Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Phase III Vaccination Study for Evaluation of Immunogenicity and Reactogenicity of Influsplit SSW 2004/2005 in People age 18 or beyond
Trial description: A pre-requisite to the yearly licensing process of the Influenza vaccine (FluarixTM/ Influsplit SSW®) is to demonstrate in clinical studies, the immunogenicity and reactogenicity of the vaccine composed of the new strains (2005/2006).
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Influsplit SSW®
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
July 2005 to August 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
- All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
Inclusion and exclusion criteria
Inclusion criteria:
- All Subjects, enrolled in this study, must not been immunized against Influenza within the season 2003/2004.
- Written informed consent obtained from the subject must be available, after the subject has been informed in an understandable language.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return, and follow-up visits) should be enrolled in the study.
Exclusion criteria:
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature / axillary temperature <37.5°C (99.5°F).
- Acute clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Pregnancy (exclusion by safe contraception; pregnancy test at day 0.
- Known allergic reactions, probably caused by one or more vaccine ingredients.
- Drug and/or Alcohol abusers
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of 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
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-08-08
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.
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