Human InfluenzaNCT02600585
Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults
An observational study of Human Influenza, run by Protein Sciences Corporation at 1 site in United States.
Trial summary
The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- Recombinant Influenza Vaccine and Inactivated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 254,648 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include adults 18 years of age and older who are vaccinated with either Flublok or IIV within the same time period, e.g. month of the year.
Who may be able to join
- Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.
Who cannot join
- Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612
About this study
Official title: Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults 18 Years of Age and Older
The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).
Read the detailed description
The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.
- Conditions
- Human Influenza
- Being tested
- Recombinant Influenza Vaccine, 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.
Recombinant Influenza VaccineBiological
Also called Flublok
Intramuscular injection of study vaccine
Inactivated Influenza VaccineBiological
Intramuscular injection of study vaccine
| Study group | Role | What they receive |
|---|---|---|
| Flublok | Recombinant influenza vaccine (RIV); Intramuscular injection of vaccine of recombinant uncleaved hemagglutinin (rHA0) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL. Receives: Biological: Recombinant Influenza Vaccine | |
| Inactivated Influenza Vaccine | Injectable, inactivated, egg-based influenza vaccines (IIV); Intramuscular injection of vaccine (whether trivalent or quadrivalent) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL. Receives: Biological: Inactivated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)
Incidence of Serious and/or Medically-Attended Adverse events
Measured: Five months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human InfluenzaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 254,648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Roger Baxter, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600585
- Sponsor's protocol ID
- PSC13
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Observational Study of Safety Following Vaccination With Flublok® Compared to Licensed IIV in Adults 18 Years of Age and Older
- ClinicalTrials.gov ID
- NCT02600585
- Acronym / sponsor ID
- PSC13
- Conditions
- Human Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254,648 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to retrospectively characterize the safety of Flublok in adults 18 years of age and older, in comparison with egg-based trivalent or quadrivalent inactivated influenza vaccines (IIVs), using a methodological approach designed to query the database of electronic health records (EHR) maintained by Kaiser-Permanente, Northern California (KPNC), a large medical care organization (MCO).
Detailed description
The primary analysis is a nonrandomized, observational retrospective cohort study. Data on adults 18 years of age and older who were enrolled in the KPNC database during the risk intervals after vaccination analyzed for this study who were vaccinated with Flublok or an IIV (either IIV3 or IIV4) will be identified for analysis. The rates of occurrence of specific MAEs of interest in pre-specified risk intervals following Flublok and IIV will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flublok | – | Biological: Recombinant Influenza VaccineRecombinant influenza vaccine (RIV); Intramuscular injection of vaccine of recombinant uncleaved hemagglutinin (rHA0) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL. |
| Inactivated Influenza Vaccine | – | Biological: Inactivated Influenza VaccineInjectable, inactivated, egg-based influenza vaccines (IIV); Intramuscular injection of vaccine (whether trivalent or quadrivalent) derived from influenza A/H1N1, A/H3N2, and B viruses, as identified for the season by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) in a total volume of 0.5 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults 18 years of age and older who are vaccinated with either Flublok or IIV within the same time period, e.g. month of the year.
Key inclusion criteria (1 listed)
- Data from the EHR of all adult KPNC members 18 years of age and older, who received Flublok for active immunization against influenza as part of routine medical care within the KPNC system. The comparator cohort will include data from all adults in the same age group who received any IIV (trivalent or quadrivalent) during the period of Flublok administration.
Key exclusion criteria (1 listed)
- Healthcare providers are expected not to administer Flublok or IIV to individuals with known contraindication to either vaccine (see product package inserts). However, there will be no exclusions other than age and KPNC membership criteria at the time of vaccination.
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 |
|---|---|---|
| Recombinant Influenza VaccineAlso: FlublokIntramuscular injection of study vaccine | Biological | Flublok |
| Inactivated Influenza VaccineIntramuscular injection of study vaccine | Biological | Inactivated Influenza Vaccine |
Primary outcome
Number of Participants with Serious adverse events (SAEs) and medically-attended adverse events (MAEs)
Time frame: Five months post-vaccination
Incidence of Serious and/or Medically-Attended Adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
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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.
Roger Baxter, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Influenza, run by Protein Sciences Corporation at 1 site 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 1 inclusion and 1 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Serious adverse events (SAEs) and medically-attended adverse events (MAEs) (time frame: Five months post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2017.