InfluenzaPhase 3NCT01481454
Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults
A Phase 3 study testing Quadrivalent Influenza Vaccine (split virion, inactivated) and 2011 to 2012 Trivalent Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 2 countries.
Trial summary
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age). Read more about this study
- Who is it for?
- Ages 9 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent Influenza Vaccine (split virion, inactivated) and 2011 to 2012 Trivalent Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,701 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2012to Dec 2012
- 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 9 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 9 to 11 years (children), 12 to 17 years (adolescents), or 18 to 60 years (adults) on the day of inclusion
- For child/adolescent subjects, informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative (and independent witness, if required by local regulations), and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations). For adult subjects, informed consent form has been signed and dated by the subject (and an independent witness, if required by local regulations).
- Subject/subject and parent/legally acceptable representative is/are able to attend all scheduled visits and to comply with all trial procedures
- Covered by health insurance, if required by local regulation.
Who cannot join
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or 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 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 trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
- Previous vaccination against influenza with the 2012 Southern Hemisphere formulation or the 2011-2012 Northern Hemisphere formulation in the previous 6 months with either the trial vaccine or another vaccine
- 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)
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- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination based on investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination based on 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 (for adolescent and adult subjects)
- 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 an investigator or employee of the investigator or study center with direct involvement in the proposed study, or identified as an immediate 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
6 sites in 2 countries.
6 sites in 2 countries
Philippines4 sites
Study site
Calamba Laguna City
Study site
City of Muntinlupa, 1781
Study site
Malate, Manila
Study site
Quezon City
About this study
Official title: Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects
The aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).
Primary Objective:
Read more
- To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants.
Secondary Objectives:
- To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency)
- To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
Read the detailed description
All participants will receive a single injection of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2), and also monitored for safety for up to 6 months post-vaccination.
- Conditions
- Influenza
- Being tested
- Quadrivalent Influenza Vaccine (split virion, inactivated), 2011 to 2012 Trivalent Influenza Vaccine
- Keywords
- Influenza, Quadrivalent Inactivated Influenza Vaccine, Trivalent 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
Quadrivalent Influenza Vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular
Quadrivalent Influenza Vaccine (split virion, inactivated)Biological
0.5 mL, Intramuscular
2011 to 2012 Trivalent Influenza VaccineBiological
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: QIV Lot 1 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1. Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
| Group 2: QIV Lot 2 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2. Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
| Group 3: QIV Lot 3 | Experimental | Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3. Receives: Biological: Quadrivalent Influenza Vaccine (split virion, inactivated) |
| Group 4: TIV | Active comparator | Participants will receive the Trivalent Influenza Vaccine (TIV). Receives: Biological: 2011 to 2012 Trivalent Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Measured: Day 0 to 7 post-vaccination
Percentage of participants reporting unsolicited systemic reactions including serious adverse events (SAE) throughout the trial.
An SAE is defined as any untoward medical occurrence that at any dose (including overdose): Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is an important medical event.
Measured: Day 0 up to six months post-vaccination
Secondary outcomes (2)
Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV
Immunogenicity assessed by hemagglutination inhibition (HAI) assay for each vaccine strain.
Seroprotection defined as a post-vaccination titer of ≥ 40 (1/dil); Seroconversion defined for participants with a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer of ≥ 40 (1/dil).
Measured: Day 21 post-vaccination
Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.
Measured: 21 Days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionDec 2012
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,701 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
- NCT01481454
- Sponsor's protocol ID
- GQM04
- Other IDs
- U1111-1122-2719, 2011-005101-79
- Status last verified
- Mar 2013
- First submitted
- 23 Nov 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, Santos J, Montalban MC, de Looze FJ, Eizenberg P, Hall S, Dupuy M, Hutagalung Y, Pepin S, Saville M. Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine. 2015 May 15;33(21):2485-92. doi: 10.1016/j.vaccine.2015.03.065. Epub 2015 Apr 2.
PubMed 25843270
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects
- ClinicalTrials.gov ID
- NCT01481454
- Acronym / sponsor ID
- GQM04
- Conditions
- Influenza
- Keywords
- Influenza, Quadrivalent Inactivated Influenza Vaccine, Trivalent Inactivated Influenza Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,701 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Nov 2011 (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 aim of the study is to assess the safety profile of a quadrivalent influenza vaccine (QIV) and to demonstrate that 3 different industrial lots of QIV induce an equivalent immune response in children/adolescents (9 to 17 years of age) and adults (18 to 60 years of age).
Primary Objective:
- To describe the safety profile (injection site reactions and systemic events) of each vaccine during the 21 days following vaccination, and serious adverse events (including adverse events of special interest) throughout the study in all adult and child/adolescent participants.
Secondary Objectives:
- To demonstrate that the 3 different industrial lots of quadrivalent influenza vaccine (QIV) induce an equivalent immune response at 21 days post-vaccination in both age groups (lot consistency)
- To describe the compliance of the immunogenicity of QIV to the European Medicines Agency Note for Guidance (NfG) (CPMP/BWP/214/96) in each age group.
Detailed description
All participants will receive a single injection of their assigned vaccine during Visit 1. They will be followed up for safety and immunogenicity through Day 21 post-vaccination (Visit 2), and also monitored for safety for up to 6 months post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: QIV Lot 1 | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1. |
| Group 2: QIV Lot 2 | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2. |
| Group 3: QIV Lot 3 | Experimental | Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3. |
| Group 4: TIV | Active comparator | Biological: 2011 to 2012 Trivalent Influenza VaccineParticipants will receive the Trivalent Influenza Vaccine (TIV). |
Who may qualify
- Ages
- 9 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 9 to 11 years (children), 12 to 17 years (adolescents), or 18 to 60 years (adults) on the day of inclusion
- For child/adolescent subjects, informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative (and independent witness, if required by local regulations), and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations). For adult subjects, informed consent form has been signed and dated by the subject (and an independent witness, if required by local regulations).
- Subject/subject and parent/legally acceptable representative is/are able to attend all scheduled visits and to comply with all trial procedures
- Covered by health insurance, if required by local regulation.
Key exclusion criteria (14 listed)
- Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or 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 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 trial vaccination or planned receipt of any vaccine in the 3 weeks following trial vaccination
- Previous vaccination against influenza with the 2012 Southern Hemisphere formulation or the 2011-2012 Northern Hemisphere formulation in the previous 6 months with either the trial vaccine or another vaccine
- 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 | Group 1: QIV Lot 1 |
| Quadrivalent Influenza Vaccine (split virion, inactivated)0.5 mL, Intramuscular | Biological | Group 2: QIV Lot 2 |
| Quadrivalent Influenza Vaccine (split virion, inactivated)0.5 mL, Intramuscular | Biological | Group 3: QIV Lot 3 |
| 2011 to 2012 Trivalent Influenza Vaccine0.5 mL, Intramuscular | Biological | Group 4: TIV |
Primary outcome
Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial
Time frame: Day 0 to 7 post-vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Percentage of participants reporting unsolicited systemic reactions including serious adverse events (SAE) throughout the trial.
Time frame: Day 0 up to six months post-vaccination
An SAE is defined as any untoward medical occurrence that at any dose (including overdose): Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability / incapacity; Is a congenital anomaly / birth defect; Is an important medical event.
2 secondary outcomes
Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV
Time frame: Day 21 post-vaccination
Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.
Time frame: 21 Days post-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 29 Mar 2013.
- Derived from this study: PubMed 25843270Cadorna-Carlos JB, Nolan T, Borja-Tabora CF, Santos J, Montalban MC, de Looze FJ, Eizenberg P, Hall S, Dupuy M, Hutagalung Y, Pepin S, Saville M. Safety, immunogenicity, and lot-to-lot consistency of a quadrivalent inactivated influenza vaccine in children, adolescents, and adults: A randomized, controlled, phase III trial. Vaccine. 2015 May 15;33(21):2485-92. doi: 10.1016/j.vaccine.2015.03.065. Epub 2015 Apr 2.
- 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
6 sites in 2 countries: 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) and 2011 to 2012 Trivalent Influenza Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 6 sites in 2 countries.
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 14 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Philippines, Australia. 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?
Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial (time frame: Day 0 to 7 post-vaccination). The study lists 2 primary outcomes in all. 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 NCT01481454, 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 29 Mar 2013.