Phase 3 N=304 Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
Japanese Encephalitis
Primary: Primary: 1. Geometric Mean Titers (GMT) at Day 56 — 100.1; 84.7; 68.1 Geometric Mean Titer - Estimate
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=300 Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Japanese Encephalitis · Hepatitis A
Primary: Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection — 15; 13; NA; NA…
Phase 3 N=75 Evaluate the Immunogenicity of a Novel Glucagon Formulation
Drug-specific Antibodies · Diabetes Mellitus
Primary: Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA) — 0; 2.0 percentage of participants
Phase 4 N=120 Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
Influenza Prophylaxis
Primary: Change in Geometric Mean Titre Ratio, A/H1N1 Strain — 3.13; 3.17 Ratio of Day 0 and Day 21-28 titres
Phase 3 N=867 Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Primary: SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 — 96.4; 93.6 percentage of participants
Phase 1 N=420 Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
Influenza
Primary: Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains. — 21.4; 22.2; 23.3; 18.4 Titer
N/A N=150 Gardasil Immunogenicity With Needle-Free Injection
HPV Seroconversion
Primary: Number of Participants With Geometric Mean Antibody Concentrations by HPV Type — 15; 12; 8; 4 Participants
Phase 3 N=27 Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles
Oocyte Donation
Primary: Number of Patients Producing Anti-FSH Antibodies. — 0 participants
Phase 3 N=310 Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Hepatitis B · Polio · Diphtheria
Primary: Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines…
Phase 2 N=729 Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Influenza · Orthomyxoviruses · Myxovirus Infection
Primary: Summary of the Pre- and Post-Vaccination Geometric Mean Titers (GMTs) for Each of the Influenza Vaccine Antigens. — 25.9; 26.4; 26.6; 184.8 Titers
N/A N=3,258 Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
Japanese Encephalitis
Primary: Percentage of Subjects With Seroconversion Rate (SCR) ≥ 1:10 Anti-JEV Neutralizing Antibody Titer (PRNT) — 81.8 percentage of subjects
Phase 4 N=59 Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
Rabies
Primary: Protective Humoral Immune Response at 1 Month Post First Vaccination. — 12; 12; 12; 11 Participants
Phase 4 N=389 Immunogenicity of the Booster Dose of Two MenC Vaccines
Meningococcal Infection
Primary: Serum Bactericidal Activity Against MenC — 6786; 6278; 2061; 1746 GMTs
Phase 4 N=182 Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults
Hepatitis B Vaccine
Primary: Number and Percentage of Participants With Anti-HBs Seroconversion at Month 7 — 75; 69 Participants
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 3 N=440 Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
Influenza
Primary: Geometric Mean Titer — 3.36; 2.61; 2.46; 2.41 GMT fold increase from baseline
Phase 4 N=31 Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Blood Loss, Surgical
Primary: Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 — 0; 0 Participants
Phase 3 N=440 Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
Influenza
Primary: Immunogenicity - Geometric Mean Titer Fold Increase From Baseline — 3.5; 4.0; 4.5; 3.4 GMT fold increase
Phase 3 N=4,648 Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok
Influenza
Primary: Number of Participants Reporting Solicited Injection Site (Local) Reactions — 1421; 2050; 797; 177 Participants
Phase 3 N=750 Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
Poliomyelitis
Primary: Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity — 187; 179; 175; 149 Participants
Phase 2 N=113 Natalizumab High Titer Immunogenicity and Safety
Multiple Sclerosis
Primary: Number of Participants With Anti-Natalizumab Antibody Negative, Transient Positive, and Persistent Positive Status — 96; 3; 9 participants
Phase 4 N=138 Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
Breast Cancer
Primary: Comparison of Cumulative Incidence of Anti-pegfilgrastim Antibodies (Binding and Neutralizing) to Pegfilgrastim Between Treatment Groups at the End of Cycle 4 (Day 84)…
Phase 2 N=29 Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune Adults
Dengue Fever
Primary: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes at Day 15 — 58.9; 15325.2; 5510.0; 11.2 titer
Phase 2 N=43 Immunogenicity of H5N1 Vaccine Following H5N2
Influenza Vaccine
Primary: Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated…
Phase 4 N=50 Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Encephalitis
Primary: Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination — 9144 titers
Phase 3 N=120 Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents
Human Influenza
Primary: Increase in Geometric Mean Titre Ratio, A/H1N1 Strain — 4.337; 4.702 Ratio of Day 0 and Day 21-28 titres
N/A N=27 Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Systemic Lupus Erythematosus
Primary: Anti-HPV 6 Seroconversion — 93.8 percentage of participants
Phase 3 N=1,607 Immunogenicity and Safety of Sci-B-Vac® to Engerix-B® in Adults
Hepatitis B Vaccines
Primary: Seroprotection Rate (SPR) Defined as Percentage of Adults ≥ 18 Years Old Achieving Anti-HBs Levels of ≥10 mIU/mL in Serum at Study Day 196 — 76.49; 91.36 percentage of…
Phase 3 N=100 Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
Encephalitis
Primary: Rate of Subjects With Serious Adverse Events (SAEs) and Medically Attended AEs up to Day 56 After the First Vaccination — 33.3; 20.7; 3.4 percentage of participants
Phase 4 N=162 The Immunogenicity of Simultaneous Administration of Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Vaccine
Pneumococcal Pneumonia · Influenza
Primary: The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody. — 63; 59 Participants