CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Monovalent Influenza Vaccine +1 morebiological
Likely dose
10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain, single intranasal doseAI-extracted
Key inclusion· 4
  • ✓Age 18 through 49 years
  • ✓Written informed consent
  • ✓Able to understand and comply with protocol requirements
  • ✓Participant available by telephone
Key exclusion· 9
  • ✕Hypersensitivity to vaccine components, egg, egg protein, or serious/severe reactions to prior influenza vaccinations
  • ✕Chronic pulmonary or cardiovascular conditions (e.g., asthma), chronic metabolic diseases (e.g., diabetes mellitus), renal dysfunction, or hemoglobinopathies requiring regular medical follow-up or hospitalization in preceding year
  • ✕Acute febrile illness (>100.0°F oral) or clinically significant respiratory illness within 14 days of randomization
  • ✕Any immunosuppressive condition, immune deficiency disease (including HIV), or ongoing immunosuppressive therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158038
NCT03158038Phase 4Completed
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A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults

MedImmune LLC·interventional·Posted May 17, 2017·Updated Jan 4, 2019

In Brief

A Phase 4 clinical trial evaluating Monovalent Influenza Vaccine and Placebo for Influenza and Healthy. Completed, enrolled 300 participants across 2 sites.

Detailed Summary

This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2017-2018 influenza season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Healthy
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartMay 30, 2017
Primary CompletionDec 14, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.1 years ago

Interventions

Monovalent Influenza Vaccinebiological

A single dose of monovalent influenza vaccine \[10\^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain\] will be administered as intranasal spray on Day 1.

Placeboother

A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.