Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

NCT ID: NCT00449670

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-24
• Study Completion Date: 2008-06-10

Brief Summary

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

Detailed Description

The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Influenza; Influenza Vaccines

Study Design

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

Study Groups

H5N1 Adjuvanted Group

Subjects received 2 doses of H5N1 adjuvanted split virus vaccine (lot 1, 2, 3 or 4) containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 during Primary Phase. A subset of these subjects (Boosted sub-cohort) received a single dose of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 during Booster Phase. The remaining subjects (Non-Boosted sub-cohort) received a single booster dose at Month 12 or 36 after initial priming in study 111443 (NCT00652743).

Group Type: EXPERIMENTAL

H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)

Intervention Type: BIOLOGICAL

Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)

Intervention Type: BIOLOGICAL

Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.

H5N1 Un-adjuvanted Group

Subjects received 2 doses of a H5N1 non-adjuvanted split virus vaccine containing A/Vietnam/1194/2004 strain at Day 0 and Day 21 and two booster doses of heterologous H5N1 adjuvanted vaccine containing A/Indonesia/05/2005 strain at Month 6 and Month 6 + 21 days.

Group Type: ACTIVE_COMPARATOR

H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)

Intervention Type: BIOLOGICAL

Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)

Intervention Type: BIOLOGICAL

Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.

Interventions

H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)

Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

Intervention Type: BIOLOGICAL

H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)

Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

Intervention Type: BIOLOGICAL

H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)

Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol
• A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

• Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
• Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups).
• Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine.
• Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required).
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of chronic alcohol consumption and/or drug abuse.
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Acute disease at the time of enrolment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first administration of the candidate vaccine or during the study.
• Lactating women.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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

Hong Kong, , Hong Kong

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Singapore, , Singapore

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Bangkok, , Thailand

Countries

Hong Kong; Singapore; Taiwan; Thailand

References

Chu DW, Hwang SJ, Lim FS, Oh HM, Thongcharoen P, Yang PC, Bock HL, Drame M, Gillard P, Hutagalung Y, Tang H, Teoh YL, Ballou RW; H5N1 Flu Study Group for Hong Kong, Singapore, Taiwan and Thailand. Immunogenicity and tolerability of an AS03(A)-adjuvanted prepandemic influenza vaccine: a phase III study in a large population of Asian adults. Vaccine. 2009 Dec 9;27(52):7428-35. doi: 10.1016/j.vaccine.2009.07.102. Epub 2009 Aug 13.

Reference Type: BACKGROUND

PMID: 19683087 (View on PubMed)

Chu DW, Kwong AS, Tsui WW, Wang JH, Ngai CK, Wan PK, Ong G, Tang HW, Roman F, Dram M, Bock HL. Cross-clade immunogenicity and safety of an AS03A-adjuvanted prepandemic H5N1 influenza vaccine in Hong Kong. Hong Kong Med J. 2011 Feb;17(1):39-46.

Reference Type: BACKGROUND

PMID: 21282825 (View on PubMed)

Hwang SJ, Chang SC, Yu CJ, Chan YJ, Chen TJ, Hsieh SL, Lai HY, Lin MH, Liu JY, Ong G, Roman F, Drame M, Bock HL, Yang PC. Immunogenicity and safety of an AS03(A)-adjuvanted H5N1 influenza vaccine in a Taiwanese population. J Formos Med Assoc. 2011 Dec;110(12):780-6. doi: 10.1016/j.jfma.2011.11.009. Epub 2011 Dec 23.

Reference Type: BACKGROUND

PMID: 22248833 (View on PubMed)

Thongcharoen P, Auewarakul P, Hutagalung Y, Ong G, Gillard P, Drame M, Bock HL. Cross-clade immunogenicity and antigen-sparing with an AS03(A)-adjuvanted prepandemic influenza vaccine in a Thai population. J Med Assoc Thai. 2011 Aug;94(8):916-26.

Reference Type: BACKGROUND

PMID: 21863672 (View on PubMed)

Gillard P, Chu DW, Hwang SJ, Yang PC, Thongcharoen P, Lim FS, Drame M, Walravens K, Roman F. Long-term booster schedules with AS03A-adjuvanted heterologous H5N1 vaccines induces rapid and broad immune responses in Asian adults. BMC Infect Dis. 2014 Mar 15;14:142. doi: 10.1186/1471-2334-14-142.

Reference Type: BACKGROUND

PMID: 24628789 (View on PubMed)

Study Documents

Document Type: Study Protocol

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: Clinical Study Report

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

Document Type: Statistical Analysis Plan

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

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Other Identifiers

109873

Identifier Type: OTHER

Identifier Source: secondary_id

109630

Identifier Type: -

Identifier Source: org_study_id