CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
Seasonal IIV 0.25 mL dose +2 morebiological
Likely dose
Fluzone IIV 0.25 mL or 0.5 mL intramuscularlyAI-extracted
Key inclusion· 8
  • Age 6–12 months for vaccination arm (cohort 1A)
  • Age 3–12 months for natural infection arm (cohort 1B)
  • Age 13–35 months for either vaccination or natural infection (cohort 2)
  • Age 36 months to 5 years for either vaccination or natural infection (cohort 3)
Key exclusion· 7
  • Immunosuppression from underlying illness, HIV, or primary immunodeficiency syndrome
  • Active neoplastic disease
  • Use of immunosuppressive medications currently or within past year, or chronic (>2 weeks) oral or inhaled steroid use
  • Asthma requiring chronic controller medication

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

Search/NCT02559505
NCT02559505N/ACompleted

Understanding How the Initial Encounter With Influenza Virus Poises Children for Protective Immunity

University of Rochester·interventional·Posted Sep 24, 2015·Updated Sep 2, 2021

In Brief

A clinical study evaluating Seasonal IIV 0.25 mL dose, Natural influenza infection, and 1 other intervention for Influenza. Completed, enrolled 134 participants across 1 site.

Detailed Summary

This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 24, 2015
Enrollment StartOct 1, 2015
Primary CompletionJul 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.8 years ago

Interventions

Seasonal IIV 0.25 mL dosebiological

Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age

Natural influenza infectionother

Children enrolled on presentation to their primary care provider with a natural influenza infection

Seasonal IIV 0.5 mL dosebiological

Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age