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NCT00926419: InjHepAVar
Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery
Phase 2/Phase 3 trial testing Varicella Vaccine in Varicella in 600 participants. Status unknown.
1 November 2009
Quick facts
| Lead sponsor | University of Sao Paulo General Hospital |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 600 |
| Start date | 1 June 2009 |
| Primary completion | 1 November 2009 |
| Estimated completion | 1 May 2010 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Varicella Vaccine — full drug profile →
- Hepatitis A Vaccine — full drug profile →
Conditions studied
- Varicella — all drugs for Varicella →
- Hepatitis A — all drugs for Hepatitis A →
Sponsor
University of Sao Paulo General Hospital
Who can join
Adults 13 Months to 30 Months, any sex, with Varicella or Hepatitis A. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Immunogenicity: General seroconversion rate 45 days following immunization. Safety: General rate of local and systemic adverse events after immunization according to definition established by Brighton Collaboration Group
Time frame: 45 days after immunization
Sponsor's own description
This study aims to assess immunogenicity and safety of nd influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT00926419
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT03375502 — A Study of MG1111 in Healthy Children · Phase 2, PHASE3 · completed
- NCT01190228 — Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV · Phase 3 · completed
Other recruiting trials for Varicella
Currently open trials in the same condition.
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- NCT05669625 — A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine · Phase 3 · active not recruiting
- NCT04471493 — Pediatric and Ambulatory Research in Infectious Diseases · recruiting
Other University of Sao Paulo General Hospital trials
Trials by the same sponsor.
- NCT07275580 — Antibiotic Prophylaxis After Simple Tooth Extraction in Immunosuppressed Patients With Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
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- NCT07341386 — Prevention of Recurrence of Herpes Simplex in Autoimmune Rheumatic Diseases · Phase 4 · not yet recruiting
- NCT07242092 — Influence of Methotrexate Discontinuation on Immunogenicity After PCV-20 Vaccine in Patients ARDs · Phase 4 · not yet recruiting
- NCT07484152 — Motor and Non-Motor Effects of Low-Intensity Focused Ultrasound (LIFU) as a Neuromodulation Tool in Essential Tremor · Phase 1, PHASE2 · not yet recruiting
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 NCT00926419 (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 University of Sao Paulo General Hospital
- Last refreshed: 22 June 2009
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/NCT00926419.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing