Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
This study is not yet open for participant recruitment.
Verified January 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01568060
First received: March 29, 2012
Last updated: February 14, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
| Condition | Intervention |
|---|---|
|
Poliomyelitis Pertussis Diphtheria Tetanus |
Other: Infanrix-IPV data collection |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 2 Months to 6 Years |
| Genders Eligible for Study: | Both |
| 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.
Criteria
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 enrolment of the subject into the post-marketing surveillance, the subject's parents/legally acceptable representatives will be requested to provide information regarding the enrolment 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568060
Contacts
| Contact: US GSK Clinical Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Korea, Republic of | |
| GSK Investigational Site | Recruiting |
| Seoul, Korea, Republic of, 130-702 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01568060 History of Changes |
| Other Study ID Numbers: | 114917 |
| Study First Received: | March 29, 2012 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Safety Infanrix-IPV Post-marketing surveillance Diphtheria, tetanus, pertussis and poliomyelitis |
Additional relevant MeSH terms:
|
Whooping Cough Diphtheria Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections Infection Respiratory Tract Diseases Myelitis |
Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Hypocalcemia Calcium Metabolism Disorders |
ClinicalTrials.gov processed this record on May 23, 2013