Seasonal InfluenzaPhase 3NCT01161264
Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects
A Phase 3 study testing Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 in people with Seasonal Influenza, run by Novartis Vaccines at 1 site in Germany.
Trial summary
Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
- Individuals able to comply with all the study requirements;
- Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
Who cannot join
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
- Cancer, except for localized skin cancer;
- Advanced congestive heart failure;
- Chronic obstructive pulmonary disease (COPD);
- Autoimmune disease (including rheumatoid arthritis);
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- Acute or progressive hepatic disease;
- Acute or progressive renal disease;
- Severe neurological or psychiatric disorder;
- Severe asthma;
- Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, polymyxin, neomycin);
- Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
- receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
- receipt of immunostimulants;
- receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
- suspected or known HIV infection or HIV-related disease;
- Individuals with known or suspected history of drug or alcohol abuse;
- Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing age do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry;
- Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study;
- Individuals that within the past 12 months have received more than one injection of influenza vaccine;
- Individuals that within the past 6 months have:
- had laboratory confirmed seasonal or pandemic influenza disease;
- received seasonal or pandemic influenza vaccine;
- Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
- Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the last 3 days of intended study vaccination;
- Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
- Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines;
- Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study;
- Individuals who are part of study personnel or close family members conducting this study;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- BMI > 35 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects
Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).
- Conditions
- Seasonal Influenza
- Being tested
- Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011
- Keywords
- Elderly, Influenza, Immunogenicity, Safety, 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.
Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011Biological
Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 18-60 YOA | Experimental | Not described Receives: Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 |
| ≥ 60 YOA | Experimental | Not described Receives: Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161264
- Sponsor's protocol ID
- V78_08S
- Other IDs
- 2010-019040-39
- Status last verified
- Sep 2011
- First submitted
- 12 Jul 2010
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects
- ClinicalTrials.gov ID
- NCT01161264
- Acronym / sponsor ID
- V78_08S
- Conditions
- Seasonal Influenza
- Keywords
- Elderly, Influenza, Immunogenicity, Safety, Influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18-60 YOA | Experimental | Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 |
| ≥ 60 YOA | Experimental | Biological: Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female volunteers of 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
- Individuals able to comply with all the study requirements;
- Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.
Key exclusion criteria (32 listed)
- Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study;
- Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to:
- Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, polymyxin, neomycin);
- Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:
- Individuals with known or suspected history of drug or alcohol abuse;
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 Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1. | Biological | 18-60 YOA, ≥ 60 YOA |
Primary outcome
Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization
Time frame: 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Results for V78\_08S from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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.
1 site 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 Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011 in people with Seasonal Influenza, run by Novartis Vaccines at 1 site in Germany.
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 3 inclusion and 32 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 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antibody response to each influenza vaccine antigen as measured by hemagglutination inhibition at 21 days post immunization (time frame: 22 days). 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 10 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.