Additional Measles Vaccine at 4 Months of Age

• ClinicalTrials.gov Identifier: NCT01486355
• Recruitment Status: Unknown
• First Posted: December 6, 2011
• Last Update Posted: November 15, 2013
• Sponsor: Bandim Health Project
• Information provided by: Bandim Health Project

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.

Condition or disease	Intervention/treatment	Phase
Measles Infection	Biological: Measles vaccine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Allocation: Randomized
• Primary Purpose: Prevention
• 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 Start Date: August 2011
• Estimated Primary Completion Date: July 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early measles vaccine; Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age	Biological: Measles vaccine; Edmonston-Zagreb measles vaccine
No Intervention: No early measles vaccine; Receives only the standard measles vaccine at 9 months of age

Outcome Measures

Primary Outcome Measures :

1. Mortality
   Differences in mortality rates between the intervention and control groups

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 4 Months to 7 Months (Child)
• Sexes Eligible for Study: All

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

Contacts and Locations

Contacts

Contact: Peter Aaby, DMSc; +45 3268 3950; p.aaby@bandim.org

Contact: Christine S Benn, MD, PhD; +45 3268 8354; cb@ssi.dk

Locations

Guinea-Bissau

Bandim Health Project; Recruiting

Bissau, Guinea-Bissau, 1004

Principal Investigator: Cesario L Martins, MD, PhD

Sponsors and Collaborators

Bandim Health Project

More Information

Additional Information:

Related Info 

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Christensen LD, Eriksen HB, Biering-Sørensen S, Balé 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.

• ClinicalTrials.gov Identifier: NCT01486355
• Other Study ID Numbers: MVurban
• First Posted: December 6, 2011
• Last Update Posted: November 15, 2013
• Last Verified: November 2013

Keywords provided by Bandim Health Project:

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

Additional relevant MeSH terms:

Measles; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs