HealthyPhase 3NCT00325260
Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China
A Phase 3 study testing Influvac; subunit influenza vaccine in people with Healthy, run by Solvay Pharmaceuticals at 1 site in China.
Trial summary
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Influvac; subunit influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- Mar 2006to not given
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- signed and dated informed consent
- being healthy
- mental health enough to understand the study, the informed consent form and the questionnaire
Who cannot join
- known to be allergic to constituents of the vaccine
- having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
- having had a documented serious adverse reaction to previous influenza vaccination
- having had documented influenza infection or vaccination in the six months prior to the start of the study
- having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.
- Conditions
- Healthy
- Being tested
- Influvac; subunit influenza vaccine
- Keywords
- influenza, non-inferiority, Influvac, Agrippal, healthy subjects
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influvac; subunit influenza vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
Secondary outcomes (1)
HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Enrolment
- 900 participants
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325260
- Sponsor's protocol ID
- S201.3.121
- Status last verified
- Oct 2006
- First submitted
- 11 May 2006
- Last updated
- 1 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.
- ClinicalTrials.gov ID
- NCT00325260
- Acronym / sponsor ID
- S201.3.121
- Conditions
- Healthy
- Keywords
- influenza, non-inferiority, Influvac, Agrippal, healthy subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 12 May 2006 (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.
In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- signed and dated informed consent
- being healthy
- mental health enough to understand the study, the informed consent form and the questionnaire
Key exclusion criteria (5 listed)
- known to be allergic to constituents of the vaccine
- having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
- having had a documented serious adverse reaction to previous influenza vaccination
- having had documented influenza infection or vaccination in the six months prior to the start of the study
- having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study
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 |
|---|---|---|
| Influvac; subunit influenza vaccine | Biological | – |
Primary outcome
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
1 secondary outcome
HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination
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 Nov 2006.
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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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
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 Influvac; subunit influenza vaccine in people with Healthy, run by Solvay Pharmaceuticals at 1 site in China.
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 5 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 Nov 2006. 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 China. 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?
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability. 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 1 Nov 2006.