arm (or left arm if dominance is not yet identified). Second doses were administered at a 21-day interval in the deltoid region of the dominant arm (or right arm).

Treatment:

Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)