Status:
COMPLETED
Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 correspon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
2902 Patients enrolled
Trial Details
Trial ID
NCT01867021
Start Date
May 1 2013
End Date
December 1 2013
Last Update
October 1 2014
Active Locations (25)
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1
Site 71 - Ordinace všeobecného lékaře
Kbel, Benátky Nad Jizerou, Czechia, 294 71
2
Site 70 - Vaccination and Travel Medicine Centre
Poliklinika II., Bratri Stefanu 895, Hradec Kralove, Czechia, 500 03
3
Site 61 - Research Institute for Tropical Medicine DOH Compound
Filinvest Corporate City, Alabang Muntinlupa City, Philippines
4
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, 4114