GSK-110084

Study Sponsor: GSK

Study Title

Persistence study of GSK Biologicals’ Tdap vaccine (776423), 1, 3, 5 and 9 years following administration as a single dose in NCT00346073 study and to evaluate the immunogenicity and safety of Boostrix as a second dose of Tdap, when administered at Year 9

Medicine or Vaccine (generic name)

Combined Reduced Antigen Content Diphtheria, Tetanus, Acellular Pertussis Vaccine

Sponsor Identification Number

110084

Trial Registry Identification Number(#'s)

NCT00489970

Medical Condition

Diphtheria; Tetanus; Acellular pertussis

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=110080

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT00489970

Link to study details on EudraCT (if available)

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

This is a follow-up study to 106316. Follow-on studies were conducted: 110080, 110082, 110086 and posted under 110080 on the GSK Study Register. A reporting and analysis plan is not available for this study.

Date Added to this Site

June 2018