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Additional Measles Vaccine at 4 Months of Age

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01486355
Enrollment
Unknown
Registered
2011-12-06
Start date
2011-08-31
Completion date
Unknown
Last updated
2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles Infection

Keywords

Mortality, Morbidity, Hospitalisations/consultations, Growth, Measles infection

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.

Interventions

BIOLOGICALMeasles vaccine

Edmonston-Zagreb measles vaccine

Sponsors

Bandim Health Project
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
4 Months to 7 Months

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

Design outcomes

Primary

MeasureTime frameDescription
MortalityDifferences in mortality rates between the intervention and control groups

Secondary

MeasureTime frameDescription
MorbiditySymptoms of infection
Hospitalisations/consultationsVisits to health center for consultation due to illness, hospitalisation
GrowthWeight, length, arm circumference
Measles infectionMeasles infection assessed by medical doctor and/or verified by blood samples

Countries

Guinea-Bissau

Contacts

Primary ContactPeter Aaby, DMSc
p.aaby@bandim.org+45 3268 3950
Backup ContactChristine S Benn, MD, PhD
cb@ssi.dk+45 3268 8354

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026