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

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ClinicalTrials.gov Identifier: NCT00244673
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : February 28, 2012
Sponsor:
Collaborators:
Aarhus University Hospital
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Bandim Health Project

Tracking Information
First Submitted Date  ICMJE October 25, 2005
First Posted Date  ICMJE October 27, 2005
Last Update Posted Date February 28, 2012
Study Start Date  ICMJE October 2005
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2007)
  • Mortality till 4 years of age [ Time Frame: June 2011 ]
  • Hospitalisations till 4 years of age [ Time Frame: June 2011 ]
  • Adverse events 1 month after intervention [ Time Frame: December 2008 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
  • Mortality till 4 years of age
  • Hospitalisations till 4 years of age
  • Adverse events 1 month after intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2007)
  • Immunological responses [ Time Frame: July 2008 ]
  • Morbidity [ Time Frame: June 2011 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2005)
  • Immunogical responses
  • Morbidity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
Official Title  ICMJE Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
Brief 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.

Detailed Description

Background: Infectious diseases are the main cause of high child mortality in Africa. In several non-randomised studies, routine childhood vaccinations have been observed to have non-targeted effects. Live vaccines like measles vaccine (MV) seem to protect against overall mortality, whereas killed vaccines, like DTP, may have no beneficial effects, especially for girls. DTP provided with or after MV may be associated with increased mortality. The mechanisms behind these effects are unknown.

Hypothesis: Not providing DTP together with or after MV is associated with a 35 % reduction in overall mortality and 23% reduction in hospitalizations.

Objectives: To examine in a randomised study of 6000 children the effect of not administering DTP simultaneously with or after MV on

  1. Overall child mortality
  2. Hospitalization rates and major causes of hospitalization
  3. The immunological profile after vaccination
  4. Sex-differences in the above mentioned outcomes

Methods:

Surveillance system: BHP's demographic surveillance system in Bissau covers 6 districts with a population of 90,000; 3,500 children are born each year.

Hospitalizations: There is only one pediatric ward in Bissau and all hospitalizations are identified in the BHP register.

Vaccinations: Vaccinations are provided and registered at the 3 health centres in the study area.

Intervention: In this study 6000 children are randomised as they come to receive DTP3 or DTP booster with or after measles vaccination (MV) at the local health centres. Children will be randomised to DTP3+OPV3 and MV versus OPV3 and MV or DTP4+OPV4 versus OPV4 (booster doses).

Follow-up: The children will be followed until 4 years of age or end of study.

  1. Adverse effects: In the first month after vaccination, 1000 children will be visited daily for three days and then weekly to register morbidity and consultations.
  2. Hospitalizations: The children will be followed at the pediatric ward.
  3. Mortality: Children will be followed by the routine surveillance system. Furthermore, all children will be visited yearly and finally when they reach four years of age. When a death is detected, a physician will conduct a verbal autopsy.

Sample size: With a total of 7500 person-years of follow-up, we will be able to document a 35% reduction in mortality and a 23% reduction in hospitalizations. A subgroup of children will be examined for possible differences in immunological profile after vaccination.

Ethical considerations: Herd immunity to pertussis should not be affected as, due to the intervention, more children is vaccinated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Mortality
  • Hospitalization
  • Adverse Events
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2012)
6534
Original Enrollment  ICMJE
 (submitted: October 25, 2005)
6000
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guinea-Bissau
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244673
Other Study ID Numbers  ICMJE CVEK2005-7041-45-DTPMV
CVEK2005-7041-45
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bandim Health Project
Study Sponsor  ICMJE Bandim Health Project
Collaborators  ICMJE
  • Aarhus University Hospital
  • Rigshospitalet, Denmark
Investigators  ICMJE
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
PRS Account Bandim Health Project
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP