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Completed

NCT Number: NCT01365494

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

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.

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Key information

Conditions

Rabies Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kempegowda Institute of Medical Sciences Hospital (KIMS), Bangalore, Karnataka, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Purified Chick Embryo Cell Inactivated Rabies Vaccine

Biological

Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.

Primary outcomes

  1. Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14

    Time frame: On Day 0 and 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

Secondary outcomes

  1. Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42

    Time frame: Study day 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.

  2. Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations

    Time frame: Day 0, Day 7, Day 14 and Day 42

    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

  3. Percentages of Subjects Reporting Adverse Events (AEs)

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2011
Registry last updated
May 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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