NCT00168545

Brief Summary

OBJECTIVES

  • General: To investigate the immunological background for the non-specific effects of diphtheria-tetanus-pertussis (DTP) and measles vaccines on child mortality
  • Specific: Examine the cytokine responses and possible association with morbidity in a study of DTP vaccinated children who will be randomised to receive a measles vaccine or no vaccine at 4½ months of age. (All children will receive a measles vaccine at 9 months of age)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Shorter than P25 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

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

September 22, 2011

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

September 21, 2011

Conditions

MeaslesDiphtheriaTetanusPertussis

Keywords

Non-specific effects of vaccinesImmunologyCytokinesInfant mortalityChild mortalityMortalityMorbidityDiphtheria-tetanus-pertussis vaccineMeasles vaccineMeaslesImmunisationLow income countryGuinea-BissauBandim Health ProjectImmunology of measles and DTP vaccination

Outcome Measures

Primary Outcomes (1)

  • Cytokine levels in the randomised groups

Interventions

Measles vaccineBIOLOGICAL

Eligibility Criteria

Age4 Months - 9 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, Apartado 861, 1004 Bissau Codex, Guinea-Bissau

Location

Related Publications (1)

  • Jensen KJ, Sondergaard M, Andersen A, Sartono E, Martins C, Garly ML, Eugen-Olsen J, Ullum H, Yazdanbakhsh M, Aaby P, Benn CS, Erikstrup C. A randomized trial of an early measles vaccine at 4(1/2) months of age in Guinea-Bissau: sex-differential immunological effects. PLoS One. 2014 May 16;9(5):e97536. doi: 10.1371/journal.pone.0097536. eCollection 2014.

    PMID: 24835247DERIVED

Related Links

MeSH Terms

Conditions

MeaslesDiphtheriaTetanusWhooping CoughInfant Death

Interventions

Measles Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsCorynebacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesClostridium InfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • PETER AABY, MSc, Dr Med

    Bandim Health Project

    STUDY DIRECTOR

  • MAY-LILL GARLY, PHD, DTM&H

    Bandim Health Project

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

January 1, 2006

Study Completion

January 1, 2007

Last Updated

September 22, 2011

Record last verified: 2006-09

Locations

GU(1)