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

28. marts 2013 opdateret af: Sanofi Pasteur, a Sanofi Company

Safety and Immunogenicity of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Child/Adolescent and Adult Subjects

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1701

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Melbourne, Australien
      • Westmead NSW, Australien, 2145
      • Calamba Laguna City, Filippinerne
      • Malate, Manila, Filippinerne
      • Muntinlupa City, Filippinerne, 1781
      • Quezon City, Filippinerne

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 60 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group 1: QIV Lot 1
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 1.
0,5 ml, intramuskulært
Eksperimentel: Group 2: QIV Lot 2
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 2.
0,5 ml, intramuskulært
Eksperimentel: Group 3: QIV Lot 3
Participants will receive the Quadrivalent Influenza Vaccine (QIV) from Lot 3.
0,5 ml, intramuskulært
Aktiv komparator: Group 4: TIV
Participants will receive the Trivalent Influenza Vaccine (TIV).
0.5 mL, Intramuscular

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants reporting solicited injection site reactions and solicited systemic reactions during the trial
Tidsramme: Day 0 to 7 post-vaccination
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.
Tidsramme: Day 0 up to six months post-vaccination
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants with seroprotection and seroconversion post vaccination with either the investigational QIV, or TIV or the licensed 2011-2012 TIV
Tidsramme: Day 21 post-vaccination

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).

Day 21 post-vaccination
Level of anti-hemagglutinin antibody titers for each of the 4 strains for each lot of the investigational QIV vaccine.
Tidsramme: 21 Days post-vaccination
21 Days post-vaccination

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Faktiske)

1. oktober 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

23. november 2011

Først indsendt, der opfyldte QC-kriterier

25. november 2011

Først opslået (Skøn)

29. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. marts 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. marts 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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