Prophylaxis: InfluenzaPhase 3NCT02256488
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
A Phase 3 study testing TIVc_LOT A, TIVc_LOT B and TIVc_LOT C in people with Prophylaxis: Influenza, run by Novartis Vaccines at 24 sites in United States.
Trial summary
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Prophylaxis: Influenza
- What is being tested?
- TIVc_LOT A, TIVc_LOT B and TIVc_LOT C
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,561 participants
- Where
- 24 sitesUnited States
- Study dates
- Sep 2014to Dec 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
Who cannot join
- Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Anaheim Clincial Trials
Anaheim, California
PMG Research of Charlotte
Charlotte, North Carolina
New Horizons Clinical Research
Cincinnati, Ohio
Clinical Research Solutions, LLC
Franklin, Tennessee
PMG Research of Hickory
Hickory, North Carolina
Broward Research Group
Hollywood, Florida
Johnson County Clin-Trials, LLC
Lenexa, Kansas
Milford Emergency Associate,Inc
Milford, Massachusetts
Clinical Research Associates, Inc
Nashville, Tennessee
Clinical Research Associates
Norfolk, Virginia
Meridian Clinical Research
Omaha, Nebraska
Columbia Research Group, Inc
Portland, Oregon
PMG Research of Raleigh
Raleigh, North Carolina
Northern California Clinical Research Center
Redding, California
Rochester Clinical Research, Inc
Rochester, New York
Foothill Family Clinc South, J. Lewis Research Inc.
Salt Lake City, Utah
Foothill Family Clinic, J. Lewis Research Inc.
Salt Lake City, Utah
Southern California CRC
San Diego, California
Meridian Clinical Research
Savannah, Georgia
Jordan River Family Medicine, J. Lewis Research, Inc.
South Jordan, Utah
Omega Medical Research
Warwick, Rhode Island
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida
Palm Bech Research
West Palm Beach, Florida
Heartland Research Associates, LLC
Wichita, Kansas
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).
The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.
The total study participation time per subject is about 3 weeks.
- Conditions
- Prophylaxis: Influenza
- Being tested
- TIVc_LOT A, TIVc_LOT B, TIVc_LOT C, TIVf
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIVc_LOT ABiological
Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
TIVc_LOT BBiological
Single IM administration dose of 0.5 mL of TIVc
TIVc_LOT CBiological
Single IM administration dose of 0.5 mL of TIVc
TIVfBiological
Single IM administration dose of 0.5 mL of TIVf
| Study group | Role | What they receive |
|---|---|---|
| TIVc-Lot A | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A Receives: Biological: TIVc_LOT A |
| TIVc-Lot B | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B Receives: Biological: TIVc_LOT B |
| TIVc-Lot C | Experimental | Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C Receives: Biological: TIVc_LOT C |
| TIVf | Active comparator | Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf Receives: Biological: TIVf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Measured: Day 22
Secondary outcomes (3)
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Measured: Day 22
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Measured: Day 1 through day 7 (without 30 min)
Number of Subjects With Unsolicited Adverse Events
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Measured: Day 1 through day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 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.
- Other trials for Prophylaxis: 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256488
- Sponsor's protocol ID
- V58_23
- Status last verified
- May 2019
- First submitted
- 26 Sep 2014
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02256488
- Acronym / sponsor ID
- V58_23
- Conditions
- Prophylaxis: Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,561 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 7 Aug 2015
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 the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).
The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.
The total study participation time per subject is about 3 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TIVc-Lot A | Experimental | Biological: TIVc_LOT ASubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A |
| TIVc-Lot B | Experimental | Biological: TIVc_LOT BSubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B |
| TIVc-Lot C | Experimental | Biological: TIVc_LOT CSubjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C |
| TIVf | Active comparator | Biological: TIVfSubjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
Key exclusion criteria (2 listed)
- Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
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 |
|---|---|---|
| TIVc_LOT ASingle IM (Intramuscular) administration dose of 0.5 mL of TIVc | Biological | TIVc-Lot A |
| TIVc_LOT BSingle IM administration dose of 0.5 mL of TIVc | Biological | TIVc-Lot B |
| TIVc_LOT CSingle IM administration dose of 0.5 mL of TIVc | Biological | TIVc-Lot C |
| TIVfSingle IM administration dose of 0.5 mL of TIVf | Biological | TIVf |
Primary outcome
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
Time frame: Day 22
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
3 secondary outcomes
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Time frame: Day 22
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Time frame: Day 1 through day 7 (without 30 min)
Number of Subjects With Unsolicited Adverse Events
Time frame: Day 1 through day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TIVc_LOT A, TIVc_LOT B and TIVc_LOT C in people with Prophylaxis: Influenza, run by Novartis Vaccines at 24 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 2 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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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 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 7 Aug 2015). 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?
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots. (time frame: Day 22). 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 11 Jun 2019.