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 2 The probability of any given safety event occurring at least once or at least twice given a true population event rate of between 1.0 and 20.0% according to the indicated samples sizes per group

True event rate (%)	n = 30		n = 60		n = 150
True event rate (%)	Probability of at least 1 event	Probability of at least 2 events	Probability of at least 1 event	Probability of at least 2 events	Probability of at least 1 event	Probability of at least 2 events
20	99.9	98.9	100.0	100.0	100.0	100.0
10	95.8	81.6	99.8	98.6	100.0	100.0
7.5	90.4	66.9	99.1	94.5	100.0	100.0
5	78.5	44.6	95.4	80.8	100.0	99.6
2.5	53.2	17.2	78.1	44.4	97.8	89.1
1	26.0	3.6	45.3	12.1	77.9	44.3

ISSN: 1745-6215