InfluenzaPhase 3NCT00310804

Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

A Phase 3 study testing Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV) and Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV) in people with Influenza, run by Novartis Vaccines at 2 sites in Lithuania.

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 present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV) and Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,200 participants
Where: 2 sitesLithuania
Study dates: Sep 2005to Apr 2006
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 to <61 years of age
mentally competent to understand the nature, the scope and the consequences of the study
able and willing to give written informed consent prior to study entry
in good health as determined by:
medical history,
physical examination,
clinical judgment of the Investigator.

Who cannot join

unwilling or unable to give written informed consent to participate in the study
participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
currently experiencing an acute infectious disease
any serious disease, such as, for example:
cancer,
autoimmune disease (including rheumatoid arthritis),

Show all 29Show fewer

advanced arteriosclerotic disease or complicated diabetes mellitus,
chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
acute or progressive hepatic disease,
acute or progressive renal disease,
congestive heart failure
surgery planned during the study period
bleeding diathesis
history of hypersensitivity to any component of the study medication or chemically related substances
history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
known or suspected impairment/alteration of immune function, for example resulting from:
receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
receipt of immunostimulants,
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
high risk for developing an immunocompromising disease
history of drug or alcohol abuse
laboratory-confirmed influenza disease within 6 months prior to Visit 1
receipt of influenza vaccine within 6 months prior to Visit 1
receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
if female, pregnant or breastfeeding
if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
planned relocation abroad during the study period
any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

2 sites in 1 country.

Lithuania2 sites

2nd Department of Internal Diseases, Panevezys Hospital,
Panevezys
Dept. Infectious Diseases and Microbiology of Vilnius University
Vilnius

Other trials in Lithuania

About this study

Official title: A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

Conditions: Influenza
Being tested: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV), Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV), Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)
Keywords: Influenza, Flu, Cell-Derived, Egg-Derived, Healthy Adults, Safety, Immunogenicity, Vaccination
Medical subject headings: Influenza, Human

What participants receive

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

Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)Biological
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)Biological
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)Biological
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)Biological
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Study groups in NCT00310804
Study group	Role	What they receive
cTIV_lot 1	Experimental	Not described Receives: Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)
cTIV_lot 2	Experimental	Not described Receives: Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)
cTIV_lot 3	Experimental	Not described Receives: Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)
TIV group	Active comparator	Not described Receives: Biological: Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)

What is being measured

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

Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
The haemagglutinin Inhibition (HI) antibody titer response following
1. one dose of cTIV for each of the three lots separately and
2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).
The HI GMTs were evaluated using egg-derived antigen assay.
Measured: Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following
1. one dose of cTIV for each of the three vaccine lots separately and
2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.
Measured: Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after
1. one dose of cTIV for each of the three vaccine lots separately and
2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.
Measured: Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after
1. one dose of cTIV for each of the three vaccine lots separately and
2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.
European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.
As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.
Measured: Day 22 postvaccination

Secondary outcomes (2)

Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of
1. one dose of cTIV for each of the three vaccine lots separately and
2. for one dose of cTIV (combined) compared to TIV.
Measured: Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Measured: Day 1 - Day 181 postvaccination

Timeline

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

Sep 2005Apr 2006

First posted5 Apr 2006 (estimated)
Study startSep 2005
Primary completionOct 2005
Study completionApr 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 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: Single blind
Who is masked: Participant
Enrolment: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310804
Sponsor's protocol ID: V58P9
Other IDs: EUDRACT: 2005-002257-47
Status last verified: Aug 2019
First submitted: 3 Apr 2006
Last updated: 15 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.
PubMed 19666152

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 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60
ClinicalTrials.gov ID: NCT00310804
Acronym / sponsor ID: V58P9
Conditions: Influenza
Keywords: Influenza, Flu, Cell-Derived, Egg-Derived, Healthy Adults, Safety, Immunogenicity, Vaccination
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Oct 2005 (actual)
Study completion: Apr 2006 (actual)
First posted: 5 Apr 2006 (estimated)
Results: Posted 18 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: 4

Arm	Type	Receives
cTIV_lot 1	Experimental	Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)
cTIV_lot 2	Experimental	Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)
cTIV_lot 3	Experimental	Biological: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)
TIV group	Active comparator	Biological: Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

18 to <61 years of age
mentally competent to understand the nature, the scope and the consequences of the study
able and willing to give written informed consent prior to study entry
in good health as determined by:

Key exclusion criteria (29 listed)

unwilling or unable to give written informed consent to participate in the study
participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
currently experiencing an acute infectious disease
any serious disease, such as, for example:
surgery planned during the study period

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
Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV)One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1	Biological	cTIV_lot 1
Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV)One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2	Biological	cTIV_lot 2
Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV)One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3	Biological	cTIV_lot 3
Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).	Biological	TIV group

Primary outcome

Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Time frame: Day 22 postvaccination
The haemagglutinin Inhibition (HI) antibody titer response following 1. one dose of cTIV for each of the three lots separately and 2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs). The HI GMTs were evaluated using egg-derived antigen assay.
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.
Percentage of Subjects With HI Titers ≥40
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after 1. one dose of cTIV for each of the three vaccine lots separately and 2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Time frame: Day 22 postvaccination
Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after 1. one dose of cTIV for each of the three vaccine lots separately and 2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion. European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%. As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

2 secondary outcomes

Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Time frame: Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Time frame: Day 1 - Day 181 postvaccination

Results and safety

Results posted to the registry on 18 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 (Combined)	1,029	1,024
TIV Group	171	171

Primary outcome: Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects

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

Measure	cTIV_lot1 n = 198	cTIV_lot 2 n = 193	cTIV_lot3 n = 198	cTIV (Combined) n = 589	TIV Group n = 98
A/H3N2 strain (day 1)	12 (11 to 14)	15 (13 to 17)	16 (14 to 19)	14 (13 to 16)	15 (12 to 18)
A/H3N2 strain (day 22)	175 (147 to 207)	171 (144 to 203)	158 (133 to 188)	168 (152 to 185)	186 (146 to 236)
A/H1N1 strain (day 1)	20 (17 to 24)	20 (17 to 25)	21 (17 to 25)	20 (18 to 22)	22 (18 to 29)
A/H1N1 strain (day 22)	390 (326 to 466)	364 (303 to 436)	366 (306 to 437)	373 (335 to 415)	329 (253 to 428)
B strain (day 1)	13 (11 to 15)	17 (14 to 19)	14 (12 to 16)	14 (13 to 16)	16 (13 to 20)
B strain (day 22)	131 (113 to 151)	157 (136 to 182)	128 (111 to 148)	138 (126 to 151)	124 (99 to 154)

Population analysed: This analysis was done on per protocol (PP) population defined as all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.

Primary outcome: Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects

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

Measure	cTIV_lot1 n = 198	cTIV_lot 2 n = 193	cTIV_lot3 n = 198	cTIV (Combined) n = 589	TIV Group n = 98
A/H1N1 strain (Day22/Day1)	20 (16 to 24)	18 (14 to 22)	18 (14 to 22)	18 (16 to 21)	15 (11 to 20)
A/H3N2 strain (Day22/Day1)	14 (12 to 17)	11 (9.55 to 14)	9.92 (8.28 to 12)	12 (11 to 13)	12 (9.57 to 16)
B strain (Day22/Day1)	10 (8.59 to 12)	9.42 (7.97 to 11)	9.37 (7.94 to 11)	9.63 (8.71 to 11)	7.53 (5.88 to 9.65)

Population analysed: The analysis was performed as PP dataset.

Primary outcome: Percentage of Subjects With HI Titers ≥40

Time frame: Day 22 postvaccination. Number (95% Confidence Interval). Unit: Percentages

Measure	cTIV_lot 1 n = 198	cTIV_lot 2 n = 193	cTIV_lot 3 n = 198	cTIV (Combined) n = 589	TIV Group n = 98
A/H1N1 strain (day 1)	36 (29 to 43)	38 (31 to 46)	34 (27 to 41)	36 (32 to 40)	38 (28 to 48)
A/H1N1 strain (day 22)	97 (94 to 99)	97 (93 to 99)	94 (90 to 97)	96 (94 to 98)	97 (91 to 99)
A/H3N2 strain (day 1)	19 (14 to 25)	31 (24 to 38)	28 (22 to 35)	26 (22 to 30)	28 (19 to 37)
A/H3N2 strain (day 22)	92 (88 to 96)	93 (88 to 96)	91 (86 to 95)	92 (90 to 94)	97 (91 to 99)
B strain (day 1)	25 (19 to 32)	31 (25 to 38)	25 (19 to 31)	27 (23 to 31)	31 (22 to 41)
B strain (day 22)	92 (88 to 96)	94 (90 to 97)	93 (89 to 96)	93 (91 to 95)	93 (86 to 97)

Population analysed: This analysis was done on PP population.

Primary outcome: Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine

Time frame: Day 22 postvaccination. Number (95% Confidence Interval). Unit: Percentages

Measure	cTIV_lot1 n = 198	cTIV_lot 2 n = 193	cTIV_lot3 n = 198	cTIV (Combined) n = 589	TIV Group n = 98
A/H1N1 strain	80 (74 to 86)	81 (75 to 86)	82 (76 to 87)	81 (78 to 84)	76 (66 to 84)
A/H3N2 strain	84 (78 to 89)	79 (72 to 84)	78 (71 to 83)	80 (77 to 83)	88 (80 to 94)
B strain	79 (72 to 84)	81 (75 to 87)	80 (74 to 85)	80 (77 to 83)	70 (60 to 79)

Population analysed: This analysis was done on PP population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through out the study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
cTIV (Combined)	16 of 599 (2.7%)	237 of 599 (39.6%)	Not reported
TIV Group	2 of 100 (2%)	35 of 100 (35%)	Not reported

Limitations and caveats (from the sponsor): Because of potential issues related to Good Clinical Practice (GCP), data from one of the sites were not used in the analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19666152Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.

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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 & Diagnostics

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 29 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 15 Aug 2019. 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 Lithuania. 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 18 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 After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects (time frame: Day 22 postvaccination). The study lists 4 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 NCT00310804, 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 15 Aug 2019.