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Post Market Surveillance for Infanrix™

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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

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Diphtheria Acellular Pertussis Tetanus Biological: GSK Biologicals' Infanrix™

Study Design
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Study Type : Observational
Actual Enrollment : 1258 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
Actual Study Start Date : August 1, 2003
Actual Primary Completion Date : June 23, 2008
Actual Study Completion Date : June 23, 2008

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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).
 Biological: GSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection
Other Name: DTPa


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children receiving Infanrix™ were eligible for this survey.
Criteria

Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908115


Locations
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Korea, Republic of
GSK Investigational Site
Daegu, Korea, Republic of, 700-712
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208355/128
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00908115    
Other Study ID Numbers: 208355/128
First Posted: May 25, 2009    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
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
Additional relevant MeSH terms:
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Diphtheria
Bacterial Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections