Safety & Immunogenicity of an Alternative Immunization Schedule of GSK Bio's Pandemic Influenza Vaccine (GSK1119711A)
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00430521
First received: February 1, 2007
Last updated: February 9, 2012
Last verified: January 2012
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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:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
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 May 23, 2013