Clinical trials: De-escalation
Advanced Non CNS Tumors
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
- Trial name
- NCT02756845
- Testing
- Talimogene Laherparepvec
- Where
- 22 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Fever, Sweats, and Hot Flashes, Infection
Recombinant Human Mannose-Binding Lectin (MBL) in Treating Young Patients With MBL Deficiency and Fever and Neutropenia
RATIONALE: Recombinant human mannose-binding lectin (MBL) may be effective in preventing infection in young patients with fever and neutropenia receiving chemotherapy for blood disease or cancer.
- Conditions
- Fever, Sweats, and Hot Flashes, Infection, Leukemia, Lymphoma
- Trial name
- NCT00886496
- Testing
- recombinant human mannose-binding lectin
- Where
- 3 sites in United States
- Sponsor
- Enzon Pharmaceuticals, Inc.
Measles, Rubella
Measles and Rubella Vaccine Microneedle Patch Phase 1-2 Age De-escalation Trial
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…
- Conditions
- Measles, Rubella, Vaccination, Healthy
- Trial name
- NCT04394689
- Testing
- Measles Rubella Vaccine (MRV-SC), MRV-MNP, PLA-MNP
- Where
- The Gambia
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Micron Biomedical, Inc
Malaria
Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya
This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or…
- Trial name
- NCT02687373
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Kenya
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria Falciparum, Malaria Infection
Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso
This is a first-in-humans randomized, double-blind, placebo-controlled, age de-escalation Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine…
- Trial name
- NCT06652737
- Testing
- PfSPZ-LARC2 Vaccine
- Where
- Burkina Faso
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Monkeypox (Mpox)
Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
- Trial name
- NCT07253675
- Testing
- MVA-SIBP low dose, MVA-SIBP high dose, MVA-BN
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
SARS-CoV-2
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an…
- Trial name
- NCT04796896
- Testing
- mRNA-1273, mRNA-1273.214
- Where
- 91 sites in United States, Canada
- Volunteers
- 11,942 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
Safety and Immunogenicity in Age De-Escalation of PfSPZ Vaccine in Tanzanian Adults, Children, and Infants
The present trial will evaluate safety and tolerability as well as the vaccine-induced humoral and cellular immune responses in healthy Tanzanian adults, adolescents, children, and infants who receive doses of 1.8x10^6, 9.0x10^5…
- Trial name
- NCT02613520
- Testing
- PfSPZ Vaccine, Normal Saline, PfSPZ Challenge (for CHMI)
- Where
- Tanzania
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Salmonella Infections
A Study on the Safety, Reactogenicity, and Immune Response to the GVGH iNTS-GMMA Vaccine Against Invasive Nontyphoidal Salmonella in Adults, Children, and Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-generalized modules for membrane…
- Trial name
- NCT06213506
- Testing
- iNTS-GMMA Dose C, iNTS-GMMA Dose B, iNTS-GMMA Dose A
- Where
- Ghana
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Multidrug Resistant Tuberculosis, Pediatric
Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis
The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.
- Trial name
- NCT01856634
- Testing
- 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid
- Where
- 2 sites in Philippines, South Africa
- Volunteers
- 37 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine…
- Trial name
- NCT01229176
- Testing
- Vi-CRM197 vaccine, Vi Polysaccharide (PS) vaccine, Pneumococcal conjugate vaccine
- Where
- 2 sites in India, Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
Malaria
Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.
This trial will evaluate the safety, tolerability, and immunogenicity of PfSPZ Vaccine in healthy Equatoguinean adults, adolescents, children and infants who receive doses of 0.9x10^6, 1.8x10^6 or 2.7x10^6 PfSPZ Vaccine via…
- Trial name
- NCT02859350
- Testing
- PfSPZ Vaccine, PfSPZ Challenge (for CHMI), Normal Saline
- Where
- Equatorial Guinea
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Respiratory Syncytial Virus, Human Metapneumovirus
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in…
- Trial name
- NCT05743881
- Testing
- mRNA-1345, mRNA-1365, Nimenrix
- Where
- 17 sites in United States, Panama and 1 more
- Volunteers
- 186 people
- Sponsor
- ModernaTX, Inc.