A Second Dose of Measles Vaccine (MV) in the Second Year of Life
Boosting the Beneficial Non-specific Effects of Live Attenuated Vaccines: A Randomized Controlled Trial (RCT) of a Second Dose of Measles Vaccine (MV) in the Second Year of Life
1 other identifier
interventional
3,812
1 country
1
Brief Summary
This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJanuary 19, 2024
January 1, 2024
3.6 years
October 13, 2016
January 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Mortality
Mortality registered monthly by Health and Demographic Surveillance System fieldworkers. Mortality will be combined with hospital admissions in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
30 months
Hospital admissions
Hospital admissions registered daily at the national hospital. Hospital admissions will be combined with mortality in the analysis to form the outcome severe morbidity. This will be examined overall and by sex
30 months
Secondary Outcomes (2)
Hospital admission by cause
30 months
Consultations
30 months
Study Arms (2)
Measles vaccine
EXPERIMENTALMeasles vaccine, 1 dose of 0.5 ml
Control
NO INTERVENTIONNothing
Interventions
Eligibility Criteria
You may qualify if:
- Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
You may not qualify if:
- Having severe malformations that impairs their health
- Having received a second dose of measles vaccine
- Severely ill (requiring hospitalization) upon clinical examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Related Publications (1)
Berendsen MLT, Silva I, Bale C, Nielsen S, Hvidt S, Martins CL, Benn CS, Aaby P. The Effect of a Second Dose of Measles Vaccine at 18 Months of Age on Nonaccidental Deaths and Hospital Admissions in Guinea-Bissau: Interim Analysis of a Randomized Controlled Trial. Clin Infect Dis. 2022 Oct 12;75(8):1370-1378. doi: 10.1093/cid/ciac155.
PMID: 35218356BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 25, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2020
Study Completion
May 1, 2021
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share