ClinicalTrials.gg
CompletedNCT02943681Updated Jan 19, 2024

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

An interventional study of Measles vaccine in Child Mortality and Child Morbidity, sponsored by Bandim Health Project. Completed at 1 site in Guinea-Bissau. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Bandim Health Project · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,812
Allocation
Randomized
Ages
18 Months to 24 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Child Mortality
  • Child Morbidity
03

In context

Lead sponsor

Bandim Health Project is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.

Exclusion criteria

Exclusion Criteria:

  • Having severe malformations that impairs their health
  • Having received a second dose of measles vaccine
  • Severely ill (requiring hospitalization) upon clinical examination
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,812 participants (actual)

Study arms

  • Experimental
    Measles vaccine

    Measles vaccine, 1 dose of 0.5 ml

    Biological: Measles vaccine

  • No intervention
    Control

    Nothing

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 months

  2. 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

    Time frame: 30 months

Secondary outcomes

  1. Hospital admission by cause

    Causes of hospital admissions registered daily at the national hospital. These will be examined overall and by sex

    Time frame: 30 months

  2. Consultations

    Consultations registered daily at the local health centers and the national hospital. These will be examined overall and by sex

    Time frame: 30 months

07

Study locations

1 site
  • Bandim Health Project, Apartado 861
    Bissau, Guinea-Bissau
08

References and documents

Publications

  • 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. PubMed 35218356 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02943681
Lead sponsor
Bandim Health Project
Responsible party
Sponsor
First posted
Oct 25, 2016
Start date
Oct 2016
Primary completion
May 2020
Completion
May 2021
Last update
Jan 19, 2024

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Measles Vaccine

Start the discussion