Immunologic Response to Influenza Vaccination in Children and Adolescents

Influenza, Human Clinical Trial

Official title:

Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03614975
• Other study ID #: PRO18050091
• Secondary ID: CDCU01IP001035
• Status: Completed
• Phase: Phase 4
• Start date: September 13, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: January 2020
• 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 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).

Description:

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two FDA approved and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per vaccine arm. Participants will be randomized using a 1:1 allocation to receive either Flucelvax or Fluzone. 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 21 (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: 166
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 20 Years

Eligibility

Inclusion Criteria:

• aged 4-20 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:
• Flucelvax inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
• Fluzone inactivated influenza vaccine
Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)

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	Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination	Hemagglutination inhibition (HI) assay will be 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.	Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Secondary	Determining Seroprotection Level at Each Time Point	Hemagglutination inhibition assay will be 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 21 timepoint)
Secondary	Determining Geometric Mean Titers (GMTs) at Each Time Point	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 21 timepoint)