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

Condition(s) targeted: Influenza

Intervention: Fluvirin(TIVf) (Biological); Agriflu (TIV) (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Vaccines, Study Chair, Affiliation: Novartis Vaccines

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years

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

Secondary outcome:

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

Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine

Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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.

Site 61 - Research Institute for Tropical Medicine DOH Compound, Filinvest Corporate City, Alabang Muntinlupa City, Philippines

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 10700, Thailand

Site 52 - 1. Faculty of Medicine, Chulalongkorn University, Rama 4 Rd., Pathumwan, Bangkok 10300, Thailand

Site 52 - 2. Queen Saovabha Memorial Institute, Thai Red Cross Society, Rama 4 Rd., Pathumwan, Bangkok 10300, Thailand

Site 71 - Ordinace všeobecného lékaře, Kbel 163, Benátky nad Jizerou 294 71, Czech Republic

Site 33 - TREAD Research , Room 41, 8th Floor, Department of Cardiology, Tygerberg Hospital, Francie van Zijl Drive, Province of the Western Cape, Cape Town 7500, South Africa

Site 43 - Allergy Diagnostic & Clinical Research Unit, UCT Lung Institute, George Street, Province of the Western Cape, Cape Town 7700, South Africa

Site 34 - Synopsis Research, Room 8, First floor, Fountain Centre, Belmont Road, Rondebosch, Cape Town 7700, South Africa

Site 41 - Tiervlei Trial Centre, Karl Bremer Hospital, c/o Mike Pienaar Boulevard & Frans Conradie Avenue, Bellville, Western Cape, Cape Town 7530, South Africa

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 4114, Philippines

Site 45 - 343 Randles Road, Sydenham, Durban 4091, South Africa

Site 44 - Dr B van der Berg and Associates, 162 Pretoria Road, Rynfield, Benoni, Gauteng 1511, South Africa

Site 31 - MD Search, 1 Paul Smit Street, Boksburg North, Gauteng 1459, South Africa

Site 32 - EMMED Research, Emmed Research, 641 5th Avenue, Eloffsdal, Gauteng 0084, South Africa

Site 35 - I Engelbrecht Research (Pty) Ltd, 174 Cradock Avenue, Lyttleton, Gauteng 0157, South Africa

Site 36 - Midrand Medical Centre, Shop #1, Health Emporium, Cnr Church and Market Street, Midrand, Gauteng 1685, South Africa

Site 39 - Medicross Sophiatown, Cnr Edward and Millar Streets, Sophiatown, Gauteng 2092, South Africa

Site 38 - Perinatal HIV Research Unit, New Nurses Home, Chris Hani Baragwanath Academic Hospital, Chris Hani Road, Soweto, Gauteng 1862, South Africa

Site 37 - Excellentis Clinical Trial Consultants, Suite 201, York Building, 72, York Street, George 6529, South Africa

Site 70 - Vaccination and Travel Medicine Centre, Poliklinika II., Bratri Stefanu 895, Hradec Kralove 500 03, Czech Republic

Site 40 - Newtown Clinical Research Centre, Suite 3, Newgate Centre, 104 Jeppe Street, Newtown, Johannesburg 2113, South Africa

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 51 - Faculty of Medicine, Srinakharinwirot University, HRH Princess, Sirindhorn Medical Center, Ongkarak, Nakhorn, Nayok 26120, Thailand

Site 46 - Helderberg Clinical Trials Centre, Suite 7G&H Arun Place, Sir Lowry's Pass Road, Somerset West 7130, South Africa

Starting date: May 2013
Last updated: September 29, 2014