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Reduced Primary Schedule of MenC and PCV in UK Infants
NCT00197808Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2005
- Primary completion
- Jan 2010
- Countries
- 1
- Sponsor
- UK Health Security Agency
- Modality
- Vaccines & Immunotherapeutics
- Conditions
- meningococcal infectionpneumococcal infection
01
Overview
Phase 4, randomised, open-label trial of Meningococcal group C polysaccharide conjugate vaccine in meningococcal infection and pneumococcal infection (6 arms), sponsored by UK Health Security Agency. Primary endpoint: Immunogenicity at 5 months. Started Apr 2005; status: completed.
02
Design
6 arms- Study design
- RandomizedOpen-label
Menjugate (2, 3 months)
Menjugate vaccine at 2 and 3 months
Menjugate (2, 4 months)
Menjugate vaccine at 2 and 4 months
NeisVac-C (2, 3 months)
NeisVac-C vaccine at 2 and 3 months
NeisVac-C (2, 4 months)
NeisVac-C vaccine at 2 and 4 months
Meningitec (2, 3 months)
Meningitec vaccine at 2 and 3 months
Meningitec (2, 4 months)
Meningitec vaccine at 2 and 4 months
03
Who it enrols
Infants aged 7-11 weeks at first dose, healthy, with no contraindications to vaccination as specified in the UK Handbook 'Immunisation Against Infectious Disease'.
04
Endpoints
Primary
Immunogenicity
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