Trials / Completed
CompletedNCT00853749
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 89 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 5 Years – 7 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Detailed description
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 13-valent pneumococcal conjugate vaccine (13vPnC) | 0.5 mL intramuscular injection |
| PROCEDURE | Blood draw | Collection of 10 mL of blood |
Timeline
- Start date
- 2009-05-05
- Primary completion
- 2009-12-16
- Completion
- 2009-12-16
- First posted
- 2009-03-02
- Last updated
- 2021-11-11
- Results posted
- 2011-01-05
Locations
2 sites across 1 country: Iceland
Source: ClinicalTrials.gov record NCT00853749. Inclusion in this directory is not an endorsement.