Immunologic Response to Influenza Vaccination in Children and Adolescents

NCT03614975 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: PRO18050091CDCU01IP001035
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Influenza, Human; Immune Response

Keywords

inactivated; influenza; vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determining Seroprotection Level at Each Time Point

  Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)

• Determining Geometric Mean Titers (GMTs) at Each Time Point

  Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)

Study Arms (2)

Flucelvax inactivated influenza vaccine

ACTIVE COMPARATOR

Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly

Biological: Flucelvax inactivated influenza vaccine

Fluzone inactivated influenza vaccine

ACTIVE COMPARATOR

Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly

Biological: Fluzone inactivated influenza vaccine

Interventions

Flucelvax inactivated influenza vaccine BIOLOGICAL

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.)

Flucelvax inactivated influenza vaccine

Fluzone inactivated influenza vaccine BIOLOGICAL

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.)

Fluzone inactivated influenza vaccine

Eligibility Criteria

• Age: 4 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard Zimmerman MD: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

General Academic Pediatrics

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Department of Family Medicine

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Moehling KK, Zimmerman RK, Nowalk MP, Jeng Lin C, Martin JM, Alcorn JF, Susick M, Burroughs A, Holiday C, Flannery B, Levine MZ. A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children. Vaccine. 2020 Jul 14;38(33):5171-5177. doi: 10.1016/j.vaccine.2020.06.023. Epub 2020 Jun 21.

  PMID: 32580919 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Richard Zimmerman, MD
• Organization: University of Pittsburgh, Department of Family Medicine

zimmrk@upmc.edu

412-383-2354

Study Officials

• Richard K Zimmerman, MD, MPH, MA

  University of Pittsburgh, School of Medicine, Dept. Family Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: August 3, 2018
• Study Start: September 13, 2018
• Primary Completion: December 13, 2018
• Study Completion: December 13, 2018
• Last Updated: January 18, 2020
• Results First Posted: November 12, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months after article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and have appropriate data security and privacy plans in place

Locations

US (2)