Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]

Table 4 Expected precision around the given immune response (seroconversion or fourfold titre/concentration rise) rate estimates in adults and toddler/infants who will receive MRV-MNP

Immune response rate in sample (%)	n = 30	n = 60
Immune response rate in sample (%)	Immune response (%) (95% CI)	Immune response (%) (95% CI)
20.0	20.0 (9.5–37.3)	20.0 (11.8–31.8)
40.0	40.0 (24.6–57.7)	40.0 (28.6–52.6)
60.0	60.0 (42.3–75.4)	60.0 (47.4–71.4)
80.0	80.0 (62.7– 90.5)	80.0 (68.2–88.2)
100.0	100.0 (88.7–100.0)	100.0 (94.0–100.0)

ISSN: 1745-6215