Influenza Clinical Trial
Official title:
A Phase IV, Multi-center, Randomized, Partially Double Blinded, Placebo Controlled Study, to Evaluate the Safety of Daily Inhaled Zanamivir 10 mg Versus Placebo and Daily Oral Oseltamivir 75 mg Versus Placebo for Influenza Prophylaxis in Healthy Volunteers for 16 Weeks
This is a multicenter, randomised, four arms placebo controlled study to evaluate the safety
and tolerability of 10 mg inhaled zanamivir once a day and 75 mg oseltamivir capsule orally
once a day relative to placebo over 16 weeks (112 days). Enrolled subjects will be randomly
assigned to 2:1:2:1 ratio (active oseltamivir: placebo: active zanamivir: placebo) on one of
the four study treatment groups.
It is hypothesized that oseltamivir and zanamivir will protect participants from becoming
infected with influenza.
We plan to recruit 130 non-pregnant subjects including Health Care Workers, which refer to
anyone who works in the hospital, into each active arm and 65 healthy, non-pregnant subjects
including Health Care Workers into each placebo arm for a total of 390 study subjects from 4
study sites in Bangkok and Nonthaburi province, Thailand: (i) Faculty of Medicine Siriraj
Hospital, (ii) Bamrasnaradura Infectious Diseases Institute, (iii) Chest Disease Institute,
and (iv) Hospital for Tropical Diseases.
Randomisation Groups:
Zanamivir for inhalation, (5 mg per inhalation), two inhalations, once daily using a
ROTADISK/DISKHALER for 112 days. The dose should be administered at approximately the same
time each day.
Placebo (lactose powder), two inhalations, once daily using a ROTADISK/ DISKHALER for 112
days. The dose should be administered at approximately the same time each day.
Oseltamivir capsules (75 mg per capsule), one capsule daily by mouth (PO) for 112 days. The
dose should be administered at approximately the same time each day.
Placebo capsules, one capsule daily for 112 days. The capsule should be administered at
approximately the same time each day.
Study duration
The study is expected to last up to about 12 months. The study will consist of:
- a screening visit
- 10 study visits: Days 0 , 7 (+2), 14 (+2), 28 (+2), 42 (+2), 56 (+2), 70 (+2), 84 (+2),
98 (+2) and 112 (+2) and
- One follow-up visit on Day 120 (+2)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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