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NCT ID: NCT01635647 Completed - Malaria Clinical Trials

A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

Start date: November 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

NCT ID: NCT01619878 Completed - Clinical trials for Acute Uncomplicated Falciparum Malaria

Efficacy, Safety and Pharmacokinetics of Artemether-lumefantrine Dispersible Tablet in the Treatment of Malaria in Infants < 5 kg

Start date: October 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.

NCT ID: NCT01603251 Completed - Malaria Clinical Trials

Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission

ACTIVE
Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.

NCT ID: NCT01577771 Completed - Clinical trials for Pneumococcal Infections

Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso

PCV13-Bobo
Start date: February 2013
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination. The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).

NCT ID: NCT01517230 Completed - Malaria Clinical Trials

Can Mass Media Campaigns Reduce Child Mortality

Start date: March 2012
Phase: N/A
Study type: Interventional

A cluster-randomised trial will be undertaken in Burkina Faso to investigate whether a comprehensive mass media campaign using local radio stations can change behaviours on a scale large enough to result in measurable and sustainable reductions in under-five child mortality. It is hypothesised that as a result of the scale and multi-pronged nature of the campaign, reductions of between 10% and 20% in child mortality will be achieved.

NCT ID: NCT01506648 Completed - Bioavailability Clinical Trials

Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

Start date: January 2011
Phase: N/A
Study type: Observational

Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study

NCT ID: NCT01407887 Completed - Clinical trials for Uncomplicated Falciparum Malaria

Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Start date: August 2011
Phase: Phase 2
Study type: Interventional

Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Phase: Phase II. Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen. Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso. Sample size: 180 patients (90 per study arm).

NCT ID: NCT01345240 Completed - Malaria Clinical Trials

Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

Start date: November 17, 2011
Phase: Phase 3
Study type: Interventional

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

NCT ID: NCT01331811 Completed - HIV Clinical Trials

Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)

Start date: April 2011
Phase: N/A
Study type: Interventional

Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children. The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as: - interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test - alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate - the Xpert MTB/RIF assay

NCT ID: NCT01258049 Completed - Clinical trials for Plasmodium Falciparum Malaria

Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by >= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications