Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568060
• Other study ID #: 114917
• Status: Completed
• Start date: May 21, 2012
• Est. completion date: December 15, 2015

Study information

• Verified date: January 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: December 15, 2015
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Diphtheria-Tetanus-acellular Pertussis Vaccines
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Other:
• Infanrix-IPV data collection
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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events		During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.
Primary	Occurrence of serious adverse events		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