Immunologic Response to FluMist vs. Flucelvax

NCT ID: NCT03982069

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2020-12-09

Brief 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).

Detailed 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.

Conditions

Influenza, Human; Immune Response

Study Design

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

Study Groups

FluMist live attenuated influenza vaccine

Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally

Group Type: ACTIVE_COMPARATOR

FluMist live attenuated influenza vaccine

Intervention Type: BIOLOGICAL

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 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 cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 21 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

Williams KV, Li ZN, Zhai B, Alcorn JF, Nowalk MP, Levine MZ, Kim SS, Flannery B, Moehling Geffel K, Merranko AJ, Collins M, Susick M, Clarke KS, Zimmerman RK, Martin JM. A Randomized Controlled Trial to Compare Immunogenicity to Cell-Based Versus Live-Attenuated Influenza Vaccines in Children. J Pediatric Infect Dis Soc. 2023 Jun 30;12(6):342-352. doi: 10.1093/jpids/piad033.

Reference Type: DERIVED

PMID: 37232430 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

1U01|P001035-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY19040242

Identifier Type: -

Identifier Source: org_study_id