InfluenzaPhase 3NCT00617851
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
A Phase 3 study testing Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine and Lot C of Influenza virus vaccine in people with Influenza, run by Novartis Vaccines at 2 sites in Dominican Republic.
Trial summary
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine and Lot C of Influenza virus vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,507 participants
- Where
- 2 sitesDominican Republic
- Study dates
- Nov 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 49 years of age;
- In good health as determined by medical history and physical examination;
- Able and willing to provide written informed consent prior to any study procedure;
- Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Who cannot join
- Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- Known or suspected impairment/alteration of immune function
- Receipt of an influenza vaccine within 6 months prior to Visit 1;
- Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
- Laboratory-confirmed influenza disease within 6 months prior to Visit 1
Trial locations and contacts
2 sites in 1 country.
Dominican Republic2 sites
Centro de Salud Galvan
Santo Domingo
Hosp. Nuestra Sra. Altagracia
Santo Domingo
About this study
Official title: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
- Conditions
- Influenza
- Being tested
- Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine, Lot C of Influenza virus vaccine, Comparator influenza virus vaccine, All 3 consecutive lots of influenza virus vaccine pooled
- Keywords
- Influenza, adults, different lots, trivalent subunit influenza virus vaccine (IVV), trivalent subunit influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lot A of Influenza virus vaccineBiological
1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly
Lot B of Influenza virus vaccineBiological
1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly
Lot C of Influenza virus vaccineBiological
1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly
Comparator influenza virus vaccineBiological
1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly
All 3 consecutive lots of influenza virus vaccine pooledBiological
1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Influenza virus vaccine (lot A) | Experimental | Lot A of the investigational influenza virus vaccine Receives: Biological: Lot A of Influenza virus vaccine |
| Influenza virus vaccine (lot B) | Experimental | Lot B of the investigational influenza virus vaccine Receives: Biological: Lot B of Influenza virus vaccine |
| Influenza virus vaccine (lot C) | Experimental | Lot C of the investigational influenza virus vaccine Receives: Biological: Lot C of Influenza virus vaccine |
| Influenza virus vaccine (pooled) | Experimental | Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine Receives: Biological: All 3 consecutive lots of influenza virus vaccine pooled |
| Comparator influenza vaccine | Active comparator | A US licensed influenza virus vaccine Receives: Biological: Comparator influenza virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers (GMTs), by Vaccine Lots
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
Measured: 21 days after vaccination
Secondary outcomes (6)
Geometric Mean Titers (GMTs), by Vaccine Group and Strain
The GMTs and 95% CIs were calculated for each of the vaccine group (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each strain.
Measured: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms
Solicited local and systemic reactions were assessed after vaccination for the two vaccines (three consecutive production lots pooled for the investigational influenza virus vaccine and comparator) and for each of the three consecutive production lots of the investigational influenza virus vaccine.
Measured: 7 days after vaccination
Number of Subjects With at Least One Unsolicited Adverse Event
Number of subjects reporting at least one unsolicited adverse event, regardless of the assessement of relatedness to the study vaccines (each of the three consecutive production lots of the investigational influenza virus vaccine, the pooled influenza virus vaccine, and the comparator influenza vaccine).
Measured: 3 weeks after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
- the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
- the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Measured: 21 days after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
- the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
- the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
Measured: 21 days after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain B)
The percentage of subjects who were seroprotected and seroconverted were considered statistically compliant with the stated CBER guidance criteria if:
- the lower bound of the two-sided 95% CI for the percentage of seroprotected subjects (HI antibody titer ≥1:40) met or exceeded 70%.
- the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion rate (prevaccination HI<10/ postvaccination HI ≥40 or at least a fourfold increase in titer from non-negative prevaccination serum [HI≥10]), for HI antibody met or exceeded 40%.
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.
- First posted18 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionJun 2008
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 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
- 1,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617851
- Sponsor's protocol ID
- V71P6
- Other IDs
- 13299
- Status last verified
- May 2012
- First submitted
- 6 Feb 2008
- Last updated
- 8 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Consistency of Three Consecutive Lots of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs in Healthy Subjects Aged 18 to 49 Years
- ClinicalTrials.gov ID
- NCT00617851
- Acronym / sponsor ID
- V71P6
- Conditions
- Influenza
- Keywords
- Influenza, adults, different lots, trivalent subunit influenza virus vaccine (IVV), trivalent subunit influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,507 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Posted 24 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Influenza virus vaccine (lot A) | Experimental | Biological: Lot A of Influenza virus vaccineLot A of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot B) | Experimental | Biological: Lot B of Influenza virus vaccineLot B of the investigational influenza virus vaccine |
| Influenza virus vaccine (lot C) | Experimental | Biological: Lot C of Influenza virus vaccineLot C of the investigational influenza virus vaccine |
| Influenza virus vaccine (pooled) | Experimental | Biological: All 3 consecutive lots of influenza virus vaccine pooledPooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine |
| Comparator influenza vaccine | Active comparator | Biological: Comparator influenza virus vaccineA US licensed influenza virus vaccine |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 49 years of age;
- In good health as determined by medical history and physical examination;
- Able and willing to provide written informed consent prior to any study procedure;
- Able to comply with all study procedures and available for all clinic visits scheduled in the study.
Key exclusion criteria (6 listed)
- Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
- Known or suspected impairment/alteration of immune function
- Receipt of an influenza vaccine within 6 months prior to Visit 1;
- Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
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 |
|---|---|---|
| Lot A of Influenza virus vaccine1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly | Biological | Influenza virus vaccine (lot A) |
| Lot B of Influenza virus vaccine1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly | Biological | Influenza virus vaccine (lot B) |
| Lot C of Influenza virus vaccine1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly | Biological | Influenza virus vaccine (lot C) |
| Comparator influenza virus vaccine1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly | Biological | Comparator influenza vaccine |
| All 3 consecutive lots of influenza virus vaccine pooled1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly | Biological | Influenza virus vaccine (pooled) |
Primary outcome
Geometric Mean Titers (GMTs), by Vaccine Lots
Time frame: 21 days after vaccination
The immunologic equivalence of three consecutive production lots of the influenza virus vaccine was measured in terms of GMTs for all vaccine influenza strains.
6 secondary outcomes
Geometric Mean Titers (GMTs), by Vaccine Group and Strain
Time frame: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms
Time frame: 7 days after vaccination
Number of Subjects With at Least One Unsolicited Adverse Event
Time frame: 3 weeks after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H1N1)
Time frame: 21 days after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain A/H3N2)
Time frame: 21 days after vaccination
Percentage of Subjects With Seroprotection and Seroconversion (Strain B)
Time frame: 21 days after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- 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.
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 Lot A of Influenza virus vaccine, Lot B of Influenza virus vaccine and Lot C of Influenza virus vaccine in people with Influenza, run by Novartis Vaccines at 2 sites in Dominican Republic.
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 6 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 8 May 2012. 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 Dominican Republic. 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 24 Jun 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?
Geometric Mean Titers (GMTs), by Vaccine Lots (time frame: 21 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.