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Trial record 1 of 1 for:    NCT03572062
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A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

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ClinicalTrials.gov Identifier: NCT03572062
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 28, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE June 5, 2018
Estimated Primary Completion Date July 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Percentage of subjects reporting local reactions and systemic events from day of vaccination 1 until Day 14 [ Time Frame: From day of vaccination until Day 14 ]
    Describe local reactions and systemic events after 1 dose of investigational product
  • Percentage of subjects reporting Adverse Events (AEs) within 1 month after vaccination [ Time Frame: Within 1 month after vaccination ]
    Describe adverse events (AEs) after vaccination
  • Percentage of subjects with at least 1 medically attended adverse event (MAE) or serious adverse events (SAE) within 30 days after vaccination, or during the follow-up phase [ Time Frame: Up to 12 months ]
    Describe medically attended (MAEs) and serious adverse events (SAEs)
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • 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
  • 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
  • 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)
  • Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination 2 [ Time Frame: Within 1 month after vaccination 2 ]
    Describe adverse events (AEs) after vaccination 2
Change History Complete list of historical versions of study NCT03572062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • RSV A- and RSV B-neutralizing antibody titers [ Time Frame: RSV A- and RSV B-neutralizing antibody titers measured at baseline and 1 month after vaccination. ]
    Immune responses measured by RSV A- and RSV B-neutralizing antibody titers at specified timepoints.
  • Hemagglutination inhibition assay (HAI) titers [ Time Frame: At baseline and 1 month after vaccination ]
    Immune responses as measured by hemagglutination inhibition assay (HAI) titers at specified timepoints.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2018)
  • RSV A- and RSV B-neutralizing antibody titers [ Time Frame: RSV A- and RSV B-neutralizing antibody titers measured at baseline, 1 week (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.
  • Hemagglutination inhibition assay (HAI) titers [ Time Frame: At baseline and 1 month after SIIV administration ]
    Immune responses as measured by hemagglutination inhibition assay (HAI) titers at specified timepoints.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older 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 AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS
Brief Summary The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV).
Detailed Description The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Observer blind
Primary Purpose: Prevention
Condition  ICMJE Respiratory Tract Infection
Intervention  ICMJE
  • Biological: Formulation A
    RSV vaccine
  • Biological: Formulation B
    Adjuvanted RSV vaccine
  • Biological: Formulation C
    RSV vaccine
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Low dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Arm 2
    Low dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Arm 3
    Mid dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Arm 4
    Mid dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Arm 5
    High dose formulation A and SIIV
    Intervention: Biological: Formulation A
  • Experimental: Arm 6
    High dose formulation B and SIIV
    Intervention: Biological: Formulation B
  • Experimental: Arm 7
    High dose formulation C and SIIV
    Intervention: Biological: Formulation C
  • Placebo Comparator: Arm 8
    Placebo and SIIV
    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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2019)
312
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
474
Estimated Study Completion Date  ICMJE July 10, 2020
Estimated Primary Completion Date July 10, 2020   (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 and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).

Exclusion Criteria:

  1. 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.
  2. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
  3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
  4. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
  5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
  6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s), including natural rubber latex. In addition, a history of severe allergic reaction (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg or egg products) or chicken proteins.
  7. Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  8. 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.Inhaled/nebulized, intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are permitted.
  9. 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 syndrome, idiopathic thrombocytopenic purpura, autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
  10. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
  11. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  12. Female subjects of childbearing potential or who are pregnant or breastfeeding; fertile male subjects who are unwilling to use a highly effective method of contraception for at least 28 days after the last dose of investigational product.
  13. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03572062
Other Study ID Numbers  ICMJE C3671002
RSV ADJUVANT ( 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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

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