A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Primary Purpose
Smallpox
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IMVAMUNE®
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Smallpox
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects, 18 to 40 years of age
- The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures
- BMI ≥ 18.5 and < 35
- Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)
- WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination
- White blood cells ≥ 2,500/mm3 < ULN
- Absolute neutrophil count (ANC) within normal limits
- Hemoglobin within normal limits
- Platelets within normal limits
Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation:
- For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min)
- For women: multiply the result by 0.85 = CrCl (ml/min).
Adequate hepatic function defined as:
- a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease
- b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 1.5 x ULN
- Troponin I < 2 x ULN
- Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia)
Exclusion criteria
- Typical vaccinia scar
- Known or suspected history of smallpox vaccination
- History of vaccination with any poxvirus-based vaccine
- US Military service prior to 1991 or after January 2003
- Pregnant or breast-feeding women
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial
- History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid replacement are not excluded
- Known or suspected impairment of immunologic function including, but not limited to, HIV Infection, clinically significant liver disease (including chronic active HBV or HCV), diabetes mellitus, moderate to severe kidney impairment
- History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site
- History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
- Clinically significant mental disorder not adequately controlled by medical treatment
- History of coronary heart disease, myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor
- Known history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to subjects 20 years of age and older
- Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
- Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris (hydroxymethyl)-amino methane, including know allergy to egg or aminoglycosides
- History of anaphylaxis or severe allergic reaction to any vaccine
- Acute disease (illness with or without a fever) at the time enrollment
- Body temperature ≥100.4°F (≥38.0°C) at the time of enrollment
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination
- Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination
- Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
- Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period
- Trial personnel
Sites / Locations
- Alabama Vaccine Research Clinic
- Anaheim Clinical Trials
- National Research Institute
- Northern California Clinical Research Center (NCCRC)
- Therapeutics Clinical Research
- Lynn Institute of the Rockies
- Avail Clinical Research, LLC
- Broward Research Group
- Accelovance Melbourne
- Southeast Regional Research Group
- Advanced Clinical Research, Inc.
- Accelovance Peoria
- Heartland Research Associates
- Heartland Research Associates, LLC
- Benchmark Research
- Washington University in St. Louis, School of Medicine
- QPS Bio-Kinetic
- Meridian Clinical Research, LLC
- Clinical Research Center of Nevada, LLC
- Rochester Clinical Research, Inc.
- Wake Research Associates
- Rapid Medical Research, Inc.
- Family Practice Center of Wooster
- Lynn Health Science Institute
- Columbia Research Group, Inc.
- Omega Medical Research
- PMG Research of Charleston
- Holston Medical Group
- Volunteer Research Group
- Benchmark Research
- Tanner Clinic
- Advanced Clinical Research
- Clinical Research Associates of Tidewater
- University Physicians Internal Medicine University Physicians & Surgeons, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Outcomes
Primary Outcome Measures
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Secondary Outcome Measures
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
PRNT Seroconversion Rate
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISA Seroconversion Rate
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Correlation PRNT vs ELISA Titers
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Cardiac Signs or Symptoms
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)).
An AESI was defined in this trial as:
Any cardiac sign or symptom developed since the first vaccination
ECG changes determined to be clinically significant
Cardiac enzyme Troponin I >= 2 x ULN (>= Grade 2)
Related Grade >=3 Adverse Events
Incidence of any Grade >=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs
Unsolicited Non-serious AEs: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Unsolicited Non-serious AEs: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Solicited Local AEs
Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.
Solicited General AEs
Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01144637
Brief Title
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4005 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
Arm Title
Group 4
Arm Type
Placebo Comparator
Arm Description
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Intervention Type
Biological
Intervention Name(s)
IMVAMUNE®
Other Intervention Name(s)
IMVANEX, MVA-BN®
Intervention Description
0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Tris-buffered-saline
Intervention Description
0.5 ml TBS
Primary Outcome Measure Information:
Title
PRNT GMT
Description
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Time Frame
2 weeks following the second vaccination
Secondary Outcome Measure Information:
Title
ELISA GMT
Description
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Time Frame
2 weeks following the second vaccination
Title
PRNT Seroconversion Rate
Description
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame
2 weeks following the second vaccination
Title
ELISA Seroconversion Rate
Description
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame
2 weeks following the second vaccination
Title
Correlation PRNT vs ELISA Titers
Description
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Time Frame
2 weeks following the second vaccination
Title
Serious Adverse Events
Description
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Time Frame
within 30 weeks
Title
Cardiac Signs or Symptoms
Description
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)).
An AESI was defined in this trial as:
Any cardiac sign or symptom developed since the first vaccination
ECG changes determined to be clinically significant
Cardiac enzyme Troponin I >= 2 x ULN (>= Grade 2)
Time Frame
within 30 weeks
Title
Related Grade >=3 Adverse Events
Description
Incidence of any Grade >=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs
Time Frame
within 29 days after any vaccination
Title
Unsolicited Non-serious AEs: Intensity
Description
Occurrence of unsolicited non-serious AEs by Intensity
Time Frame
within 29 days after any vaccination
Title
Unsolicited Non-serious AEs: Relationship to Vaccination
Description
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time Frame
within 29 days after any vaccination
Title
Solicited Local AEs
Description
Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.
Time Frame
within 8 days after any vaccination
Title
Solicited General AEs
Description
Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Time Frame
within 8 days after any vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects, 18 to 40 years of age
The subject has read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedures
BMI ≥ 18.5 and < 35
Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or with a history of hysterectomy (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)
WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each vaccination
White blood cells ≥ 2,500/mm3 < ULN
Absolute neutrophil count (ANC) within normal limits
Hemoglobin within normal limits
Platelets within normal limits
Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation:
For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min)
For women: multiply the result by 0.85 = CrCl (ml/min).
Adequate hepatic function defined as:
a. Total bilirubin ≤ 1.5 x ULN in the absence of other evidence of significant liver disease
b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 1.5 x ULN
Troponin I < 2 x ULN
Electrocardiogram (ECG) without clinically significant findings (e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia)
Exclusion criteria
Typical vaccinia scar
Known or suspected history of smallpox vaccination
History of vaccination with any poxvirus-based vaccine
US Military service prior to 1991 or after January 2003
Pregnant or breast-feeding women
Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial
History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid replacement are not excluded
Known or suspected impairment of immunologic function including, but not limited to, HIV Infection, clinically significant liver disease (including chronic active HBV or HCV), diabetes mellitus, moderate to severe kidney impairment
History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site
History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
Clinically significant mental disorder not adequately controlled by medical treatment
History of coronary heart disease, myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor
Known history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years
Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to subjects 20 years of age and older
Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
Known allergy to IMVAMUNE® vaccine and its constituents, e.g. tris (hydroxymethyl)-amino methane, including know allergy to egg or aminoglycosides
History of anaphylaxis or severe allergic reaction to any vaccine
Acute disease (illness with or without a fever) at the time enrollment
Body temperature ≥100.4°F (≥38.0°C) at the time of enrollment
Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination
Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination
Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy
Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at last physical trial visit (V5)
Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period
Trial personnel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turner Overton, MD
Organizational Affiliation
Division of Infectious Diseases University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Vaccine Research Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Northern California Clinical Research Center (NCCRC)
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Broward Research Group
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Accelovance Melbourne
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Southeast Regional Research Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Advanced Clinical Research, Inc.
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Accelovance Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Heartland Research Associates
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Washington University in St. Louis, School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
QPS Bio-Kinetic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Center of Nevada, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Family Practice Center of Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Columbia Research Group, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
PMG Research of Charleston
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University Physicians Internal Medicine University Physicians & Surgeons, Inc.
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29652929
Citation
Overton ET, Lawrence SJ, Wagner E, Nopora K, Rosch S, Young P, Schmidt D, Kreusel C, De Carli S, Meyer TP, Weidenthaler H, Samy N, Chaplin P. Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial. PLoS One. 2018 Apr 13;13(4):e0195897. doi: 10.1371/journal.pone.0195897. eCollection 2018.
Results Reference
derived
Learn more about this trial
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
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