Mortality Clinical Trial
Official title:
Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
Verified date | February 2012 |
Source | Bandim Health Project |
Contact | n/a |
Is FDA regulated | No |
Health authority | Guinea-Bissau: Ministry of Health |
Study type | Interventional |
In non-randomized studies, routine childhood vaccinations have been observed to have
non-targeted effects. Difteria-tetanus-pertussis (DTP) vaccine provided with or after
measles vaccine (MV) is associated with increased mortality in areas with herd immunity to
pertussis.
We will examine in a randomised study of 6000 children the effect of not administering DTP
simultaneously with or after MV on overall child mortality, hospitalization rates, and the
immunological responses after vaccination. We will also examine potential sex-differential
effects in the outcomes and interactions with other vaccines, other health interventions and
season.
Status | Completed |
Enrollment | 6534 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 9 Months to 4 Years |
Eligibility |
Inclusion Criteria: 1. The child should be missing DTP3 or DTP4 2. The child should have received DTP2 3. The child should have received MV already or receive MV on the day of enrolment Exclusion Criteria: Normally applied contraindications for receiving vaccinations, including high fever |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Guinea-Bissau | Bandim Health Project, Apartado 861 | Bissau |
Lead Sponsor | Collaborator |
---|---|
Bandim Health Project | Aarhus University Hospital, Rigshospitalet, Denmark |
Guinea-Bissau,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality till 4 years of age | June 2011 | Yes | |
Primary | Hospitalisations till 4 years of age | June 2011 | Yes | |
Primary | Adverse events 1 month after intervention | December 2008 | Yes | |
Secondary | Immunological responses | July 2008 | Yes | |
Secondary | Morbidity | June 2011 | Yes |
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 |
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 | |
Completed |
NCT04032288 -
Establish a Prospective Registration System of ARDS Patients for Improving Quality of Care
|