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NCT ID: NCT05447377 Not yet recruiting - Yellow Fever Clinical Trials

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants

Start date: July 30, 2022
Phase: Phase 3
Study type: Interventional

The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.

NCT ID: NCT05409274 Active, not recruiting - Covid19 Clinical Trials

Understanding COVID-19 Infections in Pregnant Women and Their Babies in 5 African Nations (periCOVID Africa)

Start date: November 1, 2020
Study type: Observational

Develop coronavirus disease 2019 (COVID-19) surveillance in pregnancy in The Gambia, Kenya, Malawi, Mozambique and Uganda Estimate the seroepidemiology of COVID-19 infection among pregnant women in these countries Define the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pregnant women and their babies and determine the presence of antibodies in cord blood Work with communities to develop understanding of infection prevention and control techniques to reduce the spread of COVID-19 amongst the pregnant population

NCT ID: NCT05325125 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Childhood TB Sequel

Start date: March 29, 2022
Study type: Observational

This study aims to describe the long-term adverse outcomes associated with PTB in children, to describe the evolution of these sequelae, and to determine the epidemiological risk factors associated with these sequelae. We will conduct a prospective cohort study. Children who have completed treatment for PTB will be enrolled. The study visit will be performed in the study clinic where clinical assessment, spirometry and radiography will be performed. The planned duration of the study is 36 months. Participant enrolment is estimated to begin in March 2022. Estimated date of last participant enrolled is December 2022.

NCT ID: NCT05190146 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden

Start date: December 20, 2021
Study type: Observational

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.

NCT ID: NCT05117528 Completed - Clinical trials for Microbial Colonization

Streptococcus Pyogenes Carriage Acquisition and Transmission Study

Start date: July 27, 2021
Study type: Observational

Group A Streptococcus (GAS) is a bacteria which causes severe infections and leads to deadly diseases such as rheumatic heart disease which kills over 300,000 people a year globally, particularly in low-income countries. It is not know how GAS is spread between people, how often people carry GAS in their throat or on their skin without having symptoms, or what factors increase the chance of this occurring. It is important to understand these factors in order to know how to reduce GAS-related disease. This study will follow 444 people in The Gambia, over 12 months, taking samples from the throats and skin of people living in the same households, and asking questions about themselves and their behaviour, at regular intervals. By taking samples over time, the investigators hope to understand how common it is to carry GAS without having symptoms, how GAS is spread between people, and whether carrying GAS leads to more GAS infections in people or their household members. The study will use state-of-the-art techniques to look at the DNA of GAS bacteria that we find, and combine this with a mathematical model to investigate how different strains spread to people within and between households in the community.

NCT ID: NCT04751994 Completed - Iron-deficiency Clinical Trials

Iron Babies Pilot Supplementation Trial

Iron Babies
Start date: August 3, 2021
Phase: Phase 3
Study type: Interventional

2-arm, double blind, placebo controlled, randomised trial, with 50 6-week-old infants per arm randomized to 98 days of daily iron (1.5mg/kg/day as ferrous sulphate) or placebo drops

NCT ID: NCT04703608 Recruiting - Covid-19 Clinical Trials

Prevention and Treatment for COVID -19 (Severe Acute Respiratory Syndrome Coronavirus 2 SARS-CoV-2) Associated Severe Pneumonia in the Gambia

Start date: January 22, 2021
Phase: Phase 3
Study type: Interventional

The trial aims to assess the impact of cheap, licenced and widely available investigational products on the natural history of SARS-CoV-2 infection in 2 groups of patients - those with mild or moderate pneumonia (Cohort 1) and those with severe pneumonia (Cohort 2), through randomisation to non-identical placebo or intervention arm.

NCT ID: NCT04424316 Active, not recruiting - Clinical trials for Respiratory Tract Infection

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Start date: June 17, 2020
Phase: Phase 3
Study type: Interventional

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

NCT ID: NCT04394689 Recruiting - Healthy Clinical Trials

Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial

Start date: May 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial. Age de-escalation will be based on a review of the safety data from the preceding cohort (adults for toddlers and toddlers for infants) up to day 14 post study product administration by a data monitoring committee (DMC). All participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) SC injection (PLA-SC) or a placebo-MNP (PLA-MNP) and MRV by the SC route (MRV-SC). Only those study staff randomizing participants and preparing the study products for administration will be aware of the products administered. Those administering the study products, all other trial staff and the participants and parents will be blinded to treatment group. 45 adults (18 to 40-years-of-age) will be randomized in a 2:1 ratio. Thus, 30 adults will receive MRV-MNP and PLA-SC while 15 adults will receive MRV-SC and PLA-MNP. 120 toddlers (15 to 18 months-of-age) will be randomized in a 1:1 ratio. Thus, 60 toddlers will receive MRV-MNP and PLA-SC while the same number of toddlers will receive MRV-SC and PLA-MNP. 120 infants (9 to 10 months) will also be randomized in a 1:1 ratio. Thus, 60 infants will receive MRV-MNP and PLA-SC while the same number of infants will receive MRV-SC and PLA-MNP. Solicited local and systemic AE will be collected daily from all participants from the day of study product administration to day 13 post study product administration. Unsolicited AE and SAE will be collected from the day of study product administration to day 180 post study product administration. All participants will have laboratory investigations (hepatitis B, hepatitis C, hematology and biochemistry) conducted as part of screening. Adults will have safety laboratory investigations repeated on day seven and day 14 post study product administration. Toddlers and infants will have safety laboratory investigations repeated on day seven post study product administration. All participants will have measles- and rubella-specific SNA titers and measles- and rubella-specific IgG concentrations measured at baseline and day 42 and 180 post study product administration. Other Expanded Program on Immunization (EPI) vaccines due in toddler (oral poliovirus vaccine, diphtheria-tetanus-pertussis) and in infants (oral poliovirus vaccine, yellow fever vaccine and MenAfriVac® [due at 12 months]) will be given by the investigator team at the day 42 study visit (V4).

NCT ID: NCT04381936 Recruiting - Clinical trials for Severe Acute Respiratory Syndrome

Randomised Evaluation of COVID-19 Therapy

Start date: March 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

RECOVERY is a randomised trial investigating whether treatment with Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Infliximab, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) prevents death in patients with COVID-19.