Infectious Disease Clinical Trials

Statistical methods in infectious disease trials

The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.

All infectious disease trials

609 results

• A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 3Results postedn = 629NCT04816669
• A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1)…Phase 3Results postedn = 109NCT03227861
• A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor: primary endpoint results,…Phase 2Results postedn = 150NCT01974206
• A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation: primary endpoint results, effect…Phase NAResults postedn = 199NCT06660069
• A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals’ Candidate Malaria Vaccine Administered to Previously Vaccinated Healthy Malaria-naïve Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Efficacy, Immunogenicity and Safety in a Sporozoite Challenge Model of a Fractional Booster Dose of GSK Biologicals' Candidate Malaria Vaccine Administered to Previously…Phase 2Results postedn = 61NCT03824236
• A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults: primary endpoint results, effect estimate…Phase 2Results postedn = 71NCT03527173
• A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age: primary endpoint results, effect…Phase 3Results postedn = 2,278NCT02545543
• A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.: primary endpoint results,…Phase 3Results postedn = 2,250NCT02914275
• A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123): Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123): primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 1Results postedn = 21NCT01396005
• A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years of Age: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety and Immune Response of mRNA-1345, a Vaccine Targeting Respiratory Syncytial Virus (RSV), When Co-administered With a Fluzone HD, in Adults ≥65 Years…Phase 3Results postedn = 1,900NCT06060457
• A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009): Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009): primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 354NCT01527383
• A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety and Immunogenicity of mRNA-1975 and mRNA-1982 Against Lyme Disease in Participants 18 Through 70 Years of Age: primary endpoint results, effect estimate…Phase 1/2Results postedn = 807NCT05975099
• A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED): Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis (V710-005)(COMPLETED): primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 206NCT00572910
• A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 1Results postedn = 33NCT03446053
• A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar: Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the rSm-p80 + GLA-SE (SchistoShield®) Candidate Vaccine in Healthy Adults in Burkina Faso and Madagascar: primary endpoint results,…Phase 1Results postedn = 120NCT05762393
• A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008): Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008): primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 1,051NCT02987972
• A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM): Complete Statistical AnalysisIndependent statistical analysis of A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM): primary endpoint results, effect estimate with confidence interval, sample-size…Phase 3Results postedn = 277NCT03565900
• A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults: Complete Statistical AnalysisIndependent statistical analysis of A Study to Find the Dose and Assess the Immune Response and Safety of a Vaccine Against Influenza in Healthy Younger and Older Adults: primary endpoint results, effect…Phase 2Results postedn = 845NCT06431607
• A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate…Phase 1Results postedn = 60NCT05763576
• A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection: Complete Statistical AnalysisIndependent statistical analysis of A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C…Phase 2Results postedn = 41NCT02421211
• A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age: Complete Statistical AnalysisIndependent statistical analysis of A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to…Phase 1Results postedn = 20NCT06354257
• A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.: Complete Statistical AnalysisIndependent statistical analysis of A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 2/3Results postedn = 243NCT04494984
• A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function: Complete Statistical AnalysisIndependent statistical analysis of A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal…Phase 1Results postedn = 29NCT00759564
• A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals: Complete Statistical AnalysisIndependent statistical analysis of A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 2/3Results postedn = 1,051NCT05997290
• A Study to Test GlaxoSmithKline’s (GSK) Herpes Zoster (HZ) Subunit Vaccine’s Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response: Complete Statistical AnalysisIndependent statistical analysis of A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses…Phase 3Results postedn = 68NCT04176939
• A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED): Complete Statistical AnalysisIndependent statistical analysis of A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 1Results postedn = 290NCT00696709
• A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine: Complete Statistical AnalysisIndependent statistical analysis of A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01665807).Phase 4Results postedn = 868NCT01665807
• A Trial of GC4419 in Patients With Critical Illness Due to COVID-19: Complete Statistical AnalysisIndependent statistical analysis of A Trial of GC4419 in Patients With Critical Illness Due to COVID-19: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 16NCT04555096
• A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older: Complete Statistical AnalysisIndependent statistical analysis of A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 4Results postedn = 1,564NCT00457249
• A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS: Complete Statistical AnalysisIndependent statistical analysis of A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS: primary…Phase 2Results postedn = 151NCT04258995
• AAINTVAPIndependent statistical analysis of Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02478710).Phase 4Results postedn = 16NCT02478710
• ABATEIndependent statistical analysis of Active Bathing to Eliminate Infection (ABATE Infection) Trial: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02063867).Phase NAResults postedn = 53NCT02063867
• ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study: Complete Statistical AnalysisIndependent statistical analysis of ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 4Results postedn = 31NCT01535235
• Acetaminophen Before Vaccines for Infants Study (AVIS): Complete Statistical AnalysisIndependent statistical analysis of Acetaminophen Before Vaccines for Infants Study (AVIS): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00325819).Phase 3Results postedn = 374NCT00325819
• ACTG 076Independent statistical analysis of ACTG 076, a phase 3 study of zidovudine in HIV-infected pregnant women and their infants, including trial design, statistical methodology, planned analysis, limitations, and interpretation.Phase 3n = 1,496NCT00000960
• ACTG 175A statistical review of ACTG 175, a randomized, double-blind phase II trial of monotherapy versus combination therapy with nucleoside analogs in HIV-infected persons with CD4 cells of 200-500/mm3.Phase 2n = 2,100NCT00000625
• ACTG 193AAn independent statistical analysis of ACTG 193A, a randomized, double-blind, four-arm phase 2 study comparing nucleoside treatment strategies for advanced HIV disease with CD4 ≤50/mm3.Phase 2n = 1,292NCT00000781
• ACTG 320An educational statistical analysis of ACTG 320, a phase 2 study of abacavir sulfate plus indinavir sulfate plus efavirenz in HIV-infected patients, including its registry design, endpoints, planned statistical analysis, and methodological…Phase 2n = 300NCT00001086
• ACTG 384An independent statistical analysis of ACTG 384, a double-blind study evaluating various combinations of anti-HIV medications for early HIV infection, including its design, endpoints, planned statistical approach, and interpretation.Phase NAn = 900NCT00000919
• ACTG 388An independent statistical analysis of ACTG 388, a randomized factorial trial evaluating simplified drug regimens in patients with HIV infection. The page explains the factorial design, planned statistical framework, endpoints reported in…Phase NAn = 240NCT00014937
• ACTIV-6: COVID-19 Study of Repurposed Medications: Complete Statistical AnalysisIndependent statistical analysis of ACTIV-6: COVID-19 Study of Repurposed Medications: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04885530).Phase 3Results postedn = 10,956NCT04885530
• ACTIVATEIndependent statistical analysis of A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 4Results postedn = 93NCT01364090
• Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002): Complete Statistical AnalysisIndependent statistical analysis of Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 1Results postedn = 12NCT03188523
• ACTT-3Independent statistical analysis of ACTT-3, the phase 3 randomized trial of remdesivir plus interferon beta-1a versus remdesivir plus placebo in COVID-19, including time-to-recovery, subgroup hazard ratios, safety, and statistical interpretation.Phase 3Results postedn = 969NCT04492475
• ACURASYSAn independent statistical analysis of ACURASYS (NCT00299650), a randomized, quadruple-masked phase 4 trial evaluating systematic early use of neuromuscular blocking agents in patients with ARDS.Phase 4n = 340NCT00299650
• Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates: Complete Statistical AnalysisIndependent statistical analysis of Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 3Results postedn = 46NCT00031460
• Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda: Complete Statistical AnalysisIndependent statistical analysis of Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 440NCT00405821
• Ad26.COV2.SIndependent statistical analysis of the phase 3 Ad26.COV2.S trial in healthy adults for COVID-19 prevention, including randomized design, influenza and SARS-CoV-2 immunogenicity endpoints, ANOVA, geometric mean ratios, non-inferiority, confidence intervals, and safety.Phase 3Results postedn = 861NCT05091307
• Adaptation Of An HPV Education Resource To Promote HPV Vaccination: Complete Statistical AnalysisIndependent statistical analysis of Adaptation Of An HPV Education Resource To Promote HPV Vaccination: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04974619).Phase NAResults postedn = 155NCT04974619
• Addressing the Continuum of Care Among High-risk Thai Men: Complete Statistical AnalysisIndependent statistical analysis of Addressing the Continuum of Care Among High-risk Thai Men: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05161689).Phase NAResults postedn = 636NCT05161689

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