- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03529773
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
1. marts 2022 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1235
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Alabama
-
Mobile, Alabama, Forenede Stater, 36608
- Coastal Clinical Research, Inc.
-
-
California
-
Anaheim, California, Forenede Stater, 92801
- Anaheim Clinical Trials
-
La Mesa, California, Forenede Stater, 91942
- Paradigm Clinical Research Centers, Inc.
-
Redding, California, Forenede Stater, 96001
- Paradigm Clinical Research Center
-
-
Florida
-
Coral Gables, Florida, Forenede Stater, 33134
- Clinical Research of South Florida
-
Orlando, Florida, Forenede Stater, 32801
- Clinical Neuroscience Solutions, INC.
-
-
Georgia
-
Savannah, Georgia, Forenede Stater, 31406
- Meridian Clinical Research
-
Stockbridge, Georgia, Forenede Stater, 30281
- Clinical Research Atlanta
-
-
Hawaii
-
Honolulu, Hawaii, Forenede Stater, 96814
- East-West Medical Research Institute
-
-
Iowa
-
Sioux City, Iowa, Forenede Stater, 51106
- Meridian Clinical Research Dakota Dunes
-
-
Kansas
-
Augusta, Kansas, Forenede Stater, 67010
- Heartland Research Associates, LLC
-
Augusta, Kansas, Forenede Stater, 67010
- Augusta Family Practice
-
Newton, Kansas, Forenede Stater, 67114
- Heartland Research Associates, LLC
-
Newton, Kansas, Forenede Stater, 67114
- Axtell Clinic, P.A.
-
Wichita, Kansas, Forenede Stater, 67207
- Heartland Research Associates, LLC
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63141
- Sundance Clinical Research, LLC
-
-
Nebraska
-
Norfolk, Nebraska, Forenede Stater, 68701
- Meridian Clinical Research, LLC
-
Omaha, Nebraska, Forenede Stater, 68114
- Quality Clinical Research, Inc.
-
-
New York
-
Binghamton, New York, Forenede Stater, 13901
- United Medical Associates
-
Endwell, New York, Forenede Stater, 13760
- Regional Clinical Research, Inc.
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
-
Rochester, New York, Forenede Stater, 14621
- Rochester Regional Health/Rochester General Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28209
- PMG Research of Charlotte, LLC
-
Raleigh, North Carolina, Forenede Stater, 27609
- PMG Research of Raleigh
-
Wilmington, North Carolina, Forenede Stater, 28401
- PMG Research of Wilmington, LLC
-
Winston-Salem, North Carolina, Forenede Stater, 27103
- PMG Research of Winston-Salem, LLC
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- Sterling Research Group, Ltd.
-
Columbus, Ohio, Forenede Stater, 43213
- Aventiv Research Inc.
-
Dayton, Ohio, Forenede Stater, 45419
- PriMed Clinical Research
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater, 73112
- Lynn Health Science Institute
-
-
Texas
-
Austin, Texas, Forenede Stater, 78705
- Benchmark Research
-
Fort Worth, Texas, Forenede Stater, 76104
- Ventavia Research Group, LLC
-
Fort Worth, Texas, Forenede Stater, 76104
- Texas Health Care, PLLC
-
Fort Worth, Texas, Forenede Stater, 76135
- Benchmark Research
-
Fort Worth, Texas, Forenede Stater, 76135
- HealthFirst Medical Group
-
San Antonio, Texas, Forenede Stater, 78229
- Clinical Trials of Texas, LLC
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
-
Salt Lake City, Utah, Forenede Stater, 84121
- J. Lewis Research, Inc. /Foothill Family Clinic South
-
South Jordan, Utah, Forenede Stater, 84095
- J.Lewis Research, Inc. / Jordan River Family Medicine
-
West Jordan, Utah, Forenede Stater, 84088
- Advanced Clinical Research
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Sentinel Arm 1
Low dose formulation A
|
RSV-vaccine
|
Eksperimentel: Sentinel Arm 2
Mid dose formulation A
|
RSV-vaccine
|
Eksperimentel: Sentinel Arm 3
High dose formulation A
|
RSV-vaccine
|
Eksperimentel: Sentinel Arm 4
Low dose formulation B
|
RSV vaccine
|
Eksperimentel: Sentinel Arm 5
Mid dose formulation B
|
RSV vaccine
|
Eksperimentel: Sentinel Arm 6
High dose formulation B
|
RSV vaccine
|
Placebo komparator: Sentinel Arm 7
Placebo
|
Placebo
|
Eksperimentel: Expanded Arm 8
Low dose formulation A and SIIV
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 9
Mid dose formulation A and SIIV
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 10
High dose formulation A and SIIV
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 11
Low dose formulation B and SIIV
|
RSV vaccine
|
Eksperimentel: Expanded Arm 12
Mid dose formulation B and SIIV
|
RSV vaccine
|
Eksperimentel: Expanded Arm 13
High dose formulation B and SIIV
|
RSV vaccine
|
Eksperimentel: Expanded Arm 14
Low dose formulation A and placebo
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 15
Mid dose formulation A and placebo
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 16
High dose formulation A and placebo
|
RSV-vaccine
|
Eksperimentel: Expanded Arm 17
Low dose formulation B and placebo
|
RSV vaccine
|
Eksperimentel: Expanded Arm 18
Mid dose formulation B and placebo
|
RSV vaccine
|
Eksperimentel: Expanded Arm 19
High dose formulation B and placebo
|
RSV vaccine
|
Placebo komparator: Expanded Arm 20
placebo and placebo
|
Placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. april 2018
Primær færdiggørelse (Faktiske)
20. november 2019
Studieafslutning (Faktiske)
28. december 2020
Datoer for studieregistrering
Først indsendt
17. april 2018
Først indsendt, der opfyldte QC-kriterier
7. maj 2018
Først opslået (Faktiske)
18. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. marts 2022
Sidst verificeret
1. marts 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C3671001
- RSV FIH (Anden identifikator: Alias Study Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Starting 24 months after study completion.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Luftvejsinfektioner
-
Federal University of Rio Grande do SulRekruttering
-
Maastricht University Medical CenterWingate Institute of NeurogastroenterologyRekrutteringfMRI | Transkutan Vagal Nerve Stimulation (tVNS) | Nucleus of the Solitary Tract (NTS)Holland, Det Forenede Kongerige
-
Majmaah UniversityIkke rekrutterer endnuSinus Tract | Singler besøg | Multibesøg | Enkel kegle obturationsteknik | Biokeramisk forsegler
-
University of Santiago de CompostelaOsteology FoundationRekruttering
-
Hadassah Medical OrganizationUkendtØvre Tract UreterolithiasisIsrael
-
Institut PasteurRekruttering
-
Second Affiliated Hospital of Wenzhou Medical UniversityRekrutteringVentrikulær udstrømning Tract Ventrikulære arytmier | RadiofrekvenskateterablationKina
-
Universidad del DesarrolloAfsluttetHealthcare Associated InfectionChile
-
The University of Texas Health Science Center,...EurofinsAfsluttetOdontogen Deep Space Neck InfectionForenede Stater
-
Imelda Hospital, BonheidenAfsluttetHealthcare Associated InfectionBelgien
Kliniske forsøg med Placebo
-
SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
-
National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
-
Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
-
Texas A&M UniversityNutraboltAfsluttetGlucose and Insulin Response
-
Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater
-
ItalfarmacoAfsluttetBeckers muskeldystrofiHolland, Italien
-
Universidade Estadual de LondrinaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...AfsluttetSund og rask | Kropssammensætning