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Table 3 Expected precision around the given safety event rate estimates in adults, toddler/infants and the whole population who will receive MRV-MNP

From: 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]

Event rate in sample (%)

n = 30

n = 60

n = 150

Event rate (%) (95% CI)

Event rate (95% CI)

Event rate (95% CI)

20.0

20.0 (9.5–37.3)

20 (11.8–31.8)

20.0 (14.4–27.1)

10.0

10.0 (3.5–25.6)

10 (4.7–20.2)

10.0 (6.2–15.8)

7.5

7.5 (22–22.4)

7.5 (3.1–17.0)

7.5 (4.3–12.9)

5.0

5.0 (1.2–19.1)

5.0 (1.7–13.7)

5.0 (2.5–9.8)

2.5

2.5 (0.3–15.4)

2.5 (0.6–10.1)

2.5 (1.0–6.4)

1.0

1.0 (0.0–13.1)

1.0 (0.1–7.8)

1.0 (0.2–4.2)