Rabies Clinical Trial
Official title:
A Randomized, Single-arm, Phase Ⅰ Clinical Trial to Evaluate the Safety of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried Vaccinated With Different Immunization Schedule in People Aged 10-60 Years
The safety of different immunization procedures of rabies vaccine (human diploid cells) was investigated by successive design of different age groups. The two vaccination procedures were carried out successively according to the age of the subjects from the oldest to the youngest. The first 40 subjects aged 18-60 were randomly assigned to the Essen experimental group and the Zagreb experimental group in a 1:1 ratio, all of whom received the experimental vaccine. After the observation of the third dose of vaccine for at least 7 days, the preliminary safety assessment was conducted. If the incidence of grade 3 or higher adverse events associated with the experimental vaccination did not exceed 15%, and no vaccination-related death or life-threatening serious adverse events occurred, 40 subjects aged 10-17 years old were enrolled, and 40 subjects aged 10-17 years old were randomly assigned to the Essen and Zagreb trials in a 1:1 ratio. Conduct safety studies. Safety study: All adverse events that occurred within 30 minutes, 0-7 days, and 0-30 days after each dose were collected, as well as all serious adverse events that occurred within 6 months after the first dose. Blood and urine samples were collected before the first dose and 3 days after the first dose, and blood routine, blood biochemical and urine routine tests were performed for safety assessment.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03961555 -
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
|
Phase 2 | |
| Completed |
NCT04644484 -
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
|
Phase 3 | |
| Active, not recruiting |
NCT05667974 -
A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried
|
Phase 3 | |
| Completed |
NCT01641315 -
Immunogenicity Study of a Reduced (4-dose) Vaccine Schedule and Rabies Immunoglobulins
|
N/A | |
| Completed |
NCT02238756 -
Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01930357 -
Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
|
Phase 2 | |
| Completed |
NCT01680016 -
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
|
Phase 3 | |
| Completed |
NCT04019444 -
Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects
|
Phase 1 | |
| Completed |
NCT02729168 -
Safety Study of Rabies Vaccine INDIRAB® Five Doses (0.5ml) Post Exposure Administered Intramuscularly
|
N/A | |
| Completed |
NCT02241135 -
RNActive® Rabies Vaccine (CV7201) in Healthy Adults
|
Phase 1 | |
| Completed |
NCT01388985 -
Simplifying the Rabies Pre-exposure Vaccination
|
Phase 3 | |
| Completed |
NCT04829630 -
Immunity Persistence After Abridged Intradermal Rabies PEP
|
N/A | |
| Completed |
NCT03713086 -
A Study to Assess the Safety, Reactogenicity and Immune Response of CureVac's Candidate Rabies mRNA Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT05350735 -
Phone Text Message Reminders on Compliance With Human Rabies Post Exposure Prophylaxis Project
|
N/A | |
| Completed |
NCT02281396 -
The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans
|
Phase 1 | |
| Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
| Completed |
NCT00825305 -
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
|
Phase 3 | |
| Completed |
NCT05547815 -
Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine
|
Phase 4 | |
| Completed |
NCT02564471 -
Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
|
Phase 4 | |
| Unknown status |
NCT01173302 -
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose
|
Phase 4 |