Immunogenicity and safety of Rabies Vaccine, adimistered with two different simulated post exposure regimens

A phase IV, multi-center, randomized, open-label study of PCECV (Rabipur®) comparing the immunogenicity and safety of two different simulated post exposure schedules (Zagreb 2-1-1 versus Essen regimen 1-1-1-1-1) in Healthy Indian subjects - Rabipur study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/07/001857

Enrollment

250

Registered

2011-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: PCECV (Rabipur®) vaccine: Zagreb (2-1-1) post exposure regimen of Rabipur®. (i.e., 2 doses of vaccine administered on days 0 and 1 dose of vaccine each administered on day 7 and day 21)

Eligibility

Inclusion criteria

Inclusion criteria: 1.Males and femalesof age greater than and equal to 18 years. 2. Individuals who have given written consent. 3. Individuals in good health and available for all the visits scheduled in the study

Exclusion criteria

Exclusion criteria: 1.Pregnancy or unwillingness to practice acceptable contraception. 2.A history of Rabies immunization. 3.History of allergy to egg protein. 4.Known hypersensitivity to neomycin, or any other vaccine component. 5.A significant acute or chronic infectious disease or use of antibiotics that may impact the subjects safety and /or immunogenicity in the Investigators opinion at the time of enrolment. 6.Body temperature greatr than or equal to 38.0°C (greater than or equal to 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.

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: Rabies virus neutralizing antibody (RVNA) geometric mean concentrations (GMCs) compared between the study groups at day 14 using the rapid fluorescent focus inhibition test (RFFIT).Timepoint: day 14	—

Secondary

Measure	Time frame
Safety Endpoints: 1.AEs will be collected for 7 days following vaccination or until time of next vaccination (whichever occurs sooner). 2.Medically attended AEs and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation (day 42) Timepoint: 42 days	—

Countries

India

Contacts

Public ContactDr Rekha J

hoshang.vakil@novartis.com022-66930860

Outcome results