A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children

Poliomyelitis Clinical Trial

Official title:

Open, Multicentric, PMS Study to Monitor Safety and Reactogenicity of GlaxoSmithKline Biologicals' Poliomyelitis Vaccine (Inactivated)-Poliorix, Administered in Korean Children as a Primary Vaccination in Healthy Subjects Aged 2 to 6 Months or as a Booster Vaccination in Subjects Aged 4 to 6 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514033
• Other study ID #: 108344
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: March 15, 2012
• Start date: July 2007
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).

Description:

An open, multicentric, post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals. Poliomyelitis vaccine (inactivated) -PoliorixTM., administered in Korean children as a primary vaccination in healthy subjects aged two to six months or as a booster vaccination in subjects aged four to six years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 6 Years

Eligibility

Inclusion Criteria:

• A healthy male or female child between two and six months of age (primary vaccination) or between four and six years of age (booster vaccination) at the time of vaccination.

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards)

• Written informed consent obtained from the parent/ guardian of the subject

Exclusion Criteria:

• At the time of study entry, the contraindications and precautions of use indicated in the Korean Label should be checked and the subject must not be included in the study if there is any contraindication or risk

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Poliomyelitis vaccine (inactivated) -PoliorixTM
Deep intramuscular injections for the primary vaccination and booster vaccination.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of unsolicited adverse events.		During 7 days (Day 0 - 6) following vaccination.	No
Primary	Occurrence of serious adverse events (SAEs).		During the entire study period.	No
Secondary	Occurrence of solicited local and general adverse events.		During 7 days (Day 0 to 6) after vaccination	No