A Second Dose of Measles Vaccine (MV) in the Second Year of Life

Child Mortality Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943681
• Other study ID #: MV18Months
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2021

Study information

• Verified date: January 2024
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3812
• Est. completion date: May 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Morbidity
• Child Mortality
• Measles

Intervention

Biological:
• Measles vaccine

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project, Apartado 861	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hospital admission by cause	Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex	30 months
Secondary	Consultations	Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex	30 months