Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults
NCT ID: NCT01481454
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1701 participants
INTERVENTIONAL
2012-03-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: QIV Lot 1
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Group 2: QIV Lot 2
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Group 3: QIV Lot 3
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Group 4: TIV
Participants will receive the Trivalent Influenza Vaccine (TIV).
2011 to 2012 Trivalent Influenza Vaccine
0.5 mL, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
2011 to 2012 Trivalent Influenza Vaccine
0.5 mL, Intramuscular
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
* 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.
9 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur SA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Melbourne, , Australia
Westmead NSW, , Australia
Calamba Laguna City, , Philippines
City of Muntinlupa, , Philippines
Malate, Manila, , Philippines
Quezon City, , Philippines
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1122-2719
Identifier Type: OTHER
Identifier Source: secondary_id
2011-005101-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GQM04
Identifier Type: -
Identifier Source: org_study_id