Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above

NCT ID: NCT01867021

Last Updated: 2014-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Agriflu

A single 0.5 mL dose of Investigational vaccine TIV (Agriflu) at visit 1, administered intramuscularly

Group Type: EXPERIMENTAL

Agriflu (TIV)

Intervention Type: BIOLOGICAL

Fluvirin

A single 0.5 mL dose of control vaccine TIVf (Fluvirin) at visit 1, administered intramuscularly

Group Type: ACTIVE_COMPARATOR

Fluvirin(TIVf)

Intervention Type: BIOLOGICAL

Interventions

Fluvirin(TIVf)

Intervention Type: BIOLOGICAL

Agriflu (TIV)

Intervention Type: BIOLOGICAL

Other Intervention Names

Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived); Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Site 71 - Ordinace všeobecného lékaře

Kbel, Benátky Nad Jizerou, Czechia

Site 70 - Vaccination and Travel Medicine Centre

Poliklinika II., Bratri Stefanu 895, Hradec Kralove, Czechia

Site 61 - Research Institute for Tropical Medicine DOH Compound

Filinvest Corporate City, Alabang Muntinlupa City, Philippines

Site 60 - De La Salle Health Sciences Institute, Room 6210 and 6206 De La Salle Angelo King Medical Research Center

Congressional Road, Dasmarinas City, Cavite, Philippines

Site 63 - Our Lady of Lourdes Hospital, 46 P. Sanchez Street, Sta.

Mesa, Manila, Philippines

Site 62 - Research Institute for Tropical Medicine DOH Compound, Filinvest Corporate City

Alabang, Muntinlupa City, Philippines

Site 33 - TREAD Research , Room 41, 8th Floor, Department of Cardiology, Tygerberg Hospital, Francie van Zijl Drive

Province of the Western Cape, Cape Town, South Africa

Site 43 - Allergy Diagnostic & Clinical Research Unit, UCT Lung Institute, George Street

Province of the Western Cape, Cape Town, South Africa

Site 34 - Synopsis Research, Room 8, First floor, Fountain Centre, Belmont Road

Rondebosch, Cape Town, South Africa

Site 41 - Tiervlei Trial Centre, Karl Bremer Hospital, c/o Mike Pienaar Boulevard & Frans Conradie Avenue, Bellville

Western Cape, Cape Town, South Africa

Site 45 - 343 Randles Road

Sydenham, Durban, South Africa

Site 44 - Dr B van der Berg and Associates, 162 Pretoria Road, Rynfield

Benoni, Gauteng, South Africa

Site 31 - MD Search, 1 Paul Smit Street

Boksburg North, Gauteng, South Africa

Site 32 - EMMED Research, Emmed Research, 641 5th Avenue

Eloffsdal, Gauteng, South Africa

Site 35 - I Engelbrecht Research (Pty) Ltd, 174 Cradock Avenue

Lyttleton, Gauteng, South Africa

Site 36 - Midrand Medical Centre, Shop #1, Health Emporium, Cnr Church and Market Street

Midrand, Gauteng, South Africa

Site 38 - Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Academic Hospital, Chris Hani Road

Soweto, Gauteng, South Africa

Site 39 - Medicross Sophiatown, Cnr Edward and Millar Streets

Vrededorp, Gauteng, South Africa

Site 37 - Excellentis Clinical Trial Consultants, Suite 201, York Building, 72

York Street, George, South Africa

Site 40 - Newtown Clinical Research Centre, Suite 3, Newgate Centre, 104 Jeppe Street

Newtown, Johannesburg, South Africa

Site 46 - Helderberg Clinical Trials Centre, Suite 7G&H Arun Place

Sir Lowry's Pass Road, Somerset West, South Africa

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.

Bangkoknoi, Bangkok, Thailand

Site 52 - 1. Faculty of Medicine, Chulalongkorn University

Rama 4 Rd., Pathumwan, Bangkok, Thailand

Site 52 - 2. Queen Saovabha Memorial Institute

Thai Red Cross Society, Rama 4 Rd., Pathumwan, Bangkok, Thailand

Site 51 - Faculty of Medicine, Srinakharinwirot University, HRH Princess, Sirindhorn Medical Center

Ongkarak, Nakhorn, Nayok, Thailand

Countries

Czechia; Philippines; South Africa; Thailand

Other Identifiers

V71_22

Identifier Type: -

Identifier Source: org_study_id