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SYN023 With Rabies Vaccine in Healthy Pediatric Subjects

NCT07342257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-01-15

No results posted yet for this study

Summary

This study is a randomized, double-blind, active-controlled design. The goal is to evaluate the safety, pharmacokinetics and pharmacodynamic of SYN023 in combination with rabies vaccine in healthy participants under 18 years of age.

Participants will:

1. Be randomly assigned to receive one of two doses of SYN023 or a dose of HRIG by intramuscular injection on Day 0, along with the first dose of the rabies vaccine.
2. Receive additional doses of the rabies vaccine on Days 3, 7, 14, and 28.
3. Have all adverse events (within 42 days) and all serious adverse events (within 126 days) after PEP administration collected and recorded.
4. Provide several blood samples for pharmacokinetics and pharmacodynamic testing.

Conditions

  • Rabies Post-exposure Prophylaxis

Interventions

BIOLOGICAL

SYN023

SYN023 should be administered intramuscularly at sites distant from the vaccine injection site, either at the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.

BIOLOGICAL

Rabies Vaccine

Dosage and administration of Rabies vaccine for human use: 0.5 mL, intramuscular injection in the deltoid muscle; Injection time: Days 0, 3, 7, 14, and 28 (Essen 5-dose regimen).

BIOLOGICAL

HRIG

HRIG should be administered intramuscularly at sites distant from the vaccine injection site, either in the gluteus maximus or vastus lateralis muscles. The investigator should determine appropriate injection sites for multiple-point administration based on the participant's age and body weight. It is recommended that not more than 6 mL be administered per single gluteus maximus or vastus lateralis muscle, with not more than 4 mL per single injection site (younger children may require reduced volumes per muscle and per injection site based on individual circumstances); Injection time: Day 0.

Sponsors & Collaborators

  • Guizhou Center for Disease Control and Prevention

    collaborator OTHER

  • Synermore Biologics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-05-09
Completion
2025-07-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07342257 on ClinicalTrials.gov