InfluenzaPhase 3NCT01959945
Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Recombinant Influenza Vaccine,Seasonal Formulation)
A Phase 3 study testing Flublok® Quadrivalent Influenza Virus Vaccine and Fluarix Quadrivalent® Influenza Virus Vaccine in people with Influenza, run by Protein Sciences Corporation at 1 site in United States.
Trial summary
Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flublok® Quadrivalent Influenza Virus Vaccine and Fluarix Quadrivalent® Influenza Virus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female age 6-17 years (Cohort A: 6-8 years of age; Cohort B: 9-17 years of age)
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to avoid becoming pregnant and to use effective method of contraception or practice abstinence for at least 28 day prior to the first study vaccine administration, until the completion of the study. Female subjects of child-bearing potential must have a negative pregnancy test within 24 hours prior to vaccine administration.
- In good general health, as determined by medical history and targeted physical examination, if indicated
- The parent(s) or legal representative(s) of each potential subject must:
- Comprehend the study requirements and agree to comply with planned study procedures and visits
- Provide written consent prior to enrollment and initiation of any study procedures Pediatric assent will be obtained in accordance with the Institutional Review Board/Independent Ethics Committee determination.
Who cannot join
- Known allergy to eggs, severe allergy (e.g. anaphylaxis) to other components of either vaccine or contraindications to receipt of the comparator IIV4
- Immunosuppression as a result of an underlying illness or treatment. Note: Subjects on nasal or topical steroids will be allowed
- Active neoplastic disease or a history of any malignancy.
- History of receiving influenza vaccine within the past 6 months or plans during the study to receive influenza vaccine outside of this study.
- History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
- Receipt of any non-study licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study, or plans during the study to receive a licensed vaccine within 4 weeks of a study dose [See above for influenza vaccines].
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- Acute or chronic medical condition that, in the opinion of the investigator, would render immunization unsafe or would interfere with the evaluation of immune responses
- History of severe reactions following immunization.
- An acute illness, including a body temperature greater than 100*F, within 3 days prior to immunization.
- Receipt of an experimental vaccine or medication within 1 month prior to enrollment in this study, or expectation of receiving an experimental vaccine, medication, or blood product during the study Stage in which the subject will participate.
- Developmental delay, neurologic disorder, or seizure disorder requiring ongoing medical management (note: history of seizure is not an exclusion criterion).
- Any other condition or situation that would, in the opinion of the investigator, place the potential subject an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- History of Guillain-Barré syndrome.
- Known pregnancy, positive urine or serum pregnancy test within 24 hours prior to planned study vaccination, or breast-feeding.
- Concurrent participation in another clinical trial (in active or follow-up phase).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Quadrivalent Recombinant Influenza Vaccine,Seasonal Formulation) Administered Intramuscularly to Healthy Children and Adolescents Age 6-17 Years
Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.
Read the detailed description
The U.S. Advisory Committee on Immunization Practices (ACIP) recommends that all people ≥6 months of age receive influenza vaccine annually. Recommendations for influenza immunization of children vary somewhat among countries in the European Union, but immunization of children at high risk for complications of influenza infection is recommended by WHO and according to criteria in most countries. Currently, the immunization practices are progressing to quadrivalent formulations of inactivated influenza vaccines (IIV4) which are approved in the US for most of the indicated population. Additionally, live attenuated vaccine (LAIV4) is approved in the U.S. for individuals aged 2-49 years and Flublok®(RIV3), a purified trivalent recombinant hemagglutinin protein vaccine is approved in the U.S. for adults 18-49 years of age. Children are at particular risk of complications of influenza, including the B lineages, so expansion of the Flublok indication into the pediatric age group with a quadrivalent formulation is warranted.
- Conditions
- Influenza
- Being tested
- Flublok® Quadrivalent Influenza Virus Vaccine, Fluarix Quadrivalent® Influenza Virus Vaccine
- Keywords
- Prevention
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flublok® Quadrivalent Influenza Virus VaccineBiological
Also called Recombinant Influenza Vaccine (RIV4), Flublok Influenza Vaccine, rHA, rHA0
Intramuscular (Relevant year formulation)
Fluarix Quadrivalent® Influenza Virus VaccineBiological
Intramuscular (Relevant year formulation)
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1, Flublok | Experimental | Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine Receives: Biological: Flublok® Quadrivalent Influenza Virus Vaccine |
| Study Group 2, Fluarix | Active comparator | Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine Receives: Biological: Fluarix Quadrivalent® Influenza Virus Vaccine |
| Study Group 3, Flublok | Experimental | Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine Receives: Biological: Flublok® Quadrivalent Influenza Virus Vaccine |
| Study Group 4, Fluarix | Active comparator | Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine Receives: Biological: Fluarix Quadrivalent® Influenza Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
Measured: Day 0 up to Day 28 post vaccination
Secondary outcomes (3)
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.
Measured: Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Measured: Day 28 after final vaccination
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.
Measured: Day 28 after final vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionOct 2014
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 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Dunkle, MD, Study chair, Protein Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959945
- Sponsor's protocol ID
- PSC08
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2013
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Cox M, Treanor JJ. Safety and Immunogenicity of a Recombinant Influenza Vaccine: A Randomized Trial. Pediatrics. 2018 May;141(5):e20173021. doi: 10.1542/peds.2017-3021. Epub 2018 Apr 2.
PubMed 29610401
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Reactogenicity and Immunogenicity of Flublok Quadrivalent (Quadrivalent Recombinant Influenza Vaccine,Seasonal Formulation) Administered Intramuscularly to Healthy Children and Adolescents Age 6-17 Years
- ClinicalTrials.gov ID
- NCT01959945
- Acronym / sponsor ID
- PSC08
- Conditions
- Influenza
- Keywords
- Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 2 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Flublok was studied previously in children 6 -59 months of age and demonstrated less than satisfactory immunogenicity results, especially in the 6-36 month age group. Thus, the initial introduction of Flublok Quadrivalent Formulation (RIV4) into the pediatric population will evaluate immunogenicity and safety older children and adolescents, aged 6-17. This clinical trial is designed to demonstrate safety and non-inferior immunogenicity of Flublok-Q in pediatric subjects 6-17 years of age as compared to IIV4. Positive results in this study may support further studies in younger children.
Detailed description
The U.S. Advisory Committee on Immunization Practices (ACIP) recommends that all people ≥6 months of age receive influenza vaccine annually. Recommendations for influenza immunization of children vary somewhat among countries in the European Union, but immunization of children at high risk for complications of influenza infection is recommended by WHO and according to criteria in most countries. Currently, the immunization practices are progressing to quadrivalent formulations of inactivated influenza vaccines (IIV4) which are approved in the US for most of the indicated population. Additionally, live attenuated vaccine (LAIV4) is approved in the U.S. for individuals aged 2-49 years and Flublok®(RIV3), a purified trivalent recombinant hemagglutinin protein vaccine is approved in the U.S. for adults 18-49 years of age. Children are at particular risk of complications of influenza, including the B lineages, so expansion of the Flublok indication into the pediatric age group with a quadrivalent formulation is warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study Group 1, Flublok | Experimental | Biological: Flublok® Quadrivalent Influenza Virus VaccineParticipants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine |
| Study Group 2, Fluarix | Active comparator | Biological: Fluarix Quadrivalent® Influenza Virus VaccineParticipants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine |
| Study Group 3, Flublok | Experimental | Biological: Flublok® Quadrivalent Influenza Virus VaccineParticipants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine |
| Study Group 4, Fluarix | Active comparator | Biological: Fluarix Quadrivalent® Influenza Virus VaccineParticipants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female age 6-17 years (Cohort A: 6-8 years of age; Cohort B: 9-17 years of age)
- Female subjects of child-bearing potential (as defined by the onset of menses) must agree to avoid becoming pregnant and to use effective method of contraception or practice abstinence for at least 28 day prior to the first study vaccine administration, until the completion of the study. Female subjects of child-bearing potential must have a negative pregnancy test within 24 hours prior to vaccine administration.
- In good general health, as determined by medical history and targeted physical examination, if indicated
- Comprehend the study requirements and agree to comply with planned study procedures and visits
- Provide written consent prior to enrollment and initiation of any study procedures Pediatric assent will be obtained in accordance with the Institutional Review Board/Independent Ethics Committee determination.
Key exclusion criteria (15 listed)
- Known allergy to eggs, severe allergy (e.g. anaphylaxis) to other components of either vaccine or contraindications to receipt of the comparator IIV4
- Immunosuppression as a result of an underlying illness or treatment. Note: Subjects on nasal or topical steroids will be allowed
- Active neoplastic disease or a history of any malignancy.
- History of receiving influenza vaccine within the past 6 months or plans during the study to receive influenza vaccine outside of this study.
- History of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
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 |
|---|---|---|
| Flublok® Quadrivalent Influenza Virus VaccineAlso: Recombinant Influenza Vaccine (RIV4), Flublok Influenza Vaccine, rHA, rHA0Intramuscular (Relevant year formulation) | Biological | Study Group 1, Flublok, Study Group 3, Flublok |
| Fluarix Quadrivalent® Influenza Virus VaccineIntramuscular (Relevant year formulation) | Biological | Study Group 2, Fluarix, Study Group 4, Fluarix |
Primary outcome
Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.
Time frame: Day 0 up to Day 28 post vaccination
Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.
3 secondary outcomes
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time frame: Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time frame: Day 28 after final vaccination
Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time frame: Day 28 after final vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29610401Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Cox M, Treanor JJ. Safety and Immunogenicity of a Recombinant Influenza Vaccine: A Randomized Trial. Pediatrics. 2018 May;141(5):e20173021. doi: 10.1542/peds.2017-3021. Epub 2018 Apr 2.
- Related InfoLink provided by the sponsor.
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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.
Lisa Dunkle, MD study chair
Protein Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flublok® Quadrivalent Influenza Virus Vaccine and Fluarix Quadrivalent® Influenza Virus Vaccine in people with 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 6 inclusion and 15 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 23 Sep 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 2 Aug 2016). 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 Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine. (time frame: Day 0 up to Day 28 post vaccination). 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 NCT01959945, 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 23 Sep 2016.