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

1. března 2022 aktualizováno: Pfizer

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

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).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

1235

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Alabama
      • Mobile, Alabama, Spojené státy, 36608
        • Coastal Clinical Research, Inc.
    • California
      • Anaheim, California, Spojené státy, 92801
        • Anaheim Clinical Trials
      • La Mesa, California, Spojené státy, 91942
        • Paradigm Clinical Research Centers, Inc.
      • Redding, California, Spojené státy, 96001
        • Paradigm Clinical Research Center
    • Florida
      • Coral Gables, Florida, Spojené státy, 33134
        • Clinical Research of South Florida
      • Orlando, Florida, Spojené státy, 32801
        • Clinical Neuroscience Solutions, Inc.
    • Georgia
      • Savannah, Georgia, Spojené státy, 31406
        • Meridian Clinical Research
      • Stockbridge, Georgia, Spojené státy, 30281
        • Clinical Research Atlanta
    • Hawaii
      • Honolulu, Hawaii, Spojené státy, 96814
        • East-West Medical Research Institute
    • Iowa
      • Sioux City, Iowa, Spojené státy, 51106
        • Meridian Clinical Research Dakota Dunes
    • Kansas
      • Augusta, Kansas, Spojené státy, 67010
        • Heartland Research Associates, LLC
      • Augusta, Kansas, Spojené státy, 67010
        • Augusta Family Practice
      • Newton, Kansas, Spojené státy, 67114
        • Heartland Research Associates, LLC
      • Newton, Kansas, Spojené státy, 67114
        • Axtell Clinic, P.A.
      • Wichita, Kansas, Spojené státy, 67207
        • Heartland Research Associates, LLC
    • Missouri
      • Saint Louis, Missouri, Spojené státy, 63141
        • Sundance Clinical Research, LLC
    • Nebraska
      • Norfolk, Nebraska, Spojené státy, 68701
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, Spojené státy, 68114
        • Quality Clinical Research, Inc.
    • New York
      • Binghamton, New York, Spojené státy, 13901
        • United Medical Associates
      • Endwell, New York, Spojené státy, 13760
        • Regional Clinical Research, Inc.
      • Rochester, New York, Spojené státy, 14642
        • University of Rochester Medical Center
      • Rochester, New York, Spojené státy, 14621
        • Rochester Regional Health/Rochester General Hospital
    • North Carolina
      • Charlotte, North Carolina, Spojené státy, 28209
        • PMG Research of Charlotte, LLC
      • Raleigh, North Carolina, Spojené státy, 27609
        • PMG Research of Raleigh
      • Wilmington, North Carolina, Spojené státy, 28401
        • PMG Research of Wilmington, LLC
      • Winston-Salem, North Carolina, Spojené státy, 27103
        • PMG Research of Winston-Salem, LLC
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45219
        • Sterling Research Group, Ltd.
      • Columbus, Ohio, Spojené státy, 43213
        • Aventiv Research Inc.
      • Dayton, Ohio, Spojené státy, 45419
        • PriMED Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73112
        • Lynn Health Science Institute
    • Texas
      • Austin, Texas, Spojené státy, 78705
        • Benchmark Research
      • Fort Worth, Texas, Spojené státy, 76104
        • Ventavia Research Group, LLC
      • Fort Worth, Texas, Spojené státy, 76104
        • Texas Health Care, PLLC
      • Fort Worth, Texas, Spojené státy, 76135
        • Benchmark Research
      • Fort Worth, Texas, Spojené státy, 76135
        • HealthFirst Medical Group
      • San Antonio, Texas, Spojené státy, 78229
        • Clinical Trials of Texas, LLC
    • Utah
      • Salt Lake City, Utah, Spojené státy, 84109
        • J. Lewis Research, Inc. / Foothill Family Clinic
      • Salt Lake City, Utah, Spojené státy, 84121
        • J. Lewis Research, Inc. /Foothill Family Clinic South
      • South Jordan, Utah, Spojené státy, 84095
        • J.Lewis Research, Inc. / Jordan River Family Medicine
      • West Jordan, Utah, Spojené státy, 84088
        • Advanced Clinical Research

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Sentinel Arm 1
Low dose formulation A
Biologický: Formulace A
RSV vakcína
Experimentální: Sentinel Arm 2
Mid dose formulation A
Biologický: Formulace A
RSV vakcína
Experimentální: Sentinel Arm 3
High dose formulation A
Biologický: Formulace A
RSV vakcína
Experimentální: Sentinel Arm 4
Low dose formulation B
Biologický: Formulation B
RSV vaccine
Experimentální: Sentinel Arm 5
Mid dose formulation B
Biologický: Formulation B
RSV vaccine
Experimentální: Sentinel Arm 6
High dose formulation B
Biologický: Formulation B
RSV vaccine
Komparátor placeba: Sentinel Arm 7
Placebo
Biologický: Placebo
Placebo
Experimentální: Expanded Arm 8
Low dose formulation A and SIIV
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 9
Mid dose formulation A and SIIV
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 10
High dose formulation A and SIIV
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 11
Low dose formulation B and SIIV
Biologický: Formulation B
RSV vaccine
Experimentální: Expanded Arm 12
Mid dose formulation B and SIIV
Biologický: Formulation B
RSV vaccine
Experimentální: Expanded Arm 13
High dose formulation B and SIIV
Biologický: Formulation B
RSV vaccine
Experimentální: Expanded Arm 14
Low dose formulation A and placebo
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 15
Mid dose formulation A and placebo
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 16
High dose formulation A and placebo
Biologický: Formulace A
RSV vakcína
Experimentální: Expanded Arm 17
Low dose formulation B and placebo
Biologický: Formulation B
RSV vaccine
Experimentální: Expanded Arm 18
Mid dose formulation B and placebo
Biologický: Formulation B
RSV vaccine
Experimentální: Expanded Arm 19
High dose formulation B and placebo
Biologický: Formulation B
RSV vaccine
Komparátor placeba: Expanded Arm 20
placebo and placebo
Biologický: Placebo
Placebo

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Časové okno: Within 14 days after vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (>) 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 Days After Vaccination
Časové okno: Within 14 days after vaccination
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Časové okno: Within 14 days after vaccination 1 on Day 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.
Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1
Časové okno: Within 14 days after vaccination 1 on Day 1
Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity.
Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination
Časové okno: Within 14 days after vaccination
Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=)38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination
Časové okno: Within 14 days after vaccination
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Časové okno: Within 14 days after vaccination 1 on Day 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination 1 on Day 1
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1
Časové okno: Within 14 days after vaccination 1 on Day 1
Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: >= 38.0 deg C, mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 h, moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.
Within 14 days after vaccination 1 on Day 1
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) Within 1 Month After Vaccination
Časové okno: Within 1 month after vaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs Within 1 Month After Vaccination
Časové okno: Within 1 month after vaccination (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1
Časové okno: Within 1 month after vaccination 1 (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination 1 (up to 35 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AE Within 1 Month After Vaccination
Časové okno: Within 1 month after vaccination 1 (up to 35 days)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 1 month after vaccination 1 (up to 35 days)
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination
Časové okno: Upto 12 months after vaccination (up to 378 days)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination (up to 378 days)
Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination
Časové okno: Upto 12 months after vaccination (upto 378 days)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1
Časové okno: Upto 12 months after vaccination 1 (upto 378 days)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1
Časové okno: Upto 12 months after vaccination 1 (upto 378 days)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Upto 12 months after vaccination 1 (upto 378 days)
Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2
Časové okno: Within 1 month after vaccination 2 (upto Day 70)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Within 1 month after vaccination 2 (upto Day 70)
Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2
Časové okno: Within 1 month after vaccination 2 (upto Day 70)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.
Within 1 month after vaccination 2 (upto Day 70)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Časové okno: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer lower limit of quantitation (LLOQ) values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)
Časové okno: Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)
Časové okno: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)
Časové okno: Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
GMTs of RSV A and RSV B antigens were measured using neutralizing assay. The neutralizing titer LLOQ values were: A = 50 and B = 70. Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution.
Before vaccination, 1, 2, 3, 6 and 12 months after vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)
Časové okno: Before vaccination and 1 Month after SIIV vaccination
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Before vaccination and 1 Month after SIIV vaccination
Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 65 to 85 Years)
Časové okno: Before vaccination and 1 Month after SIIV vaccination
The HAI titer LLOQ value for each strain was 10. Assay values below LLOQ were set to 0.5* LLOQ for analysis. Titers were expressed in terms of 1/dilution.
Before vaccination and 1 Month after SIIV vaccination

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. dubna 2018

Primární dokončení (Aktuální)

20. listopadu 2019

Dokončení studie (Aktuální)

28. prosince 2020

Termíny zápisu do studia

První předloženo

17. dubna 2018

První předloženo, které splnilo kritéria kontroly kvality

7. května 2018

První zveřejněno (Aktuální)

18. května 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. března 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. března 2022

Naposledy ověřeno

1. března 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • C3671001
  • RSV FIH (Jiný identifikátor: Alias Study Number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

Starting 24 months after study completion.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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