Phase 2 N=72 ACAM 3000 MVA at Harvard Medical School
Smallpox
Primary: Number of Participants Reporting Moderate or Greater Solicited Local Reactions — 3; 0; 1; 6 Participants
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Phase 2 N=353 Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Smallpox
Primary: Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 2; 4; 3; 4 Participants
Phase 2 N=226 MVA Post-Event: Administration Timing and Boost Study
Smallpox
Primary: Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B — 10.8; 30.2 titer
Phase 3 N=1,129 Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
Smallpox
Primary: Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) — 252.7; 269.9; 242.0 Titer
Phase 4 N=22 Special Access Program IMVAMUNE®
Vaccination
Primary: ELISA Seropositivity Rate — 40.9; 100.0 percentage of subjects
Phase 2 N=357 Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Smallpox
Primary: The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 77; 112; 76; 91 PRNT50 Titers
Phase 3 N=123 Safety and Efficacy of CJ-50300 in Healthy Volunteers
Smallpox
Primary: Cutaneous Take Reaction — 81; 41 participants
Phase 2 N=523 Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Smallpox
Primary: Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus…
Phase 2 N=91 High Dose IMVAMUNE® in Vaccinia-Naive Individuals
Smallpox
Primary: Time to Seroconversion After One Vaccination Using Bavarian Nordic's (BN) Enzyme Linked Immunosorbent Assay (ELISA) in the Intent-to-Treat (ITT) Population — 14; 14 days
Phase 2 N=632 A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Atopic Dermatitis
Primary: Percentage of Participants With Seroconversion by ELISA — 98.5; 97.3 percentage of subjects
Phase 2 N=82 Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis
Atopic Dermatitis
Primary: Comparison of Anti-YF Antibody Levels by Measurement of Log10 Neutralization Index (LNI): YFV-17D TC- (AD) Participants Compared to YFV-17D TC- (Non-AD) Participants…
Phase 2 N=526 A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Monkeypox
Primary: Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) — 470.3; 295.7; 293.2 titer — p=<0.001
Phase 2 N=686 COVID19 SARS Vaccinations: Systemic Allergic Reactions to SARS-CoV-2 Vaccinations
SARS-CoV Infection · COVID-19 · Allergic Reaction
Primary: Proportion of Participants Who Experienced a Systemic Allergic Reaction (CoFAR Grade 2+ Regardless of Tryptase or CoFAR Grade 1 With Elevated Tryptase) Within 90 Minutes…
Phase 2 N=745 A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
Smallpox
Primary: Percentage of Participants With Seroconversion by ELISA — 98.9; 82.2; 3.4; 95.5 percentage of subjects
Phase 2 N=120 A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
Smallpox
Primary: Related Serious Adverse Events — 0; 0 Participants
Phase 3 N=440 A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®
18-42 Year Old Healthy Vaccinia-naïve Subjects
Primary: Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits — 153.5; 79.3 Titer
Phase 4 N=3,032 VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Smallpox Vaccine Adverse Reaction
Primary: Number of Vaccinated Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs) — 1420 Participants
Phase 4 N=215 Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Pertussis · Diphtheria · Tetanus
Primary: Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine — 89; 87; 85; 87 Participants
Phase 3 N=4,005 A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Smallpox
Primary: PRNT GMT — 110.7; 100.5; 117.2; 1.0 Titer
Phase 3 N=25 VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
Smallpox Vaccine Adverse Reaction
Primary: Percent of Participants With Adverse Events Related to ACAM2000 Vaccine Administration — 52; 8; 4 percentage of participants
Phase 2 N=651 A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
Smallpox
Primary: ELISA GMT — 875.1; 1099.6 Titer
Phase 2 N=581 Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
HIV Infections
Primary: Serious Adverse Events — 0; 17; 0; 6 Participants
Phase 2 N=229 Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
Monkeypox
Primary: Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43 — 203.2; 113.2; 288.9 titer — p=0.045
Phase 2 N=87 Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
Smallpox
Primary: Number of Participants With SAEs — 0; 0; 2; 0 Participants
N/A N=7,645 Surveillance for Adverse Events Following Influenza Immunization
Influenza · Vaccines Adverse Reaction
Primary: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation — 153 participants
Phase 4 N=103 Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
COVID-19 · Corona Virus Infection
Primary: Participants Who Had a Reaction to an Initial or Additional Dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA Vaccine, or Who Had Long COVID — 71; 2; 1; 1 Participants
N/A N=3,493 Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Special Drug Use Surveillance of Vaccinees After the First Vaccination
Measles/Rubella
Primary: Number of Participants With Serious Adverse Drug Reactions — 7 participants
N/A N=3,331 Freeze-dried Live Attenuated Measles/Rubella Combined Vaccine (Schwarz FF-8 Strain/TO-336 Strain) Specified Drug-use Survey of Vaccinees After the Second Vaccination
Measles/Rubella
Primary: Number of Participants With Serious Adverse Drug Reactions (ADRs) — 2 Participants
N/A N=6,525 Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Novel Influenza A/H1N1
Primary: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. — 234…
Phase 4 N=500 Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
Monkeypox
Primary: Frequency of SAEs After First Dose of MVA-BN Vaccine — 0 Participants