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Neutralizing Immunogenicity Antibody After 2 Intradermal Doses Pre-Exposure Prophylaxis of Purified Vero Cell Rabies Vaccine (PVRV) to 12-24 month-old Children, concomitantly with Chimeric Live-Attenuated JE Vaccine (IMOJEV)

Neutralizing Immunogenicity Antibody After 2 Intradermal Doses Pre-Exposure Prophylaxis of Purified Vero Cell Rabies Vaccine (PVRV) to 12-24 month-old Children, concomitantly with Chimeric Live-Attenuated JE Vaccine (IMOJEV)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180531004
Enrollment
Unknown
Registered
2018-05-31
Start date
2015-03-18
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To describe immune response and proportion of seroprotective level of JE at baseline prebooster vaccination Rabies&#44

Interventions

0.1 ml of purified Vero cell rabies vaccine (PVRV) intradermally each at two sites of both deltoid muscle on day 0 and 28 and chimeric live attenuated JE vaccine (IMOJEV) subcutaneously on day 0 and 3
7 and 28&#44
as a conventional WHO intramuscular regimen for pre&#45
exposure prophylaxis and chimeric live attenuated JE vaccine (IMOJEV) subcutaneously on day 0 and 365
Active Comparator Drug,Placebo Comparator Drug
PVRV 2&#45
site on day 0&#44
28 and JE day 0&#44
365,PVRV 1&#45
7&#44
365

Sponsors

Queen Saovabha Memorial Institute, The Thai Red Cross Society
Lead Sponsor
Queen Saovabha Memorial Institute&#44
Collaborator
The Thai Red Cross Society
Collaborator

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1) Children aged 12-24 months 2) In a good general health after physical exam at the time of inclusion 3) Informed consent form has been signed and dated by the parent(s)/legal guardian(s) 4) Be able to complete the vaccine course and every blood sample collection

Exclusion criteria

Exclusion criteria: 1) History of receiving rabies vaccination or Rabies Nab titers ≥ 0.5 IU/ml 2) History of receiving JE vaccination 3) Contraindications to Live attenuated vaccine i.e. immunodeficiency, cancer with treatment of immunosuppressive agents 4) Parents reject to participate in study 5) History of receiving any vaccine in the 8 weeks preceding the study

Design outcomes

Primary

MeasureTime frame
To assess the immunogenicity of new two-visit intradermal regimen (day 0 and 28) compared with the c Day 0, 42 and 365 Rabies Neutralizing Antibody—

Secondary

MeasureTime frame
To assess the immunogenicity of chimeric JE vaccine after receiving primary and booster JE vaccinati day 0, day 42, day 365 and 379 Geometric mean titer for JE neutralizing antibody—

Countries

Thailand

Contacts

Public ContactPiyada Angsuwatcharakon

Queen Saovabha Memorial Insitute

piyada.angs@gmail.com022520161

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026