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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01929291
Study type Observational
Source GlaxoSmithKline
Contact
Status Completed
Phase
Start date September 23, 2013
Completion date January 11, 2016

See also
  Status Clinical Trial Phase
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Completed NCT02377349 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women Phase 4
Completed NCT02569879 - Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.
Completed NCT00548171 - Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058 Phase 4
Completed NCT01568060 - Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
Completed NCT03311659 - Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects Phase 3
Completed NCT00835237 - Evaluation of GlaxoSmithKline Biologicals' Boostrix® Vaccine in Comparison With Decavac™ Vaccine. Phase 3