Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01306006
Other study ID # MV-EPI
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2011
Est. completion date December 2, 2017

Study information

Verified date April 2021
Source Bandim Health Project
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV). Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality. To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy). The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.


Recruitment information / eligibility

Status Completed
Enrollment 3500
Est. completion date December 2, 2017
Est. primary completion date December 2, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Months to 35 Months
Eligibility Inclusion Criteria: - Age 9-35 months, not yet received routine measles vaccination, resident in study area Exclusion Criteria: - To ill to be vaccinated (according to local practice)

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Normal measles vaccines licensed for distribution through the national EPI program

Locations

Country Name City State
Guinea-Bissau Bandim Health Project Bissau

Sponsors (2)

Lead Sponsor Collaborator
Bandim Health Project Institudo Nacional de Saude Publica INASA

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality
Secondary Hospital morbidity
See also
  Status Clinical Trial Phase
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04092465 - Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Completed NCT04149873 - Effectness of Treatment With Mechanical Insufflation-Exsufflation N/A
Completed NCT05905042 - Follow-up of Recovery Condition in Survivors of Acute Respiratory Distress Syndrome
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00518856 - Lufwanyama Neonatal Survival Project N/A
Completed NCT06408636 - Prognostic Role of LA Strain in Acute Myocardial Infarction
Completed NCT06051526 - The African Critical Illness Outcomes Study
Recruiting NCT05055089 - Short- and Medium-term Results of New Generation Aortic
Active, not recruiting NCT04132492 - AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
Completed NCT03885206 - Effectiveness and Clinical Outcomes of Municipal Acute Wards Versus a General Hospital N/A
Completed NCT05573659 - Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients N/A
Withdrawn NCT03245658 - The Effect of Cannabis in Pancreatic Cancer Phase 2
Recruiting NCT04094428 - Burden, Mortality and Supply Costs in Intensive Care Unit Patients
Completed NCT01631799 - Outcome of Patients After Total Knee Replacement: A Comparison of Femoral Nerve Block and Epidural Anesthesia N/A
Completed NCT00244673 - Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination Phase 4
Completed NCT03378843 - Spermidine Intake and All-cause Mortality N/A
Recruiting NCT04424511 - Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali Phase 3

External Links