Recruitment

Recruitment Status
Completed
Estimated Enrollment
600

Inclusion Criterias

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.
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 Criterias

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

Summary

Conditions
Diphtheria-Tetanus-acellular Pertussis Vaccines
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 10 years and 125 years
Gender
Both males and females

Description

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

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

Inclusion Criterias

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.
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 Criterias

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

Locations

Suwon-si, 443-380
Suwon-si, 443-380

Tracking Information

NCT #
NCT01929291
Collaborators
Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline