- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03529773
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
1. März 2022 aktualisiert von: 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).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
1235
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Alabama
-
Mobile, Alabama, Vereinigte Staaten, 36608
- Coastal Clinical Research, Inc.
-
-
California
-
Anaheim, California, Vereinigte Staaten, 92801
- Anaheim Clinical Trials
-
La Mesa, California, Vereinigte Staaten, 91942
- Paradigm Clinical Research Centers, Inc.
-
Redding, California, Vereinigte Staaten, 96001
- Paradigm Clinical Research Center
-
-
Florida
-
Coral Gables, Florida, Vereinigte Staaten, 33134
- Clinical Research of South Florida
-
Orlando, Florida, Vereinigte Staaten, 32801
- Clinical Neuroscience Solutions, Inc.
-
-
Georgia
-
Savannah, Georgia, Vereinigte Staaten, 31406
- Meridian Clinical Research
-
Stockbridge, Georgia, Vereinigte Staaten, 30281
- Clinical Research Atlanta
-
-
Hawaii
-
Honolulu, Hawaii, Vereinigte Staaten, 96814
- East-West Medical Research Institute
-
-
Iowa
-
Sioux City, Iowa, Vereinigte Staaten, 51106
- Meridian Clinical Research Dakota Dunes
-
-
Kansas
-
Augusta, Kansas, Vereinigte Staaten, 67010
- Heartland Research Associates, LLC
-
Augusta, Kansas, Vereinigte Staaten, 67010
- Augusta Family Practice
-
Newton, Kansas, Vereinigte Staaten, 67114
- Heartland Research Associates, LLC
-
Newton, Kansas, Vereinigte Staaten, 67114
- Axtell Clinic, P.A.
-
Wichita, Kansas, Vereinigte Staaten, 67207
- Heartland Research Associates, LLC
-
-
Missouri
-
Saint Louis, Missouri, Vereinigte Staaten, 63141
- Sundance Clinical Research, LLC
-
-
Nebraska
-
Norfolk, Nebraska, Vereinigte Staaten, 68701
- Meridian Clinical Research, LLC
-
Omaha, Nebraska, Vereinigte Staaten, 68114
- Quality Clinical Research, Inc.
-
-
New York
-
Binghamton, New York, Vereinigte Staaten, 13901
- United Medical Associates
-
Endwell, New York, Vereinigte Staaten, 13760
- Regional Clinical Research, Inc.
-
Rochester, New York, Vereinigte Staaten, 14642
- University of Rochester Medical Center
-
Rochester, New York, Vereinigte Staaten, 14621
- Rochester Regional Health/Rochester General Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Vereinigte Staaten, 28209
- PMG Research of Charlotte, LLC
-
Raleigh, North Carolina, Vereinigte Staaten, 27609
- PMG Research of Raleigh
-
Wilmington, North Carolina, Vereinigte Staaten, 28401
- PMG Research of Wilmington, LLC
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27103
- PMG Research of Winston-Salem, LLC
-
-
Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45219
- Sterling Research Group, Ltd.
-
Columbus, Ohio, Vereinigte Staaten, 43213
- Aventiv Research Inc.
-
Dayton, Ohio, Vereinigte Staaten, 45419
- PriMed Clinical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Vereinigte Staaten, 73112
- Lynn Health Science Institute
-
-
Texas
-
Austin, Texas, Vereinigte Staaten, 78705
- Benchmark Research
-
Fort Worth, Texas, Vereinigte Staaten, 76104
- Ventavia Research Group, LLC
-
Fort Worth, Texas, Vereinigte Staaten, 76104
- Texas Health Care, PLLC
-
Fort Worth, Texas, Vereinigte Staaten, 76135
- Benchmark Research
-
Fort Worth, Texas, Vereinigte Staaten, 76135
- HealthFirst Medical Group
-
San Antonio, Texas, Vereinigte Staaten, 78229
- Clinical Trials of Texas, LLC
-
-
Utah
-
Salt Lake City, Utah, Vereinigte Staaten, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Vereinigte Staaten, 84121
- J. Lewis Research, Inc. /Foothill Family Clinic South
-
South Jordan, Utah, Vereinigte Staaten, 84095
- J.Lewis Research, Inc. / Jordan River Family Medicine
-
West Jordan, Utah, Vereinigte Staaten, 84088
- Advanced Clinical Research
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Sentinel Arm 1
Low dose formulation A
|
RSV-Impfstoff
|
Experimental: Sentinel Arm 2
Mid dose formulation A
|
RSV-Impfstoff
|
Experimental: Sentinel Arm 3
High dose formulation A
|
RSV-Impfstoff
|
Experimental: Sentinel Arm 4
Low dose formulation B
|
RSV vaccine
|
Experimental: Sentinel Arm 5
Mid dose formulation B
|
RSV vaccine
|
Experimental: Sentinel Arm 6
High dose formulation B
|
RSV vaccine
|
Placebo-Komparator: Sentinel Arm 7
Placebo
|
Placebo
|
Experimental: Expanded Arm 8
Low dose formulation A and SIIV
|
RSV-Impfstoff
|
Experimental: Expanded Arm 9
Mid dose formulation A and SIIV
|
RSV-Impfstoff
|
Experimental: Expanded Arm 10
High dose formulation A and SIIV
|
RSV-Impfstoff
|
Experimental: Expanded Arm 11
Low dose formulation B and SIIV
|
RSV vaccine
|
Experimental: Expanded Arm 12
Mid dose formulation B and SIIV
|
RSV vaccine
|
Experimental: Expanded Arm 13
High dose formulation B and SIIV
|
RSV vaccine
|
Experimental: Expanded Arm 14
Low dose formulation A and placebo
|
RSV-Impfstoff
|
Experimental: Expanded Arm 15
Mid dose formulation A and placebo
|
RSV-Impfstoff
|
Experimental: Expanded Arm 16
High dose formulation A and placebo
|
RSV-Impfstoff
|
Experimental: Expanded Arm 17
Low dose formulation B and placebo
|
RSV vaccine
|
Experimental: Expanded Arm 18
Mid dose formulation B and placebo
|
RSV vaccine
|
Experimental: Expanded Arm 19
High dose formulation B and placebo
|
RSV vaccine
|
Placebo-Komparator: Expanded Arm 20
placebo and placebo
|
Placebo
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
18. April 2018
Primärer Abschluss (Tatsächlich)
20. November 2019
Studienabschluss (Tatsächlich)
28. Dezember 2020
Studienanmeldedaten
Zuerst eingereicht
17. April 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. Mai 2018
Zuerst gepostet (Tatsächlich)
18. Mai 2018
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. März 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. März 2022
Zuletzt verifiziert
1. März 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- C3671001
- RSV FIH (Andere Kennung: Alias Study Number)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Starting 24 months after study completion.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Infektionen der Atemwege
-
Maastricht University Medical CenterWingate Institute of NeurogastroenterologyRekrutierungfMRT | Transkutane Vagusnervstimulation (tVNS) | Kern des Solitary Tract (NTS)Niederlande, Vereinigtes Königreich
-
Duke UniversityAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)Vereinigte Staaten
-
Catholic University of the Sacred HeartAbgeschlossenCentral Line-associated Bloodstream Infection (CLABSI)
-
Abbott Medical DevicesThoratec CorporationAbgeschlossenDriveline Heart-assisted Device Related InfectionVereinigte Staaten
-
NovavaxAbgeschlossen
-
PfizerAbgeschlossenRespiratory-Syncytial-VirenBelgien
-
NovavaxAbgeschlossenRespiratory Synctial VirusKanada
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyRekrutierungCentral Line-associated Bloodstream Infection (CLABSI)Niederlande
-
Janssen Vaccines & Prevention B.V.AbgeschlossenRespiratory-Syncytial-Virus-PräventionVereinigte Staaten
-
NovavaxAbgeschlossenRespiratory-Syncytial-Virus (RSV)Vereinigte Staaten
Klinische Studien zur Placebo
-
SamA Pharmaceutical Co., LtdUnbekanntAkute Bronchitis | Akute Infektion der oberen AtemwegeKorea, Republik von
-
National Institute on Drug Abuse (NIDA)AbgeschlossenCannabiskonsumVereinigte Staaten
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAbgeschlossenMännliche Probanden mit Typ-II-Diabetes (T2DM)Deutschland
-
Instituto de Investigación Hospital Universitario...Creaciones Aromáticas Industriales, S.A. (CARINSA)Abgeschlossen
-
Texas A&M UniversityNutraboltAbgeschlossenGlucose and Insulin Response
-
Soroka University Medical CenterAbgeschlossen
-
Regado Biosciences, Inc.AbgeschlossenGesunder FreiwilligerVereinigte Staaten
-
ItalfarmacoAbgeschlossenBecker-MuskeldystrophieNiederlande, Italien
-
Heptares Therapeutics LimitedAbgeschlossenPharmakokinetik | SicherheitsproblemeVereinigtes Königreich