Clinical trial NCT01568060: Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
Official title: Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus Vaccine, Infanrix-IPV When Administered According to the Approved Prescribing Information in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acellular Pertussis
Diphtheria
Tetanus
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines
Keywords: Safety
Infanrix-IPV
Post-marketing surveillance
Diphtheria, tetanus, pertussis and poliomyelitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 645
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children who receive at least one dose of Infanrix-IPV as a part of routine practice at a private clinic or hospital.

Brief summary: The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol.
* Korean male or female subjects who are eligible for the primary and/or booster doses of Infanrix-IPV according to the Korean Prescribing Information.
* Written or signed informed consent obtained from the parent(s)/ legally acceptable representative(s) of the child. Where parent(s)/ legally acceptable representatives are illiterate, the consent form will be countersigned by an impartial witness. Prior to enrollment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrollment of their child in a same/similar study previously. And prior to obtaining informed consent form, the investigator will check whether the subject is eligible for vaccination.

Exclusion Criteria:

* At the time of post-marketing surveillance (PMS) entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the subject must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
* Subjects who receive any investigational or non-licensed DTPa-IPV vaccine within 30 days prior to study start will not be enrolled.
* Child in care.

Primary outcomes:
measure: Occurrence of adverse events
timeFrame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
measure: Occurrence of serious adverse events
timeFrame: Starting at Visit 1 in the post-marketing surveillance (PMS) up to 30 days (Day 0 to Day 29) after the last dose is administered in the PMS
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lee SM, Kim SJ, Chen J, Song R, Kim JH, Devadiga R, Kim YK. Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children. Hum Vaccin Immunother. 2019;15(5):1145-1153. doi: 10.1080/21645515.2019.1572406. Epub 2019 Mar 19.