NCT03020472

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 3, 2017

Completed
Last Updated

October 18, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

January 11, 2017

Results QC Date

January 12, 2017

Last Update Submit

September 21, 2021

Conditions

Influenza

Keywords

Live, attenuated influenza vaccineChildren

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Received Influenza Vaccine

    Day 0 to Day 28

Secondary Outcomes (1)

  • Number of Participants With Related Adverse Events

    Day 0 to Day 28

Other Outcomes (2)

  • Post- Immunization B- Cell Response

    5-13 days post immunization

  • PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.

    Day 0 to Day 28

Study Arms (1)

2008-2009 FluMist LAIV (Intranasal)

EXPERIMENTAL

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

Biological: 2008-2009 FluMist LAIV (Intranasal)

Interventions

2008-2009 FluMist LAIV (Intranasal)BIOLOGICAL

2008-2009 FluMist vaccine delivered intranasally

2008-2009 FluMist LAIV (Intranasal)

Eligibility Criteria

Age24 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Otherwise healthy children, aged 24-35 months of age, inclusive.
  • Parent(s) or guardian(s) willing to sign informed consent.
  • Availability for follow-up for the planned duration of the study.
  • Acceptable medical history by screening evaluation and brief clinical assessment.
  • Able to understand and comply with planned study procedures

You may not qualify if:

  • Prior vaccination with LAIV.
  • TIV vaccination during two prior influenza vaccine seasons
  • Known prior MD diagnosis of, or hospitalization for influenza
  • History of asthma, active/recurrent wheezing or reactive airways disease
  • History of immunodeficiency
  • Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; diabetes mellitus; moderate to severe kidney impairment.
  • Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure) predisposing to influenza complications.
  • Household contact with immunodeficiency due to disease, medication or radiation
  • Child receiving aspirin therapy or aspirin-containing therapy
  • History of Guillain-BarrĂ© syndrome
  • Malignancy, other than squamous cell or basal cell skin cancer
  • Autoimmune disease
  • Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.
  • Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza, Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after administration of FluMist.
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow-up or hospitalization during the preceding year.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr Cornelia Dekker
Organization
Stanford University School of Medicine, Dept. of Pediatrics
cdekker@stanford.edu
650-724-4437

Study Officials

  • Harry B Greenberg, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Xiaosong He, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

November 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 18, 2021

Results First Posted

March 3, 2017

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)