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

NCT03529773

Last updated date
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Respiratory Tract InfectionsCompliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections
NCT00939185
ALL GENDERS
1 Year+
years
MULTIPLE SITES
Respiratory Tract InfectionsA Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
NCT03529773
  1. Mobile, Alabama
  2. Coral Gables, Florida
  3. Orlando, Florida
  4. Stockbridge, Georgia
  5. Honolulu, Hawaii
  6. Saint Louis, Missouri
  7. Binghamton, New York
  8. Endwell, New York
  9. Charlotte, North Carolina
  10. Raleigh, North Carolina
  11. Wilmington, North Carolina
  12. Winston-Salem, North Carolina
  13. Cincinnati, Ohio
  14. Columbus, Ohio
  15. Dayton, Ohio
  16. Oklahoma City, Oklahoma
  17. Dakota Dunes, South Dakota
  18. Austin, Texas
  19. Austin, Texas
  20. Salt Lake City, Utah
  21. Salt Lake City, Utah
  22. South Jordan, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Respiratory Tract InfectionsSafety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
NCT00793000
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Respiratory Tract InfectionsMultiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
NCT01026545
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Respiratory Tract Infections
Intervention  ICMJE
  • Biological: Formulation A
    RSV vaccine
  • Biological: Formulation B
    RSV vaccine
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Sentinel Arm 1
    Low dose formulation A
    Intervention: Biological: Formulation A
  • Experimental: Sentinel Arm 2
    Mid dose formulation A
    Intervention: Biological: Formulation A
  • Experimental: Sentinel Arm 3
    High dose formulation A
    Intervention: Biological: Formulation A
  • Experimental: Sentinel Arm 4
    Low dose formulation B
    Intervention: Biological: Formulation B
  • Experimental: Sentinel Arm 5
    Mid dose formulation B
    Intervention: Biological: Formulation B
  • Experimental: Sentinel Arm 6
    High dose formulation B
    Intervention: Biological: Formulation B
  • Placebo Comparator: Sentinel Arm 7
    Placebo
    Intervention: Biological: Placebo
  • Experimental: Expanded Arm 8
    Low dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 9
    Mid dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 10
    High dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 11
    Low dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Expanded Arm 12
    Mid dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Expanded Arm 13
    High dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Expanded Arm 14
    Low dose formulation A and placebo
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 15
    Mid dose formulation A and placebo
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 16
    High dose formulation A and placebo
    Intervention: Biological: Formulation A
  • Experimental: Expanded Arm 17
    Low dose formulation B and placebo
    Intervention: Biological: Formulation B
  • Experimental: Expanded Arm 18
    Mid dose formulation B and placebo
    Intervention: Biological: Formulation B
  • Experimental: Expanded Arm 19
    High dose formulation B and placebo
    Intervention: Biological: Formulation B
  • Placebo Comparator: Expanded Arm 20
    placebo and placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 31, 2019)
1235
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2018)
1182
Estimated Study Completion Date  ICMJE December 29, 2020
Actual Primary Completion Date November 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529773
Other Study ID Numbers  ICMJE C3671001
RSV FIH ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Time Frame:Starting 24 months after study completion.
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP