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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01568060
First received: March 29, 2012
Last updated: November 6, 2014
Last verified: November 2014

March 29, 2012
November 6, 2014
May 2012
November 2015   (final data collection date for primary outcome measure)
  • Occurrence of adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01568060 on ClinicalTrials.gov Archive Site
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Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
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

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Acellular Pertussis
  • Diphtheria
  • Tetanus
  • Poliomyelitis
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.
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
Intervention: Other: Infanrix-IPV data collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
November 2015
November 2015   (final data collection date for primary outcome measure)

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.
Both
2 Months to 6 Years
Yes
Contact: US GSK Clinical Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Korea, Republic of
 
NCT01568060
114917
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP