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700 male and female healthy school-children (age 5 to 8) in Thailand were randomized to receive 2 or 3 primary rabies vaccine doses (PCECV, Rabipur) given intradermally in a dose of 0.1mL into the skin in the deltoid region. In a subset of 100 children blood was taken for rabies virus neutralizing antibody determination on day 49. All subjects were randomized to receive 2 booster doses (the recommended vaccination schedule for pre-immunized individuals in case of an exposure) on days 0 and 3, one, three or five years later. Blood was taken before and after booster for up to one year.Safety and tolerability of the vaccine was assessed and persistence of immune response up to 1 year after the booster doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 primary ID doses | Experimental | two doses of rabies vaccines given intradermally on days 0 and 28 |
|
| 3 primary ID doses | Experimental | three doses of rabies vaccines given intradermally on days 0, 7, and 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabies vaccine | Biological | intradermal vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| rabies virus neuralizing antibody, assessed by RFFIT | rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) | seven days after the first booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| rabies virus neuralizing antibody, assessed by RFFIT | rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) | one year after the first booster dose |
| rabies virus neuralizing antibody, assessed by RFFIT |
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Inclusion criteria:
Male and female 5-8 years old school children will be included in the study if:
Exclusion criteria:
Subjects are not to be enrolled into the study if:
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| Name | Affiliation | Role |
|---|---|---|
| Thavatchai Kamoltham, MD | Provincial PHO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phetchabun Province primary schools | Phetchabun | Phetchabun | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17643772 | Result | Kamoltham T, Thinyounyong W, Phongchamnaphai P, Phraisuwan P, Khawplod P, Banzhoff A, Malerczyk C. Pre-exposure rabies vaccination using purified chick embryo cell rabies vaccine intradermally is immunogenic and safe. J Pediatr. 2007 Aug;151(2):173-7. doi: 10.1016/j.jpeds.2007.02.044. |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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rabies virus neuralizing antibody concentrations were measured in serum samples using the rapid fluorescent focus inhibition test (RFFIT) |
| immediately before administration of the first booster dose |
| D007239 | Infections |