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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240530003

Enrollment

105

Registered

2024-05-30

Start date

2020-07-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy participants aged 2 months to 10 years . rabies vaccine

Interventions

This was a phase 3, prospective, cohort study in 105 healthy young children who consented to participate in the study. Participants were stratified by age into five groups of equal (1:1:1:1:1) ratios

Experimental Drug

Rabies vaccine

Eligibility

Sex/Gender

All

Age

2 Months to 10 Years

Inclusion criteria

Inclusion criteria: 1. Participants in good health based of previous medical history and physical examination, as assessed by the research physicians 2. Participants of ages 2 months to 10 years at the time of consent for participation in the study. 3. Participants of ages 2 to 6 months at the time of consent must reside in environments considered at risk (for example, having pets present in living space).

Exclusion criteria

Exclusion criteria: 1. Participants with known or suspected immunodeficiency disorder. 2. Participants with fevers within 72 hours prior to investigational product administration. Fever is determined by rectal temperatures from 38.1 C (from100.5 F) or axillary temperatures from 37.8 C (from 100.0 F). 3. Participants with a receipt of rabies vaccination. 4. Participants a receipt of any other vaccines within 2 weeks prior to investigational product administration. 5. Participants at ages of less than 1 year and with a maternal receipt of receiving rabies vaccination during infancy. 6. Participants with a receipt of any blood transfusions received within 3 months prior to investigational product administration (including blood products, blood components or immunoglobulin antibodies transfusions).

Design outcomes

Primary

Measure	Time frame
Immunogenicity Visit 1, 3, 4 and 5 RVNA titers (seroconversion and seroprotection)	—

Secondary

Measure	Time frame
AE Visit 1, 2, 3, 4, 5 Frequency of the occurrence	—

Countries

Thailand

Contacts

Public ContactWanatpreeya Phongsamart

Faculty of Medicine, Siriraj Hospital

wanatpreeya@gmail.com028660225

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026