Clinical trial NCT01867021: Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above
Official title: A Multi-Center, Phase IV, Randomized, Controlled, Observer Blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Trivalent Subunit Inactivated Influenza Vaccine in Healthy Subjects Aged 50 Years and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Trivalent inactivated subunit influenza vaccines
50 years and above
healthy subjects
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2013-06-03
Enrollment: 2902
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Demonstrate non-inferiority of the post-vaccination (Day 22) Hemagglutination inhibition (HI) Geometric Mean Titers (GMTs) of trivalent, inactivated, subunit influenza vaccine (TIV) over the corresponding GMTs of the comparator vaccine for all three strains, in healthy adults aged 50 years and above.

Demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the TIV group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 50 years and above, mentally competent, willing and able to give written informed consent prior to study entry and after the nature of the study has been explained according to local regulatory requirements.
* Individuals able to comply with all the study requirements.
* Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

* Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
* Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillain-Barré syndrome.
* Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
* Individuals who have received any seasonal or pandemic influenza vaccine or have had a laboratory confirmed seasonal or pandemic influenza disease within the past 6 months.
* Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
* Individuals with positive HIV test result, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy within 6 months or use of any parenteral or oral corticosteroids within the previous 30 days.
* Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
* Individuals who have any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
* Individuals with history of any anaphylactic adverse event and/or serious allergic adverse event following a vaccination, a proven hypersensitivity to any component of the study vaccine (eg, to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate) or latex allergy.
* Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
* Receipt of nonstudy vaccines (with the exception of post-exposure vaccination in a medical emergency, eg, hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1.
* Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
* Individuals who have received antibiotics within 6 days before vaccination.
* Individuals with body temperature (axillary temperature) ≥38 degrees Celsius (≥ 100.4° F) within the last 3 days of intended study vaccination.
* BMI \> 35 kg/m2.
* Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures, for the whole duration of the study. Adequate contraception is defined as hormonal (eg, oral, injection, transdermal patch, implant, cervical ring), barrier (eg, condom with spermicide or diaphragm with spermicide), intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry; Abstinence.
* Individuals who are part of study personnel or close family members conducting this study.
* Individuals with history of substance or alcohol abuse within the past 2 years.

Primary outcomes:
measure: Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years
timeFrame: Day 22
measure: Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years
timeFrame: Day 22
Secondary outcomes:
measure: Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine
timeFrame: Day 22
measure: Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine
timeFrame: Day 22
measure: Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf
timeFrame: Day 1 to 7 postvaccination
Other outcomes:
Locations:
city: Kbel 163
country: Czech Republic
facility: Site 71 - Ordinace všeobecného lékaře
state: Benátky nad Jizerou
city: Poliklinika II., Bratri Stefanu 895
country: Czech Republic
facility: Site 70 - Vaccination and Travel Medicine Centre
state: Hradec Kralove
city: Filinvest Corporate City
country: Philippines
facility: Site 61 - Research Institute for Tropical Medicine DOH Compound
state: Alabang Muntinlupa City
city: Congressional Road, Dasmarinas City
country: Philippines
facility: Site 60 - De La Salle Health Sciences Institute, Room 6210 and 6206 De La Salle Angelo King Medical Research Center
state: Cavite
city: Mesa
country: Philippines
facility: Site 63 - Our Lady of Lourdes Hospital, 46 P. Sanchez Street, Sta.
state: Manila
city: Alabang
country: Philippines
facility: Site 62 - Research Institute for Tropical Medicine DOH Compound, Filinvest Corporate City
state: Muntinlupa City
city: Province of the Western Cape
country: South Africa
facility: Site 33 - TREAD Research , Room 41, 8th Floor, Department of Cardiology, Tygerberg Hospital, Francie van Zijl Drive
state: Cape Town
city: Province of the Western Cape
country: South Africa
facility: Site 43 - Allergy Diagnostic & Clinical Research Unit, UCT Lung Institute, George Street
state: Cape Town
city: Rondebosch
country: South Africa
facility: Site 34 - Synopsis Research, Room 8, First floor, Fountain Centre, Belmont Road
state: Cape Town
city: Western Cape
country: South Africa
facility: Site 41 - Tiervlei Trial Centre, Karl Bremer Hospital, c/o Mike Pienaar Boulevard & Frans Conradie Avenue, Bellville
state: Cape Town
city: Sydenham
country: South Africa
facility: Site 45 - 343 Randles Road
state: Durban
city: Benoni
country: South Africa
facility: Site 44 - Dr B van der Berg and Associates, 162 Pretoria Road, Rynfield
state: Gauteng
city: Boksburg North
country: South Africa
facility: Site 31 - MD Search, 1 Paul Smit Street
state: Gauteng
city: Eloffsdal
country: South Africa
facility: Site 32 - EMMED Research, Emmed Research, 641 5th Avenue
state: Gauteng
city: Lyttleton
country: South Africa
facility: Site 35 - I Engelbrecht Research (Pty) Ltd, 174 Cradock Avenue
state: Gauteng
city: Midrand
country: South Africa
facility: Site 36 - Midrand Medical Centre, Shop #1, Health Emporium, Cnr Church and Market Street
state: Gauteng
city: Sophiatown
country: South Africa
facility: Site 39 - Medicross Sophiatown, Cnr Edward and Millar Streets
state: Gauteng
city: Soweto
country: South Africa
facility: Site 38 - Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Academic Hospital, Chris Hani Road
state: Gauteng
city: York Street
country: South Africa
facility: Site 37 - Excellentis Clinical Trial Consultants, Suite 201, York Building, 72
state: George
city: Newtown
country: South Africa
facility: Site 40 - Newtown Clinical Research Centre, Suite 3, Newgate Centre, 104 Jeppe Street
state: Johannesburg
city: Sir Lowry's Pass Road
country: South Africa
facility: Site 46 - Helderberg Clinical Trials Centre, Suite 7G&H Arun Place
state: Somerset West
city: Bangkoknoi
country: Thailand
facility: Site 53 - Clinical Trials Unit, Office for Research and Development, His Majesty the King's 80th Birthday December 2007 Building, 3rd floor, room 307, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Prannok Rd.
state: Bangkok
city: Rama 4 Rd., Pathumwan
country: Thailand
facility: Site 52 - 1. Faculty of Medicine, Chulalongkorn University
state: Bangkok
city: Thai Red Cross Society, Rama 4 Rd., Pathumwan
country: Thailand
facility: Site 52 - 2. Queen Saovabha Memorial Institute
state: Bangkok
city: Ongkarak, Nakhorn
country: Thailand
facility: Site 51 - Faculty of Medicine, Srinakharinwirot University, HRH Princess, Sirindhorn Medical Center
state: Nayok
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References: