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PCEC Rabies Vaccine and JE Vaccine in Toddlers
NCT00694460Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2002
- Primary completion
- Aug 2004
- Countries
- 1
- Sponsor
- Novartis
- Modality
- Whole Inactivated Vaccines
- Conditions
- rabies
01
Overview
Phase 2, randomised, open-label trial of rabies vaccine purified chick embryo cell in rabies (5 arms), sponsored by Novartis. Primary endpoint: Rabies virus neutralizing antibody concentrations at 2 years. Started Aug 2002; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
3 Full IM Doses Rabies + JE
Rabies vaccine 1.0 mL IM (D0, D7, D28) + JE vaccine (D0, D7)
3 Half IM Doses Rabies + JE
Rabies vaccine 0.5 mL IM (D0, D7, D28) + JE vaccine (D0, D7)
3 ID Doses Rabies + JE
Rabies vaccine 0.1 mL ID (D0, D7, D28) + JE vaccine (D0, D7)
2 ID Doses Rabies + JE
Rabies vaccine 0.1 mL ID (D0, D28) + JE vaccine (D0, D7)
JE Vaccine Only
JE vaccine (D0, D7)
03
Who it enrols
Healthy toddlers aged 12-18 months without prior rabies or Japanese encephalitis immunization.
04
Endpoints
Primary
Rabies virus neutralizing antibody concentrations
Secondary
Japanese encephalitis virus neutralizing antibody titers
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