Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings (NCT06667206) | Clinical Trial Compass
UnknownPhase 2
Earlier Prime-BOOST Schedule to Improve MEasles Protection in High Burden Settings
Uganda450 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
Age range23 Weeks – 28 Weeks
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Trial Participants Children aged 6 months (23 - 28 weeks) at time of screening
2. Inclusion Criteria
* 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
3. Exclusion Criteria
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
What they're measuring
1
Protective measles antibody concentrations at 2.5 years of age
Timeframe: 2.5 years of age
2
Local and systemic reactions
Timeframe: 7 days post each vaccination
3
Serious Adverse Events
Timeframe: 2 years: (from baseline vaccination until 2 year follow up visit)