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NCT02445703
Phase IV Immunogenicity and Safety Study of Different Immunization Schedules of Inactivated Hepatitis A Vaccine (HAV) and/ or Combined Hepatitis A and Hepatitis B Vaccine (HABV) in Healthy Chinese Infants
Phase 4 trial testing Inactivated Hepatitis A vaccine (HAV) in Hepatitis A in 301 participants. Completed in 1 June 2016.
1 January 2015
Quick facts
| Lead sponsor | Sinovac Biotech Co., Ltd |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 301 |
| Start date | 1 May 2014 |
| Primary completion | 1 January 2015 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- Inactivated Hepatitis A vaccine (HAV) — full drug profile →
- Combined hepatitis A and hepatitis B vaccine (HABV) — full drug profile →
Conditions studied
- Hepatitis A — all drugs for Hepatitis A →
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
Sinovac Biotech Co., Ltd — full company profile →
Who can join
Adults 18 Months to 24 Months, any sex, with Hepatitis A or Hepatitis B. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The Post-immunization Seropositivity Rates (SPR) to Hepatitis A
Time frame: 7 months
The post-immunization SPR is the percent of participants with anti-HAV titers ≥ 20 mIU/mL at month 7. Anti-HAV titers were detected in participants' serum samples using electrochemiluminescence immunoassay.
Sponsor's own description
The purpose of this study is to compare the immunogenicity and safety of three different immunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis A and B vaccine (HABV) in healthy Chinese infants.
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 NCT02445703
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Sinovac Biotech Co., Ltd trials
Trials by the same sponsor.
- NCT07418229 — Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine · Phase 1 · not yet recruiting
- NCT07416110 — Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine · Phase 3 · not yet recruiting
- NCT07055295 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07055893 — Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen · Phase 3 · not yet recruiting
- NCT07400003 — Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine · Phase 1, PHASE2 · 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 NCT02445703 (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 Sinovac Biotech Co., Ltd
- Last refreshed: 26 July 2021
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/NCT02445703.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing