RecruitingPhase 2NCT06667206

Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings

Sponsor

University of Oxford

Enrollment

450 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Measles

Summary

This is a phase IIb clinical trial investigating the non-inferiority of immune responses in children given two doses of measles vaccine at different timepoints. The study will randomise 450 children to 3 groups: group A will receive measles containing vaccine (MCV) at 6 and 12 months ; group B at 9 and 18 months; Group C at 6 and 18 months.

Eligibility

Min Age: 23 WeeksMax Age: 28 Weeks

Inclusion Criteria4

Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening
Aged 6 months (23 - 28 weeks) at time of screening
Received all previous vaccines as per country Expanded Programme of Immunization (EPI) schedule, verified by child health card
Parents/caretakers willing to give informed consent for their and their children's participation and stay in the geographical area where the study would be conducted

Exclusion Criteria10

The participant may not enter the trial if any of the following apply:
Child not healthy enough to be vaccinated in the opinion of the investigator
Recent family history of measles infection (since birth)
Previous receipt of any measles vaccination
A family history of congenital or hereditary immunodeficiency other than HIV
Receipt of more than 1 week of immunosuppressant or immune modifying drugs e.g. high dose steroids.
Major congenital defects or serious chronic illness that in the opinion of the investigator are likely to modify immune responses or the ability to comply with the requirements of the study.
History of any neurological disorders or seizures
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
Other abnormalities or medical history that contraindicated measles vaccination