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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01481454




Trial ID
NCT01481454
Ethics application status
Date submitted
23/11/2011
Date registered
25/11/2011
Date last updated
28/03/2013

Titles & IDs
Public title
Study of a Quadrivalent Influenza Vaccine Administered Intramuscularly in Children/Adolescents and Adults
Scientific title
Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects
Secondary ID [1] 0 0
U1111-1122-2719
Secondary ID [2] 0 0
GQM04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Quadrivalent Influenza Vaccine (split virion, inactivated)
Other interventions - Quadrivalent Influenza Vaccine (split virion, inactivated)
Other interventions - Quadrivalent Influenza Vaccine (split virion, inactivated)
Other interventions - 2011 to 2012 Trivalent Influenza Vaccine

Experimental: Group 1: QIV Lot 1 - Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.

Experimental: Group 2: QIV Lot 2 - Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.

Experimental: Group 3: QIV Lot 3 - Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.

Active Comparator: Group 4: TIV - Participants will receive the Trivalent Influenza Vaccine (TIV).


Other interventions: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular

Other interventions: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular

Other interventions: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular

Other interventions: 2011 to 2012 Trivalent Influenza Vaccine
0.5 mL, Intramuscular

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 0 to 7 post-vaccination
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 0 up to six months post-vaccination
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
Day 21 post-vaccination
Secondary outcome [2] 0 0
Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.
Timepoint [2] 0 0
21 Days post-vaccination

Eligibility
Key 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.
Minimum age
9 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment hospital [2] 0 0
- Westmead NSW
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
2145 - Westmead NSW
Recruitment outside Australia
Country [1] 0 0
Philippines
State/province [1] 0 0
Calamba Laguna City
Country [2] 0 0
Philippines
State/province [2] 0 0
Malate, Manila
Country [3] 0 0
Philippines
State/province [3] 0 0
Muntinlupa City
Country [4] 0 0
Philippines
State/province [4] 0 0
Quezon City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01481454
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Sanofi Pasteur SA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries