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
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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=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=420 RSV-MVA-BN Vaccine Phase II Trial in ≥ 55 Year Old Adults
Respiratory Syncytial Virus Infections
Primary: PRNT (Subtype A) GMT — 300.5; 278.9; 311.9; 373.3 Titer
Phase 3 N=3,196 A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
Avian Influenza
Primary: Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot — 16.1; 17.0; 17.0; 128.6 geometric mean titer
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=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 1 N=105 Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Bacillus Anthracis (Anthrax) Infection
Primary: Incidence of Injection Site Reactions From Subject Diary Cards by Injection and Severity (Mild, Moderate or Severe) Following the First Vaccination (Day 0) — 11; 17; 13…
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=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=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 4 N=152 Age and Response to Flu Vaccines
Influenza · Influenza Immunisation
Primary: Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI) — 528 titer
Phase 1 N=420 Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
Pertussis · Whooping Cough · Tetanus
Primary: The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine — 30; 33; 32; 35…
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 2 N=20 Safety/Immunogenicity/Genetic Drift of MP-12 Rift Valley Fever Vaccine
Rift Valley Fever
Primary: Safety as Measured by the Number of Adverse Events — 22; 130 AEs
Phase 3 N=126 Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvanted Influenza Study Vaccine in Adults Aged 18 Years and Above
Human Influenza
Primary: Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc — 66; 41; 98; 84…
Phase 4 N=2,902 Immunogenicity, Safety and Tolerability of a Trivalent Subunit Inactivated Vaccine in Healthy Subjects 50 Years and Above
Influenza
Primary: Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years — 315; 581; 697; 1048…
Phase 1 N=60 Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Influenza · Healthy
Primary: Solicted Adverse Events — 8; 12; 13; 14 participants
Phase 2 N=126 Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above
Human Influenza
Primary: Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV — 52; 41; 100; 78…
Phase 1 N=87 Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Influenza
Primary: Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. — 2; 2; 1; 0…
Phase 1 N=48 Andes Virus DNA Vaccine for the Prevention of Hantavirus Pulmonary Syndrome Using the PharmaJet Stratis(R) Needle-Free Injection Delivery Device
Hantavirus Pulmonary Infection · Immunisation
Primary: Number of Participants Experiencing Clinical Safety Laboratory Adverse Events — 0; 2; 0; 0 participants
Phase 4 N=38 Live Attenuated Influenza Vaccine (LAIV) Versus Trivalent Inactivated Influenza Vaccine in Healthy Adults 18-49 Years
Influenza
Primary: Serum Antibody Responses — 11.76; 11.11; 47.03; 9.33 Titers — p=0.89
N/A N=77 Systems Biology of Zoster Vaccine (ZOSTAVAX®) in Young and Elderly
Shingles
Primary: Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX — 44; 33 participants
Phase 2 N=200 Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Plague, Pneumonic · Plague · Vaccine-Preventable Diseases
Primary: Rates of Reactogenicity and Safety — 16; 67; 57; 0 Participants
Phase 3 N=125 Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults, Aged 18 Years and Above
Human Influenza
Primary: Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf — 17; 36; 95; 80…
Phase 2 N=469 Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged 18-64 Years
Influenza
Primary: Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. — 43; 121; 109; 57…
Phase 3 N=5,712 A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
Meningitis, Meningococcal
Primary: Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study — 1.55; 2.52 percentage of participants
Phase 2 N=601 Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above
Influenza
Primary: To Demonstrate the Equivalence of Antibody Response Against A/H5N1 Strain Elicited by the Three Different Immunization Schedules on Day 43. — 4.64; 4.10; 4.61; 14 Area…
Phase 2 N=406 Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
Influenza
Primary: Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) — 0; 0 Participants
Phase 1 N=46 Study to Evaluate the Safety, Tolerability and Immunogenicity of a Potential Enteric Fever Vaccine
Enteric Fever
Primary: Number of Participants With Treatment Emergent Adverse Events — 4; 9; 8; 9 Participants