Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00510874
First received: August 1, 2007
Last updated: April 14, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase I/II, Observer-Blind, Randomized, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Two-Dose Series of GSK Biologicals' Candidate Influenza Vaccine GSK 1557484A Antigens With or Without Adjuvant |
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:
- Vaccine-homologous virus antibody response in subjects receiving two doses of vaccine, as demonstrated by the hemagglutination-inhibition (HI) antibody titer [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
- The occurrence of specifically-solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after each dose of vaccine and overall considering both post-immunization periods. ] [ Designated as safety issue: No ]
- The occurrence of unsolicited adverse events (AEs) [ Time Frame: During a 21-day follow-up period after the first vaccination and 21 days after the second vaccination, as well as overall. ] [ Designated as safety issue: No ]
- The occurrence of serious adverse events (SAEs), medically-attended events, and new onset chronic diseases [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The vaccine-homologous virus antibody response in subjects receiving two doses of vaccine, as demonstrated by the HI antibody titer [ Time Frame: At Day 42. ] [ Designated as safety issue: No ]
- The vaccine-homologous virus antibody response, and also persistence of this response. [ Time Frame: At 21 days following receipt of a first dose of vaccine through approximately 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 780 |
| Study Start Date: | July 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 |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
| Experimental: Group B |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
| Experimental: Group C |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
| Experimental: Group D |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
| Experimental: Group E |
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
|
Experimental: Group F (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
|
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
|
Experimental: Group G (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
|
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
|
Experimental: Group H (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
|
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
|
Experimental: Group I (contingent)
Based on an analysis concerning immunogenicity performance at Day 42, 2 of 4 possible additional groups will be recruited, randomized, and studied
|
Biological: Influenza vaccine GSK 1557484A - 9 different formulations, of which 7 will be tested
Intramuscular injection, 2 doses
|
Detailed Description:
The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male and female adults 18 to 64 years of age at time of first vaccination, inclusive.
- Good general health as assessed by medical history and physical examination.
- Access to a consistent means of telephone contact
- Written informed consent obtained from the subject.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion Criteria:
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Blood pressure abnormalities
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll, but other histologic types of skin cancer are exclusionary.
- Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
- Presence of an oral temperature ≥ 37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Receipt of cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- Administration of any non-influenza vaccines within 30 days before study enrollment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the study period.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any known or suspected allergy to any constituent of influenza vaccines.
- Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21.
- Lactating or nursing.
- Women of child bearing potential who lack a history of reliable contraceptive practices.
- Known receipt of analgesic or antipyretic medication on the day of treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510874
Locations
| United States, Alabama | |
| GSK Investigational Site | |
| Huntsville, Alabama, United States, 35802 | |
| United States, California | |
| GSK Investigational Site | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33143 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Stockbridge, Georgia, United States, 30281 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Lenexa, Kansas, United States, 66219 | |
| United States, Montana | |
| GSK Investigational Site | |
| Missoula, Montana, United States, 59801 | |
| United States, Nevada | |
| GSK Investigational Site | |
| Las Vegas, Nevada, United States, 89104 | |
| Canada, Nova Scotia | |
| GSK Investigational Site | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| GSK Investigational Site | |
| Truro, Nova Scotia, Canada, B2N 1L2 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 4J6 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
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: | NCT00510874 History of Changes |
| Other Study ID Numbers: | 110028 |
| Study First Received: | August 1, 2007 |
| Last Updated: | April 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Influenza GSK 1557484A vaccine |
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 16, 2013