Study to Evaluate the Safety and Immunogenicity of GSK Biological Pandemic Candidate Influenza Vaccine (H1N1) in Children

NCT ID: NCT01014091

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-01
• Study Completion Date: 2011-01-14

Brief Summary

The objective of this study is to evaluate the safety and immunogenicity study of GSK Biologicals' pandemic influenza candidate vaccine (GSK2340272A) in children aged 3 to 9 years.

Conditions

Influenza

Study Design

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

Study Groups

GSK2340272A F1 Y3-5 GROUP

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

GSK2340272A F1 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

GSK2340272A F2 Y3-5 GROUP

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

GSK2340272A F2 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

GSK2340272A F3 Y3-5 GROUP

Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

GSK2340272A F3 Y6-9 GROUP

Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

Group Type: EXPERIMENTAL

GSK pandemic vaccine GSK2340272A

Intervention Type: BIOLOGICAL

2 intramuscular injections

Interventions

GSK pandemic vaccine GSK2340272A

2 intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
• Children, male or female, aged between 3 and 9 years at the time of first study vaccination.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject.
• Healthy children, as established by medical history and clinical examination when entering the study.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Clinically or virologically confirmed influenza infection within six months preceding the study start.
• Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
• Have received any seasonal flu vaccine since last year.
• Previous administration of any H1N1 A/California-like vaccine
• Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment:

• Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38°C on rectal setting.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
• Child in Care.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 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

Děčín, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Prague, , Czechia

Countries

Czechia

Study Documents

Document Type: Study Protocol

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: Clinical Study Report

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

Document Type: Annotated Case Report Form

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

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

113810

Identifier Type: -

Identifier Source: org_study_id