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Additional Measles Vaccine at 4 Months of Age

Primary Purpose

Measles Infection

Status
Unknown status
Phase
Phase 4
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
Measles vaccine
Sponsored by
Bandim Health Project
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles Infection focused on measuring Mortality, Morbidity, Hospitalisations/consultations, Growth, Measles infection

Eligibility Criteria

4 Months - 7 Months (Child)All Sexes

Inclusion Criteria:

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

Exclusion Criteria:

  • Malformations
  • Severely ill
  • Severely malnourished

Sites / Locations

  • Bandim Health ProjectRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early measles vaccine

No early measles vaccine

Arm Description

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

Receives only the standard measles vaccine at 9 months of age

Outcomes

Primary Outcome Measures

Mortality
Differences in mortality rates between the intervention and control groups

Secondary Outcome Measures

Morbidity
Symptoms of infection
Hospitalisations/consultations
Visits to health center for consultation due to illness, hospitalisation
Growth
Weight, length, arm circumference
Measles infection
Measles infection assessed by medical doctor and/or verified by blood samples

Full Information

First Posted
August 3, 2011
Last Updated
November 14, 2013
Sponsor
Bandim Health Project
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1. Study Identification

Unique Protocol Identification Number
NCT01486355
Brief Title
Additional Measles Vaccine at 4 Months of Age
Official Title
A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles Antibodies for the Beneficial Non-specific Effects of Measles Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bandim Health Project

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles Infection
Keywords
Mortality, Morbidity, Hospitalisations/consultations, Growth, Measles infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Early measles vaccine
Arm Type
Experimental
Arm Description
Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age
Arm Title
No early measles vaccine
Arm Type
No Intervention
Arm Description
Receives only the standard measles vaccine at 9 months of age
Intervention Type
Biological
Intervention Name(s)
Measles vaccine
Intervention Description
Edmonston-Zagreb measles vaccine
Primary Outcome Measure Information:
Title
Mortality
Description
Differences in mortality rates between the intervention and control groups
Secondary Outcome Measure Information:
Title
Morbidity
Description
Symptoms of infection
Title
Hospitalisations/consultations
Description
Visits to health center for consultation due to illness, hospitalisation
Title
Growth
Description
Weight, length, arm circumference
Title
Measles infection
Description
Measles infection assessed by medical doctor and/or verified by blood samples

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
7 Months
Eligibility Criteria
Inclusion Criteria: Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier Exclusion Criteria: Malformations Severely ill Severely malnourished
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Aaby, DMSc
Phone
+45 3268 3950
Email
p.aaby@bandim.org
First Name & Middle Initial & Last Name or Official Title & Degree
Christine S Benn, MD, PhD
Phone
+45 3268 8354
Email
cb@ssi.dk
Facility Information:
Facility Name
Bandim Health Project
City
Bissau
ZIP/Postal Code
1004
Country
Guinea-Bissau
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesario L Martins, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21118875
Citation
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.
Results Reference
background
PubMed Identifier
35747181
Citation
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.
Results Reference
derived
PubMed Identifier
28545041
Citation
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. Erratum In: PLoS One. 2019 Oct 30;14(10):e0224782.
Results Reference
derived
PubMed Identifier
24522160
Citation
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.
Results Reference
derived
Links:
URL
http://www.bandim.org
Description
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Additional Measles Vaccine at 4 Months of Age

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