A Study to Evaluate the One Year Long-term Persistence of Immune Responses Following Two Different Rabies Vaccine Post-exposure Regimens in Chinese Children

This is an interventional prevention trial for Virus Diseases focused on measuring Zagreb regimen, Encephalitis, Antibody persistence, Essen regimen, Post-Exposure Prophylaxis (PEP), Rabies Read More

Inclusion Criteria:

1. Individuals of 6 through 17 years of age on the day of informed consent/assent.
2. Individuals who are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator.
3. Individuals who or whose parent(s)/legal guardian(s) have voluntarily given written informed consent on behalf of their child, and adolescents who have provided written assent, after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
4. Individuals who can comply with study procedures and are available for the duration of follow-up.

Exclusion Criteria:

1. A body temperature ≥38°C (axillary) within 3 days of intended study vaccination.
2. Known hypersensitivity to gentamycin, known allergies to excipients of Rabipur such as Polygeline, chicken protein, egg products or any other vaccine component.
3. Previously received any rabies vaccine or rabies immune globulin.
4. Subjects currently receiving or planning to receive antimalarial medications 4 days prior to V1/Day 1 vaccination and until the final vaccination.
5. Progressive, unstable or uncontrolled clinical conditions.
6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

7. Abnormal function of the immune system resulting from:

   1. Clinical conditions.
   2. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to informed consent.
   3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
8. Received immunoglobulins or any blood products within 180 days prior to informed consent.
9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
10. Study personnel as an immediate family or household member.
11. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
12. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
13. Children in care: A child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
14. If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" for the duration of the study.