Healthy infants and children aged 2 months to 10 years old. Rabies Vaccines Infant Child Immunogenicity vaccine Safety
Conditions
Interventions
CRPV vaccine (SPEEDA) 0.5 ml,
administered intramuscularly on day 0 and day 7
Experimental Biological/Vaccine
chromatograpically purified vero cell rabies vaccine (SPEEDA)
Sponsors
Liaoning Cheng Da Biotechnology Co.,Ltd
Eligibility
Sex/Gender
All
Age
2 Months to 10 Years
Inclusion criteria
Inclusion criteria: 1. Healthy participants as deemed by investigator (from history taking and physical examination) 2. Age from 2 months to 10 years old on the day when informed consent is obtained. 3. Participant's legal guardian(s) understand the study procedures, existing alternative treatments, and risks of the study. The willingness to participate in the study and informed consent is documented.
Exclusion criteria
Exclusion criteria: 1. Documented or suspected immunodeficiency condition. 2. Recent fever within 72 hours prior to receipt of study vaccine (defined as rectal temperature >/= 38.1 C, >/= 100.5 F or axillary temperature >/= 37.8 C, >/= 100 F). 3. Previous receipt of rabies vaccine in mother of infant participants aged < 1 year old. 4. Any previous receipt of rabies vaccine. 5. Previous receipt of any vaccines within 2 weeks prior to first study vaccine administration. 6. Any previous receipt of blood, blood products or immunoglobulin within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotective level Day 28 GMT level of rabies virus neutralizing antibody (RVNA) ,Seroprotection rate Day 28 Proportion of participants with GMT level of rabies virus neutralizing antibody (RVNA) > 0.5 IU/ml | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody persistennce by seroprotective level months 3, 6, and 12 GMT level of rabies virus neutralizing antibody (RVNA) ,Antibody persistennce by seroprotection rate months 3, 6, and 12 Proportion of participants with GMT level of rabies virus neutralizing antibody (RVNA) > 0.5 IU/ml ,Anamnestic response by seroprotective level months 12, day 7 following booster dose GMT level of rabies virus neutralizing antibody (RVNA) ,Anamnestic response by seroprotection rate months 12, day 7 following booster dose Proportion of participants with GMT level of rabies virus neutralizing antibody (RVNA) > 0.5 IU/ml ,Local adverse events day 7, 14, 21,28 and months 3, 6 percentage of participants with local adverse events ,Systemic adverse events day 7, 14, 21,28 and months 3, 6 percentage of participants with systemic adverse events ,Vaccine-related serious adverse events. day 7, 14, 21,28 and months 3, 6 Percentage of participants with vaccine-related serious adverse events. | — |
Countries
Thailand
Contacts
Public ContactWanatpreeya Phongsamart
Siriraj Hospital Mahidol University
Outcome results
None listed