Trials / Completed
CompletedNCT01248988
Post Marketing Surveillance of Synflorix Vaccine Safety Among Infants in Korea
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 622 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 5 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect safety information following routine vaccination with Synflorix™ among infants in Korea.
Detailed description
Rationale for the protocol amendment: The therapeutic indication for Synflorix in Korea has been updated. The protocol is being amended to reflect this update.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2015-09-01
- Completion
- 2015-09-01
- First posted
- 2010-11-25
- Last updated
- 2017-01-13
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01248988. Inclusion in this directory is not an endorsement.