Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

PHASE3CompletedINTERVENTIONAL
Enrollment

885

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

August 31, 2015

Conditions
Rabies Infection
Interventions
BIOLOGICAL

Rabies vaccine

"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8)."

BIOLOGICAL

Rabies vaccines + Rabies immunoglobulins

"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle."

BIOLOGICAL

Rabies vaccine

"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29)."

BIOLOGICAL

Rabies vaccines + Rabies immunoglobulins

"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle."

Trial Locations (6)

1781

1, Research Institute for Tropical Medicine, City of Muntinlupa

2, Asian Hospital and Medical Center, City of Muntinlupa

4114

4, De La Salle Health Sciences Institute, Cavite

10400

11, Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao hospital, Bangkok

12, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok

Unknown

3, Research Institute for Tropical Medicine, City of Muntinlupa

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY