Trials / Completed
CompletedNCT01929291
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 682 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Detailed description
Protocol amendment 3 rationale was as follows: * Age for analysis set is specified. * Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination. * Pregnancy notifications must be done within 2 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Boostrix | Single intramuscular injection |
| OTHER | Safety data collection | Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form |
Timeline
- Start date
- 2013-09-23
- Primary completion
- 2016-01-11
- Completion
- 2016-01-11
- First posted
- 2013-08-27
- Last updated
- 2019-09-25
- Results posted
- 2019-03-29
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01929291. Inclusion in this directory is not an endorsement.