FLUPhase 2NCT00644540
Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study
A Phase 2 study testing Influenza Trivalent Inactivated Vaccines in people with FLU, run by Novartis Vaccines at 1 site in Finland.
Trial summary
The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. Read more about this study
- Who is it for?
- Ages 16 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- FLU
- What is being tested?
- Influenza Trivalent Inactivated Vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2007to Jun 2008
- Phase
- Phase 2
- 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 16 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given 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
- Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start;
- Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 15 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
- Fever (defined as axillary temperature ≥ 38.0°C/rectal temperature ≥ 38.5°C) within the 7 days before enrolment;
- Any serious disease including, for example:cancer,autoimmune disease (including rheumatoid arthritis),diabetes mellitus,chronic pulmonary disease,acute or progressive hepatic disease,acute or progressive renal disease;
- Known or suspected impairment/alteration of immune function, for example, resulting from:receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy),receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,high risk for developing an immunocompromising disease;
- Bleeding diathesis;
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- History of hypersensitivity to any component of the study medication or chemically related substances;
- History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component;
- Laboratory confirmed influenza disease in the past 6 months;
- Surgery planned during the study period;
- Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 4 weeks after last vaccination in the respective season) has been concluded;
- Participation to another trial of an investigational agent within 90 days of enrolment;
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.
The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.
- Conditions
- FLU
- Being tested
- Influenza Trivalent Inactivated Vaccines
- Keywords
- Influenza, vaccines, children
- 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 Trivalent Inactivated VaccinesBiological
This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
Influenza Trivalent Inactivated VaccinesBiological
This phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age.
Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial.
Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Influenza Trivalent Inactivated Vaccines |
| 2 | Active comparator | Not described Receives: Biological: Influenza Trivalent Inactivated Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months.
Measured: 181 days
Secondary outcomes (2)
Immunogenicity of a single 0.25 or 0.5mL IM injection of two different influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 48 months.
Measured: 181 days
To evaluate the safety and tolerability of a single 0.25 or 0.5 mL IM injection of two different influenza vaccines in healthy children aged up to 48 months
Measured: 181 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FLUStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644540
- Sponsor's protocol ID
- V70P2E1
- Status last verified
- Jan 2014
- First submitted
- 21 Mar 2008
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Vesikari T, Groth N, Karvonen A, Borkowski A, Pellegrini M. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine. 2009 Oct 23;27(45):6291-5. doi: 10.1016/j.vaccine.2009.02.004.
PubMed 19840662
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Observer-Blind, Parallel Groups, Single Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine in the Previous V70P2 Study.
- ClinicalTrials.gov ID
- NCT00644540
- Acronym / sponsor ID
- V70P2E1
- Conditions
- FLU
- Keywords
- Influenza, vaccines, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Mar 2008 (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.
The purpose of this research is to evaluate the immunogenicity of a single dose of Influenza Vaccines (0.5mL or 0.25mL) in healthy children aged up to 35 months or 36 up to 48 months. To evaluate the safety and tolerability of a single 0.25mL IM of injection influenza vaccines in healthy children aged up to 35 months; to evaluate the safety and tolerability of a single 0.50mL IM injection of influenza vaccines in healthy children aged up to 48 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Influenza Trivalent Inactivated Vaccines |
| 2 | Active comparator | Biological: Influenza Trivalent Inactivated Vaccines |
Who may qualify
- Ages
- 16 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children up to 48 months of age, who received both doses of one of the two study vaccines in the previous V70P2 trial, whose parents/legal guardians have given written informed consent prior to study entry,
- in good health as determined by:medical history, physical examination, clinical judgment of the investigator.
Key exclusion criteria (13 listed)
- Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start;
- Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 15 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
- Fever (defined as axillary temperature ≥ 38.0°C/rectal temperature ≥ 38.5°C) within the 7 days before enrolment;
- Any serious disease including, for example:cancer,autoimmune disease (including rheumatoid arthritis),diabetes mellitus,chronic pulmonary disease,acute or progressive hepatic disease,acute or progressive renal disease;
- Known or suspected impairment/alteration of immune function, for example, resulting from:receipt of immunosuppressive therapy (corticosteroid - except topical or inhaled steroids - or cancer chemotherapy),receipt of immunostimulants,receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,high risk for developing an immunocompromising disease;
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 Trivalent Inactivated VaccinesThis phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age. Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial. Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm. | Biological | 1 |
| Influenza Trivalent Inactivated VaccinesThis phase II, observer-blind, parallel groups, single center, extension study will be performed over a period of approximately 6 months in a study population of healthy children up to 48 months of age. Up to two hundred and forty-four children (244) having previously participated in Novartis Vaccines Study V70P2 will be vaccinated with the same influenza vaccines received in the previous trial. Each subject will receive a single vaccine dose of 0.25mL, or of 0.5mL, if aged respectively up to 35 months or 36 up to 48 months, administered intramuscularly (IM) in the deltoid muscle, preferably of the non-dominant arm. | Biological | 2 |
Primary outcome
To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months.
Time frame: 181 days
2 secondary outcomes
Immunogenicity of a single 0.25 or 0.5mL IM injection of two different influenza vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test in healthy children aged up to 48 months.
Time frame: 181 days
To evaluate the safety and tolerability of a single 0.25 or 0.5 mL IM injection of two different influenza vaccines in healthy children aged up to 48 months
Time frame: 181 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 1 Dec 2016.
- Results publication: PubMed 19840662Vesikari T, Groth N, Karvonen A, Borkowski A, Pellegrini M. MF59-adjuvanted influenza vaccine (FLUAD) in children: safety and immunogenicity following a second year seasonal vaccination. Vaccine. 2009 Oct 23;27(45):6291-5. doi: 10.1016/j.vaccine.2009.02.004.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza Trivalent Inactivated Vaccines in people with FLU, run by Novartis Vaccines at 1 site in Finland.
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 2 inclusion and 13 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 Dec 2016. 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 Finland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the immunogenicity of a single 0.25mL or 0.5mL IM injection of two different influenza vaccines, in terms of post-immunization geometric mean titers (GMTs), as measured by HI test, in healthy children aged up to 48 months. (time frame: 181 days). 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 NCT00644540, 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 Dec 2016.