Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
Information source: Bandim Health Project
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mortality; Hospitalization; Adverse Events
Intervention: DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4 (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Bandim Health Project Official(s) and/or principal investigator(s): Peter Aaby, DMSc, Principal Investigator, Affiliation: Bandim Health Project
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.
Clinical Details
Official title: Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Mortality till 4 years of ageHospitalisations till 4 years of age Adverse events 1 month after intervention
Secondary outcome: Immunological responsesMorbidity
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.
Eligibility
Minimum age: 9 Months.
Maximum age: 4 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Bandim Health Project, Apartado 861, Bissau, Guinea-Bissau
Additional Information
Starting date: October 2005
Last updated: February 25, 2012
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