Rabies
Conditions
Interventions
Experimental:zagreb regimen (2-1-1)
Biological :Essen regimen (1-1-1-1-1)
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
10 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy permanent residents aged 10-60 years; 2. Obtain informed consent from the participants or their guardians, and signed informed consent form; 3. Be in good health as determined by blood pressure measurement of being less than 160/100 mmHg (in any case); 4. The participants or their guardians can comply with the requirements of clinical trial scheme and also are able to comply with the follow-up schedule of the protocol; 5. The axillary temperature is 37.0 degree or less; 6. Be in good health as determined by medical history, and a targeted physical examination based on medical history.
Exclusion criteria
Exclusion criteria: 1. Participants who previously were immunized with rabies vaccines; 2. Participants who were suspect or had a history of injury by mammals; 3. Participants who had history of epilepsy, seizures, encephalopathy, or family history of mental illness; 4. Participants who have a known allergy or sensitivity to amylomaltose or human immunoglobulin, or have a known serious adverse reactions to any of the components of vaccines; 5. Participants who are pregnant, or lactating, or of childbearing potential; 6. Participants who were diagnosed or suspected to be suffering from acute illness/infection, according to investigator judgement; 7. Participants who had a history of congenital malformation, congenital disorder or chronic disease, such as asthma, diabetes, or thyroid disease, et al.; 8. Participants who had a history of angioedema or angioneurotic oedema; 9. Participants who had a history urticaria one year ago; 10. Participants who self-reported asplenia, or functional asplenia; 11. Participants who self-reported thrombocytopenia, or coagulation disorders due to contraindicating intramuscular vaccination; 12. Participants who had a history of acupuncture syncope; 13. Participants who had a known receipt of immunosuppressive therapy, antianaphylactic treatment, cytotoxic therapy, inhaled corticosteroids within the past six months. (excluding corticosteroid spray treatment of allergic rhinitis, surface treatment with corticosteroids because of acute uncomplicated dermatitis); 14. Participants who had received blood products in the past 4 months; 15. Participants who had received other researching drug in the past one month; 16. Participants who had received live attenuated vaccines one month before the clinical trial began; 17. Participants who had received subunit vaccines or inactivated vaccines 14 days before the clinical trial began; 18. Participants who are having anti-tuberculosis treatment; 19. There are other conditions (including medical, psychological, and social conditions), in the opinion of the investigators, that would render the participant unable to comply with the protocol or place the participant at an unacceptable risk of injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rabies virus neutralizing antibody concentration;Percentages of subjects reporting adverse reactions; | — |
Countries
China
Contacts
Public ContactZhiping Chen
Zhejiang Provincial Center for Disease Control and Prevention
Outcome results
None listed