InfluenzaPhase 3NCT00464672

Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

A Phase 3 study testing Influenza virus vaccine and Comparator influenza vaccine in people with Influenza, run by Novartis at 2 sites in Argentina.

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

Who is it for?: Ages 3 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza virus vaccine and Comparator influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,893 participants
Where: 2 sitesArgentina
Study dates: Apr 2007to Dec 2007
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 64 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy subjects 3 to 64 years of age

Who cannot join

Receipt of other investigational products within 3 months or other vacine within 1 month;
Allergy to eggs, egg products, or any other vaccine component;
Laboratory confirmed influenza disease within 6 months;
Have previously received an influenza vaccination (3 to 8 years only);

Trial locations and contacts

2 sites in 1 country.

Argentina2 sites

Site 2: C1425AWK
Buenos Aires
Site 1: X5000BJH
Córdoba

Other trials in Argentina

About this study

Official title: A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Conditions: Influenza
Being tested: Influenza virus vaccine, Comparator influenza vaccine
Keywords: Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, 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.

Influenza virus vaccineBiological
Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Comparator influenza vaccineBiological
Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Study groups in NCT00464672
Study group	Role	What they receive
Influenza virus vaccine	Experimental	Not described Receives: Biological: Influenza virus vaccine
Comparator influenza vaccine	Active comparator	Not described Receives: Biological: Comparator influenza vaccine

What is being measured

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

Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Measured: 21 days after vaccination
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
Measured: 21 days after vaccination

Secondary outcomes (10)

Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
Measured: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Measured: 21 days after vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Measured: 21 days after vaccination
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Measured: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
Measured: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Measured: 50 days after last vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Measured: 50 days after last vaccination
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Measured: 50 days after last vaccination
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
Measured: 7 days after each vaccination
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
Measured: 21 days after vaccination

Timeline

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

Apr 2007Dec 2007

First posted24 Apr 2007 (estimated)
Study startApr 2007
Primary completionJul 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,893 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00464672
Sponsor's protocol ID: V71P5
Other IDs: IND: 13299
Status last verified: Sep 2015
First submitted: 23 Apr 2007
Last updated: 1 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063.
PubMed 22691101

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 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
ClinicalTrials.gov ID: NCT00464672
Acronym / sponsor ID: V71P5
Conditions: Influenza
Keywords: Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,893 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Apr 2007
Primary completion: Jul 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 24 Apr 2007 (estimated)
Results: Posted 5 May 2010

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Influenza virus vaccine	Experimental	Biological: Influenza virus vaccine
Comparator influenza vaccine	Active comparator	Biological: Comparator influenza vaccine

Who may qualify

Ages: 3 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Healthy subjects 3 to 64 years of age

Key exclusion criteria (4 listed)

Receipt of other investigational products within 3 months or other vacine within 1 month;
Allergy to eggs, egg products, or any other vaccine component;
Laboratory confirmed influenza disease within 6 months;
Have previously received an influenza vaccination (3 to 8 years only);

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 vaccineTwo intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.	Biological	Influenza virus vaccine
Comparator influenza vaccineTwo intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.	Biological	Comparator influenza vaccine

Primary outcome

Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
Time frame: 21 days after vaccination
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition [HI] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Time frame: 21 days after vaccination
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum [HI<10]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.

10 secondary outcomes

Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Time frame: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
Time frame: 21 days after vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Time frame: 21 days after vaccination
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
Time frame: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Time frame: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
Time frame: 50 days after last vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Time frame: 50 days after last vaccination
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
Time frame: 50 days after last vaccination
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Time frame: 7 days after each vaccination
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Time frame: 21 days after vaccination

Results and safety

Results posted to the registry on 5 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influenza Virus Vaccine (18 to 64 Years)	460	435
Comparator Influenza Vaccine (18 to 64 Years)	232	222
Influenza Virus Vaccine (9 to 17 Years)	400	400
Comparator Influenza Vaccine (9 to 17 Years)	200	199
Influenza Virus Vaccine (3 to 8 Years)	402	392
Comparator Influenza Vaccine (3 to 8 Years)	199	195

Primary outcome: Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age

Time frame: 21 days after vaccination. Mean (95% Confidence Interval). Unit: Percentages of participants

Measure	Influenza Virus Vaccine (A/H1N1) n = 424	Influenza Virus Vaccine (A/H3N2) n = 424	Influenza Virus Vaccine (Strain B) n = 424	Comparator Influenza Vaccine (A/H1N1) n = 219	Comparator Influenza Vaccine (A/H3N2) n = 219	Comparator Influenza Vaccine (Strain B) n = 219
Value	93 (90 to 95)	96 (94 to 98)	91 (87 to 93)	99 (97 to 100)	100 (98 to 100)	86 (81 to 91)

Population analysed: The analysis was performed on the per-protocol (PP) population.

Primary outcome: Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age

Time frame: 21 days after vaccination. Mean (95% Confidence Interval). Unit: Percentage of participants

Measure	Influenza Virus Vaccine (A/H1N1) n = 424	Influenza Virus Vaccine (A/H3N2) n = 424	Influenza Virus Vaccine (Strain B) n = 424	Comparator Influenza Vaccine (A/H1N1) n = 219	Comparator Influenza Vaccine (A/H3N2) n = 219	Comparator Influenza Vaccine (Strain B) n = 219
Value	74 (69 to 78)	72 (68 to 76)	77 (72 to 81)	86 (81 to 90)	89 (84 to 92)	74 (68 to 80)

Population analysed: The analysis was performed on the per-protocol (PP) population.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Unsolicited adverse events were collected from 21 days after the last vaccination (up to day 53) to study termination (up to day 216). All serious adverse events were collected throughout the entire study period (up to day 216).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influenza Virus Vaccine (18 to 64 Years)	6 of 460 (1.3%)	235 of 460 (51.1%)	Not reported
Comparator Influenza Vaccine (18 to 64 Years)	2 of 233 (0.9%)	128 of 233 (54.9%)	Not reported
Influenza Virus Vaccine (9 to 17 Years)	4 of 400 (1%)	167 of 400 (41.8%)	Not reported
Comparator Influenza Vaccine (9 to 17 Years)	0 of 199 (0%)	80 of 199 (40.2%)	Not reported
Influenza Virus Vaccine (3 to 8 Years)	3 of 402 (0.7%)	153 of 402 (38.1%)	Not reported
Comparator Influenza Vaccine (3 to 8 Years)	3 of 199 (1.5%)	91 of 199 (45.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22691101Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063.

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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 and Diagnostics study director

Novartis

2 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 Influenza virus vaccine and Comparator influenza vaccine in people with Influenza, run by Novartis at 2 sites in Argentina.

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 1 inclusion and 4 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 1 Oct 2015. 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 Argentina. 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 5 May 2010). 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?

Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age (time frame: 21 days after vaccination). 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 NCT00464672, 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 1 Oct 2015.