Phase 4 N=66 An Alternate Dosing Schedule for Pentavalent Rotavirus Vaccine (RotaTeq)
Diarrhea · Gastroenteritis
Primary: G1 Serum-neutralizing Antibody — 188; 184.5 titers
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Phase 4 N=456 Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana
Rotavirus Gastroenteritis
Primary: Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules — 28.9; 43.4 percentage of participants — p=0.014
Phase 2 N=246 Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis
Lyme Borreliosis
Primary: GMTs for IgG Against Each OspA Serotype — 278.5; 274.7; 21.0; 545.2 Units per milliliter (U/mL)
Phase 4 N=72 Alternate Dosing Schedules Study for HPV Vaccine
Cervical Cancer · Genital Warts
Primary: Pain Following HPV Vaccine — 17; 32 participants
Phase 2 N=1,551 ProQuad Dose Selection Study (V221-011)(COMPLETED)
Measles · Mumps · Rubella
Primary: Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units — 198; 299; 253; 303 Participants
Phase 3 N=644 A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Rabies
Primary: Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC…
Phase 4 N=353 A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Hepatitis B
Primary: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults — 1847.99; 839.27; 1244.8 mIU/ml — p=<0.05
N/A N=200 Randomized Trial of Alternative Quadrivalent Human Papilloma Virus (HPV) Vaccination Schedules in a University Setting
Human Papillomavirus Infection
Primary: Geometric Mean Antibody Titers Following the Third Dose of Human Papilloma Virus (HPV) Vaccine by Virus Type and by Administration Schedule — 1894; 4221; 1773; 5623…
Phase 4 N=95 SCHEDULE Follow Up Visit 5-7 yr
Heart Transplantation
Primary: Measured Glomerular Filtration Rate (mGFR) — 74.7; 62.4 mL/min/1.73m2 — p=0.0043
Phase 2 N=154 Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
Malaria
Primary: Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls — 9; 5; 8…
Phase 2 N=168 A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Anthrax
Primary: Toxin Neutralizing Antibody (TNA) Level at Day 63 — 56.8; 100; 100; 90.2 percentage of participants
Phase 2 N=1,800 Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Participants
Dengue Fever
Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity…
Phase 2 N=1,050 Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age
Dengue Fever · Dengue Hemorrhagic Fever
Primary: STAGE-I: Geometric Mean Titers (GMTs) Against Each Dengue Virus Serotype 28 Days After Last CYD Dengue Vaccination in Participants Who Were Seropositive at Baseline…
Phase 2 N=1,500 Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
Malaria
Primary: Incidence of Clinical Malaria Meeting the Primary Case Definition — 0.45; 0.36 events per person-year — p=0.154
Phase 1 N=140 A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
Healthy
Primary: Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported — 25; 25; 24; 21 participants
Phase 2 N=333 Dose Comparison Study of Menactra® in US Children
Meningitis · Meningococcal Infection · Neisseria Meningitidis
Primary: Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination — 59; 36; 65; 83 Percentage of Participants
Phase 3 N=385 Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Neisseria Meningitidis · Bacterial Infections · Virus Diseases
Primary: Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL — 98.9 Percentage of Participants
Phase 3 N=1,447 Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
Infections, Papillomavirus
Primary: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and…
Phase 2 N=855 A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Clostridium Difficile Associated Disease
Primary: Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 — 12.5; 68.4; 85.5 percentage of participants
Phase 2 N=390 Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine
Dengue · Dengue Fever · Dengue Hemorrhagic Fever
Primary: Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2 — 5.38…
Phase 3 N=267 Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Influenza
Primary: Seroprotection Rate Infants (6-11 Months)-A/Brisbane/59/07(H1N1) — 41; 34 participants
Phase 4 N=250 Immunogenicity and Safety of Rabies Vaccine, Administered With Two Different Simulated Post Exposure Schedules
Rabies
Primary: Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14 — 0.09; 0.099; 12; 12 IU/mL
Phase 3 N=354 Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older
Herpes Zoster
Primary: Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA). — 110; 104 Subjects
Phase 2 N=60 An Alternative Dosing Schedule of Varenicline for Smoking Cessation
Smoking Cessation
Primary: Change in Smoking Behavior — -6.3; -3.2 Change in Cigarettes Per Day
Phase 3 N=66 A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Major Depressive Disorder
Primary: Number of Subjects With Adverse Events (AEs) — 27; 28 Participants
N/A N=51 Individualized Dosing Schedule of Inhaled Bronchodilator for Endotracheally Intubated COPD Patients
Chronic Obstructive Pulmonary Disease
Primary: ∆Raw (the Difference Between Measured and Target Airway Resistance) — 9; 44 percentage of relative Raw deviation
N/A N=220 Randomized Trial of Alternative HPV Vaccination Schedules in Males in a University Setting
Quadrivalent HPV Vaccine · Human Papillomavirus Vaccine
Primary: Immunogenicity After Dose 3 — 1063; 794; 1961; 1043 mM units/ml
Phase 2 N=162 Dose Finding Study to Treat High Phosphate Levels in the Blood.
Hyperphosphatemia
Primary: Change in Serum Phosphate Levels — -.47; -1.18; -1.7; -1.98 mg/dL — p=0.012
Phase 2 N=123 A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma
Multiple Myeloma
Primary: Percentage of Participants Who Achieved a Complete Response (CR) by International Myeloma Working Group (IMWG) Criteria — 4.9; 12.2; 0 percentage of participants
Phase 4 N=328 Assessment of the Immunogenicity and Safety of a Dose-Sparing BioThrax® AVA Schedule
Bacillus Anthracis (Anthrax)
Primary: Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody…