GSK-112581

Study Sponsor: GSK

Study Title

An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ Inactivated Poliomyelitis vaccine Poliorix administered as a three-dose primary vaccination course at 2, 3 and 4 months of age in healthy infants in China.

Medicine or Vaccine (generic name)

Poliomyelitis Vaccine (Inactivated)

Sponsor Identification Number

112581

Trial Registry Identification Number(#'s)

NCT00937404 2017-001607-80

Medical Condition

Poliomyelitis

Phase

Phase 1

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=112581

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

http://clinicaltrials.gov/show/NCT00937404

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-001607-80

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

An annotated case report form is not available for this study. A blank case report form will be provided. This is primary study with booster study 112683

Date Added to this Site

March 2017