Reflections on designing and conducting a randomized clinical trial of annual versus biannual influenza vaccination in Singapore /
Recent studies in temperate climates have shown that protection after influenza vaccination wanes within a few months after administration. In Singapore and other parts of the tropics where influenza infections occur year-round, it is not known what this means for vaccination strategies. We sought t...
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| Format: | eBook |
| Language: | English |
| Published: |
London :
SAGE Publications Ltd.,
2020.
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| Series: | SAGE Research Methods Cases : Medicine and Health.
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| Subjects: | |
| Online Access: | Connect to the full text of this electronic book |
| Summary: | Recent studies in temperate climates have shown that protection after influenza vaccination wanes within a few months after administration. In Singapore and other parts of the tropics where influenza infections occur year-round, it is not known what this means for vaccination strategies. We sought to conduct a clinical trial of annual versus biannual influenza vaccination to determine whether vaccinating twice yearly would improve year-round immune measures of protection against infection. This study was conducted in 200 adults aged ≥65 years who were living independently in the community in Singapore. Individuals who joined the study received the standard-dose trivalent inactivated influenza vaccine on Day 1 of the study. They were then randomized to receive either a repeat influenza vaccine or the active-comparator tetanus-diphtheria-pertussis vaccine at Day 180. The influenza vaccine administered at Day 180 contained the same influenza strains as Day 1. Primary endpoint was the proportion of participants with a hemagglutination inhibition titer ≥1:40 at Day 208--28 days after the second vaccine was administered. We also monitored participants for any symptoms of an influenza infection. The study completed recruitment ahead of schedule and successfully met its objectives. Recruitment and retention of study participants was not easy, however, and some aspects of the study design could have been improved to ease study conduct. This case study shares the thinking behind the design and challenges at implementing an observer-blinded clinical trial of an influenza vaccine. |
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| Physical Description: | 1 online resource. |
| Bibliography: | Includes bibliographical references and index. |
| ISBN: | 9781529744118 1529744113 |