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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01481454
First received: November 23, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Influenza
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
Biological: 2011 to 2012 Trivalent Influenza Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial [ Time Frame: Day 0 to 7 post-vaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).


  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1701
Study Start Date: March 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: QIV Lot 1
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Experimental: Group 2: QIV Lot 2
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Experimental: Group 3: QIV Lot 3
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.
Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)
0.5 mL, Intramuscular
Active Comparator: Group 4: TIV
Participants will receive the Trivalent Influenza Vaccine (TIV).
Biological: 2011 to 2012 Trivalent Influenza Vaccine
0.5 mL, Intramuscular

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.

  Eligibility

Ages Eligible for Study:   9 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481454

Locations
Australia
Melbourne, Australia
Westmead NSW, Australia, 2145
Philippines
Calamba Laguna City, Philippines
Malate, Manila, Philippines
Muntinlupa City, Philippines, 1781
Quezon City, Philippines
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01481454     History of Changes
Other Study ID Numbers: GQM04, U1111-1122-2719, 2011-005101-79
Study First Received: November 23, 2011
Last Updated: March 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Philippines: Department of Health

Keywords provided by Sanofi:
Influenza
Quadrivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014