Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules

Novartis

Status and phase: Completed; Phase 4

Conditions: Rabies

Treatments: Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01365494

V49_25

Details and patient eligibility

About

This study was planned to establish the non-inferiority of Rabipur administered as simulated post exposure Zagreb schedule as compared to Essen schedule, in healthy Indian adult subjects.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females of age ≥ 18 years.
2. Individuals who had given written consent.
3. Individuals in good health and available for all the visits scheduled in the study.

Exclusion criteria

1. Pregnancy or unwillingness to practice acceptable contraception.
2. A history of Rabies vaccination.
3. History of allergy to egg protein.
4. Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
5. A significant acute or chronic infectious disease or use of antibiotics that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment.
6. Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
7. Treatment with an anti-malarial drug, up to two months prior to the study.
8. Individuals who received any other vaccines within 28 days prior to enrollment.
9. Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
10. Any planned surgery during the study period.
11. Subjects who have cancer disorders excluding nonmelanotic skin cancer.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Group A-Zagreb

Active Comparator group

Description:

Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)

Treatment:

Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine

Group B-Essen

Active Comparator group

Description:

Purified Chick Embryo Cell Inactivated Rabies Vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14, and 28)

Treatment:

Biological: Purified Chick Embryo Cell Inactivated Rabies Vaccine