Evaluate Reactogenicity & Immunogenicity of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults
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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 |
|---|---|---|
|
Pandemic Flu |
Biological: Pandemic influenza candidate vaccine (GSK1562902A) |
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 |
- 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 ]
- Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroconversion factors [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
- Humoral immune response in terms of anti-HA antibodies (adjuvanted groups): Seroprotection rates [ Time Frame: Day 0, Day 21 ] [ Designated as safety issue: No ]
- 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 ]
- 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 ]
- 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 ]
- 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: Group 5
Subjects are planned to receive 1 dose of the candidate vaccine by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 6
Subjects are planned to receive 1 dose of the candidate vaccine by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 7
Subjects are planned to receive 1 dose of the candidate vaccine by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 4
Subjects are planned to receive 2 doses of the candidate vaccine 21 days apart by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 8
Subjects are planned to receive 1 dose of the candidate vaccine by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 3
Subjects are planned to receive 2 doses of the candidate vaccine 21 days apart by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 9
Subjects are planned to receive 2 doses of the candidate vaccine by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 2
Subjects are planned to receive 2 doses of the candidate vaccine 21 days apart by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
|
Experimental: Group 1
Subjects are planned to receive 2 doses of the candidate vaccine 21 days apart by intramuscular injection
|
Biological: Pandemic influenza candidate vaccine (GSK1562902A)
Subjects are planned to receive one or two booster doses of the pandemic influenza candidate vaccine (GSK1562902A). Different formulations (adjuvanted and non-adjuvanted) will be tested.
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00506350 History of Changes |
| Other Study ID Numbers: | 109817 |
| Study First Received: | July 24, 2007 |
| Last Updated: | February 4, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products United States: Food and Drug Administration |
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 May 19, 2013