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

• (EPOC)Independent statistical analysis of Evaluation of Point-of-Care (EPOC) for COVID-19: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT05227404).Phase NAResults postedn = 330NCT05227404
• 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants: Complete Statistical AnalysisIndependent statistical analysis of 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 3Results postedn = 1,997NCT04382326
• 3MVIndependent statistical analysis of Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 1/2Results postedn = 341NCT00137631
• 4 Pillars Toolkit for Adolescent Vaccination: Complete Statistical AnalysisIndependent statistical analysis of 4 Pillars Toolkit for Adolescent Vaccination: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT02165722).Phase NAResults postedn = 22NCT02165722
• A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB): Complete Statistical AnalysisIndependent statistical analysis of A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB): primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 37NCT01859923
• A Challenge Study to Assess the Safety, Immunogenicity and Efficacy of a Malaria Vaccine Candidate: Complete Statistical AnalysisIndependent statistical analysis of A Challenge Study to Assess the Safety, Immunogenicity and Efficacy of a Malaria Vaccine Candidate: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 1/2Results postedn = 88NCT02927145
• A Clinical Trial of CSL’s 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children: Complete Statistical AnalysisIndependent statistical analysis of A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 2Results postedn = 370NCT00940108
• A Clinical Trial of CSL’s 2010/2011 Formulation of Enzira® in a Healthy Adult Population: Complete Statistical AnalysisIndependent statistical analysis of A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 4Results postedn = 120NCT01113580
• A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions: Complete Statistical AnalysisIndependent statistical analysis of A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo…Phase 3Results postedn = 333NCT03843541
• A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV: Complete Statistical AnalysisIndependent statistical analysis of A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With…Phase 1Results postedn = 20NCT05828095
• A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS: Complete Statistical AnalysisIndependent statistical analysis of A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase NAResults postedn = 300NCT05372575
• A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis: Complete Statistical AnalysisIndependent statistical analysis of A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase NAResults postedn = 128NCT00921895
• A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers: Complete Statistical AnalysisIndependent statistical analysis of A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration,…Phase 1Results postedn = 140NCT01542632
• A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults: Complete Statistical AnalysisIndependent statistical analysis of A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 1Results postedn = 28NCT04661839
• A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection: Complete Statistical AnalysisIndependent statistical analysis of A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection: primary endpoint results, effect estimate with confidence…Phase 2Results postedn = 35NCT00720434
• A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine: Complete Statistical AnalysisIndependent statistical analysis of A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT04669691).Phase 2Results postedn = 420NCT04669691
• A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area: Complete Statistical AnalysisIndependent statistical analysis of A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area: primary…Phase 1Results postedn = 75NCT03548064
• A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants: Complete Statistical AnalysisIndependent statistical analysis of A Double-Blind Single-Ascending Dose (SAD) and Multiple-Ascending Dose (MAD) Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7049389 in Healthy Chinese Participants: primary endpoint results, effect estimate…Phase 1Results postedn = 31NCT03570658
• A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals’ Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults: Complete Statistical AnalysisIndependent statistical analysis of A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su)…Phase 3Results postedn = 7,539NCT02723773
• A Multi-dose Study of ARC-520 in Patients With Hepatitis B ‘e’ Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection: Complete Statistical AnalysisIndependent statistical analysis of A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 2Results postedn = 32NCT02604212
• A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold: Complete Statistical AnalysisIndependent statistical analysis of A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 2Results postedn = 146NCT01883453
• A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®: Complete Statistical AnalysisIndependent statistical analysis of A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT01913353).Phase 3Results postedn = 440NCT01913353
• A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 1/2Results postedn = 122NCT03678688
• A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age: Complete Statistical AnalysisIndependent statistical analysis of A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years…Phase 2Results postedn = 365NCT03170609
• A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Clinical Trial of VLA1553 in Healthy Children Aged 1 to 11 Years: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 2Results postedn = 304NCT06106581
• A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 388NCT05412030
• A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2, Muti-Center Study of Repeat Dosing of Squaric Acid Dibutyl Ester in Subjects With Herpes Labialis: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 40NCT03521479
• A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma: primary endpoint results, effect estimate with confidence interval,…Phase 2Results postedn = 11NCT00590720
• A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1: Complete Statistical AnalysisIndependent statistical analysis of A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)Ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1…Phase 2Results postedn = 105NCT00823979
• A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1): primary endpoint results, effect estimate…Phase 3Results postedn = 352NCT03927716
• A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results…Phase 3Results postedn = 147NCT03935217
• A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants:…Phase 3Results postedn = 1,574NCT04713553
• A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine): Complete Statistical AnalysisIndependent statistical analysis of A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 3Results postedn = 3,258NCT05072080
• A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults: Complete Statistical AnalysisIndependent statistical analysis of A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults: primary endpoint results, effect estimate with confidence interval,…Phase 3Results postedn = 18NCT01478347
• A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis: Complete Statistical AnalysisIndependent statistical analysis of A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis: primary endpoint results, effect estimate with confidence interval, sample-size planning…Phase 2Results postedn = 632NCT00316602
• A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients: Complete Statistical AnalysisIndependent statistical analysis of A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on…Phase 3Results postedn = 183NCT01292239
• A Phase III Study to Assess the Lot-to-lot Consistency of GSK’s Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK’s Influenza D-QIV Vaccine in Healthy Non-pregnant Women.: Complete Statistical AnalysisIndependent statistical analysis of A Phase III Study to Assess the Lot-to-lot Consistency of GSK's Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone…Phase 3Results postedn = 1,586NCT05045144
• A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM: Complete Statistical AnalysisIndependent statistical analysis of A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase NAResults postedn = 82NCT03432819
• A Pilot Study of Daptomycin for Antimicrobial Prophylaxis: Complete Statistical AnalysisIndependent statistical analysis of A Pilot Study of Daptomycin for Antimicrobial Prophylaxis: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT00572260).Phase 4Results postedn = 11NCT00572260
• A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery: Complete Statistical AnalysisIndependent statistical analysis of A Pilot Study Of Smoking Cessation Treatment Including Varenicline In Patients Scheduled For Planned Surgery: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase 4Results postedn = 16NCT00889720
• A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.: Complete Statistical AnalysisIndependent statistical analysis of A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical…Phase NAResults postedn = 42NCT00976950
• A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors: Complete Statistical AnalysisIndependent statistical analysis of A Post-Market Clinical Follow Up Study to Evaluate BD PureHub™ Disinfecting Cap Use on Needle-Free Connectors: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase NAResults postedn = 157NCT05130762
• A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study): Complete Statistical AnalysisIndependent statistical analysis of A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study): primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 3Results postedn = 143NCT01892345
• A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations: Complete Statistical AnalysisIndependent statistical analysis of A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety,…Phase NAResults postedn = 611NCT01039584
• A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults: Complete Statistical AnalysisIndependent statistical analysis of A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and…Phase 3Results postedn = 644NCT01680016
• A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women: Complete Statistical AnalysisIndependent statistical analysis of A Reinforcement Intervention for Increasing HIV Testing Among At-Risk Women: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov results (NCT03768986).Phase NAResults postedn = 364NCT03768986
• A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients: Complete Statistical AnalysisIndependent statistical analysis of A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients: primary endpoint results, effect estimate with confidence…Phase 3Results postedn = 119NCT01330316
• A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.: Complete Statistical AnalysisIndependent statistical analysis of A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.: primary endpoint results, effect estimate with confidence interval, sample-size…Phase 3Results postedn = 206NCT03571607
• A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia: Complete Statistical AnalysisIndependent statistical analysis of A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based…Phase 2Results postedn = 146NCT00515034
• A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia: Complete Statistical AnalysisIndependent statistical analysis of A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia: primary endpoint results, effect estimate with confidence interval, sample-size planning illustration, and safety, based on ClinicalTrials.gov…Phase 3Results postedn = 969NCT01808092

← All therapeutic areas