Status:
UNKNOWN
Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Measles
Varicella
Eligibility:
All Genders
18-19 years
Phase:
PHASE4
Brief Summary
This trial will evaluate the safety and immunogenicity of: i) measles vaccine (CAM-70) after primary dose at 6 months (MV1) and booster vaccination at 12 months (MV2); ii) a single dose of varicella v...
Detailed Description
Measles vaccine (MV) can reduce childhood mortality and is currently recommended to all South African children aged 6 months. Only one study has examined the safety and immunogenicity of the recommend...
Eligibility Criteria
Inclusion
- Aged ≤18 weeks;
- Parent/guardian able to provide informed consent;
- Available for the duration of the study;
- Enrolled as a participant in the PVC1+1 trial AND born to HIV-uninfected woman; OR Born to HIV-infected mother AND infant CD4% ≥25% if HIV-infected;
- Birth weight \>2499g AND weight of \>3.5 kg at time of proposed enrolment;
- Being a healthy child (except for HIV status in HIV-exposed cohort) based on medical history and physical examination by the study staff.
Exclusion
- Significant major congenital abnormalities;
- Received measles vaccination, varicella vaccination or hepatitis-A vaccination since birth;
- Previous hospitalization for respiratory illness following discharge from hospital at birth;
- Known allergy to vaccine components;
- Febrile illness (axillary temperature ≥37.8°C) at time of screening;
- Known or suspected immunodeficiency condition other than HIV;
- Planning to relocate outside of the study area during the study period;
- Receipt of blood transfusion or any other blood products (including immunoglobulins) since birth, receipt of such products during the course of the study will require withdrawal of the child from the study;
- History of confirmed measles, varicella or hepatitis-A disease since birth.
Key Trial Info
Start Date :
April 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT03330171
Start Date
April 10 2017
End Date
December 1 2022
Last Update
March 17 2020
Active Locations (1)
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1
Chris Hani Baragwanath Academic Hospital; Nrf/Dst Vpd Rmpru
Soweto, Gauteng, South Africa, 2013