- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03529773
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
tiistai 1. maaliskuuta 2022 päivittänyt: 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).
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
1235
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Alabama
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Mobile, Alabama, Yhdysvallat, 36608
- Coastal Clinical Research, Inc.
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California
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Anaheim, California, Yhdysvallat, 92801
- Anaheim Clinical Trials
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La Mesa, California, Yhdysvallat, 91942
- Paradigm Clinical Research Centers, Inc.
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Redding, California, Yhdysvallat, 96001
- Paradigm Clinical Research Center
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Florida
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Coral Gables, Florida, Yhdysvallat, 33134
- Clinical Research of South Florida
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Orlando, Florida, Yhdysvallat, 32801
- Clinical Neuroscience Solutions, INC.
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Georgia
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Savannah, Georgia, Yhdysvallat, 31406
- Meridian Clinical Research
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Stockbridge, Georgia, Yhdysvallat, 30281
- Clinical Research Atlanta
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Hawaii
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Honolulu, Hawaii, Yhdysvallat, 96814
- East-West Medical Research Institute
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Iowa
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Sioux City, Iowa, Yhdysvallat, 51106
- Meridian Clinical Research Dakota Dunes
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Kansas
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Augusta, Kansas, Yhdysvallat, 67010
- Heartland Research Associates, LLC
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Augusta, Kansas, Yhdysvallat, 67010
- Augusta Family Practice
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Newton, Kansas, Yhdysvallat, 67114
- Heartland Research Associates, LLC
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Newton, Kansas, Yhdysvallat, 67114
- Axtell Clinic, P.A.
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Wichita, Kansas, Yhdysvallat, 67207
- Heartland Research Associates, LLC
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Missouri
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Saint Louis, Missouri, Yhdysvallat, 63141
- Sundance Clinical Research, LLC
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Nebraska
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Norfolk, Nebraska, Yhdysvallat, 68701
- Meridian Clinical Research, LLC
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Omaha, Nebraska, Yhdysvallat, 68114
- Quality Clinical Research, Inc.
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New York
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Binghamton, New York, Yhdysvallat, 13901
- United Medical Associates
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Endwell, New York, Yhdysvallat, 13760
- Regional Clinical Research, Inc.
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Rochester, New York, Yhdysvallat, 14642
- University of Rochester Medical Center
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Rochester, New York, Yhdysvallat, 14621
- Rochester Regional Health/Rochester General Hospital
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28209
- PMG Research of Charlotte, LLC
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Raleigh, North Carolina, Yhdysvallat, 27609
- PMG Research of Raleigh
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Wilmington, North Carolina, Yhdysvallat, 28401
- PMG Research of Wilmington, LLC
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Winston-Salem, North Carolina, Yhdysvallat, 27103
- PMG Research of Winston-Salem, LLC
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
- Sterling Research Group, Ltd.
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Columbus, Ohio, Yhdysvallat, 43213
- Aventiv Research Inc.
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Dayton, Ohio, Yhdysvallat, 45419
- PriMed Clinical Research
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73112
- Lynn Health Science Institute
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Texas
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Austin, Texas, Yhdysvallat, 78705
- Benchmark Research
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Fort Worth, Texas, Yhdysvallat, 76104
- Ventavia Research Group, LLC
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Fort Worth, Texas, Yhdysvallat, 76104
- Texas Health Care, PLLC
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Fort Worth, Texas, Yhdysvallat, 76135
- Benchmark Research
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Fort Worth, Texas, Yhdysvallat, 76135
- HealthFirst Medical Group
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San Antonio, Texas, Yhdysvallat, 78229
- Clinical Trials of Texas, LLC
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Yhdysvallat, 84121
- J. Lewis Research, Inc. /Foothill Family Clinic South
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South Jordan, Utah, Yhdysvallat, 84095
- J.Lewis Research, Inc. / Jordan River Family Medicine
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West Jordan, Utah, Yhdysvallat, 84088
- Advanced Clinical Research
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 85 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
Inclusion Criteria:
- 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.
- Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- 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.
- Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
- 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:
- Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
- 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.
- 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.
- Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
- Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
- Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- 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.
- 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).
- Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
- 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.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant or breastfeeding.
- Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
- Expanded-cohort subjects only: Allergy to egg proteins (egg or egg products) or chicken proteins.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Sentinel Arm 1
Low dose formulation A
|
RSV-rokote
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Kokeellinen: Sentinel Arm 2
Mid dose formulation A
|
RSV-rokote
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Kokeellinen: Sentinel Arm 3
High dose formulation A
|
RSV-rokote
|
Kokeellinen: Sentinel Arm 4
Low dose formulation B
|
RSV vaccine
|
Kokeellinen: Sentinel Arm 5
Mid dose formulation B
|
RSV vaccine
|
Kokeellinen: Sentinel Arm 6
High dose formulation B
|
RSV vaccine
|
Placebo Comparator: Sentinel Arm 7
Placebo
|
Plasebo
|
Kokeellinen: Expanded Arm 8
Low dose formulation A and SIIV
|
RSV-rokote
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Kokeellinen: Expanded Arm 9
Mid dose formulation A and SIIV
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RSV-rokote
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Kokeellinen: Expanded Arm 10
High dose formulation A and SIIV
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RSV-rokote
|
Kokeellinen: Expanded Arm 11
Low dose formulation B and SIIV
|
RSV vaccine
|
Kokeellinen: Expanded Arm 12
Mid dose formulation B and SIIV
|
RSV vaccine
|
Kokeellinen: Expanded Arm 13
High dose formulation B and SIIV
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RSV vaccine
|
Kokeellinen: Expanded Arm 14
Low dose formulation A and placebo
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RSV-rokote
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Kokeellinen: Expanded Arm 15
Mid dose formulation A and placebo
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RSV-rokote
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Kokeellinen: Expanded Arm 16
High dose formulation A and placebo
|
RSV-rokote
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Kokeellinen: Expanded Arm 17
Low dose formulation B and placebo
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RSV vaccine
|
Kokeellinen: Expanded Arm 18
Mid dose formulation B and placebo
|
RSV vaccine
|
Kokeellinen: Expanded Arm 19
High dose formulation B and placebo
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RSV vaccine
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Placebo Comparator: Expanded Arm 20
placebo and placebo
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Plasebo
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Aikaikkuna: 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
Aikaikkuna: 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
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Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.
- Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 18. huhtikuuta 2018
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 20. marraskuuta 2019
Opintojen valmistuminen (Todellinen)
Maanantai 28. joulukuuta 2020
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 17. huhtikuuta 2018
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 7. toukokuuta 2018
Ensimmäinen Lähetetty (Todellinen)
Perjantai 18. toukokuuta 2018
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 3. maaliskuuta 2022
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Tiistai 1. maaliskuuta 2022
Viimeksi vahvistettu
Tiistai 1. maaliskuuta 2022
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C3671001
- RSV FIH (Muu tunniste: Alias Study Number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
Starting 24 months after study completion.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
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NovavaxValmisRespiratory Syncytal Virus (RSV)Yhdysvallat
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NovavaxValmisRespiratory Syncytal Virus (RSV)Yhdysvallat
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VaxartValmisRespiratory Syncytal Virus (RSV)Yhdysvallat
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PfizerValmisRESPIRATORY SYNCYTIAL VIRUS (RSV)Yhdysvallat
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NovavaxValmisRespiratory Syncytal Virus (RSV)Yhdysvallat
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MedImmune LLCValmisRespiratory Syncytal Virus (RSV)Yhdysvallat
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National Institute on Drug Abuse (NIDA)ValmisKannabiksen käyttöYhdysvallat
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Chiesi Farmaceutici S.p.A.ValmisAstmaYhdistynyt kuningaskunta
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MedImmune LLCValmis
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Eli Lilly and CompanyLopetettuNivelreumaYhdysvallat, Saksa, Taiwan, Ranska, Japani, Meksiko, Puola, Venäjän federaatio, Espanja, Kolumbia, Argentiina, Kreikka, Uusi Seelanti, Etelä-Afrikka, Australia, Korean tasavalta, Brasilia, Italia, Malesia
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Alzheon Inc.National Institute on Aging (NIA)Aktiivinen, ei rekrytointiVarhainen Alzheimerin tautiYhdysvallat, Espanja, Kanada, Alankomaat, Tšekki, Yhdistynyt kuningaskunta, Ranska, Saksa, Islanti
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GlaxoSmithKlineValmisLihavuus | Diabetes mellitus, tyyppi 2Yhdistynyt kuningaskunta
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Chonbuk National University HospitalValmisToiminnallinen ummetusKorean tasavalta
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Vitae Pharmaceuticals Inc., an Allergan affiliateValmis
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Starpharma Pty LtdNational Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy... ja muut yhteistyökumppanitValmisTerveYhdysvallat, Puerto Rico