Safety and Immunogenicity of Different Formulations of an Adjuvanted, Trivalent Subunit Influenza Vaccine in Elderly Subjects 65 Years of Age and Above

NCT02126761 | Completed Phase 1 DMC

• 2 other identifiers: V133_01EXP2013-005344-29
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the safety and immunogenicity of the current formulation of aTIV will be compared to aTIV-modified formulations in which the dosage of the MF59 adjuvant will be doubled or tripled and/or the dosage of the 3 influenza virus strains will be doubled, in independently-living elderly subjects ≥ 65 years of age.

Conditions

Influenza

Keywords

Influenza; elderly; adjuvant

Outcome Measures

Primary Outcomes (5)

• Reactogenicity up to 7 days after vaccination

  Safety of aTIV or aTIV-modified formulations

  Days 1-7 post-vaccination

• Unsolicited AEs within 28 days after vaccination

  Days 1-28 post-vaccination

• SAEs, non-scheduled physician visits, unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, NOCDs, and AESIs from study start to study completion.

  Days 1-366 post-vaccination

• Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer 21 days post-vaccination.

  Antibody responses to all three influenza virus vaccine strains, 21days after a dose or doses of aTIV or aTIV-modified formulations, as measured by hemagglutination inhibition (HI) assay and microneutralization (MN) assay.

  Day 22 post-vaccination

• HI and MN GMT and GMR at baseline and 21 days post-vaccination.

  Day 1; Day 22 post-vaccination

Secondary Outcomes (4)

• Seroconversion/significant increase in antibody HI titers; ≥4-fold rise in MN titer, 7 days and 6 months post-vaccination.

  Day 8 and 181 post-vaccination

• HI and MN (GMT) 7 days and 6 months post-vaccination.

  Day 8 and 181 post-vaccination

• HI and MN (GMR) 7 days, 21 days, and 6 months post-vaccination.

  Day 1, 8, 22, and 181 post-vaccination

• Percentage of subjects with HI titers ≥1:40, ≥1:110, ≥1:160, and ≥1:330 7 days, 21 days, and 6 months post-vaccination.

  Day 8, 22, and 181 post-vaccination

Study Arms (7)

Group 1

ACTIVE COMPARATOR

aTIV

Biological: Adjuvanted, trivalent subunit influenza vaccine

Group 2

EXPERIMENTAL

aTIV + 1X MF59

Biological: Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 3

EXPERIMENTAL

aTIV + TIV

Biological: Antigen level modified adjuvanted, trivalent subunit influenza vaccine

Group 4

EXPERIMENTAL

aTIV + aTIV

Biological: Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 5

ACTIVE COMPARATOR

aTIV (Left deltoid) Saline (Right deltoid)

Biological: Adjuvanted, trivalent subunit influenza vaccine

Group 6

EXPERIMENTAL

aTIV+2X MF59 (Left deltoid) Saline (Right deltoid)

Biological: Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Group 7

EXPERIMENTAL

aTIV (Left deltoid) aTIV (Right deltoid)

Biological: Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine

Interventions

Adjuvanted, trivalent subunit influenza vaccine BIOLOGICAL

Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid

Group 1; Group 5

Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine BIOLOGICAL

Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid

Group 2; Group 6

Antigen level modified adjuvanted, trivalent subunit influenza vaccine BIOLOGICAL

Group 3 is experimental with double the usual antigen dosage

Group 3

Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine BIOLOGICAL

Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant

Group 4; Group 7

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male and female subjects ≥65 years of age on the day of screening who are healthy or have chronic illnesses that are stable and well controlled.
• Subjects assessed as mentally competent, who have given informed consent after the nature of the study has been explained according to local requirements
• In good health as determined by:
• Ability to live independently
• Medical history
• Physical examination
• Clinical judgment of the Investigator
• Able to understand and comply with all study procedures and visits, and are able to complete an eDiary
• Individuals who have access to a working telephone and are able to receive periodic telephone calls

You may not qualify if:

• Individuals who have received any type of influenza vaccine (licensed or experimental) within the past 6 months
• Individuals who have received any other licensed vaccines within 30 days (for inactivated vaccines) or 42 days (for live vaccines) prior to enrollment in this study
• Individuals who have cancer except for:
• Benign localized skin cancer
• Localized prostate cancer that has been clinically stable for ≥ 2 years without treatment
• Cancer in remission for ≥ 10 years (from end of cancer treatment)
• Individuals with autoimmune disease (including rheumatoid arthritis)
• Individuals with diabetes mellitus, type I
• Individuals with a body mass index (BMI) ≤18 or ≥35.
• Asthma that is greater than mild in severity and / or has exacerbations more than 2 days per week
• Congestive heart failure with symptoms as severe as or more severe than dyspnea with short walks or climbing a single flight of stairs (for example, greater than New York Heart Association class 2)
• History of progressive or severe neurologic disorders including but not limited to multiple sclerosis, Parkinson's disease, Guillain-Barré syndrome, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, epilepsy disorders requiring medication for control, encephalitis, Alzheimer's and CVA
• Individuals who are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulfate or any other component of the vaccines in study
• Individuals who have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
• Individuals who have a known or suspected (or have a high risk of developing) impairment/alteration of immune function resulting from, for example,

Sponsors & Collaborators

• Seqirus: lead
• Novartis Vaccines: collaborator

Study Sites (1)

PAREXEL Early Phase Clinical Unit

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Antigens

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: April 30, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2015-12

Locations

DE (1)