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Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine

NCT03330171 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2020-03-17

No results posted yet for this study

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 vaccination at 18 months; and iii) a single dose of hepatitis-A vaccination at 18 months in HIV-exposed and HIV-unexposed South African children.

Conditions

Interventions

BIOLOGICAL

Measles vaccine

All participants will receive measles vaccine at 6 and 12 months of age, according to the South African immunization schedule. All study vaccines are currently licensed in South Africa and will be administered according to their approved dosages, formulations and indications.

BIOLOGICAL

Hepatitis-A vaccine

Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.

BIOLOGICAL

Varicella vaccine

Half of the participants (n=135) will receive varicella vaccine at 18 months of age.

Sponsors & Collaborators

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Shabir A Madhi, MD, PhD · University of Witwatersrand, South Africa

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Weeks
Max Age
19 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-02-26
Completion
2022-12-01

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03330171 on ClinicalTrials.gov