Last updated: 11/03/2018 16:15:03
Drug Use Investigation for Arepanrix® (H1N1)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Drug Use Investigation for Arepanrix® (H1N1)
Trial description: This post-marketing surveillance study is designed to collect safety information such as post-vaccination adverse events and adverse reactions from recipients of Arepanrix® (H1N1) Intramuscular Injection. The following items will be investigated as priority investigation items.<Priority investigation items>1) Allergic reactions2) Anaphylaxis
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of recipients who have adverse reactions after injection
Timeframe: 29 days
The number of recipients who have post-vaccination adverse events after injection
Timeframe: 29 days
The number of recipients who have allergic reactions after injection
Timeframe: 29 days
The number of recipients who have anaphylaxis after injection
Timeframe: 29 days
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
3405
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Suminobu Ito et al. (2013) Post-marketing Surveillance of AS03-adjuvanted Influenza (H1N1) Vaccine in Japan. Pharma Medica. 31(4):135-141.
Medical condition
Influenza
Product
GSK2340274A
Collaborators
Not applicable
Study date(s)
February 2010 to October 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
Yes
- Subjects who receive Arepanrix® intramuscular injection for the first time
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who receive Arepanrix® intramuscular injection for the first time
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-29-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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