Revaccination With Influenza Vaccine GSK1247446A
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00545025
First received: October 15, 2007
Last updated: June 7, 2012
Last verified: May 2012
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Purpose
The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Influenza, Human |
Biological: Influenza Vaccine GSK1247446A Biological: Fluarix™ |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656 |
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:
- Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: During a 7-day follow-up period after re-vaccination ] [ Designated as safety issue: No ]
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During a 30-day follow-up period after re-vaccination ] [ Designated as safety issue: No ]
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During a 30-day follow-up period after re-vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Subjects Seropositive for Serum Haemagglutination-Inhibition (HI) Antibody Titre [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
- Geometric Mean Titre (GMT) of Serum HI Antibodies [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
- Number of Seroconverted Subjects [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
- Number of Seroprotected Subjects [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
- Seroconversion Factor [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
| Enrollment: | 243 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational Influenza Vaccine GSK1247446A Group
Subjects who received a single dose of investigational Influenza Vaccine GSK1247446A.
|
Biological: Influenza Vaccine GSK1247446A
Single dose, Intramuscular injection
|
|
Active Comparator: Fluarix Group
Subjects who previously received one dose of Fluarix vaccine during study NCT00374842, and who received one dose of Fluarix vaccine during the current study.
|
Biological: Fluarix™
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: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Free of obvious health problems 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 vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period
- Previous vaccination against influenza since January 2007.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration 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 three months preceding the dose of study vaccine or planned administration during the study period.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- Pregnancy.
- 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 More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00545025 History of Changes |
| Other Study ID Numbers: | 110674 |
| Study First Received: | October 15, 2007 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
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 October 17, 2012
