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

NCT01568060 | Completed

• 1 other identifier: 114917
• Study Type: observational
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acellular Pertussis; Diphtheria; Tetanus; Poliomyelitis; Diphtheria-Tetanus-acellular Pertussis Vaccines

Keywords

Safety; Infanrix-IPV; Post-marketing surveillance; Diphtheria, tetanus, pertussis and poliomyelitis

Outcome Measures

Primary Outcomes (2)

• Occurrence of adverse events

  During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.

• 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

Study Arms (1)

Infanrix-IPV group

Infants and children who received at least one dose of Infanrix-IPV as a part of routine practice at a private clinic or hospital in korea

Other: Infanrix-IPV data collection

Interventions

Infanrix-IPV 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.

Infanrix-IPV group

Eligibility Criteria

• Age: 2 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Seoul, 130-702, South Korea

Location

Related 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.

  PMID: 30668217 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Tetanus; Poliomyelitis; Whooping Cough

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: May 21, 2012
• Primary Completion: December 15, 2015
• Study Completion: December 15, 2015
• Last Updated: January 27, 2023

Record last verified: 2023-01

Locations

KR (1)