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
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: 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 July 31, 2014