Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00652743
First received: March 21, 2008
Last updated: July 23, 2012
Last verified: September 2011
  Purpose

Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is imminent and could be severe. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the best formulation and vaccination schedule.

The purpose of this study is to assess the immune response of a candidate pandemic vaccine. The protocol posting deals with objectives & outcome measures of the secondary phase of this study. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = 00449670).


Condition Intervention Phase
Pandemic Flu
Biological: Pandemic influenza vaccine GSK1562902A
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response: Serum anti-HA antibody titres [ Time Frame: At Month 12 + 21 days, Month 36 + 21 Days, Month 12 and Month 36 ] [ Designated as safety issue: No ]
  • Humoral immune response: Geometric mean titres [ Time Frame: At Month 12 + 21 days, Month 36 + 21 Days, Month 12, Month 24 and Month 36-boosted subjects ] [ Designated as safety issue: No ]
  • Humoral immune response: Booster response [ Time Frame: At Month 12 + 21 days, Month 36 + 21 Days, Month 12, Month 24 and Month 36-boosted subjects ] [ Designated as safety issue: No ]
  • Humoral immune response: Booster factor [ Time Frame: At Month 12 + 21 days, Month 36 + 21 Days, Month 12, Month 24 and Month 36-boosted subjects ] [ Designated as safety issue: No ]
  • Humoral immune response: Seroprotection rates [ Time Frame: At Month 12 + 21 days, Month 36 + 21 Days, Month 12, Month 24 and Month 36-boosted subjects ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage, intensity and relationship to vaccination of solicited local and general signs & symptoms [ Time Frame: 7-day follow-up after booster vaccination ] [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of unsolicited local & general signs & symptoms [ Time Frame: During 30 days follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Occurrence of adverse events of specific interest (AESIs) [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies: serum anti-HA antibody titres [ Time Frame: Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies: GMTs [ Time Frame: Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies: booster response [ Time Frame: Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies: booster factor [ Time Frame: Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies: seroprotection rate [ Time Frame: Month 18, Month 24, Month 30, Month 36, Month 42 and Month 48 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies: GMTs of H5N1 antibody titres and derived variables in a subset of subjects [ Time Frame: At month 36, at month 12 + 21 days and Month 36 + 21 at Month 12 and Month 36. at Month 48 according to the protocol defined subset of subjects. ] [ Designated as safety issue: No ]
  • CMI response in subject subset in each group: Frequency of antigen-specific CD4/CD8 T-cells producing at least 2 of 4 cytokines (CD40L, IL-2, TNF-α, IFN-γ) upon in vitro stimulation. [ Time Frame: At month 18, month 24, Month 30, Month 36, Month 42 and Month 48. ] [ Designated as safety issue: No ]
  • CMI response in subject subset from the Month 12 and Month 36 boosted subjects: Frequency of antigen-specific CD4/CD8 T-cells producing at least 2 of 4 cytokines (CD40L, IL-2, TNF-α, IFN-γ) upon in vitro stimulation. [ Time Frame: At month 12 + 12 days, Month 36 + 21 days ] [ Designated as safety issue: No ]

Enrollment: 516
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Pandemic influenza vaccine GSK1562902A
IM administration

  Eligibility

Ages Eligible for Study:   19 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who completed participation in primary phase of this study.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • 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 be post-menopausal; 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 4 weeks prior to enrolment in this study.
  • Planned administration of a vaccine not foreseen by the study protocol: 4 weeks prior to any visit or within 30 days after vaccination.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first visit or planned use during the study
  • 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 three months preceding the first visit or planned use during the study.
  • Pregnant or 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 visit, or planned use during the study period.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652743

Locations
Hong Kong
GSK Investigational Site
Hong Kong, Hong Kong
Singapore
GSK Investigational Site
Singapore, Singapore, 308433
GSK Investigational Site
Singapore, Singapore, 529889
Thailand
GSK Investigational Site
Bangkok, Thailand, 10700
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Chu D et al. Immune responses after boosting with a heterologous H5N1 vaccine 36 months after primary vaccination. Abstract presented at the 4th European Influenza Conference - European Scientific Working group on Influenza (ESWI). Malta, 11-14 September 2011.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00652743     History of Changes
Other Study ID Numbers: 111443, 111470, 111471, 111472
Study First Received: March 21, 2008
Last Updated: July 23, 2012
Health Authority: Hong Kong: Department of Health

Keywords provided by GlaxoSmithKline:
immunogenicity
safety
GSK pandemic candidate vaccine

ClinicalTrials.gov processed this record on September 29, 2014