|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
6 February 2023 |
|
Main ID: |
NCT01568060 |
|
Date of registration:
|
29/03/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
|
|
Scientific 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 |
|
Date of first enrolment:
|
May 21, 2012 |
|
Target sample size:
|
645 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01568060 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
GSK Clinical Trials |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
GlaxoSmithKline |
| | |
|
Key inclusion & exclusion 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 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.
Age minimum:
2 Months
Age maximum:
6 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Acellular Pertussis
|
|
Diphtheria-Tetanus-acellular Pertussis Vaccines
|
|
Tetanus
|
|
Diphtheria
|
|
Poliomyelitis
|
|
Intervention(s)
|
|
Other: Infanrix-IPV data collection
|
|
Primary Outcome(s)
|
|
Occurrence of adverse events
[Time Frame: During the 30-day (Day 0 - Day 29) follow-up period after each vaccine dose.]
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|