Immunologic Response to Influenza Vaccination in Children and Adolescents

NCT ID: NCT03614975

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-13
• Study Completion Date: 2018-12-13

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).

Detailed 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.

Conditions

Influenza, Human; Immune Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Flucelvax inactivated influenza vaccine

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

Group Type: ACTIVE_COMPARATOR

Flucelvax inactivated influenza vaccine

Intervention Type: 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.)

Fluzone inactivated influenza vaccine

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

Group Type: ACTIVE_COMPARATOR

Fluzone inactivated influenza vaccine

Intervention Type: 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.)

Interventions

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.)

Intervention Type: BIOLOGICAL

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.)

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Richard Zimmerman MD

OTHER

Sponsor Role: lead

Responsible Party

Richard Zimmerman MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Richard K Zimmerman, MD, MPH, MA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

General Academic Pediatrics

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Department of Family Medicine

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32580919 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CDCU01IP001035

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO18050091

Identifier Type: -

Identifier Source: org_study_id