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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early measles vaccine | Experimental | Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age |
|
| No early measles vaccine | No Intervention | Receives only the standard measles vaccine at 9 months of age |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles vaccine | Biological | Edmonston-Zagreb measles vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Differences in mortality rates between the intervention and control groups |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Symptoms of infection | |
| Hospitalisations/consultations | Visits to health center for consultation due to illness, hospitalisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Aaby, DMSc | Contact | +45 3268 3950 | p.aaby@bandim.org | |
| Christine S Benn, MD, PhD | Contact | +45 3268 8354 | cb@ssi.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandim Health Project | Recruiting | Bissau | Bissau Region | 1004 | Guinea-Bissau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21118875 | Background | 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. | |
| 35747181 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008458 | Measles Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Growth | Weight, length, arm circumference |
| Measles infection | Measles infection assessed by medical doctor and/or verified by blood samples |
| 28545041 | Derived | 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. |
| 24522160 | Derived | 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. |