Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318149
First received: April 25, 2006
Last updated: December 16, 2010
Last verified: December 2010
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Purpose
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults, probably as a result of immunosenescence, there is a desire to devise ways to increase the current vaccines efficacy for this target population. Adjuvants are known to boost immune responses, thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix™ influenza vaccine in elderly subjects. The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects. For immunogenicity and safety evaluations, healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix™ and form the control groups of this trial.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Fluarix, 4 adjuvanted candidate influenza vaccines |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Demonstrate the Non Inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population (Aged 65 y & Older) vs Fluarix™ (Known as Alpha-Rix™ in Belgium) Administered in Adults (18-40 y) |
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:
- To demonstrate the non inferiority 21 d post-vaccination of the influenza adjuvanted vaccines administered in elderly subjects (aged 65 y and older) [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
- as compared to Fluarix™ administered in adults (aged 18-40 y) in terms of cellular mediated immune response. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety and reactogenicity of vaccination with adjuvanted influenza vaccines during 21 d following the intramuscular administration of the vaccine [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
- in elderly subjects (aged 65 y and older). Fluarix will be used as reference. [ Time Frame: 21 days post vaccination ] [ Designated as safety issue: No ]
- To evaluate the humoral immune response (anti-haemagglutinin titre) 21,90 and 180d after vaccination with influenza adjuvanted candidate vaccines. [ Time Frame: 21, 90 and 180 days post vaccination ] [ Designated as safety issue: No ]
| Enrollment: | 425 |
| Study Start Date: | October 2005 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: Fluarix, 4 adjuvanted candidate influenza vaccines
- Fluarix
- 4 adjuvanted candidate influenza vaccines
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female aged between 18 and 40 years or aged 65 years or older at the time of the vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
- History of confirmed influenza infection since a year from the date of previous vaccination.
- 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.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00318149 History of Changes |
| Other Study ID Numbers: | 104886 |
| Study First Received: | April 25, 2006 |
| Last Updated: | December 16, 2010 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
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 22, 2013