NCT00168558

Brief Summary

The specific aims are to examine in Guinea-Bissau:

  • whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles vaccine will be the best vaccine strain for use in a routine one-dose measles vaccination schedule and a two-dose measles vaccination schedule in terms of antibody response, protection against measles and child survival, and
  • whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a very early two-dose schedule vaccinating at 4½ and 9 months of age

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,879

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2003

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

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
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

4.7 years

First QC Date

September 9, 2005

Last Update Submit

March 4, 2012

Conditions

Measles

Keywords

Non-specific effects of vaccinesInfant mortalityChild mortalityMortalityMorbidityDiphtheria-tetanus-pertussis vaccineMeasles vaccineMeaslesImmunisationLow income countryGuinea-BissauBandim Health ProjectImmunology

Outcome Measures

Primary Outcomes (3)

  • Vaccine efficacy

    Assessed by study completion

  • Measles specific mortality

    Assessed by study completion

  • All cause sex-specific mortality until 3 years of age

    Assessed by study completion

Secondary Outcomes (3)

  • Measles antibody level at 4½, 9, 18 and 24 months of age

    Assessed by study completion

  • Morbidity from 4½ to 12 months of age

    Assessed by study completion

  • Anthropometric measures at 4½, 9, 18 and 24 months of age

    Assessed by study completion

Study Arms (3)

1

ACTIVE COMPARATOR

Standard titre Edmonston-Zagreb measles vaccine at 4½ and 9 months of age

Biological: Measles vaccine

2

ACTIVE COMPARATOR

Standard titre Schwarz measles vaccine at 9 months of age

Biological: Measles vaccine

3

ACTIVE COMPARATOR

Standard titre Edmonston-Zagreb measles vaccine at 9 months of age

Biological: Measles vaccine

Interventions

Measles vaccineBIOLOGICAL

The children will be randomised to the following three arms: Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age. Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age. Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age. V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine

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Eligibility Criteria

Age4 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants of 4½ months of age registered in the Bandim Health Project registration system and currently living in the Bandim Health Project areas: Bandim I, Bandim II, Belem, Mindará and Cuntum; and who received all three diphtheria-tetanus-pertussis vaccinations at least 4 weeks before enrollment

You may not qualify if:

  • Severe illness requiring immediate hospitalisation

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 (9)

  • Brond M, Martins CL, Byberg S, Benn CS, Whittle H, Garly ML, Aaby P, Fisker AB. Randomized Trial of 2 Versus 1 Dose of Measles Vaccine: Effect on Hospital Admission of Children After 9 Months of Age. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):226-233. doi: 10.1093/jpids/pix042.

    PMID: 28992261DERIVED

  • Rasmussen SM, Biering-Sorensen S, Byberg S, Andersen A, Bjerregaard-Andersen M, Rodrigues A, Benn CS, Martins CL, Aaby P. The effect of early measles vaccination at 4.5 months of age on growth at 9 and 24 months of age in a randomized trial in Guinea-Bissau. BMC Pediatr. 2016 Dec 3;16(1):199. doi: 10.1186/s12887-016-0738-z.

    PMID: 27912735DERIVED

  • Benn CS, Martins CL, Fisker AB, Diness BR, Garly ML, Balde I, Rodrigues A, Whittle H, Aaby P. Interaction between neonatal vitamin A supplementation and timing of measles vaccination: a retrospective analysis of three randomized trials from Guinea-Bissau. Vaccine. 2014 Sep 22;32(42):5468-74. doi: 10.1016/j.vaccine.2014.07.090. Epub 2014 Aug 13.

    PMID: 25131735DERIVED

  • Aaby P, Martins CL, Garly ML, Andersen A, Fisker AB, Claesson MH, Ravn H, Rodrigues A, Whittle HC, Benn CS. Measles vaccination in the presence or absence of maternal measles antibody: impact on child survival. Clin Infect Dis. 2014 Aug 15;59(4):484-92. doi: 10.1093/cid/ciu354. Epub 2014 May 14.

    PMID: 24829213DERIVED

  • Martins C, Garly ML, Bale C, Rodrigues A, Njie-Jobe J, Benn CS, Whittle H, Aaby P. Measles virus antibody responses in children randomly assigned to receive standard-titer edmonston-zagreb measles vaccine at 4.5 and 9 months of age, 9 months of age, or 9 and 18 months of age. J Infect Dis. 2014 Sep 1;210(5):693-700. doi: 10.1093/infdis/jiu117. Epub 2014 Mar 31.

    PMID: 24688075DERIVED

  • Martins CL, Benn CS, Andersen A, Bale C, Schaltz-Buchholzer F, Do VA, Rodrigues A, Aaby P, Ravn H, Whittle H, Garly ML. A randomized trial of a standard dose of Edmonston-Zagreb measles vaccine given at 4.5 months of age: effect on total hospital admissions. J Infect Dis. 2014 Jun 1;209(11):1731-8. doi: 10.1093/infdis/jit804. Epub 2014 Jan 16.

    PMID: 24436454DERIVED

  • Martins C, Garly ML, Bale C, Rodrigues A, Benn CS, Whittle H, Aaby P. Measles antibody levels after vaccination with Edmonston-Zagreb and Schwarz measles vaccine at 9 months or at 9 and 18 months of age: a serological study within a randomised trial of different measles vaccines. Vaccine. 2013 Nov 19;31(48):5766-71. doi: 10.1016/j.vaccine.2013.08.044. Epub 2013 Aug 28.

    PMID: 23994379DERIVED

  • Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.

    PMID: 21118875DERIVED

  • Martins CL, Garly ML, Bale C, Rodrigues A, Ravn H, Whittle HC, Lisse IM, Aaby P. Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months: interim analysis of a randomised clinical trial. BMJ. 2008 Jul 24;337:a661. doi: 10.1136/bmj.a661.

    PMID: 18653640DERIVED

Related Links

MeSH Terms

Conditions

MeaslesInfant Death

Interventions

Measles Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsDeathPathologic 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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

July 1, 2003

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

GU(1)