Clinical trials: System Safety
Contraception
Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.
- Trial name
- NCT01181479
- Testing
- AG200-15 (cycles 1-13), Lessina crossover to AG200-15
- Where
- 80 sites in United States
- Volunteers
- 1,504 people, healthy volunteers welcome
- Sponsor
- Agile Therapeutics
Diphtheria, Tetanus
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT04073459
- Testing
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Systemic Lupus, Sjogren's Syndrome
Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases
Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B.
- Trial name
- NCT03540823
- Testing
- Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)
- Where
- Brazil
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Hepatitis B
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine.
- Trial name
- NCT00366366
- Testing
- Infanrix-Hexa
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dermatitis, Atopic
Intervention Study to Evaluate a Probiotic in Mild Atopic Dermatitis Young Patients
The aim of the study is to evaluate the beneficial effect of a probiotic preparation with an antiinflammatory and modulating activity on immunological processes, with positive results on different inflammatory and atopic…
- Trial name
- NCT02585986
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Biopolis S.L.
Japanese Encephalitis, Chickenpox
Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine…
- Trial name
- NCT01815073
- Testing
- Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine, Live Attenuated Varicella Vaccine, live attenuated JE vaccine
- Where
- China
- Volunteers
- 497 people, healthy volunteers welcome
- Sponsor
- Changchun Keygen Biological Products Co., Ltd.
Malaria,Falciparum, Feasibility
Malaria Vaccine Pilot Evaluation
The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya.
- Conditions
- Malaria,Falciparum, Feasibility, Safety, Mortality
- Trial name
- MVPE (NCT03806465)
- Testing
- Feasibility survey, Sentinel hospital surveillance, Community mortality surveillance
- Where
- 3 sites in Ghana, Kenya and 1 more
- Volunteers
- 30,124 people, healthy volunteers welcome
- Sponsor
- Rafiq OKINE
Infections, Meningococcal
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose…
- Trial name
- NCT00718666
- Testing
- Meningococcal vaccine GSK134612
- Where
- 14 sites in United States
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim™ in an Indian Population
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose…
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis
- Trial name
- NCT00259337
- Testing
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Where
- India
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Sanofi
Safety Issues, Effect of Drugs
The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury
- Trial name
- NCT03696745
- Testing
- autologous umbilical cord blood stem cells, 0.9% Sodium-chloride
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Guangdong Women and Children Hospital
Poliomyelitis
Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV
With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) are required to use in the "Strategy…
- Trial name
- NCT03614702
- Testing
- 1-dose cIPV + 2-doses bOPV (Candy), 1-dose sIPV + 2-doses bOPV (Candy), 2-doses cIPV + 1-dose bOPV (Candy)
- Where
- China
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Institute of Medical Biology, Chinese Academy of Medical Sciences
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).
- Trial name
- NCT00779779
- Testing
- Rotarix™
- Where
- Sri Lanka
- Volunteers
- 522 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV-1, HIV Infections
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.
- Trial name
- PedVacc001 (NCT00982579)
- Testing
- MVA.HIVA
- Where
- The Gambia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Medical Research Council
Encephalitis, Tick-borne
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers…
- Trial name
- NCT00161876
- Testing
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Where
- 8 sites in Poland
- Volunteers
- 3,973 people, healthy volunteers welcome
- Sponsor
- Pfizer
Meningitis, Meningococcal
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease…
- Trial name
- NCT05087056
- Testing
- MenABCWY vaccine
- Where
- 30 sites in United States, Germany
- Volunteers
- 305 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Allergic Rhinitis
3 Month Safety Study of Dymista Nasal Spray and Fluticasone Propionate in Children 4-11 Years of Age With Allergic Rhinitis
This is a 3 month safety study of Dymista Nasal spray in children aged 4 to 11 years with allergic rhinitis
- Trial name
- NCT01794741
- Testing
- Dymista Nasal Spray, Fluticasone propionate nasal spray
- Where
- 41 sites in United States
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- Meda Pharmaceuticals
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
- Trial name
- NCT06741397
- Testing
- CAB LA, New formulation of CAB LA
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Japanese Encephalitis, Varicella
Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV
The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in…
- Trial name
- NCT01190228
- Testing
- JE-CV Vaccine, Varicella Vaccine
- Where
- Philippines
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Pediatric Obstructive Sleep Apnea Syndrome
Investigating the Safety of Post-surgical Analgesics in Children With Obstructive Sleep Apnea
Every year thousands of young children with obstructive sleep apnea undergo surgery which requires them to be prescribed pain medication.
- Trial name
- NCT01680939
- Testing
- Morphine, Ibuprofen
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Hamilton Health Sciences Corporation
Poliomyelitis
Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation
The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of…
- Trial name
- SCOPE (NCT06895486)
- Testing
- Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 2 (nOPV2)
- Where
- 3 sites in Panama
- Volunteers
- 675 people, healthy volunteers welcome
- Sponsor
- PATH