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Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination

NCT00244673 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6534

Last updated 2012-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Mortality
  • Hospitalization
  • Adverse Events

Interventions

BIOLOGICAL

DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4

Trial of not providing 3. and/or 4. DTP together with or after MV at 9 to 18 month of age.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Peter Aaby, DMSc · Bandim Health Project

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Guinea-Bissau

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00244673 on ClinicalTrials.gov