InfluenzaPhase 3NCT01967784
Study of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
A Phase 3 study testing Quadrivalent Influenza Vaccine (split virion, inactivated) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Taiwan.
Trial summary
The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan Primary Objective: To describe the immunogenicity of the QIV (split-virion, inactivated) NH… Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent Influenza Vaccine (split virion, inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2013to Jul 2014
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 9 to 17 years on the day of inclusion
- Assent form (AF) and/or informed consent form (ICF) have been signed and dated by the subject according to each site requirements, and ICF has been signed and dated by the parent(s) or another legally acceptable representative(s) and by an independent witness if applicable
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Subject is pregnant (or positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
- Participation at the time of study enrollment or in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
- Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or in the previous 6 months if administered in the context of a flu vaccination campaign
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Show all 15Show fewer
- Self-reported history of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, after questioning
- Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and octoxynol-9, or to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances
- Known or suspected thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination upon investigator's judgment
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Current alcohol abuse or drug addiction
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as a family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan
Primary Objective:
- To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation
Secondary Objective:
- To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
Read the detailed description
Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.
- Conditions
- Influenza
- Being tested
- Quadrivalent Influenza Vaccine (split virion, inactivated)
- Keywords
- Influenza, Quadrivalent Inactivated 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.
Quadrivalent Influenza Vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants age 9 to 17 years will receive a dose of Quadrivalent Influenza Vaccine Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Measured: Day 21 post-vaccination
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Measured: Day 0 (pre-vaccination) and Day 21 post-vaccination
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Measured: Day 0 up to Day 7 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionJul 2014
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.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967784
- Sponsor's protocol ID
- GQM09
- Other IDs
- U1111-1127-7693
- Status last verified
- Dec 2015
- First submitted
- 18 Oct 2013
- Last updated
- 20 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Children and Adolescents in Taiwan
- ClinicalTrials.gov ID
- NCT01967784
- Acronym / sponsor ID
- GQM09
- Conditions
- Influenza
- Keywords
- Influenza, Quadrivalent Inactivated Influenza Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 20 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to describe the immunogenicity and safety of the new formulation of Quadrivalent Influenza Vaccine (QIV) for the 2013-2014 season in the Northern Hemisphere (NH) in subjects aged 9 to 17 years in Taiwan
Primary Objective:
- To describe the immunogenicity of the QIV (split-virion, inactivated) NH seasonal formulation
Secondary Objective:
- To describe the safety of the QIV (split-virion, inactivated) NH seasonal formulation
Detailed description
Study participants will be vaccinated with one dose of the QIV (split-virion, inactivated) NH 2013-2014 formulation by the intramuscular route or deep subcutaneous. Immunogenicity will be assessed at baseline (Day 0) and 21 days after injection; they will also be followed-up for safety for 21 days after injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Participants age 9 to 17 years will receive a dose of Quadrivalent Influenza Vaccine |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 9 to 17 years on the day of inclusion
- Assent form (AF) and/or informed consent form (ICF) have been signed and dated by the subject according to each site requirements, and ICF has been signed and dated by the parent(s) or another legally acceptable representative(s) and by an independent witness if applicable
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
Key exclusion criteria (15 listed)
- Subject is pregnant (or positive urine pregnancy test), or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)
- Participation at the time of study enrollment or in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
- Vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or in the previous 6 months if administered in the context of a flu vaccination campaign
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
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 |
|---|---|---|
| Quadrivalent Influenza Vaccine (split virion, inactivated)0.5 mL, Intramuscular | Biological | Study Group |
Primary outcome
Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.
Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine
Time frame: Day 21 post-vaccination
Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.
Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine
Time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination
Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine
Time frame: Day 0 up to Day 7 post-vaccination
Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink 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.
Medical Director study director
Sanofi Pasteur SA
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 Quadrivalent Influenza Vaccine (split virion, inactivated) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Taiwan.
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 15 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 20 Jan 2016. 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 Taiwan. 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 20 Jan 2016). 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 of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine (time frame: Day 0 (pre-vaccination) and Day 21 post-vaccination). The study lists 5 primary outcomes in all. 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 20 Jan 2016.