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Biotechnology - Biotech Clinical Trials

10:25 EDT 20th September 2017 | BioPortfolio

Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.

RESULT: Reliable, Emergent Solution Using Liprotamase Treatment

Liprotamase powder is a non-porcine, soluble and stable mixture of biotechnology-derived lipase, protease, and amylase digestive enzymes. The purpose of the present study is to to evaluate the non-inferiority of liprotamase compared with porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT). The primary efficacy endpoint of the study will be compa...

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)(the Chronic Hepatitis B Patients )

This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in the chronic Hepatitis B patients on the clinical stability and aged over 30 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscula...

Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant

Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to cytosol. This research study is evaluating the use of the...

A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose...

A Phase III Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind, parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 3-6 months in China.

A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial

This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may pro...

Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C ...

A Pilot Scheme - Specimen Collection of Health Management Center

Biomedical and biotechnology industry is internationally regarded as the most brilliant star performer of the future. The development of biomedical depends on a high quality academic research environment, while innovation and uniqueness should be emphasized for the development of biotechnology industry. The successful development of biotechnology industry will be impossible...

Safety and Immunogenicity Study of a Virosomal Vaccine Against Recurrent Vulvovaginal Candida Infection

Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis (VVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is designed to evaluate the safety and tolerability of the vaccine, administered by two different routes (...

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fasting Condition

The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fasting conditions, and to assess the bioequivalence.

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition

The objective of the study is to compare the bioavailability and characterise the pharmacokinetic profile of Mycophenolate mofetil 250 mg capsules Panacea Biotech Ltd, India and Cellcept® 250 mg capsules Mycophenolate mofetil capsule, Roche Labs Inc. New Jersey, USA in normal, healthy, adult human subjects under fed conditions, and to assess the bioequivalence.

Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream

Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mil...

Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old

This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10^4.0, 10^5.0 and 10^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 ...

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