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

January 18, 2024 updated by: Bandim Health Project

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
      • Bissau, Guinea-Bissau
        • Bandim Health Project, Apartado 861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Measles vaccine
Measles vaccine, 1 dose of 0.5 ml
Biological: Measles vaccine
No Intervention: Control
Nothing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 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
30 months
Hospital admissions
Time Frame: 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
30 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimated)

October 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MV18Months

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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