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Phase III & IV

Below is a cumulative list of Phase III & IV Trials

Phase 3 & 4 Experience: Publications

A Phase III,

Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of XXXXX compared to flumist in Adults 18 to 49 Years of Age.

A Phase III,

Randomized, Double-blind, Placebo-Controlled 3-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of Live Oral Cholera Vaccine Candidate XXXXX, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR.

A Phase III,

Comparison of the Protective Efficacy of Flublok® Quadrivalent Versus Licensed Inactivated Influenza Vaccine (IIV4) in Healthy, Medically Stable Adults ≥50 Years of Age.

A Phase III,

Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity and the Consistency of Three Consecutive Lots of a XXXXX Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects Aged 65 Years and Older.

A Phase III,

Randomized, Age-stratified, Double Blind, Controlled Study Comparing a Vero Cell-derived Trivalent Seasonal Influenza Vaccine Made by the Modified Manufacturing Process With Vaccine Made by the Current Manufacturing Process and a Licensed Trivalent Influenza Vaccine in Healthy Adults Aged 18 Years and Older.

A Phase III,

Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of XXXXX in Adults 18 to 49 Years of Age.

A Phase III,

Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (XXXXX) Vaccine Given In Healthy Subjects Aged Greater Than Or Equal To 10 To Less Than 26 Years.

A Phase III,

Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study of XXXXX in the Treatment of Recurrent Herpes Labialis.

A Phase III,

Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects.

A Phase III,

8-Week, Parallel Group, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of XXXXX Cream Administered QD in Subjects with Chronic Plaque Psoriasis.

A Phase III,

Multicenter, Open-Label Extension Study of the Long-Term Safety of XXXXX Cream 0.3% in Subjects with Chronic Plaque Psoriasis who have Completed Preceding Studies XXXXX  or XXXXX.

A Phase III,

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (XXXXX) in Subjects with Prurigo Nodularis.

A Phase III,

Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (XXXXX) in Subjects with Moderate-to-Severe Atopic Dermatitis.

A Phase III,

two-year, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. Secukinumab versus placebo, in combination with SoC therapy, in patients with active lupus nephritis.

A Phase IV,

Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB).

A Phase IV,

Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.

A Phase IV,

Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen.

A Phase V,

A Post-Market Surveillance of Tobacco Products: A Multicenter Clinical Trial of Natural Adopters of Cigarettes, Moist Snuff, Camel SNUS, and Dual Use.

               Experience with all phases

                      of Clinical Research

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