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Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00506350
First received: July 24, 2007
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)

Condition Intervention Phase
Influenza
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Geometric mean titres [ Time Frame: Day 0, Day 21 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroconversion rates [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion rate for anti-HA antibody response is defined as the percentage of vaccinees who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroconversion factors [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
    Seroconversion factor is defined as the fold increase in serum anti-HA antibody GMTs post-vaccination compared to Day 0.

  • Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroprotection rates [ Time Frame: Day 0, Day 21 ] [ Designated as safety issue: No ]
    Seroprotection rate is defined as the percentage of vaccinees with a serum anti-HA antibody titer >= 1:40 that usually is accepted as indicating protection.


Secondary Outcome Measures:
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Geometric mean titres [ Time Frame: days 0, 21, 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroconversion rates [ Time Frame: days 7, 21 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroconversion rate for anti-HA antibody response is defined as the percentage of vaccinees who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer.

  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroconversion factors [ Time Frame: days 7, 21 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroconversion factor is defined as the fold increase in serum anti-HA antibody GMTs post-vaccination compared to Day 0.

  • Humoral immune response in terms of anti-HA antibodies and neutralising antibodies (all groups): Seroprotection rates [ Time Frame: days 0, 7, 14, 21, 28, 35, 42, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]
    Seroprotection rate is defined as the percentage of vaccinees with a serum anti-HA antibody titer >= 1:40 that usually is accepted as indicating protection.

  • Cell-mediated immunity (groups 1, 5 and 9): Frequency of antigen-specific CD4/CD8 cells per 10E6 in tests identified as producing at least two out of four different cytokines [ Time Frame: days 0, 21, Month 6, Month 12, Month 18 and Month 24. ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H5N1 non-AD Formulation 1 Primed Group
Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 1 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Experimental: H5N1 non-AD Formulation 2 Primed Group
Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 2 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Experimental: H5N1 non-AD Formulation 3 Primed Group
Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 3 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Experimental: H5N1 non-AD Formulation 4 Primed Group
Subjects primed with 2 doses of a non-adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 4 in study 106750 (NCT00309634) receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.
Experimental: H5N1 AD Formulation 1 Primed Group
Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 1 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: H5N1 AD Formulation 2 Primed Group
Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 2 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: H5N1 AD Formulation 3 Primed Group
Subjects primed with 2 doses of an adjuvanted investigational H5N1 vaccine (A/Vietnam/1194/04 strain) formulation 3 in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: H5N1 AD Approved Formulation Primed Group
Subjects primed with 2 doses of approved formulation of adjuvanted H5N1 vaccine (A/Vietnam/1194/04 strain) in study 106750 (NCT00309634) received 1 dose of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study at Day 0.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose
A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.
Experimental: Control Group
Unprimed subjects receiving 2 doses of Pandemic influenza candidate vaccine (GSK1562902A) in this booster study, one at Day 0 and one at Day 21.
Biological: Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses
Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.

Detailed Description:
The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. The persistence of antibodies will be analysed at 6, 12, 18 and 24 months.
  Eligibility

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

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • For previously primed subjects: participation in the primary study (NCT00309634).
  • For unprimed subjects: male or female between and including, 19 and 61 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 she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • For unprimed subjects who did not participate in the primary study (NCT00309634): Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a licenced vaccine not foreseen by the study protocol within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) of the first dose of vaccine(s).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Applicable for control group only: previous vaccination with a pandemic candidate vaccine or a vaccine containing the investigational vaccine adjuvant.
  • History of hypersensitivity to vaccines.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • 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 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.
  • Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
  • Lactating female.
  • History of chronic alcohol consumption and/or drug abuse
  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: NCT00506350

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 109817
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00506350     History of Changes
Other Study ID Numbers: 109817 
Study First Received: July 24, 2007
Last Updated: October 6, 2016
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016