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13vPnC vs 7vPnC in Healthy Infants in Korea
NCT00689351Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2008
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- Prevnar 13
- Conditions
- pneumococcal disease
01
Overview
Phase 2, randomised, double-blind trial of Prevnar 13 in pneumococcal disease (2 arms), sponsored by Pfizer. Primary endpoint: Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥ 0.35 mcg/mL at 7 months. Started Jun 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
13vPnC
13-valent pneumococcal conjugate vaccine at 2, 4, 6, 12 months
7vPnC
7-valent pneumococcal conjugate vaccine at 2, 4, 6, 12 months
03
Who it enrols
Healthy 2-month-old infants (42 to 98 days) available for the entire study period.
04
Endpoints
Primary
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥ 0.35 mcg/mL
Secondary
Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥ 0.35 mcg/mL
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