Trials / Completed
CompletedNCT01568060
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 645 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 2 Months – 6 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-05-21
- Primary completion
- 2015-12-15
- Completion
- 2015-12-15
- First posted
- 2012-04-02
- Last updated
- 2023-01-27
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01568060. Inclusion in this directory is not an endorsement.