Status:
ACTIVE_NOT_RECRUITING
Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
Lead Sponsor:
Codagenix, Inc
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
6-5 years
Phase:
PHASE1
Brief Summary
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vac...
Eligibility Criteria
Inclusion
- Age at the time of informed consent:
- Part A: 2 to 5 years, inclusive
- Part B: 6 months to \< 2 years
- RSV Status at Screening:
- Part A: RSV-seropositive
- Part B: RSV-seronegative
- Good general health status
- Product of normal full-term pregnancy (36 to 42 weeks gestation)
Exclusion
- Household contact with any of the following groups of individuals for the period up to 14 days after each dose:
- Pregnant women
- Infants \< 6 months of age
- With hospitalization for asthma or other chronic respiratory disease in the past 5 years
- Immunocompromised individuals, which includes, but is not limited to, those with the following conditions:
- AIDS
- Receipt of chemotherapy within the past 6 months
- Current receipt of immunosuppressive agents
- Solid organ or bone marrow transplant
- Enrolled in the same classroom at full-time day care with infants \< 6 months of age for 14 days after each dose
- Household contact of another child enrolled into the study
- Inadequate venous access for repeated phlebotomy
- Height and weight ≤ 5th percentile for age and sex (according to CDC growth charts for children in Part A, according to World Health Organization Child Growth Standards for children in Part B)
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 27 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04919109
Start Date
March 28 2023
End Date
August 27 2025
Last Update
February 6 2025
Active Locations (5)
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1
Velocity
Lincoln, Nebraska, United States, 658510
2
Velocity
Omaha, Nebraska, United States, 68134
3
Velocity
Providence, Rhode Island, United States, 02818
4
Velocity
West Jordan, Utah, United States, 84088