Back to resultsA Second Dose of Measles Vaccine (MV) in the Second Year of Life
Primary Purpose
Child Mortality, Child Morbidity
Status
Unknown status
Phase
Not Applicable
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
Measles vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Child Mortality
Eligibility Criteria
Inclusion Criteria:
- Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
Exclusion Criteria:
- Having severe malformations that impairs their health
- Having received a second dose of measles vaccine
- Severely ill (requiring hospitalization) upon clinical examination
Sites / Locations
- Bandim Health Project, Apartado 861Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Measles vaccine
Control
Arm Description
Measles vaccine, 1 dose of 0.5 ml
Nothing
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Hospital admission by cause
Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex
Consultations
Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex
Full Information
NCT ID
NCT02943681
First Posted
October 13, 2016
Last Updated
October 27, 2016
Sponsor
Bandim Health Project
1. Study Identification
Unique Protocol Identification Number
NCT02943681
Brief Title
A Second Dose of Measles Vaccine (MV) in the Second Year of Life
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bandim Health Project
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Mortality, Child Morbidity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Measles vaccine
Arm Type
Experimental
Arm Description
Measles vaccine, 1 dose of 0.5 ml
Arm Title
Control
Arm Type
No Intervention
Arm Description
Nothing
Intervention Type
Biological
Intervention Name(s)
Measles vaccine
Primary Outcome Measure Information:
Title
Mortality
Description
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
Time Frame
30 months
Title
Hospital admissions
Description
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
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Hospital admission by cause
Description
Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex
Time Frame
30 months
Title
Consultations
Description
Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.
Exclusion Criteria:
Having severe malformations that impairs their health
Having received a second dose of measles vaccine
Severely ill (requiring hospitalization) upon clinical examination
Facility Information:
Facility Name
Bandim Health Project, Apartado 861
City
Bissau
Country
Guinea-Bissau
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Aaby
Phone
0045 3268 3268
Email
p.aaby@bandim.org
First Name & Middle Initial & Last Name & Degree
Amabelia Rodrigues
Email
a.rodrigues@bandim.org
First Name & Middle Initial & Last Name & Degree
Peter Aaby
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35218356
Citation
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.
Results Reference
derived
Learn more about this trial
A Second Dose of Measles Vaccine (MV) in the Second Year of Life
We'll reach out to this number within 24 hrs