The concomitant diseases of participants did not affect the vaccine safety. The QazCovid-in® vaccine was safe over the 6-month monitoring period after two intramuscular immunisations inducing only local short-lived adverse events. The trial was registered with NCT04691908. The primary endpoint was the incidence of symptomatic cases of the SARS-CoV-2 infection confirmed by RT-PCR starting from day 14 after the first immunisation. QazCovid-in® is a whole-virion formaldehyde-inactivated anti-COVID-19 vaccine, adjuvanted with aluminium hydroxide. A total of 3000 eligible participants aged 18 years or older were randomly assigned (4:1) to receive two doses of the vaccine (5 μg each, 21 days apart) or placebo administered intramuscularly. Vaccination remains the primary measure to prevent the spread of the SARS-CoV-2 virus, further necessitating the use of effective licensed vaccines.įrom Dec 25, 2020, to July 11, 2021, we conducted a multicenter, randomised, single-blind, placebo-controlled phase 3 efficacy trial of the QazCovid-in® vaccine with a 180-day follow-up period in three clinical centres in Kazakhstan. This difference in coverage probabilities is often exaggerated when the sample sizes are unequal, 16 as shown in the right panel of Figure 2. Agresti and Min 16 and Agresti 21 demonstrate that inverting one two-sided test (Agresti-Min interval) is less conservative and gives shorter intervals than inverting two one-sided tests (Chan-Zhang interval). However, the Chan-Zhang interval can be seriously conservative, as shown in the right panel of Figure 2. 21 The two intervals based on inverting exact score tests sometimes perform similarly, for instance, when n 1+ ¼ n 2+ ¼ 15 and p 1 À p 2 ¼ 0.2 (left panel of Figure 2). The lower bound on the coverage probability of tail method intervals such as SantnerSnell is sometimes 1 À a/2 instead of 1 À a. The unstandardized test statistic used in the SantnerSnell interval can be seriously discrete with small sample sizes, which makes the interval overly conservative. Llustrates the difference in coverage probabilities of the Santner-Snell, Chan-Zhang and Agresti-Min exact unconditional intervals.
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