Last updated: 02/20/2024 09:21:46
Study to collect and assess information about the safety of GlaxoSmithKline’s Rabipur Injection
GSK study ID
212403
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title:
Trial description: The purpose of this study is to assess the safety of Rabipur vaccine in Japanese for the first time (Common to Both Immunizations).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of Adverse Drug Reactions (ADRs)
Timeframe: From the initial date of vaccination through one week after the final vaccination (approximately 4 years)
Occurrence of events defined as concern in the safety specification
Timeframe: From the initial date of vaccination through one week after the final vaccination (approximately 4 years)
Proportion of rabies occurrence for postexposure immunization
Timeframe: From the initial date of vaccination through one week after the final vaccination (approximately 4 years)
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
630
Primary completion date:
2025-30-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Virus Diseases
Product
GSK3536851A
Collaborators
Not applicable
Study date(s)
January 2021 to September 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Subjects who receive Rabipur for the first time with the objective of preexposure immunization for rabies prophylaxis or postexposure immunization for rabies prevention
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who receive Rabipur for the first time with the objective of preexposure immunization for rabies prophylaxis or postexposure immunization for rabies prevention
Exclusion criteria:
- N/A
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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