Immunogenicity and safety of chromatographically purified vero cell rabies vaccine in 2-dose pre-exposure vaccination schedule in infants and children.

Not Applicable

Recruiting

• Conditions: Healthy infants and children aged 2 months to 10 years old.; Rabies Vaccines; Infant; Child; Immunogenicity vaccine; Safety

• Registration Number: TCTR20200202001
• Lead Sponsor: iaoning Cheng Da Biotechnology Co.,Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-02
• Study Completion: 2023-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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