A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

NCT03572062

Last updated date
Study Location
Mater Hospital
South Brisbane, Queensland, 4101, Australia
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Respiratory Tract Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 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 and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).

5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

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


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 before
enrollment into the study, 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 (applies to Primary Study Cohort - Stages 1 and
2).


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.


14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after
Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).

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

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
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) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose.

In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.

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.

If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination.

62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.

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 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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 10, 2020)
317
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2018)
474
Estimated Study Completion Date  ICMJE July 9, 2021
Estimated Primary Completion Date July 9, 2021   (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).
  5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

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 before enrollment into the study, 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 (applies to Primary Study Cohort - Stages 1 and 2).
  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.
  14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).
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 information is only displayed when the study is recruiting subjects
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/d….
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 March 2020

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