NCT00244673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,534

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

6.2 years

First QC Date

October 25, 2005

Last Update Submit

February 25, 2012

Conditions

MortalityHospitalizationAdverse Events

Keywords

VaccinationDTPChild mortalitySexNon-specific effects

Outcome Measures

Primary Outcomes (3)

  • Mortality till 4 years of age

    June 2011

  • Hospitalisations till 4 years of age

    June 2011

  • Adverse events 1 month after intervention

    December 2008

Secondary Outcomes (2)

  • Immunological responses

    July 2008

  • Morbidity

    June 2011

Interventions

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.

Eligibility Criteria

Age9 Months - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Normally applied contraindications for receiving vaccinations, including high fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project, Apartado 861

Bissau, Guinea-Bissau

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Peter Aaby, DMSc

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

GU(1)