Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00321763
First received: May 3, 2006
Last updated: November 10, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations Biological: Fluarix TM |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate & Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate vs Fluarix™ Administered Intramuscularly in Elderly |
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 haemagglutination-inhibition (HI) antibody titre, against each of the 3 vaccine influenza virus strains, in a subset of subjects of groups A, B & C [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
- Occurrence of rare events(adverse events), in subjects in groups A, B & C [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after vaccination in each group ] [ Designated as safety issue: No ]
- Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: During a 30 day follow-up period after vaccination in each group. ] [ Designated as safety issue: No ]
- Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
- Occurrence of new onset chronic diseases [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
- Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Serum HI antibody titre in a subset of subjects in groups A, B & C [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
| Enrollment: | 3124 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group A |
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
|
| Experimental: Group B |
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
|
| Experimental: Group C |
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
|
| Active Comparator: Group D |
Biological: Fluarix TM
Single dose, Intramuscular injection
|
Detailed Description:
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female age 60 years or older at the time of the vaccination.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321763
Hide Study Locations
Hide Study LocationsLocations
| Estonia | |
| GSK Investigational Site | |
| Tartu, Estonia, 50417 | |
| France | |
| GSK Investigational Site | |
| Caen cedex 4, France, 14052 | |
| GSK Investigational Site | |
| Gières, France, 38610 | |
| GSK Investigational Site | |
| Lagord, France, 17140 | |
| GSK Investigational Site | |
| Lille, France, 59019 | |
| GSK Investigational Site | |
| Montpellier Cedex 5, France, 34295 | |
| GSK Investigational Site | |
| Paris, France, 75679 | |
| GSK Investigational Site | |
| Poitiers, France, 86000 | |
| GSK Investigational Site | |
| Rouen, France, 76100 | |
| GSK Investigational Site | |
| Toulouse, France, 31300 | |
| Germany | |
| GSK Investigational Site | |
| Haag, Bayern, Germany, 83527 | |
| GSK Investigational Site | |
| Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635 | |
| GSK Investigational Site | |
| Marktl, Bayern, Germany, 84533 | |
| GSK Investigational Site | |
| Oberaudorf, Bayern, Germany, 83080 | |
| GSK Investigational Site | |
| Ketzin, Brandenburg, Germany, 14669 | |
| GSK Investigational Site | |
| Koenigslutter, Niedersachsen, Germany, 38154 | |
| GSK Investigational Site | |
| Tostedt, Niedersachsen, Germany, 21255 | |
| GSK Investigational Site | |
| Wolmirstedt, Sachsen-Anhalt, Germany, 39326 | |
| GSK Investigational Site | |
| Delitzsch, Sachsen, Germany, 04509 | |
| GSK Investigational Site | |
| Freital, Sachsen, Germany, 01705 | |
| GSK Investigational Site | |
| Kamenz, Sachsen, Germany, 01917 | |
| GSK Investigational Site | |
| Pirna, Sachsen, Germany, 01796 | |
| GSK Investigational Site | |
| Weissenberg, Sachsen, Germany, 02627 | |
| GSK Investigational Site | |
| Bad Bramstedt, Schleswig-Holstein, Germany, 24576 | |
| Greece | |
| GSK Investigational Site | |
| Athens, Greece, 11527 | |
| GSK Investigational Site | |
| Goudi / Athens, Greece, 115 27 | |
| GSK Investigational Site | |
| Haidari, Greece, 124 62 | |
| GSK Investigational Site | |
| Marousi, Greece, 151 26 | |
| GSK Investigational Site | |
| Nikaia Piraeus, Greece, 184 54 | |
| GSK Investigational Site | |
| Orestiada, Greece, 682 00 | |
| GSK Investigational Site | |
| Papagos/Athens, Greece, 15669 | |
| GSK Investigational Site | |
| Thessaloniki, Greece, 54642 | |
| Norway | |
| GSK Investigational Site | |
| Elverum, Norway, 2408 | |
| GSK Investigational Site | |
| Hamar, Norway, 2317 | |
| GSK Investigational Site | |
| Paradis, Norway, 5231 | |
| GSK Investigational Site | |
| Stavanger, Norway, 4010 | |
| Russian Federation | |
| GSK Investigational Site | |
| Ekaterinburg, Russian Federation, 620078 | |
| GSK Investigational Site | |
| Kazan, Russian Federation, 420015 | |
| GSK Investigational Site | |
| Saratov, Russian Federation, 410018 | |
| United Kingdom | |
| GSK Investigational Site | |
| Reading, Berkshire, United Kingdom, RG2 7AG | |
| GSK Investigational Site | |
| Cardiff, Glamorgan, United Kingdom, CF14 5GJ | |
| GSK Investigational Site | |
| Glasgow, Lanarkshire, United Kingdom, G81 4SA | |
| GSK Investigational Site | |
| Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA | |
| GSK Investigational Site | |
| Manchester, United Kingdom, M15 6SX | |
| GSK Investigational Site | |
| Waterloo, Liverpool, United Kingdom, L22 0LG | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00321763 History of Changes |
| Other Study ID Numbers: | 107192, 107214 |
| Study First Received: | May 3, 2006 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
Influenza Influenza 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