Additional Measles Vaccine at 4 Months of Age

Measles Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01486355
• Other study ID #: MVurban
• Status: Recruiting
• Phase: Phase 4
• First received: August 3, 2011
• Last updated: November 14, 2013
• Start date: August 2011

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: Peter Aaby, DMSc
• Phone: +45 3268 3950
• Email: p.aaby[@]bandim.org
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsGuinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: July 2016
• Gender: Both
• Age group: 4 Months to 7 Months

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Measles
• Measles Infection

Intervention

Biological:
• Measles vaccine
Edmonston-Zagreb measles vaccine

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

References & Publications (1)

Aaby P, Martins CL, Garly ML, Balé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Differences in mortality rates between the intervention and control groups
Secondary	Morbidity	Symptoms of infection
Secondary	Hospitalisations/consultations	Visits to health center for consultation due to illness, hospitalisation
Secondary	Growth	Weight, length, arm circumference
Secondary	Measles infection	Measles infection assessed by medical doctor and/or verified by blood samples

External Links

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