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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01568060
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : April 25, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Acellular Pertussis Diphtheria Tetanus Poliomyelitis Other: Infanrix-IPV data collection

Study Type : Observational
Actual Enrollment : 645 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort Intervention/treatment
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
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.

Primary Outcome Measures :
  1. Occurrence of adverse events [ Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose. ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01568060

Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 130-702
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01568060     History of Changes
Other Study ID Numbers: 114917
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

Keywords provided by GlaxoSmithKline:
Post-marketing surveillance
Diphtheria, tetanus, pertussis and poliomyelitis

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases