(d) The study described is an example of a noninferiority clinical trial intended to show that the effect of a new treatment, the aerosolized vaccine, is not worse than the standard treatment by more than a specified margin.* Spe- cifically, is the percentage of children who developed an immune response for the aerosol treatment more than 5% below the percentage for the sub- cutaneous injected vaccine? The five-percentage-point difference was based on previous studies and the fact that with a bigger difference the aerosol- ized vaccine would not provide the levels of protection necessary to achieve herd immunity. Using your answer in part (c), do you feel the investigators demonstrated the noninferiority of the aerosolized vaccine? Explain.
(d) The study described is an example of a noninferiority clinical trial intended to show that the effect of a new treatment, the aerosolized vaccine, is not worse than the standard treatment by more than a specified margin.* Spe- cifically, is the percentage of children who developed an immune response for the aerosol treatment more than 5% below the percentage for the sub- cutaneous injected vaccine? The five-percentage-point difference was based on previous studies and the fact that with a bigger difference the aerosol- ized vaccine would not provide the levels of protection necessary to achieve herd immunity. Using your answer in part (c), do you feel the investigators demonstrated the noninferiority of the aerosolized vaccine? Explain.
MATLAB: An Introduction with Applications
6th Edition
ISBN:9781119256830
Author:Amos Gilat
Publisher:Amos Gilat
Chapter1: Starting With Matlab
Section: Chapter Questions
Problem 1P
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just need part d answerd
Transcribed Image Text:23.2 Aerosolized Vaccine for Measles. An aerosolized vaccine for measles wwas
(pages 530 and 532).
process
developed in Mexico and has been used on more than 4 million children since
1980, Aerosolized vaccines have the advantages of being able to be administered
by people without clinical training and do not cause injection-associated infec
tions. Despite these advantages, data about efficacy of the aerosolized vaccines
against measles compared to subcutaneously injection of the vaccine have been
inconsistent. Because of this, a large randomized controlled study was conducted
using children in India. The primary outcome was an immune response to measles
measured 91 days after the treatments. Among the 785 children receiving the sub-
cutaneous injection, 743 developed an immune response, while among the 775
children receiving the aerosolized vaccine, 662 developed an immune response.
(a) Compute the proportion of subjects experiencing the primary outcome for
both the aerosol and injection groups.
(b) Can we safely use the large-sample confidence interval for comparing the
proportion of children who developed an immune response to measles in
the aerosol and injection groups? Explain.
(c) Give a 95% confidence interval for the difference between the propor-
tion of children in the aerosol and injection groups who experienced the
primary outcome.
(d) The study described is an example of a noninferiority clinical trial intended
to show that the effect of a new treatment, the aerosolized vaccine, is not
4
worse than the standard treatment by more than a specified margin. Spe-
cifically, is the percentage of children who developed an immune response
for the aerosol treatment more than 5% below the percentage for the sub-
cutaneous injected vaccine? The five-percentage-point difference was based
on previous studies and the fact that with a bigger difference the aerosol-
ized vaccine would not provide the levels of protection necessary to achieve
herd immunity. Using your answer in part (c), do you feel the investigators
demonstrated the noninferiority of the aerosolized vaccine? Explain.
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