Immunologic Response to FluMist vs. Flucelvax

Influenza, Human Clinical Trial

Official title:

Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982069
• Other study ID #: STUDY19040242
• Secondary ID: 1U01|P001035-01
• Status: Completed
• Phase: Phase 4
• Start date: September 20, 2019
• Est. completion date: December 9, 2020

Study information

• Verified date: September 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).

Description:

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The primary objective of the study is to determine pre- and post-serologic responses to each vaccine type.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 21 Years

Eligibility

Inclusion Criteria:

• aged 4-21 years;
• has prior vaccination history available (which can be determined based either on medical record review or through state registry review);
• plans to receive the current seasonal influenza vaccination at one of the recruiting sites

Exclusion Criteria:

• unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
• has already received influenza vaccine for the current season;
• has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days);
• is known to be pregnant;
• has a history of severe allergy to eggs or to influenza vaccine or any of its components

Related Conditions & MeSH terms

• Immune Response
• Influenza, Human

Intervention

Biological:
• FluMist live attenuated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
• Flucelvax inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.

Locations

Country	Name	City	State
United States	General Academic Pediatrics	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Department of Family Medicine	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Richard Zimmerman MD	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Seroconversion Response In 2019	Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40.	Post-vaccination (at Day 28 timepoint)
Primary	Number of Participants With Seroconversion Response In 2020	Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >=10 and a final HI titer of >=40.	Post-vaccination (at Day 28 timepoint)
Secondary	Number of Participants With Seroprotection Response in 2019	Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Secondary	Geometric Mean Titers (GMTs) at Each Time Point 2019	Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition assay was conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Secondary	Number of Participants With Seroprotection Response in 2020	Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Secondary	Geometric Mean Titers (GMTs) at Each Time Point 2020	Rows in data tables represent different influenza antigens measured in 2020. Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)