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Post Market Surveillance for Infanrix™

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908115
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : July 17, 2009
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date May 21, 2009
First Posted Date May 25, 2009
Results First Submitted Date May 28, 2009
Results First Posted Date July 17, 2009
Last Update Posted Date January 2, 2020
Actual Study Start Date August 1, 2003
Actual Primary Completion Date June 23, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2019)
  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: Since the beginning of the study and during the entire study period (up to 6 years) ]
    A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
  • Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
    Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: Within the 31-day (Day 0-30) following vaccination. ]
    An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Original Primary Outcome Measures
 (submitted: May 21, 2009)
  • Occurrence of Serious Adverse Events [ Time Frame: Throughout the study ]
  • Occurrence of solicited local symptoms and general symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 4-week follow-up period after each dose ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Market Surveillance for Infanrix™
Official Title Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
Brief Summary

The purpose of this study was to investigate the following questions through post-marketing surveillance:

  • Unknown/Unexpected adverse events and the serious adverse events.
  • The circumstances in which the adverse events occurred under the practical application.
  • Factors considered to have influence on safety.
  • Factors considered to have influence on efficacy.
  • Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All children receiving Infanrix™ were eligible for this survey.
Condition
  • Diphtheria
  • Acellular Pertussis
  • Tetanus
Intervention Biological: GSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection
Other Name: DTPa
Study Groups/Cohorts Infanrix Group
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
Intervention: Biological: GSK Biologicals' Infanrix™
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2009)
1258
Original Actual Enrollment
 (submitted: May 21, 2009)
657
Actual Study Completion Date June 23, 2008
Actual Primary Completion Date June 23, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00908115
Other Study ID Numbers 208355/128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=364
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date December 2019