Last updated: 11/03/2018 19:23:26
A study for evaluation of immunogenicity and reactogenicity of Fluarix/Influsplit SSW 2012/2013 in people aged 18 years and above
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix/Influsplit SSW 2012/2013 in people aged 18 years and above
Trial description: The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals’ trivalent influenza vaccine manufactured for the 2012/2013 influenza season administered in adults (18 to 60 years) and in elderly (over 60 years).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Humoral immune response in terms of Haemagglutination (HA) antibody titers against each of the three vaccine influenza strains
Timeframe: At Day 0 and Day 21
Number of subjects who were seroprotected for anti-HA antibodies against each of the three vaccine influenza strains.
Timeframe: At Day 0 and Day 21
Number of seroconverted subjects for anti-HA antibodies against each of the three vaccine influenza strains.
Timeframe: At Day 21
Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains.
Timeframe: At Day 21
Number of subjects with seroprotection power (SPP) for HI antibody titer against each of the three vaccine influenza strains above the cut-off value.
Timeframe: At Day 21
Secondary outcomes:
Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains.
Timeframe: At Day 0 and Day 21
Number of subjects who were seroprotected for anti-HA antibodies against each of the three vaccine influenza strains.
Timeframe: At Day 0 and Day 21
Number of subjects who seroconverted for anti-HA antibodies against each of the three vaccine influenza strains.
Timeframe: At Day 21
Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains.
Timeframe: At Day 21
Duration of solicited local symptoms.
Timeframe: During the 4-day follow-up period (Days 0-3) after vaccination
Number of subjects reporting any and grade 3 solicited local symptoms.
Timeframe: During the 4-day (Day 0-Day 3) follow-up period after vaccination
Duration of solicited general symptoms.
Timeframe: During the 4-day follow-up period (Days 0-3) after vaccination
Number of subjects reporting any, grade 3 and related solicited general symptoms.
Timeframe: During the 4-day follow-up period (Day 0-3) after vaccination
Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).
Timeframe: During the 21-day follow-up period (Days 0-20) after vaccination
Number of subjects reporting any and related serious adverse events (SAEs)
Timeframe: During the entire study period (Days 0-21)
Interventions:
Biological/vaccine: Fluarix/Influsplit SSW 2012-2013
Enrollment:
119
Observational study model:
Not applicable
Primary completion date:
2012-31-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
July 2012 to July 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female aged 18 years or above at the time of vaccination.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
Inclusion and exclusion criteria
Inclusion criteria:
- A male or female aged 18 years or above at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of vaccination.
Subjects who the investigator believes can and will comply with the requirements of the protocol.
Exclusion criteria:
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period.
- Administration of an influenza vaccine within the six months preceding the study vaccination.
- Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
- Acute disease and/or fever at the time of enrolment.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic underlying disease, not stabilized or clinically serious.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of Guillain-Barré syndrome.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Anaphylaxis following the administration of vaccine(s).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
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
2012-31-07
Actual study completion date
2012-31-07
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
Additional information
Not applicable
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