Clinical Trial Protocol Registry and Library

Design, Analyze, Communicate: Working together to improve clinical study outcomes.

Focusing on research Protocols where the trial sites were located in low- and middle-income countries, this resource includes three ways to access the Protocol Library:

  1. A table of all of the clinical trial protocols included in the Protocol Library
  2. A downloadable Excel registry list of all the clinical trial protocols included in the Protocol Library
  3. The Protocol Library sorted into disease area folders to allow direct access to relevant protocols

Clinical Trial Protocol Registry Table

Use this table to filter the Protocol Library to access specific protocols.

Filter the resources using the dropdown menus. Select a column heading to sort. Click or tap on a row to view the full record

First Principal Investigator Protocol Title Disease/Disease Area Region of Study
Rubhana, Raqib A Phase 1 Randomized, Double-Blinded, Placebo-controlled, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Live Attenuated, Oral Shigella WRSS1 Vaccine in Bangladeshi Toddlers

Link to Protocol

First Principal Investigator
Raqib, Rubhana

Disease/Disease Area
Shigellosis

Region of Study
Asia

Site Countries
Bangladesh

Link to Protocol
Bangladesh

Source of Protocol
clinicaltrials.gov

Approximate Page Count
64

Date of Scientific Journal Publication
19/03/2019

Scientific Journal Publication
A phase I trial of WRSS1, a Shigella sonnei live oral vaccine in Bangladeshi adults and children

Shigellosis Asia
Mauro, Sancovski A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

Link to Protocol

First Principal Investigator
Sancovski, Mauro

Disease/Disease Area
Tdap

Region of Study
South America

Site Countries
Brazil

Link to Protocol
Brazil

Source of Protocol
Clinicaltrials.gov

Approximate Page Count
80

Date of Scientific Journal Publication
20/06/2019

Scientific Journal Publication
Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study

Tdap South America
Firdausi, Qadri A Randomized, Double-blind, Placebo-controlled Study evaluating the safety, tolerability, and immunogenicity of an oral inactivated ETEC Vaccine (ETVAX) alone and together with dmLT adjuvant in descending age groups in Bangladesh

Link to Protocol

First Principal Investigator
Qadri, Firdausi

Disease/Disease Area
E. coli

Region of Study
Asia

Site Countries
Bangladesh

Link to Protocol
Bangladesh

Source of Protocol
Clinicaltrials.gov

Approximate Page Count
65

Date of Scientific Journal Publication
19/11/2019

Scientific Journal Publication
Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial?

E. coli Asia
Nicola, Low Pivotal study to evaluate the immunogenicity and safety of a measles vaccine given by aerosolized inhalation: randomized controlled trial

Link to Protocol

First Principal Investigator
Low, Nicola

Disease/Disease Area
Measles

Region of Study
Asia

Site Countries
India

Link to Protocol
India

Source of Protocol
NEJM

Approximate Page Count
193

Date of Scientific Journal Publication
16/04/2015

Scientific Journal Publication
A Randomized, Controlled Trial of an Aerosolized Vaccine against Measles

Measles Asia
Robert, Heyderman Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial

Link to Protocol

First Principal Investigator
Heyderman, Robert

Disease/Disease Area
Group B Strep

Region of Study
Africa

Site Countries
South Africa, Malawi

Link to Protocol
South Africa, Malawi

Source of Protocol
Lancet

Approximate Page Count
47

Date of Scientific Journal Publication
08/02/2016

Scientific Journal Publication
Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial

Group B Strep Africa
Franco, Piazza A Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in BCG-Vaccinated Healthy Adults

Link to Protocol

First Principal Investigator
Piazza, Franco

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
clinicaltrials.gov

Approximate Page Count
55

Date of Scientific Journal Publication
01/04/2018

Scientific Journal Publication
Safety and immunogenicity of the novel tuberculosis vaccine ID93 + GLA-SE in BCG-vaccinated healthy adults in South Africa: a randomised, double-blind, placebo-controlled phase 1 trial

Tuberculosis Africa
Mark, Hatherill A Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents

Link to Protocol

First Principal Investigator
Hatherill, Mark

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
NEJM

Approximate Page Count
363

Date of Scientific Journal Publication
12/07/2018

Scientific Journal Publication
Prevention of M. tuberculosis Infection with H4:IC31 Vaccine or BCG Revaccination

Tuberculosis Africa
Dawson, Rodney A Phase 2 Open?Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of combinations of bedaquiline, moxifloxacin, PA?824 and pyrazinamide during 8 weeks of treatment in Adult Subjects with Newly Diagnosed Drug?Sensitive or Multi Drug? Resistant, Smear?Positive Pulmonary Tuberculosis.

Link to Protocol

First Principal Investigator
Dawson, Rodney

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
South Africa, Tanzania, Uganda

Link to Protocol
South Africa, Tanzania, Uganda

Source of Protocol
clinicaltrials.gov

Approximate Page Count
112

Date of Scientific Journal Publication
07/12/2019

Scientific Journal Publication
Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial

Tuberculosis Africa
Jennifer, Keiser Efficacy and safety of a single dose regimen and a multi dose regimen of mebendazole against hookworm infections in children: a randomized controlled trial

Link to Protocol

First Principal Investigator
Keiser, Jennifer

Disease/Disease Area
Hookworm

Region of Study
Africa

Site Countries
Tanzania

Link to Protocol
Tanzania

Source of Protocol
clinicaltrials.gov

Approximate Page Count
51

Date of Scientific Journal Publication
01/07/2018

Scientific Journal Publication
Efficacy and Safety of a Single Dose versus a Multiple Dose Regimen of Mebendazole against Hookworm Infections in Children: A Randomised, Double-blind Trial

Hookworm Africa
Carlos, Morillo A randomized double-blind placebo-controlled trial of benznidazole in patients with chronic Chagas<92> heart disease

Link to Protocol

First Principal Investigator
Morillo, Carlos

Disease/Disease Area
Chagas

Region of Study
South America

Site Countries
Brazil

Link to Protocol
Brazil

Source of Protocol
NEJM

Approximate Page Count
74

Date of Scientific Journal Publication
01/10/2015

Scientific Journal Publication
Randomized Trial of Benznidazole for Chronic Chagas<92> Cardiomyopathy

Chagas South America
Xavier, Sez Llorens A Phase II, double-blind, controlled trial to assess the Safety and Immunogenicity of different schedules of Takeda<92>s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and <18 years and living in dengue endemic countries in Asia and Latin America

Link to Protocol

First Principal Investigator
Sez Llorens, Xavier

Disease/Disease Area
Dengue

Region of Study
Multi

Site Countries
Dominican Republic, Panama, Philippines

Link to Protocol
Dominican Republic, Panama, Philippines

Source of Protocol
clinicaltrials.gov

Approximate Page Count
84

Date of Scientific Journal Publication
01/06/2017

Scientific Journal Publication
Safety and immunogenicity of one versus two doses of Takeda’s tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study

Dengue Multi
Gary, Weil Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis in Haiti

Link to Protocol

First Principal Investigator
Weil, Gary

Disease/Disease Area
Filariasis

Region of Study
North America

Site Countries
Haiti

Link to Protocol
Haiti

Source of Protocol
clinicaltrials.gov

Approximate Page Count
67

Date of Scientific Journal Publication
24/06/2019

Scientific Journal Publication
The safety of double- and triple-drug community mass drug administration for lymphatic filariasis: A multicenter, open-label, cluster-randomized study

Filariasis North America
Gary, Weil Community Based Safety and Efficacy Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis in Indonesia

Link to Protocol

First Principal Investigator
Weil, Gary

Disease/Disease Area
Filariasis

Region of Study
Asia

Site Countries
Indonesia

Link to Protocol
Indonesia

Source of Protocol
clinicaltrials.gov

Approximate Page Count
108

Date of Scientific Journal Publication
25/06/2019

Scientific Journal Publication
The safety of double- and triple-drug community mass drug administration for lymphatic filariasis: A multicenter, open-label, cluster-randomized study

Filariasis Asia
Gary, Weil Community Based Safety Study of 2-drug (Diethylcarbamazine and Albendazole) versus 3-drug (Ivermectin, Diethylcarbamazine and Albendazole) Therapy for Lymphatic Filariasis in Papua New Guinea

Link to Protocol

First Principal Investigator
Weil, Gary

Disease/Disease Area
Filariasis

Region of Study
Oceania

Site Countries
Papua New Guinea

Link to Protocol
Papua New Guinea

Source of Protocol
clinicaltrials.gov

Approximate Page Count
90

Date of Scientific Journal Publication
26/06/2019

Scientific Journal Publication
The safety of double- and triple-drug community mass drug administration for lymphatic filariasis: A multicenter, open-label, cluster-randomized study

Filariasis Oceania
Jean, Humphrey Sanitation Hygiene Infant Nutrition Efficacy Project

Link to Protocol

First Principal Investigator
Humphrey, Jean

Disease/Disease Area
Stunting

Region of Study
Africa

Site Countries
Zimbabwe

Link to Protocol
Zimbabwe

Source of Protocol
Lancet

Approximate Page Count
91

Date of Scientific Journal Publication
01/01/2019

Scientific Journal Publication
Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial

Stunting Africa
Maitland, Kathryn TRACT

Link to Protocol

First Principal Investigator
Maitland, Kathryn

Disease/Disease Area
Anemia

Region of Study
Africa

Site Countries
Malawi, Uganda

Link to Protocol
Malawi, Uganda

Source of Protocol
NEJM

Approximate Page Count
194

Date of Scientific Journal Publication
01/08/2019

Scientific Journal Publication
Transfusion Volume for Children with Severe Anemia in Africa

Anemia Africa
Jeremy, Keenan Mortality Reduction After Oral Azithromycin

Link to Protocol

First Principal Investigator
Keenan, Jeremy

Disease/Disease Area
Pneumonia

Region of Study
Africa

Site Countries
Malawi, Niger, Tanzania

Link to Protocol
Malawi, Niger, Tanzania

Source of Protocol
NEJM

Approximate Page Count
183

Date of Scientific Journal Publication
26/04/2018

Scientific Journal Publication
Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa

Pneumonia Africa
Elizabeth, Alexander A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC-3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia

Link to Protocol

First Principal Investigator
Alexander, Elizabeth

Disease/Disease Area
Pneumonia

Region of Study
Multi

Site Countries
Argentina, Brazil, Chile, Mexico, Peru, US, Bulgaria, Georgia, Latvia, Russia, Serbia, Ukraine, Hungary, Poland, Spain, Philippines, South Korea, Taiwan, South Africa

Link to Protocol
Argentina, Brazil, Chile, Mexico, Peru, US, Bulgaria, Georgia, Latvia, Russia, Serbia, Ukraine, Hungary, Poland, Spain, Philippines, South Korea, Taiwan, South Africa

Source of Protocol
JAMA

Approximate Page Count
175

Date of Scientific Journal Publication
27/09/2019

Scientific Journal Publication
Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia The LEAP 2 Randomized Clinical Trial

Pneumonia Multi
Dereck, Tait A phase IIb, double-blind, randomised, placebocontrolled study to evaluate the efficacy, safety, and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine GSK

Link to Protocol

First Principal Investigator
Tait, Dereck

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
Zambia, South Africa, Kenya

Link to Protocol
Zambia, South Africa, Kenya

Source of Protocol
NEJM

Approximate Page Count
387

Date of Scientific Journal Publication
19/12/2019

Scientific Journal Publication
Final Analysis of a Trial of M72/AS01E Vaccine to Prevent Tuberculosis

Tuberculosis Africa
Sara, Suliman A Phase I/IIa Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-negative Adults with and without Latent Tuberculosis Infection

Link to Protocol

First Principal Investigator
Suliman, Sara

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
clinicaltrials.gov

Approximate Page Count
74

Date of Scientific Journal Publication
15/01/2019

Scientific Journal Publication
Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial

Tuberculosis Africa

Downloadable Clinical Trial Protocol Registry

Download the Clinical Trial Protocol Registry to access a detailed Excel spreadsheet of all the publicly available global health protocols included in the Protocol Library and the links to access them.

Protocol Library

The Protocol Library includes publicly available global health trial protocols (sorted into disease area folders).

Human Immunodeficiency Virus

Neglected Tropical Diseases

Tuberculosis

Malaria

Maternal, Newborn, & Child Health

Nutrition

Vaccines

Enteric & Diarrheal Diseases

Pneumonia

Polio

Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.