Phase 4 N=250 Randomized Prevention

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

Rabies

Bottom Line

View on ClinicalTrials.gov: NCT01365494 ↗

Enrolled (actual)

250

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14 — 0.09; 0.099; 12; 12 IU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Purified Chick Embryo Cell Inactivated Rabies Vaccine (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14	0.09; 0.099; 12; 12	—
SECONDARY Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42	6; 9; 74; 97; 100; 100	—
SECONDARY Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations	0.091; 0.099; 0.66; 1.74; 12; 12	—
SECONDARY Percentages of Subjects Reporting Adverse Events (AEs)	17; 15; 4; 11; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Pregnancy or unwillingness to practice acceptable contraception.
A history of Rabies vaccination.
History of allergy to egg protein.
Known hypersensitivity to neomycin, tetracycline, amphotericin-B or any other vaccine component.
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.
Body temperature ≥38.0°C (≥ 100.4°F) within 3 days of study vaccination.
Treatment with an anti-malarial drug, up to two months prior to the study.
Individuals who received any other vaccines within 28 days prior to enrollment.
Subjects who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
Any planned surgery during the study period.
Subjects who have cancer disorders excluding nonmelanotic skin cancer.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01365494). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.