Additional Measles Vaccine at 4 Months of Age

Bandim Health Project

Status and phase: Unknown; Phase 4

Conditions: Measles Infection

Treatments: Biological: Measles vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01486355

MVurban

Details and patient eligibility

About

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.

Sex: All

Ages: 4 to 7 months old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Early measles vaccine

Experimental group

Description:

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

Treatment:

Biological: Measles vaccine

No early measles vaccine

No Intervention group

Description:

Receives only the standard measles vaccine at 9 months of age