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

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365494
• Other study ID #: V49_25
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2011
• Last updated: April 3, 2014
• Start date: July 2011
• Est. completion date: November 2011

Study information

• Verified date: April 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Purified Chick Embryo Cell Inactivated Rabies Vaccine
Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.

Locations

Country	Name	City	State
India	Kempegowda Institute of Medical Sciences Hospital (KIMS)	Bangalore	KA
India	Mandya Institute of Medical Sciences	Mandya	KA
India	Padmashree Dr. D.Y Patil Hospital	Pune	MS

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14	Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule	On Day 0 and Day 14	No
Secondary	Percentages of Subjects With Anti-RVNA Titer =0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42	Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer =0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.	Study day 7, 14 and 42	No
Secondary	Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations	Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules	Day 0, Day 7, Day 14 and Day 42	No
Secondary	Percentages of Subjects Reporting Adverse Events (AEs)	Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.	All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period	Yes