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NCT01137045
An Immunogenicity and Safety Study of Modified TRC-ID Regimen With A New Chromatographically Purified Vero Cell Rabies Vaccine(SPEEDA/TRCS SPEEDA) and Rabies Immunoglobulin
Phase 4 trial testing SPEEDA and TRCS SPEEDA in Rabies in 210 participants. Completed in 1 April 2018.
1 April 2018
Quick facts
| Lead sponsor | Queen Saovabha Memorial Institute |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 210 |
| Start date | 1 June 2010 |
| Primary completion | 1 April 2018 |
| Estimated completion | 1 April 2018 |
| Sites | 2 locations across Thailand |
Drugs / interventions tested
- SPEEDA and TRCS SPEEDA — full drug profile →
Conditions studied
- Rabies — all drugs for Rabies →
Sponsor
Queen Saovabha Memorial Institute
Who can join
Adults 15 to 60, any sex, with Rabies. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
immunogenicity (the level of rabies neutralizing antibodies by RFFIT test)
Time frame: 32 months
The immunogenicity (Rabies neutralizing antibodies) would be checked from the blood samples for 7 times (on days 0,7,14,28,90,180 and 360)for one year duration in each phase.
Sponsor's own description
A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01137045
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rabies
Currently open trials in the same condition.
- NCT07275645 — A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years · Phase 3 · active not recruiting
- NCT07021703 — A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried · Phase 1 · recruiting
- NCT06998004 — A Trial to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for the Prevention of Yellow Fever, and · Phase 1 · recruiting
Other Queen Saovabha Memorial Institute trials
Trials by the same sponsor.
- NCT03524417 — Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01137045 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Queen Saovabha Memorial Institute
- Last refreshed: 5 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01137045.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing