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NCT03231605
Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Phase 4 trial testing Hepatitis A Vaccine in Hepatitis A in 300 participants. Status unknown.
31 August 2017
Quick facts
| Lead sponsor | China National Biotec Group Company Limited |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 26 July 2017 |
| Primary completion | 31 August 2017 |
| Estimated completion | 29 December 2017 |
| Sites | 1 location across China |
Drugs / interventions tested
- Hepatitis A Vaccine — full drug profile →
Conditions studied
- Hepatitis A — all drugs for Hepatitis A →
Sponsor
China National Biotec Group Company Limited — full company profile →
Who can join
Adults 18 Months to 24 Months, any sex, with Hepatitis A. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03231605
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hepatitis A Vaccine
Trials testing the same drug.
- NCT02038907 — Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine · Phase 2 · completed
Other recruiting trials for Hepatitis A
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT06978621 — Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV · Phase 3 · recruiting
- NCT06058416 — Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old · Phase 4 · active not recruiting
Other China National Biotec Group Company Limited trials
Trials by the same sponsor.
- NCT07338851 — the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines · not yet recruiting
- NCT07377175 — Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses. · Phase 1 · recruiting
- NCT05839301 — A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age · Phase 3 · unknown
- NCT05669625 — A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine · Phase 3 · active not recruiting
- NCT05480436 — Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population · Phase 4 · 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 NCT03231605 (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 China National Biotec Group Company Limited
- Last refreshed: 1 August 2017
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/NCT03231605.
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