Seasonal InfluenzaPhase 3NCT01209780

Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

A Phase 3 study testing TIV, TIVf and Comparator TIV in people with Seasonal Influenza, run by Novartis Vaccines at 13 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine. Read more about this study

Who is it for?: Ages 3 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza
What is being tested?: TIV, TIVf and Comparator TIV
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,116 participants
Where: 13 sitesin 4 countries
Study dates: Sep 2010to Sep 2011
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 3 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Males and females aged 3 to 17 years, in good health as determined by medical history, physical examination and clinical judgment of the investigator
Documented consent provided by parents or legal guardians
For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study had been explained to them in terms they could understand
Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study

Who cannot join

Parents or legal guardians and individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study
Parents or legal guardians and individuals providing assent who do not consent to the retention of the subject's serum samples after study completion
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study
Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or posed additional risk to the subjects due to participation in the study
History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, to any excipients, and to eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propiolactone, or nonoxynol-9
History of any serious disease, such as:

Show all 19Show fewer

cancer
history of serious chronic, rheumatologic, neurologic and hematologic diseases
history of underlying medical condition such as inborn errors of metabolism
Known or suspected impairment/alteration of immune function, including:
chronic use of oral steroids within 60 days prior to Visit 1 (use of inhaled, intranasal, or topical corticosteroids is allowed)
receipt of immunostimulants within 60 days prior to Visit 1
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
HIV infection or HIV-related disease
Pregnant or breast-feeding female and any positive or indeterminate pregnancy test
Received an influenza vaccine within 6 months prior to Visit 1
Laboratory-confirmed or suspected influenza disease within 6 months prior to Visit 1
Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
Experienced a fever and/or any acute illness within 3 days prior to each study vaccination

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

Philippines7 sites

Research Institute for Tropical Medicine, Department of Health Compound, FILINVEST Corporate City
Alabang, Muntinlupa City, 1781
University of the East Ramon Magsaysay Medical Center, 64 Aurora Boulevard
Barangay Dona Imelda Quezon City, 1113
De La Salle Health Sciences Institute
Dasmarinas Cavite, 4115
Research Institute for Tropical Medicine, Department of Health Compound
Filinvest Corporate City, Alabang, Muntinlupa City, 1781
Mary Chiles General Hospital, 667 Gastambide St. Sampaloc
Manila, 1008
Philippine Children's Medical Center, Quezon Avenue corner Agham Road
Quezon City
Philippine General Hospital
Taft Avenue, Manila, Manila, 1000

Other trials in Philippines

Panama4 sites

Centro de Salud Magally Ruiz, Street Bolivar
Panama - La Chorrera
Clinica Hospital San Fernando, Floor 4 Office 419 via España las Sabanas
Panama City
Consultorios America Floor 2 Office 201-1, Via España Vista Hermosa
Panama City
Consultorios Medicos San Judas Tadeo Principal Street, Floor 5 Office 507, Villa Lucre
Panama City

Other trials in Panama

Colombia1 site

Centro de Atención e Investigación Medica - CAIMED
Carrera 42A # 17-50, Bogotá

Other trials in Colombia

Mexico1 site

Clinical research institute ,S.C(CRI), Blvd Manuel Avila Camacho 1994 Consultorio 1103 Col. San Lucas Tepetlacalco, C.P.54055 Tlalnepantla
Estado de México

Other trials in Mexico

About this study

Official title: A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Conditions: Seasonal Influenza
Being tested: TIV, TIVf, Comparator TIV
Keywords: seasonal influenza, vaccine

What participants receive

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

TIVBiological
Investigational egg-derived trivalent subunit influenza vaccine.
TIVfBiological
US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.
Comparator TIVBiological
US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.

Study groups in NCT01209780
Study group	Role	What they receive
TIV (3-8 years)	Experimental	Non-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV) Receives: Biological: TIV
Control TIV (3-8 years)	Active comparator	Non-Naive subjects received one dose and Naive subjects received two doses, administered 4 weeks apart, of control vaccine. Subjects aged 3 to <4 years and subjects aged 4 to 8 years received different control TIV. Receives: Biological: TIVf; Biological: Comparator TIV
TIV ( 9-17 years)	Experimental	All subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis. Receives: Biological: TIV
Control TIV ( (9-17 years)	Active comparator	All subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis. Receives: Biological: TIVf

What is being measured

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

Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination.
Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer
Measured: Day 22 for non-naive/Day 50 for naive subjects
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.
Measured: Day 22 for non-naive/Day 50 for naive subjects

Secondary outcomes (6)

Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
The percentages of 3 to 8 year old subjects achieving HI titers ≥40 after receiving either one or two doses of investigational TIV or control vaccine, 21 days after last vaccination, are reported.
This criterion according to the US (CBER)guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40, is ≥70%.
Measured: Day 22 for non-naive/Day 50 for naive subjects
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine
The percentages of 3 to 8 years-old subjects achieving seroconversion in HI antibody titers after receiving either one or two doses of investigational TIV or control vaccine, at 21 days after last vaccination, are reported.
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 22 and day 50 (21 days after last vaccination) is ≥40.
Measured: Day 22 for non-naive/Day 50 for naive
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.
The percentage of 3 to 8 years-old vaccine-naive subjects achieving HI titers ≥40, after receiving two doses of investigational TIV or control vaccine. The time frame of evaluation was 28 days after first (Day 29) and 21 days after second vaccine dose (Day 50).
This criterion according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%, for each vaccine strain.
Measured: Day 1, Day 29, and Day 50
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine
The percentages of 3 to 8 years-old vaccine naive children achieving seroconversion or significant increase in HI antibody titers after receiving two doses of investigational TIV or control vaccine, are reported. The time frame of evaluation was 28 days after first (Day 29) and 21 days after the second dose (Day 50).
This criterion, according to the US (CBER) guideline, is met if the lower limit of 95% CI of percentage of subjects achieving seroconversion or significant increase at day 29 and day 50 is ≥40, for each vaccine strain.
Measured: Day 29 and Day 50
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
The number of 3-17 year old children with solicited local and systemic adverse events and other adverse events, after receiving either one or two doses of investigational TIV as compared to control vaccine are reported.
Measured: Day 1 to 7 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
The number of 3-17 year old children reporting any unsolicited adverse event and any serious adverse event (SAE) after receiving either one or two doses of investigational TIV and control vaccine are reported.
Measured: Day 1 to 180 (non-naive )/Day 1 to 209 (naive)

Timeline

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

Sep 2010Sep 2011

First posted27 Sep 2010 (estimated)
Study startSep 2010
Primary completionMar 2011
Study completionSep 2011

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 Seasonal 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01209780
Sponsor's protocol ID: V71_18
Status last verified: Feb 2014
First submitted: 24 Sep 2010
Last updated: 11 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Seasonal Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age
ClinicalTrials.gov ID: NCT01209780
Acronym / sponsor ID: V71_18
Conditions: Seasonal Influenza
Keywords: seasonal influenza, vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,116 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 27 Sep 2010 (estimated)
Results: Posted 11 Mar 2014

Clinical summary

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

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
TIV (3-8 years)	Experimental	Biological: TIVNon-Naive subjects received one dose and naive subjects received two doses, administered 4 weeks apart, of investigational trivalent influenza vaccine (TIV)
Control TIV (3-8 years)	Active comparator	Biological: TIVf, Biological: Comparator TIVNon-Naive subjects received one dose and Naive subjects received two doses, administered 4 weeks apart, of control vaccine. Subjects aged 3 to <4 years and subjects aged 4 to 8 years received different control TIV.
TIV ( 9-17 years)	Experimental	Biological: TIVAll subjects received one dose of investigational TIV. The subjects in this cohort were included only for safety analysis.
Control TIV ( (9-17 years)	Active comparator	Biological: TIVfAll subjects received one dose of the control vaccine. The subjects from this cohort were included only for safety analysis.

Who may qualify

Ages: 3 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Males and females aged 3 to 17 years, in good health as determined by medical history, physical examination and clinical judgment of the investigator
Documented consent provided by parents or legal guardians
For individuals 8 years of age and older, informed assent to participate in the study after the nature of the study had been explained to them in terms they could understand
Individuals and parents/guardians who were able to comply with all study procedures and were available for all clinic visits scheduled in the study

Key exclusion criteria (19 listed)

Parents or legal guardians and individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study
Parents or legal guardians and individuals providing assent who do not consent to the retention of the subject's serum samples after study completion
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may have interfered with the subject's ability to participate in the study
Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or posed additional risk to the subjects due to participation in the study
History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, latex, to any excipients, and to eggs (including ovalbumin), chicken protein, influenza viral protein, kanamycin, neomycin sulphate, cetyltrimethylammonium bromide (CTAB), polysorbate 80, neomycin, polymixin, formaldehyde, thimerosal, beta propiolactone, or nonoxynol-9

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
TIVInvestigational egg-derived trivalent subunit influenza vaccine.	Biological	TIV ( 9-17 years), TIV (3-8 years)
TIVfUS licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.	Biological	Control TIV ( (9-17 years), Control TIV (3-8 years)
Comparator TIVUS licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.	Biological	Control TIV (3-8 years)

Primary outcome

Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion
Time frame: Day 22 for non-naive/Day 50 for naive subjects
The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination. Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer <1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer
Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)
Time frame: Day 22 for non-naive/Day 50 for naive subjects
The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.

6 secondary outcomes

Percentages of Subjects Achieving HI Titers ≥40 Following Vaccination With Investigational TIV or Control Vaccine.
Time frame: Day 22 for non-naive/Day 50 for naive subjects
Percentages of Subjects With Seroconversion in Antibody Titers Following Vaccination With Investigational TIV or Control Vaccine
Time frame: Day 22 for non-naive/Day 50 for naive
Percentages of Vaccine-naive Children Achieving HI Titers ≥40 After Receiving Two Doses of Investigational TIV or Control Vaccine.
Time frame: Day 1, Day 29, and Day 50
Percentages of Vaccine-naive Children Achieving Seroconversion in Antibody Titers, After Receiving Two Doses of Investigational TIV or Control Vaccine
Time frame: Day 29 and Day 50
Number of Subjects Reporting Solicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Time frame: Day 1 to 7 after vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination With Investigational TIV and Control Vaccine
Time frame: Day 1 to 180 (non-naive )/Day 1 to 209 (naive)

Results and safety

Results posted to the registry on 11 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TIV (3-8 Years Old)	1,042	1,016
Control (4-8 Years)	485	467
Control (3 to < 4 Years)	48	44
TIV (9-17 Years)	817	807
Control (9-17 Years)	412	407

Primary outcome: Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion

Time frame: Day 22 for non-naive/Day 50 for naive subjects. Number (95% Confidence Interval). Unit: Percentages

Measure	TIV (3-8 Years) n = 918	Control (3-8 Years) n = 468
H1N1 strain (N=916,467)	95 (93 to 96)	94 (91 to 96)
H3N2 strain (N=917,468)	78 (75 to 80)	87 (84 to 90)
B strain	87 (84 to 89)	85 (82 to 89)

TIV (3-8 Years) vs Control (3-8 Years): Vaccine group difference (%): -1 (95% CI -4 to 2)
TIV (3-8 Years) vs Control (3-8 Years): Vaccine group difference (%): 10 (95% CI 6 to 14)
TIV (3-8 Years) vs Control (3-8 Years): Vaccine group difference (%): -1 (95% CI -5 to 3)

Population analysed: Analysis was done on per protocol population i.e-all subjects who correctly received study vaccinations,provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding.

Primary outcome: Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs)

Time frame: Day 22 for non-naive/Day 50 for naive subjects. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	TIV (3-8 Years) n = 918	Control (3-8 Years) n = 468
Baseline (H1N1 strain, N=917,467)	26 (22 to 31)	28 (25 to 31)
Day 22 or Day 50 (H1N1 strain,N=917,468)	1157 (1052 to 1272)	1501 (1283 to 1756)
Baseline (H3N2 strain)	142 (127 to 158)	150 (129 to 175)
Day 22 or Day 50 (H3N2 strain, N=917,468)	1385 (1300 to 1475)	2032 (1843 to 2240)
Baseline (B strain)	12 (11 to 13)	13 (12 to 14)
Day 22 or Day 50 (B strain)	208 (193 to 224)	195 (174 to 217)

TIV (3-8 Years) vs Control (3-8 Years): Ratio of GMTs: 1.32 (95% CI 1.11 to 1.56)
TIV (3-8 Years) vs Control (3-8 Years): Ratio of GMTs: 1.48 (95% CI 1.34 to 1.64)
TIV (3-8 Years) vs Control (3-8 Years): Ratio of GMTs: 0.95 (95% CI 0.85 to 1.07)

Population analysed: Analysis was performed on the per protocol population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events collected from Day 1-7 after each vaccination. Serious adverse events and other unsolicited adverse events were collected from Day 1-180 for non-naive and Day 1-209 for vaccine-naive subjects.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TIV (3-8 Years)	14 of 1,039 (1.3%)	657 of 1,039 (63.2%)	Not reported
Control (3-8 Years)	3 of 531 (0.6%)	342 of 531 (64.4%)	Not reported
TIV (9-17 Years)	4 of 817 (0.5%)	385 of 817 (47.1%)	Not reported
Control (9-17 Years)	3 of 412 (0.7%)	196 of 412 (47.6%)	Not reported

Limitations and caveats (from the sponsor): Due to GCP non-compliance at the Mexico site, data of 312 subjects (3-8 year olds) enrolled from this site were excluded from the final immunogenicity and safety analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2014.
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.

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TIV, TIVf and Comparator TIV in people with Seasonal Influenza, run by Novartis Vaccines at 13 sites in 4 countries.

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 4 inclusion and 19 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 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Philippines, Panama, Colombia, Mexico. 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 11 Mar 2014). 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?

Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion (time frame: Day 22 for non-naive/Day 50 for naive subjects). 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 NCT01209780.

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 Mar 2014.