NCT01481454

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,701

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

7 months

First QC Date

November 23, 2011

Last Update Submit

March 28, 2013

Conditions

Influenza

Keywords

InfluenzaQuadrivalent Inactivated Influenza VaccineTrivalent Inactivated Influenza Vaccine

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    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

    Day 21 post-vaccination

  • Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.

    21 Days post-vaccination

Study Arms (4)

Group 1: QIV Lot 1

EXPERIMENTAL

Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.

Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

Group 2: QIV Lot 2

EXPERIMENTAL

Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.

Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

Group 3: QIV Lot 3

EXPERIMENTAL

Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.

Biological: Quadrivalent Influenza Vaccine (split virion, inactivated)

Group 4: TIV

ACTIVE COMPARATOR

Participants will receive the Trivalent Influenza Vaccine (TIV).

Biological: 2011 to 2012 Trivalent Influenza Vaccine

Interventions

Quadrivalent Influenza Vaccine (split virion, inactivated)BIOLOGICAL

0.5 mL, Intramuscular

Group 1: QIV Lot 1
2011 to 2012 Trivalent Influenza VaccineBIOLOGICAL

0.5 mL, Intramuscular

Group 4: TIV

Eligibility Criteria

Age9 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Melbourne, Australia

Location

Unknown Facility

Westmead NSW, 2145, Australia

Location

Unknown Facility

Calamba Laguna City, Philippines

Location

Unknown Facility

City of Muntinlupa, 1781, Philippines

Location

Unknown Facility

Malate, Manila, Philippines

Location

Unknown Facility

Quezon City, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 25843270DERIVED

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Director

    Sanofi Pasteur SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 29, 2011

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

PH(4)AU(2)