Rabies Infection Clinical Trial
Official title:
Phase 3, Randomized, Stratified, Open Label, Multicenter, Controlled Clinical Study to Evaluate Safety and Immunogenicity of a Rabies Vaccine Administered, With and Without Human Rabies Immunoglobulin, Using the New "4-sites, 1-week" Intradermal Regimen for Postexposure Prophylaxis Compared to the Currently Recommended "2-sites, TRC" Intradermal Regimen in Children and Adults Subjects.
Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.
| Status | Completed |
| Enrollment | 885 |
| Est. completion date | August 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 1 Year and older |
| Eligibility |
Inclusion Criteria: 1. Healthy males and females = 1 years of age 2. Individuals/ individual's parents or legal guardians who have given written consent 3. Individuals in good health 4. Individuals who can comply with study procedures Exclusion Criteria: 1. Behavioral or cognitive impairment or psychiatric disease. 2. Unable to comprehend and to follow all required study procedures for the whole period of the study. 3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study. 4. Individuals = 1 to = 17 years of age, who have or ever had a malignancy. 5. Individuals = 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder. 6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable). 7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry. 8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50. 9. Female of childbearing potential, with a positive pregnancy test prior to enrollment. 10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks. 11. Allergic to any of the vaccine components. 12. Allergic to any of the human rabies immunoglobulin components. 13. Contraindication or precaution against rabies vaccination. 14. Contraindication or precaution against man rabies immunoglobulin administration. 15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50. 16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. 17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. 18. Body temperature = 38.0°C (= 100.4°F) within 3 days of intended study vaccination. 19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies. 20. Part of the study personnel or immediate family members of study personnel conducting this study. 21. Current or history of drug or alcohol abuse within the past 2 years. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Philippines | 4, De La Salle Health Sciences Institute | Cavite | |
| Philippines | 1, Research Institute for Tropical Medicine | Muntinlupa | |
| Philippines | 2, Asian Hospital and Medical Center | Muntinlupa | |
| Philippines | 3, Research Institute for Tropical Medicine | Muntinlupa | |
| Thailand | 11, Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao hospital | Bangkok | |
| Thailand | 12, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis | Novartis Vaccines |
Philippines, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects with RVNA titer = 0.5 IU/mL at day 50 and group differences. | Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer = 0.5 IU/ml at day 50 in the whole study population. | study day 50 | No |
| Secondary | RVNA Geometric Mean Concentration at day 50 and between-group ratio of GMCs (4-sites, 1-week versus 2-sites, TRC) in the whole study population | Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population. | study day 50 | No |
| Secondary | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at days 8, 15, 91, 181 and 366 and group differences (4-sites, 1-week versus 2-sites, TRC) in the whole study population | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population. | study days 8, 15, 91, 181 and 366 | No |
| Secondary | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of new 4-sites, 1-week ID regimen of rabies vaccine, with HRIG and without HRIG administration, in adult subjects. | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG) | study days 8, 15, 91, 181 and 366 | No |
| Secondary | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with HRIG, in adult subjects. | study days 8, 15, 91, 181, and 366 | No | |
| Secondary | RVNA GMCs and percentage of subjects with RVNA titer = 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), without HRIG, in the whole study population. | study days 8, 15, 91, 181, and 366 | No | |
| Secondary | Percentages of subjects reporting solicited local and systemic adverse events (AEs), and associated medications, will be collected | 7 days following administration of each study vaccination or until time of next vaccination | Yes | |
| Secondary | Percentages of subjects reporting AEs | All reported SAEs and AEs leading to subject withdrawal, and associated medications, were collected up to 366 days after first vaccination | Yes |