Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

NCT ID: NCT01035749

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-01
• Study Completion Date: 2011-05-10

Brief Summary

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

AREPANRIX-ADJUVANTED F1 2D GROUP

Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Group Type: EXPERIMENTAL

GSK Biologicals' Influenza investigational vaccine GSK2340274A

Intervention Type: BIOLOGICAL

One or two doses administered intramuscularly

Placebo (saline)

Intervention Type: BIOLOGICAL

One dose intramuscularly

AREPANRIX-ADJUVANTED F2 2D GROUP

Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Group Type: EXPERIMENTAL

GSK Biologicals' Influenza investigational vaccine GSK2340274A

Intervention Type: BIOLOGICAL

One or two doses administered intramuscularly

Placebo (saline)

Intervention Type: BIOLOGICAL

One dose intramuscularly

AREPANRIX-ADJUVANTED F2 3D GROUP

Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).

Group Type: EXPERIMENTAL

GSK Biologicals' Influenza investigational vaccine GSK2340274A

Intervention Type: BIOLOGICAL

One or two doses administered intramuscularly

AREPANRIX-UNADJUVANTED F2 2D GROUP

Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.

Group Type: EXPERIMENTAL

GSK Biologicals' Influenza investigational vaccine GSK2340273A

Intervention Type: BIOLOGICAL

Two doses intramuscularly

Placebo (saline)

Intervention Type: BIOLOGICAL

One dose intramuscularly

Interventions

GSK Biologicals' Influenza investigational vaccine GSK2340274A

One or two doses administered intramuscularly

Intervention Type: BIOLOGICAL

GSK Biologicals' Influenza investigational vaccine GSK2340273A

Two doses intramuscularly

Intervention Type: BIOLOGICAL

Placebo (saline)

One dose intramuscularly

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Male or female children 10 to < 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.
• Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.

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.
• 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 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; 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tartu, , Estonia

GSK Investigational Site

Cífer, , Slovakia

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Dunajská Streda, , Slovakia

GSK Investigational Site

Nová Dubnica, , Slovakia

GSK Investigational Site

Nové Mesto nad Váhom, , Slovakia

GSK Investigational Site

Púchov, , Slovakia

GSK Investigational Site

Ružomberok, , Slovakia

GSK Investigational Site

Trenčín, , Slovakia

Countries

Estonia; Slovakia

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

113883

Identifier Type: -

Identifier Source: org_study_id