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

NCT ID: NCT02943681

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3812 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2021-05-31

Brief Summary

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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

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Conditions

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Child Mortality Child Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Measles vaccine

Measles vaccine, 1 dose of 0.5 ml

Group Type EXPERIMENTAL

Measles vaccine

Intervention Type BIOLOGICAL

Control

Nothing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Measles vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bandim Health Project, Apartado 861

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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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.

Reference Type BACKGROUND
PMID: 35218356 (View on PubMed)

Other Identifiers

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MV18Months

Identifier Type: -

Identifier Source: org_study_id

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