Last updated: 08/22/2019 07:10:12
Open, multicentric, randomized, compared vaccination study to evaluate non-inferiority of influenza-vaccine Influsplit SSW®/Fluarix™ 2002/2003 versus the adjuvanted influenza-vaccines Fluad® 2002/2003 and Inflexal V® 2002/2003 concerning immunogenicity and reactogenicity in subjects aged over 60 years
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Open, multicentric, randomized, compared vaccination study to evaluate non-inferiority of influenza-vaccine Influsplit SSW®/Fluarix™ 2002/2003 versus the adjuvanted influenza-vaccines Fluad® 2002/2003 and Inflexal V® 2002/2003 concerning immunogenicity and reactogenicity in subjects aged over 60 years
Trial description: Open, multicentric, randomized, compared vaccination study to evaluate non-inferiority of influenza-vaccine Influsplit SSW®/Fluarix™ 2002/2003 versus the adjuvanted influenza-vaccines Fluad® 2002/2003 and Inflexal V® 2002/2003 concerning immunogenicity and reactogenicity in subjects aged over 60 years
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ruf BR et al. (2004) Open, randomized study to compare the immunogenicity and reactogenicity of an influenza split vaccine with an MF59-adjuvanted subunit vaccine and a virosome-based subunit vaccine in elderly. Infect. 32(4):191-198.
Medical condition
Influenza
Product
Influenza Vaccine (Split Virion, Inactivated)
Collaborators
Not applicable
Study date(s)
N/A to Invalid Date
Type
Interventional
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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Access to clinical trial data by researchers
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