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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943681
Enrollment
3812
Registered
2016-10-25
Start date
2016-10-31
Completion date
2021-05-31
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Mortality, Child Morbidity

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.

Interventions

BIOLOGICALMeasles vaccine

Sponsors

Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 monthsMortality 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 admissions30 monthsHospital 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

MeasureTime frameDescription
Hospital admission by cause30 monthsCauses of hospital admissions registered daily at the national hospital. These will be examined overall and by sex
Consultations30 monthsConsultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex

Countries

Guinea-Bissau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026