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A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03529773
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Biological: Formulation A Biological: Formulation B Biological: Placebo Phase 2

Detailed Description:
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A Phase 1/2, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding, First-in-Human Study to Describe the Safety, Tolerability, and Immunogenicity of a Respiratory Syncytial Virus (RSV) Vaccine in Healthy Adults
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Arm Intervention/treatment
Experimental: Sentinel Arm 1
Low dose formulation A
Biological: Formulation A
RSV vaccine

Experimental: Sentinel Arm 2
Mid dose formulation A
Biological: Formulation A
RSV vaccine

Experimental: Sentinel Arm 3
High dose formulation A
Biological: Formulation A
RSV vaccine

Experimental: Sentinel Arm 4
Low dose formulation B
Biological: Formulation B
RSV vaccine

Experimental: Sentinel Arm 5
Mid dose formulation B
Biological: Formulation B
RSV vaccine

Experimental: Sentinel Arm 6
High dose formulation B
Biological: Formulation B
RSV vaccine

Placebo Comparator: Sentinel Arm 7
Placebo
Biological: Placebo
Placebo

Experimental: Expanded Arm 8
Low dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 9
Mid dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 10
High dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 11
Low dose formulation B and SIIV
Biological: Formulation B
RSV vaccine

Experimental: Expanded Arm 12
Mid dose formulation B and SIIV
Biological: Formulation B
RSV vaccine

Experimental: Expanded Arm 13
High dose formulation B and SIIV
Biological: Formulation B
RSV vaccine

Experimental: Expanded Arm 14
Low dose formulation A and placebo
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 15
Mid dose formulation A and placebo
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 16
High dose formulation A and placebo
Biological: Formulation A
RSV vaccine

Experimental: Expanded Arm 17
Low dose formulation B and placebo
Biological: Formulation B
RSV vaccine

Experimental: Expanded Arm 18
Mid dose formulation B and placebo
Biological: Formulation B
RSV vaccine

Experimental: Expanded Arm 19
High dose formulation B and placebo
Biological: Formulation B
RSV vaccine

Placebo Comparator: Expanded Arm 20
placebo and placebo
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage of subjects reporting local reactions and systemic events from day of vaccination 1 until Day 14 [ Time Frame: From day of vaccination 1 until Day 14 ]
    Describe local reactions and systemic events after 1 dose of investigational product

  2. Percentage of subjects reporting Adverse Events (AEs) within 1 month after vaccination 1 [ Time Frame: Within 1 month after vaccination 1 ]
    Describe adverse events (AEs) after 1 dose of investigational product

  3. Percentage of subjects with at least 1 medically attended adverse event (MAE) or serious adverse events (SAE) within 30 days after each vaccination, or during the follow-up phase [ Time Frame: Up to 12 months ]
    Describe medically attended (MAEs) and serious adverse events (SAEs)

  4. Percentage of subjects reporting adverse evnts (AEs) within 1 month after vaccination 2 [ Time Frame: Within 1 month after vaccination 2 ]
    Describe adverse events (AEs) after vaccination 2


Secondary Outcome Measures :
  1. RSV A- and RSV B-neutralizing antibody titers [ Time Frame: RSV A- and RSV B-neutralizing antibody titers measured at baseline, 2 weeks (sentinel subjects only) and 1, 2, 3, and 6 months after vaccination 1. ]
    Immune responses measured by RSV A- and RSV B-neutralizing antibody titers at specified timepoints.

  2. Hemagglutination inhibition assay (HAI) titers [ Time Frame: At baseline and 1 month after SIIV administration ]
    Immune responses as measured by HAI titers at specified timepoints.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
  2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
  3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
  4. Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
  5. Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
  6. Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).

Exclusion Criteria:

  1. Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
  2. Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
  3. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  4. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
  5. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
  6. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
  7. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
  8. Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  9. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  10. Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
  11. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
  12. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  14. Women who are pregnant or breastfeeding.
  15. Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
  16. Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529773


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Alabama
Coastal Clinical Research, Inc. Not yet recruiting
Mobile, Alabama, United States, 36608
United States, Florida
Clinical Research of South Florida Not yet recruiting
Coral Gables, Florida, United States, 33134
Clinical Neuroscience Solutions, Inc. Not yet recruiting
Orlando, Florida, United States, 32801
United States, Georgia
Clinical Research Atlanta Recruiting
Stockbridge, Georgia, United States, 30281
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
United States, Missouri
Sundance Clinical Research, LLC Not yet recruiting
Saint Louis, Missouri, United States, 63141
United States, New York
United Medical Associates Not yet recruiting
Binghamton, New York, United States, 13901
Regional Clinical Research, Inc. Not yet recruiting
Endwell, New York, United States, 13760
United States, North Carolina
PMG Research of Charlotte, LLC Not yet recruiting
Charlotte, North Carolina, United States, 28209
PMG Research of Raleigh, LLC Not yet recruiting
Raleigh, North Carolina, United States, 27609
PMG Research of Wilmington, LLC Not yet recruiting
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research Group, Ltd. Not yet recruiting
Cincinnati, Ohio, United States, 45219
Aventiv Research Inc. Not yet recruiting
Columbus, Ohio, United States, 43213
PriMed Clinical Research Not yet recruiting
Dayton, Ohio, United States, 45419
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, South Dakota
Meridian Clinical Research, LLC Not yet recruiting
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Benchmark Research Recruiting
Austin, Texas, United States, 78705
Benchmark Urgent & Family Care Recruiting
Austin, Texas, United States, 78705
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. /Foothill Family Clinic South Recruiting
Salt Lake City, Utah, United States, 84121
J.Lewis Research, Inc. / Jordan River Family Medicine Not yet recruiting
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03529773     History of Changes
Other Study ID Numbers: C3671001
RSV FIH ( Other Identifier: Alias Study Number )
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Respiratory tract infections, RSV, vaccine

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs