NCT01486355

Brief Summary

Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months. Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls. Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb. Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.

Trial Health

55
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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

4.9 years

First QC Date

August 3, 2011

Last Update Submit

November 14, 2013

Conditions

Measles Infection

Keywords

MortalityMorbidityHospitalisations/consultationsGrowthMeasles infection

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Differences in mortality rates between the intervention and control groups

Secondary Outcomes (4)

  • Morbidity

  • Hospitalisations/consultations

  • Growth

  • Measles infection

Study Arms (2)

Early measles vaccine

EXPERIMENTAL

Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age

Biological: Measles vaccine

No early measles vaccine

NO INTERVENTION

Receives only the standard measles vaccine at 9 months of age

Interventions

Measles vaccineBIOLOGICAL

Edmonston-Zagreb measles vaccine

Early measles vaccine

Eligibility Criteria

Age4 Months - 7 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier

You may not qualify if:

  • Malformations
  • Severely ill
  • Severely malnourished

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, Bissau Region, 1004, Guinea-Bissau

RECRUITING

Related Publications (4)

  • 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: 21118875BACKGROUND

  • Nielsen S, Fisker AB, da Silva I, Byberg S, Biering-Sorensen S, Bale C, Barbosa A, Bjerregaard-Andersen M, Hansen NS, Do VA, Baek O, Rasmussen SM, Damkjaer L, Hvidt S, Baltzersen O, Rodrigues A, Martins C, Jensen KJ, Whittle HC, Smits G, van der Klis F, Aaby P, Benn CS. Effect of early two-dose measles vaccination on childhood mortality and modification by maternal measles antibody in Guinea-Bissau, West Africa: A single-centre open-label randomised controlled trial. EClinicalMedicine. 2022 May 27;49:101467. doi: 10.1016/j.eclinm.2022.101467. eCollection 2022 Jul.

    PMID: 35747181DERIVED

  • Hansen NS, Byberg S, Hervig Jacobsen L, Bjerregaard-Andersen M, Jensen AKG, Martins C, Aaby P, Skov Jensen J, Benn CS, Whittle H. Effect of early measles vaccine on pneumococcal colonization: A randomized trial from Guinea-Bissau. PLoS One. 2017 May 17;12(5):e0177547. doi: 10.1371/journal.pone.0177547. eCollection 2017.

    PMID: 28545041DERIVED

  • Christensen LD, Eriksen HB, Biering-Sorensen S, Bale C, Do VA, Andersen A, Martins CL, Sodemann M, Aaby P, Benn CS. The effect of early measles vaccination on thymic size. A randomized study from Guinea-Bissau. Vaccine. 2014 Mar 26;32(15):1641-4. doi: 10.1016/j.vaccine.2014.01.034. Epub 2014 Feb 9.

    PMID: 24522160DERIVED

Related Links

MeSH Terms

Interventions

Measles Vaccine

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Peter Aaby, DMSc

CONTACT

+45 3268 3950p.aaby@bandim.org

Christine S Benn, MD, PhD

CONTACT

+45 3268 8354cb@ssi.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2011

First Posted

December 6, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2016

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

GU(1)