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OpenTrials
Completed

NCT Number: NCT00406562

Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.

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Key information

Conditions

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

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site

Suining, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female between, and including, 6-8 years of age at the time of vaccination,
  • Written informed consent obtained from the parent or guardian of the subject,
  • Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,

Exclusion criteria

  • subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate
  • Subjects with history of diphtheria, pertussis or tetanus diseases can not participate

Treatment and study plan

Boostrix

Biological

Primary outcomes

  1. Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age.

Important dates

Study start
2007
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
Oct 27, 2016

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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