Influenza, HumanPhase 4NCT03982069
Immunologic Response to FluMist vs. Flucelvax
A Phase 4 study testing FluMist live attenuated influenza vaccine and Flucelvax inactivated influenza vaccine in people with Influenza, Human and Immune Response, run by Richard Zimmerman MD at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 4 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Immune Response
- What is being tested?
- FluMist live attenuated influenza vaccine and Flucelvax inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2019to 9 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
General Academic Pediatrics
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Department of Family Medicine
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
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).
Read the 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
- Being tested
- FluMist live attenuated influenza vaccine, Flucelvax inactivated influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMist live attenuated influenza vaccineBiological
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 vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| FluMist live attenuated influenza vaccine | Active comparator | Participants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally Receives: Biological: FluMist live attenuated influenza vaccine |
| Flucelvax inactivated influenza vaccine | Active comparator | Participants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly Receives: Biological: Flucelvax inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-vaccination (at Day 28 timepoint)
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.
Measured: Post-vaccination (at Day 28 timepoint)
Secondary outcomes (4)
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.
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
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
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
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.
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
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
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start20 Sep 2019
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Zimmerman MD
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Richard Zimmerman MD, University of Pittsburgh
- Investigators
- Richard K Zimmerman, MD, MPH, MA, Principal investigator, University of Pittsburgh, School of Medicine, Dept. Family Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982069
- Sponsor's protocol ID
- STUDY19040242
- Other IDs
- 1U01|P001035-01
- Status last verified
- Sep 2021
- First submitted
- 6 Jun 2019
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.
Publications
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.
PubMed 37232430
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax
- ClinicalTrials.gov ID
- NCT03982069
- Acronym / sponsor ID
- STUDY19040242
- Conditions
- Influenza, Human, Immune Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Richard Zimmerman MDUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FluMist live attenuated influenza vaccine | Active comparator | Biological: FluMist live attenuated influenza vaccineParticipants receiving live attenuated FluMist influenza vaccine will receive 0.2 mL given intranasally |
| Flucelvax inactivated influenza vaccine | Active comparator | Biological: Flucelvax inactivated influenza vaccineParticipants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluMist live attenuated influenza vaccineParticipants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete. | Biological | FluMist live attenuated influenza vaccine |
| Flucelvax inactivated influenza vaccineParticipants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete. | Biological | Flucelvax inactivated influenza vaccine |
Primary outcome
Number of Participants With Seroconversion Response In 2019
Time frame: Post-vaccination (at Day 28 timepoint)
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.
Number of Participants With Seroconversion Response In 2020
Time frame: Post-vaccination (at Day 28 timepoint)
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.
4 secondary outcomes
Number of Participants With Seroprotection Response in 2019
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2019
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Number of Participants With Seroprotection Response in 2020
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Geometric Mean Titers (GMTs) at Each Time Point 2020
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 28 timepoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37232430Williams 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary article, after deidentification, will be placed at the site mentioned below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard K Zimmerman, MD, MPH, MA principal investigator
University of Pittsburgh, School of Medicine, Dept. Family Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FluMist live attenuated influenza vaccine and Flucelvax inactivated influenza vaccine in people with Influenza, Human and Immune Response, run by Richard Zimmerman MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Seroconversion Response In 2019 (time frame: Post-vaccination (at Day 28 timepoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.