Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children

NCT ID: NCT01323946

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-18
• Study Completion Date: 2012-11-02

Brief Summary

The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

Detailed Description

This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK1562902A 6 to 12 M Group

Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational vaccine GSK1562902A

Intervention Type: BIOLOGICAL

Three intramuscular injections

GSK1562902A 12 to 24 M Group

Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational vaccine GSK1562902A

Intervention Type: BIOLOGICAL

Three intramuscular injections

GSK1562902A 24 to 36 M Group

Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.

Group Type: EXPERIMENTAL

GSK Biologicals' investigational vaccine GSK1562902A

Intervention Type: BIOLOGICAL

Three intramuscular injections

Interventions

GSK Biologicals' investigational vaccine GSK1562902A

Three intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
• Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject.
• Healthy children as established by medical history and clinical examination before entering 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 are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of any neurological disorders or seizures.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
• Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
• Child in care.
• Previous vaccination at any time with an H5N1 vaccine.
• Medical history of physician-confirmed infection with a H5N1 virus.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• 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

Garran, Australian Capital Territory, Australia

GSK Investigational Site

Westmead, New South Wales, Australia

GSK Investigational Site

North Adelaide, South Australia, Australia

GSK Investigational Site

Carlton, Victoria, Australia

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

Countries

Australia; Singapore

References

Nolan T, Izurieta P, Lee BW, Chan PC, Marshall H, Booy R, Drame M, Vaughn DW. Heterologous prime-boost vaccination using an AS03B-adjuvanted influenza A(H5N1) vaccine in infants and children<3 years of age. J Infect Dis. 2014 Dec 1;210(11):1800-10. doi: 10.1093/infdis/jiu359. Epub 2014 Jun 27.

Reference Type: BACKGROUND

PMID: 24973461 (View on PubMed)

Study Documents

Document Type: Annotated Case Report 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: Study Protocol

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: Informed Consent Form

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

2011-004734-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109825

Identifier Type: -

Identifier Source: org_study_id