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

Not Applicable

Completed

• Conditions: Child Morbidity; Child Mortality
• Interventions: Biological: Measles vaccine

• Registration Number: NCT02943681
• Lead Sponsor: Bandim Health Project

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-25
• Primary Completion: 2020-05
• Study Completion: 2021-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3812

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Measles vaccine	Measles vaccine	Measles vaccine, 1 dose of 0.5 ml

Primary Outcome Measures

Name	Time	Method
Mortality	30 months	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	30 months	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

Name	Time	Method
Hospital admission by cause	30 months	Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex
Consultations	30 months	Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex

Trial Locations

Locations (1)

Bandim Health Project, Apartado 861; 🇬🇼 Bissau, Guinea-Bissau