Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01248988
First received: November 24, 2010
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 Synflorix™ among infants in Korea.
| Condition | Intervention |
|---|---|
|
Pneumococcal Diseases |
Other: Synflorix™ Data collection |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Safety of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal-protein D-diphtheria Toxoid-tetanus Toxoid Conjugate (10PN-PD-DiT) Vaccine, Synflorix When Administered According to the Approved Prescribing Information in Korea |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of unexpected 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 expected 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: From the first dose in the study up to 30 days (Day 0 - Day 29) after the last dose. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Synflorix Group
Infants and children who received at least one dose of Synflorix™ as a part of routine practice at a private clinic or hospital
|
Other: Synflorix™ Data collection
Safety monitoring: recording of adverse events during 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: | 6 Weeks to 23 Months |
| 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 Synflorix 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 Representatives can and will comply with the requirements of the protocol.
- Korean male or female subjects whose age while receiving the first vaccination with Synflorix is 6 weeks - 23 months.
- Written, signed or thumb-printed 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 a witness.
Exclusion Criteria:
- At the time of Post Marketing Surveillance entry, the contraindications and precautions of use indicated in the local Prescribing Information should be checked and the infant must not be included in the Post Marketing Surveillance if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
- Subjects who receive any investigational or non-registered pneumococcal vaccine 30 days prior to the study start will not be enrolled. Subjects who had previous administration of a pneumococcal vaccine other than Synforix will not be enrolled into the study.
- A male or female children >= 23 months of age at study entry.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248988
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Korea, Republic of | |
| GSK Investigational Site | Recruiting |
| Suwon, Kyonggi-do, Korea, Republic of, 443-721 | |
| 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: | NCT01248988 History of Changes |
| Other Study ID Numbers: | 114469 |
| Study First Received: | November 24, 2010 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Pneumococcal vaccine Safety Synflorix Pneumococcal diseases |
ClinicalTrials.gov processed this record on June 18, 2013