Last updated: 06/13/2019 11:50:15
Revaccination with influenza vaccine GSK1247446A
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects with any, grade 3 and related solicited local symptoms
Timeframe: During a 7-day (Days 0-6) follow-up period after re-vaccination
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: During a 7-day (Days 0-6) follow-up after re-vaccination
Number of subjects with any, grade 3 and related unsolicited Adverse Events (AEs)
Timeframe: During a 30-day (Days 0-29) follow-up period after re-vaccination
Number of subjects with any and related Serious Adverse Events (SAEs)
Timeframe: During the entire study period (Days 0-30)
Secondary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease.
Timeframe: At Days 0 and 21
Number of seroconverted subjects against 3 strains of influenza disease.
Timeframe: At Day 21
Number of seroprotected subjects against 3 strains of influenza disease.
Timeframe: At Day 0 and 21
Seroconversion Factor for HI antibodies against 3 strains of influenza disease.
Timeframe: At Day 21
Interventions:
Biological/vaccine: Influenza Vaccine GSK1247446A
Biological/vaccine: Fluarix™
Enrollment:
243
Observational study model:
Not applicable
Primary completion date:
2007-12-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1247446A
Collaborators
Not applicable
Study date(s)
October 2007 to December 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.
Exclusion criteria:
- 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.
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-12-12
Actual study completion date
2007-12-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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