Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age

Phase 4

Terminated

• Conditions: Influenza
• Interventions: Biological: 2008-2009 FluMist LAIV (Intranasal)

• Registration Number: NCT03020472
• Lead Sponsor: Stanford University

Brief Summary

This pilot study will investigate B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples taken at designated time points before and after vaccination.

Detailed Description

This is an exploratory study to determine the peripheral antibody secreting cell response during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).

Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment, the study was halted. Due to the limited number of samples, no analysis was performed.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Results First Submitted: 2017-01-12
• Results First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-13
• Results First Posted: 2017-03-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2008-2009 FluMist LAIV (Intranasal)	2008-2009 FluMist LAIV (Intranasal)	2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received Influenza Vaccine	Day 0 to Day 28

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Related Adverse Events	Day 0 to Day 28

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States