Revaccination With Influenza Vaccine GSK1247446A - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00545025

Purpose

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination

Condition	Intervention	Phase
Influenza	Biological: Influenza Vaccine GSK1247446A Biological: Fluarix™	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety Study
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence, intensity and relationship to re-vaccination of solicited local and general signs and symptoms. [ Time Frame: During a 7-day follow-up period after re-vaccination in each group. ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship to re-vaccination of unsolicited adverse events (AEs) [ Time Frame: During a 30-day follow-up period after re-vaccination in each group ] [ Designated as safety issue: Yes ]
Occurrence and relationship to re-vaccination of serious adverse events [ Time Frame: During the entire study period in each group. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine influenza virus strains, in each group [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
For each vaccine strain, geometric mean titre (GMT) of serum HI antibody [ Time Frame: At Days 0 and 21. ] [ Designated as safety issue: No ]
For each vaccine strain, seroconversion rate [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
For each vaccine strain, seroprotection rate [ Time Frame: At Day 0 and 21 ] [ Designated as safety issue: No ]
For each vaccine strain, seroconversion factor [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]

Enrollment:	243
Study Start Date:	October 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator	Biological: Fluarix™ Single dose, Intramuscular injection
Group A: Experimental	Biological: Influenza Vaccine GSK1247446A Single dose, Intramuscular injection

Detailed Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545025

Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110674
Study First Received:	October 15, 2007
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00545025
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

Influenza
Influenza vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009