Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00430521
First received: February 1, 2007
Last updated: February 9, 2012
Last verified: January 2012
  Purpose

The aim of the study is to assess the safety & immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Pandemic Flu
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reactogenicity and Immunogenicity Study of GlaxoSmithKline Biologicals Pandemic Influenza Vaccine (GSK1119711A) Administered According to Different Vaccination Schedules

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum anti-haemagglutinin (HA)antibody titers, in Group C [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6 + 21 Days ] [ Designated as safety issue: No ]
  • Geometric mean titres (GMTs) of H5N1 antibody titers [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroconversion rates (SC) [ Time Frame: At Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroconversion factors [ Time Frame: At Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At Day 0, Month 6, Month 6+ 7 Days, Month 6+ 21 Days ] [ Designated as safety issue: No ]
  • Occurence of solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after each vaccination and overall. ] [ Designated as safety issue: Yes ]
  • Occurence of unsolicited local and general signs and symptoms [ Time Frame: During a 30-day follow-up period after priming vaccination(s) and booster vaccination, and overall. ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • GMTs of anti-HA antibody titres [ Time Frame: At Day 0, Day 21, Day 42, Month 6/12, Month 6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Seroconversion rates [ Time Frame: At Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18. ] [ Designated as safety issue: No ]
  • In addition, humoral immune response in terms of anti-HA antibodies: Seroconversion factors [ Time Frame: At Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At Day 0, Day 21, Day 42, Month 6/12, Month .6/12 + 7days, Month 6/12 + 21 days, Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least two different cytokines [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least CD40L and another signal molecule (IL-2, IFN-γ, TNF-α) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least IL-2 and another signal molecule (CD40L, IFN-γ, TNF-α) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]
  • Frequency of influenza-specific CD4/CD8 T-cells per 10E6 in tests producing at least TNF-α and another signal molecule (IL-2, IFN-γ, CD40L) [ Time Frame: At Day 0, Month 6/12, Month 6/12 + 7 Days, Month 6/12 + 21 Days and Month 18 ] [ Designated as safety issue: No ]

Enrollment: 512
Study Start Date: February 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects received two doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group B
Subjects received two doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group C
Subjects received two doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group D
Subjects received two doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group E
Subjects received three doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group F
Subjects received three doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group G
Subjects received three doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
2 or 3 doses, intramuscular injection, at different time points.
Experimental: Group H
Subjects received three doses of vaccine
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 1
2 or 3 doses, intramuscular injection, at different time points.
Biological: Pandemic influenza vaccine (GSK1119711A)-formulation 2
2 or 3 doses, intramuscular injection, at different time points.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • 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 be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

  • Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
  • History of vaccination with investigational influenza pandemic vaccine.
  • History of administration of an experimental/licensed vaccine
  • Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
  • 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, based on 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 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430521

Locations
Germany
GSK Investigational Site
Deggendorf, Bayern, Germany, 94469
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Neu-Ulm, Bayern, Germany, 89231
GSK Investigational Site
Regensburg, Bayern, Germany, 93053
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Hamburg, Germany, 20253
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Schwarz TF et al. AS03-adjuvanted pre-pandemic H5N1 vaccines in a randomized trial: Single dose Clade 1 strain primary vaccination enables a strong, broad and rapid immune response to Clade 2 strain booster vaccination in adults. Abstract presented at the 3rd International Conference on Influenza Vaccines for the World (IVW), Cannes, France, 27-30 April 2009.
Roman F et al. AS03 adjuvant system prepares the immune system for a fast and strong immune response after vaccination with a heterologous H5N1 influenza vaccine. Abstract presented at the 3rd Vaccine Global Congress, Singapore, Singapore, 4-6 October 2009.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00430521     History of Changes
Other Study ID Numbers: 107495
Study First Received: February 1, 2007
Last Updated: February 9, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
Pandemic Flu
Pandemic influenza vaccine (GSK1119711A)

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014