A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
This study has been withdrawn prior to enrollment.
(Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.)
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00866580
First received: March 19, 2009
Last updated: February 24, 2011
Last verified: February 2011
Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | February 24, 2011 | ||||
Start Date ICMJE | May 2010 | ||||
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Serum HI antibody titres [ Time Frame: Day -30, Day 42 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00866580 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine | ||||
Official Title ICMJE | Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A. | ||||
Brief Summary | This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Pandemic Influenza | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Estimated Enrollment ICMJE | 252 | ||||
Estimated Completion Date | July 2011 | ||||
Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 61 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Brazil | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866580 | ||||
Other Study ID Numbers ICMJE | 112865 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | February 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |