Influenza, HumanPhase 4NCT03614975
Immunologic Response to Influenza Vaccination in Children and Adolescents
A Phase 4 study testing Flucelvax inactivated influenza vaccine and Fluzone 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 4-20 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… Read more about this study
- Who is it for?
- Ages 4 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Immune Response
- What is being tested?
- Flucelvax inactivated influenza vaccine and Fluzone inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Sep 2018to 13 Dec 2018
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
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: Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines
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).
Read the 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
- Being tested
- Flucelvax inactivated influenza vaccine, Fluzone inactivated influenza vaccine
- Keywords
- 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.
Flucelvax inactivated influenza vaccineBiological
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 vaccineBiological
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| Fluzone inactivated influenza vaccine | Active comparator | Participants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly Receives: Biological: Fluzone inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Secondary outcomes (2)
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.
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
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
Measured: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start13 Sep 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
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
- Model description
- 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
- Masking
- None (open label)
- Enrolment
- 166 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
- NCT03614975
- Sponsor's protocol ID
- PRO18050091
- Other IDs
- CDCU01IP001035
- Status last verified
- Jan 2020
- First submitted
- 6 Jun 2018
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
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.
PubMed 32580919
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines
- ClinicalTrials.gov ID
- NCT03614975
- Acronym / sponsor ID
- PRO18050091
- Conditions
- Influenza, Human, Immune Response
- Keywords
- inactivated, influenza, vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Richard Zimmerman MDUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 12 Nov 2019
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 4-20 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
| Arm | Type | Receives |
|---|---|---|
| Flucelvax inactivated influenza vaccine | Active comparator | Biological: Flucelvax inactivated influenza vaccineParticipants receiving inactivated Flucelvax influenza vaccine will receive 0.5 mL given intramuscularly |
| Fluzone inactivated influenza vaccine | Active comparator | Biological: Fluzone inactivated influenza vaccineParticipants receiving inactivated Fluzone influenza vaccine will receive 0.5 mL given intramuscularly |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Flucelvax inactivated influenza vaccineParticipants 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.) | Biological | Flucelvax inactivated influenza vaccine |
| Fluzone inactivated influenza vaccineParticipants 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.) | Biological | Fluzone inactivated influenza vaccine |
Primary outcome
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
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.
2 secondary outcomes
Determining Seroprotection Level at Each Time Point
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Determining Geometric Mean Titers (GMTs) at Each Time Point
Time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32580919Moehling 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.
- 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 Flucelvax inactivated influenza vaccine and Fluzone 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 18 Jan 2020. 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 12 Nov 2019). 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?
Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination (time frame: Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)). 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 NCT03614975, 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 18 Jan 2020.