A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

Novartis

Status and phase: Completed; Phase 3

Conditions: Rabies

Treatments: Biological: Essen; Biological: Zagreb

Study type: Interventional

Funder types: Industry

Identifiers

NCT01680016

V49_24

Details and patient eligibility

About

This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.

Full description

This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1.

240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio.

The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort

Enrollment: 644 patients

Sex: All

Ages: 6+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals between 6-17 years of age and 51 years of age or older
• Individuals who were in good health
• Provided consent, complied with study procedures and duration of follow-up

Exclusion criteria

• Contraindications to vaccination with rabies vaccine
• Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination
• Known hypersensitivity to the components of the vaccine
• Previously received any rabies vaccine or immune globulin
• Previous or planned treatment with antimalarial medications
• History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy
• Female subjects who were pregnant or unwilling to practice acceptable birth control methods
• Individuals enrolled or plans to enroll in another investigational trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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644 participants in 4 patient groups

Zagreb(≥6 to ≤17 Years)

Experimental group

Treatment:

Biological: Zagreb

Zagreb(≥51 Years)

Experimental group

Treatment:

Biological: Zagreb

Essen(≥6 to ≤17 Years)

Active Comparator group

Treatment:

Biological: Essen

Essen(≥51 Years)

Active Comparator group

Treatment:

Biological: Essen