CompletedNCT01481454Updated Mar 29, 2013

Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults

A Phase 3 interventional study of Quadrivalent Influenza Vaccine (split virion, inactivated) and Quadrivalent Influenza Vaccine (split virion, inactivated) in Influenza, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 6 sites in 2 countries. Open to participants aged 9 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-29.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,701
Allocation: Randomized
Ages: 9 Years to 60 Years
Sex: All

Study 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).

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.

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 studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Quadrivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 1,701 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 9 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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)
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.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 1,701 participants (actual)

Study arms

Experimental
Group 1: QIV Lot 1
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
Experimental
Group 2: QIV Lot 2
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
Experimental
Group 3: QIV Lot 3
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
Active comparator
Group 4: TIV
Participants will receive the Trivalent Influenza Vaccine (TIV).
Biological: 2011 to 2012 Trivalent Influenza Vaccine

Interventions

BiologicalQuadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
BiologicalQuadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
BiologicalQuadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Biological2011 to 2012 Trivalent Influenza Vaccine
0.5 mL, Intramuscular

What researchers measure

Primary outcomes

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
Time frame: 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.
Time frame: Day 0 up to six months post-vaccination

Secondary outcomes

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).
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

Study locations

6 sites

Melbourne, Australia
Westmead NSW, 2145, Australia
Calamba Laguna City, Philippines
Malate, Manila, Philippines
Muntinlupa City, 1781, Philippines
Quezon City, Philippines

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01481454
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Nov 29, 2011
Start date: Mar 2012
Primary completion: Oct 2012
Completion: Dec 2012
Last update: Mar 29, 2013

Study contacts

Medical Director

study director · Sanofi Pasteur SA

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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