Trials / Completed
CompletedNCT00680914
Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A or Prevenar™ Co-administered With Hiberix™
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 503 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A.
Detailed description
Vaccination course at 2, 4, 6 months of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumococcal vaccine GSK1024850A (Synflorix) | 3 doses administered intramuscularly. |
| BIOLOGICAL | Prevenar | 3 doses administered intramuscularly. |
| BIOLOGICAL | GSK Biologicals' Hiberix™ | 3 doses administered intramuscularly. |
Timeline
- Start date
- 2008-06-10
- Primary completion
- 2009-05-08
- Completion
- 2009-05-08
- First posted
- 2008-05-20
- Last updated
- 2018-06-08
- Results posted
- 2010-06-14
Locations
14 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00680914. Inclusion in this directory is not an endorsement.