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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00908115
Other study ID # 208355/128
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2003
Est. completion date June 23, 2008

Study information

Verified date December 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1258
Est. completion date June 23, 2008
Est. primary completion date June 23, 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Locations

Country Name City State
Korea, Republic of GSK Investigational Site Daegu

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting Serious Adverse Events 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. Since the beginning of the study and during the entire study period (up to 6 years)
Primary Number of Subjects Reporting Solicited Symptoms 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. During the 4-week follow-up period after each dose
Primary Number of Subjects Reporting Unsolicited Adverse Events 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. Within the 31-day (Day 0-30) following vaccination.
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