Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)

NCT03023683 | Completed Phase 4 Results

• 2 other identifiers: SU-24965U19AI057229-07
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to investigate and compare the human immune response in epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza vaccine (LAIV) in adults and in children.

Conditions

Influenza

Keywords

Live, attenuated influenza vaccine; Children and young adults

Outcome Measures

Primary Outcomes (1)

• Number of Participants From Each Arm Who Received Influenza Vaccine

  Day 0 to 28

Secondary Outcomes (1)

• Number of Participants With Related Adverse Events

  Day 0 to 28 post-immunization

Study Arms (2)

Group A: 2-8 yo healthy non-twins

OTHER

Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.

Biological: FluMist®

Group B: 18-49 yo healthy non-twins

OTHER

Participants will be given seasonal LAIV, FluMist® .

Biological: FluMist®

Interventions

FluMist® BIOLOGICAL

Influenza Virus Vaccine Live, Intranasal Spray

Group A: 2-8 yo healthy non-twins; Group B: 18-49 yo healthy non-twins

Eligibility Criteria

• Age: 2 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Otherwise healthy, ambulatory 2-8 years old (Group A) or 18-49 years old (Group B).
• Willing to complete the informed consent process (including assent for minors 7 years old and above).
• Availability for follow-up for the planned duration of the study at least 28 days after immunization.

You may not qualify if:

• Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV.
• Allergy to egg or egg products, or to vaccine components, including gentamicin, gelatin, arginine or MSG (LAIV)
• Life-threatening reactions to previous influenza vaccinations
• Asthma or history of wheezing
• Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
• History of immunodeficiency (including HIV infection)
• Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• Blood pressure \>150 systolic or \>95 diastolic at the first study visit and on the day of vaccination.
• Hospitalization in the past year for congestive heart failure or emphysema.
• Chronic Hepatitis B or C.
• Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible)
• Participants in close contact with anyone who has a severely weakened immune system should not receive LAIV
• Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
• Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
• History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory 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

• Cornelia Dekker, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Harry 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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 18, 2021
• Results First Posted: March 9, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share