Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244673
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2005-10-25
Brief Title:
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Diphteria-tetanus-pertussis DTP Vaccination and Child Survival Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 BHPs demographic surveillance system in Bissau covers 6 districts with a population of 90000 3500 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 DTP3OPV3 and MV versus OPV3 and MV or DTP4OPV4 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
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 BHPs demographic surveillance system in Bissau covers 6 districts with a population of 90000 3500 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 DTP3OPV3 and MV versus OPV3 and MV or DTP4OPV4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CVEK2005-7041-45 | None | None | None |