Influenza Disease; FluPhase 2NCT00264576

Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults

A Phase 2 study testing Influenza Virus Vaccine in people with Influenza Disease; Flu, run by Novartis Vaccines at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 < 50 years. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Influenza Disease; Flu
What is being tested?: Influenza Virus Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 613 participants
Where: 4 sitesUnited States
Study dates: Oct 2005to May 2006
Phase: Phase 2
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

18 to <50 years of age;
able to comprehend and follow all required study procedures;
able and willing to provide written informed consent prior to study entry;
available for all the visits scheduled in the study;
in general good health as determined by:
subject-reported medical history,
physical examination by a qualified study nurse, a physician's assistant, or a physician,
clinical judgment of the investigator; among all female volunteers, evidence of a negative pregnancy test conducted on the same day as and prior to study vaccination, and agreement to practice adequate contraception for at least 6 weeks after vaccination as further described in the protocol.

Who cannot join

received influenza vaccine within the past 6 months;
laboratory-confirmed influenza disease in the past 6 months;
any acute respiratory disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or fever ≥38°C (100.4°F) within the past 3 days;
receipt of another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment, and unwilling to refuse participation in another investigational study through the end of the study;
any history of or current serious disease, such as: d) cancer (except for benign or localized skin cancer), e) autoimmune disease (including rheumatoid arthritis), f) advanced arteriosclerotic disease or diabetes mellitus, g) chronic obstructive pulmonary disease (COPD), h) acute, chronic, or progressive hepatic disease, i) acute, chronic, or progressive renal disease, j) congestive heart failure, k) bleeding diathesis, l) an inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome), m) any other serious, acute, or chronic disease including progressive neurological disease or seizure disorder unrelated to fever;
surgery or hospitalization planned during the study period;

Show all 17Show fewer

history of any anaphylaxis, serious vaccine reactions, vaccine-associated oculorespiratory syndrome, or allergy to eggs, egg products, mercury-containing compounds (such as sodium-ethyl-mercuro-thio-salicylate), or any other vaccine component or component of the potential packaging materials (latex);
known or suspected disease of the immune system, or receiving immunosuppressive therapy, including use of: n) systemic corticosteroids, known to be associated with suppression of the hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids [15 mg/day of prednisone or its equivalent] or chronic use of inhaled high potency corticosteroids [budesonide 800 μg/day or fluticasone 750 μg/day]), both within the previous 60 days, o) receipt of immunostimulants within 60 days, p) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the 3 months prior to study entry or anticipated during the full length of the study;
at high risk for developing an immunocompromising disease;
history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
pregnant or breastfeeding;
if female of childbearing potential, refusal to use a reliable contraceptive method, as described further in the protocol, during the first 6 weeks after vaccination;
if female of childbearing potential and sexually active, has not used any of the following birth control methods for the specified time period prior to study entry:
hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), or intrauterine device (e.g., IUD) for 2 months or more prior to study entry,
monogamous relationship with vasectomized partner: partner has been vasectomized for 6 months or more prior to the subject's study entry;
obese (e.g., with a body mass index [BMI] ≥35, where BMI reflects obesity and not high muscle mass);
any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or might interfere with the safety of the study subject.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Bardstown, Kentucky, 40004
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84121

Other trials in United States

About this study

Official title: A Phase 2, Observer-Blinded, Randomized, Multicenter Study in Healthy Adults to Evaluate Safety and Tolerability and to Compare Immunogenicity of a Single Dose of Either an Investigational Trivalent Inactivated Influenza Vaccine Produced in Mammalian Cell Culture or a US-licensed Trivalent Inactivated Influenza Vaccine (Fluvirin®) Produced in Embryonated Hen Eggs

Conditions: Influenza Disease; Flu
Being tested: Influenza Virus Vaccine
Keywords: influenza, flu
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Influenza Virus VaccineBiological

Study groups in NCT00264576
Study group	Role	What they receive
cTIV	Experimental	Received one dose of cell-culture derived trivalent influenza vaccine (cTIV). Receives: Biological: Influenza Virus Vaccine
TIV	Active comparator	Received one dose of egg-derived trivalent vaccine (TIV). Receives: Biological: Influenza Virus Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Measured: 3 weeks postvaccination (Day 22)
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Measured: 3 weeks postvaccination (Day 22)

Secondary outcomes (6)

Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5.
Measured: 3 weeks postvaccination (Day 22)
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is > 2.5.
Measured: 3 weeks postvaccination (Day 22)
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Measured: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay.
This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is >70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%.
Measured: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Seroconversion.
As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer <10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is >40%.
Measured: 3 weeks postvaccination (Day 22)
Number of Subjects Reporting Local and Systemic Reactions
Safety and tolerability of cTIV and eTIV_f postvaccination.
Difference between demography and safety numbers was due to one misrandomization.
Measured: 7 days postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005May 2006

First posted13 Dec 2005 (estimated)
Study startOct 2005
Primary completionDec 2005
Study completionMay 2006

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 Disease; FluStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00264576
Sponsor's protocol ID: V58P5
Status last verified: Dec 2012
First submitted: 9 Dec 2005
Last updated: 24 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis. 2009 Sep 15;200(6):849-57. doi: 10.1086/605506.
PubMed 19673652

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Observer-Blinded, Randomized, Multicenter Study in Healthy Adults to Evaluate Safety and Tolerability and to Compare Immunogenicity of a Single Dose of Either an Investigational Trivalent Inactivated Influenza Vaccine Produced in Mammalian Cell Culture or a US-licensed Trivalent Inactivated Influenza Vaccine (Fluvirin®) Produced in Embryonated Hen Eggs
ClinicalTrials.gov ID: NCT00264576
Acronym / sponsor ID: V58P5
Conditions: Influenza Disease; Flu
Keywords: influenza, flu
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 613 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines and Diagnostics (formerly Chiron Vaccines)
Study start: Oct 2005
Primary completion: Dec 2005 (actual)
Study completion: May 2006 (actual)
First posted: 13 Dec 2005 (estimated)
Results: Posted 28 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
cTIV	Experimental	Biological: Influenza Virus VaccineReceived one dose of cell-culture derived trivalent influenza vaccine (cTIV).
TIV	Active comparator	Biological: Influenza Virus VaccineReceived one dose of egg-derived trivalent vaccine (TIV).

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

18 to <50 years of age;
able to comprehend and follow all required study procedures;
able and willing to provide written informed consent prior to study entry;
available for all the visits scheduled in the study;
in general good health as determined by:

Key exclusion criteria (17 listed)

received influenza vaccine within the past 6 months;
laboratory-confirmed influenza disease in the past 6 months;
any acute respiratory disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or fever ≥38°C (100.4°F) within the past 3 days;
receipt of another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever was longer, prior to enrollment, and unwilling to refuse participation in another investigational study through the end of the study;
any history of or current serious disease, such as: d) cancer (except for benign or localized skin cancer), e) autoimmune disease (including rheumatoid arthritis), f) advanced arteriosclerotic disease or diabetes mellitus, g) chronic obstructive pulmonary disease (COPD), h) acute, chronic, or progressive hepatic disease, i) acute, chronic, or progressive renal disease, j) congestive heart failure, k) bleeding diathesis, l) an inherited genetic anomaly (known cytogenic disorders, e.g., Down's Syndrome), m) any other serious, acute, or chronic disease including progressive neurological disease or seizure disorder unrelated to fever;

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
Influenza Virus Vaccine	Biological	TIV, cTIV

Primary outcome

Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Time frame: 3 weeks postvaccination (Day 22)
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Time frame: 3 weeks postvaccination (Day 22)
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.

6 secondary outcomes

Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
Time frame: 3 weeks postvaccination (Day 22)
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
Time frame: 3 weeks postvaccination (Day 22)
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
Time frame: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
Time frame: 3 weeks postvaccination (Day 22)
Percentages of Subjects With Seroconversion.
Time frame: 3 weeks postvaccination (Day 22)
Number of Subjects Reporting Local and Systemic Reactions
Time frame: 7 days postvaccination

Results and safety

Results posted to the registry on 28 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
cTIV	308	307
eTIV_f	305	304

Primary outcome: Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.

Time frame: 3 weeks postvaccination (Day 22). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	cTIV n = 307	eTIV_f n = 303
A/H1N1 (egg-derived assay)	259 (225 to 298)	306 (265 to 352)
A/H3N2 (egg-derived assay)	181 (157 to 210)	320 (276 to 370)
B (egg-derived assay)	179 (157 to 203)	157 (138 to 179)
A/H1N1 (cell-culture-derived assay)	468 (407 to 538)	508 (441 to 585)
A/H3N2 (cell-culture-derived assay)	287 (250 to 331)	468 (406 to 539)
B (cell-culture-derived assay)	176 (155 to 199)	134 (118 to 153)

cTIV vs eTIV_f: Ratio of GMT: 0.85 (95% CI 0.70 to 1.04), ANOVA
cTIV vs eTIV_f: Ratio of GMT: 0.57 (95% CI 0.46 to 0.70), ANOVA
cTIV vs eTIV_f: Ratio of GMT: 1.14 (95% CI 0.95 to 1.36), ANOVA

Population analysed: Analysis was done on per protocol set

Primary outcome: Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.

Time frame: 3 weeks postvaccination (Day 22). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	cTIV n = 307	eTIV_f n = 303
A/H1N1 (egg-derived assay)	263 (229 to 302)	310 (270 to 355)
A/H3N2 (egg-derived assay)	199 (173 to 229)	316 (275 to 364)
B (egg-derived assay)	185 (163 to 210)	159 (141 to 181)
A/H1N1 (cell-culture-derived assay)	478 (417 to 549)	518 (451 to 595)
A/H3N2 (cell-culture-derived assay)	306 (267 to 350)	444 (388 to 508)
B (cell-culture-derived assay)	180 (160 to 203)	135 (120 to 153)

cTIV vs eTIV_f: Ratio of GMT: 0.85 (95% CI 0.70 to 1.03), ANCOVA
cTIV vs eTIV_f: Ratio of GMT: 0.63 (95% CI 0.52 to 0.76), ANCOVA
cTIV vs eTIV_f: Ratio of GMT: 1.16 (95% CI 0.98 to 1.38), ANCOVA

Population analysed: Analysis was done on per protocol set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
cTIV	3 of 309 (1%)	236 of 309 (76.4%)	Not reported
eTIV_f	5 of 304 (1.6%)	237 of 304 (78%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19673652Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis. 2009 Sep 15;200(6):849-57. doi: 10.1086/605506.

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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.

Novartis Vaccines study chair

Novartis Vaccines

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza Virus Vaccine in people with Influenza Disease; Flu, run by Novartis Vaccines at 4 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 8 inclusion and 17 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Jan 2013). 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?

Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method. (time frame: 3 weeks postvaccination (Day 22)). 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 NCT00264576, 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 24 Mar 2017.