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OpenTrials
Completed

NCT Number: NCT00297856

Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine

Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Key information

Conditions

Diphtheria Acellular Pertussis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Gram-Positive Bacterial Infections Infections Tetanus

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Oakland, California, 94612, United States

About this study

Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available

Treatment and study plan

Boostrix®

Biological

Single dose

Td (Tetanus diphtheria) vaccine

Biological

Single dose

Primary outcomes

  1. Occurrence of medically-attended neurological events.

    Time frame: 30 days following vaccination with Boostrix.

Secondary outcomes

  1. Occurrence of medically-attended hematologic events

    Time frame: 30 days following vaccination with Boostrix

  2. Occurrence of allergic reactions.

    Time frame: 30 days following vaccination with Boostrix

  3. Occurrence of new onset chronic illnesses

    Time frame: 6-month period following vaccination with Boostrix

  4. Occurrence of neurological and hematological events and allergic reactions

    Time frame: Within the second 30-day period following vaccination with Boostrix

  5. Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 1, 2006
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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