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Randomized open label trial of 2-dose or 3-dose of primary rabies immunization in Thai children

Randomized open label trial of 2-dose or 3-dose of primary rabies immunization in Thai children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20171101001
Enrollment
110
Registered
2017-11-01
Start date
2017-09-30
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

Healthy children aged 2 to 12 years No history of previous rabies immunization

Interventions

Received 2 doses of rabies vaccine at day0 and day28.,Received 3 doses of rabies vaccine at day0&#44
day7 and day28.,Received 2 doses of rabies vaccine at day0 and day28.,Received 3 doses of rabies vaccine at day0&#44
day7 and day28.
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine,Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
2&#45
dose of primary rabies immunization in 2&#45
6 years old children,3&#45
6 years old children,2&#45
dose of primary rabies immunization in >6&#45
12 years old children,3&#45
12 years old children

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: - Children aged 2 to 12 years on the day of inclusion - No history of previous rabies immunization - In good general health at the time of inclusion - Provision of informed consent/assent by the parent(s) or legal guardian(s)

Exclusion criteria

Exclusion criteria: - Receipt of blood or blood products in the past 3 months - Acute febrile illness on the day of vaccination.( body temperature ≥ 38C)

Design outcomes

Primary

MeasureTime frame
To compare the seroprotection rate of 2-dose and 3-dose regimen of a primary rabies immunization 7 day post booster vaccination proportion of children with targeted rabies neutralizing antibody ≥ 0.5 IU/ml—

Secondary

MeasureTime frame
To compare the seroprotection rate of 2-dose and 3-dose regimen of a primary rabies immunization 1 year post primary vaccination proportion of children with targeted rabies neutralizing antibody ≥ 0.5 IU/ml ,To compare the GMT of rabies neutralizing antibody between 2-dose and 3-dose regimen group 14 days, 1 year post primary vaccination and 7 days post-booster vaccination the geometric mean titer (GMT) ,To compare the interferon gamma titer between 2-dose and 3-dose regimen group 1 year post primary vaccination and 7 days post-booster vaccination interferon gamma titer/spot forming cell—

Countries

thailand

Contacts

Public Contactpakpoom janewongwirot

Chulalongkorn University

tee_to@hotmail.com66814396604

Outcome results

None listed

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