Post Market Surveillance for Infanrix™

NCT00908115 | Completed Results

• 1 other identifier: 208355/128
• Study Type: observational
• Target: 1,258
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria; Acellular Pertussis; Tetanus

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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.

Study Arms (1)

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™

Interventions

GSK Biologicals' Infanrix™ BIOLOGICAL

Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Also known as: DTPa

Infanrix Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All children receiving Infanrix™ were eligible for this survey.

You may qualify if:

• All children receiving Infanrix™ were eligible for this survey.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Daegu, 700-712, South Korea

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diphtheria; Tetanus

Interventions

Pentetic Acid

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: August 1, 2003
• Primary Completion: June 23, 2008
• Study Completion: June 23, 2008
• Last Updated: January 2, 2020
• Results First Posted: July 17, 2009

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

KR (1)