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OpenTrials
Completed

NCT Number: NCT01929291

Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea

The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.

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Key information

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Suwon, 443-380, South Korea

About this study

Protocol amendment 3 rationale was as follows:

  • Age for analysis set is specified.
  • Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
  • Pregnancy notifications must be done within 2 weeks

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.

Exclusion criteria

  • Those who are not eligible for vaccination according to the local Prescribing Information.
  • Child in care.

Treatment and study plan

Boostrix

Biological

Single intramuscular injection

Other names: dTPa vaccine

Safety data collection

Other

Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form

Primary outcomes

  1. Number of Unexpected Adverse Events (AEs)

    Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

    Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.

  2. Number of Expected AEs.

    Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

    Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.

  3. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.

    An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2013
Registry last updated
Sep 25, 2019

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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