MortalityPhase 4NCT00244673
Randomized Study of Not Giving Diphteria-tetanus-pertussis Vaccination With or After Measles Vaccination
A Phase 4 study testing DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4 in people with Mortality and Hospitalization, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 months to 4 years
- Conditions the study is for
- Mortality, Hospitalization, Adverse Events
- What is being tested?
- DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4
- How many people
- 6,534 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Oct 2005to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child should be missing DTP3 or DTP4
- The child should have received DTP2
- The child should have received MV already or receive MV on the day of enrolment
Who cannot join
- Normally applied contraindications for receiving vaccinations, including high fever
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
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.
Read the 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
- Overall child mortality
- Hospitalization rates and major causes of hospitalization
- The immunological profile after vaccination
- 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.
- 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.
- Hospitalizations: The children will be followed at the pediatric ward.
- 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.
- Conditions
- Mortality, Hospitalization, Adverse Events
- Being tested
- DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4
- Keywords
- Vaccination, DTP, Child mortality, Sex, Non-specific effects
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4Biological
Trial of not providing 3. and/or 4. DTP together with or after MV at 9 to 18 month of age.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality till 4 years of age
Measured: June 2011
Hospitalisations till 4 years of age
Measured: June 2011
Adverse events 1 month after intervention
Measured: December 2008
Secondary outcomes (2)
Immunological responses
Measured: July 2008
Morbidity
Measured: June 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Aaby, DMSc, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244673
- Sponsor's protocol ID
- CVEK2005-7041-45-DTPMV
- Other IDs
- CVEK2005-7041-45
- Status last verified
- Feb 2012
- First submitted
- 25 Oct 2005
- Last updated
- 28 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diphteria-tetanus-pertussis (DTP) Vaccination and Child Survival: Randomized Study of Not Providing DTP Vaccination Together With or After Measles Vaccination
- ClinicalTrials.gov ID
- NCT00244673
- Acronym / sponsor ID
- CVEK2005-7041-45-DTPMV
- Conditions
- Mortality, Hospitalization, Adverse Events
- Keywords
- Vaccination, DTP, Child mortality, Sex, Non-specific effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,534 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Oct 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Overall child mortality
- Hospitalization rates and major causes of hospitalization
- The immunological profile after vaccination
- 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.
- 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.
- Hospitalizations: The children will be followed at the pediatric ward.
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child should be missing DTP3 or DTP4
- The child should have received DTP2
- The child should have received MV already or receive MV on the day of enrolment
Key exclusion criteria (1 listed)
- Normally applied contraindications for receiving vaccinations, including high fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4Trial of not providing 3. and/or 4. DTP together with or after MV at 9 to 18 month of age. | Biological | – |
Primary outcome
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
2 secondary outcomes
Immunological responses
Time frame: July 2008
Morbidity
Time frame: June 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Aaby, DMSc principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DTP3/4+OPV+MV versus OPV+MV or DTP4+OPV4 versus OPV4 in people with Mortality and Hospitalization, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality till 4 years of age (time frame: June 2011). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.