[Translation] Phase I clinical trial to evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in an open-label trial in people over 2 years old and a randomized blinded controlled trial in infants

评价北京科兴生物制品有限公司研制的13价肺炎球菌结合疫苗应用于18-59岁成人、2-11岁儿童、≥60岁老人和42-77天龄婴儿的安全性和免疫原性。

[Translation]

To evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine developed by Beijing Sinovac Biotech Co., Ltd. in adults aged 18-59 years, children aged 2-11 years, elderly people aged ≥60 years, and infants aged 42-77 days.

Start Date-

Sponsor / Collaborator

Sinovac Biotech Co. Ltd.

[+1]

NCT06617715 / Not yet recruitingPhase 3

A Phase Ⅲ Clinical Study to Evaluate the Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) in Healthy Infants

A Phase Ⅲ clinical trial of 13-valent pneumococcal conjugate vaccine (PCV13) developed by Sinovac Life Science Co., Ltd will be conducted in pediatric population aged 2 months (minimum 6 weeks)-5 years (before 6th birthday). The objective of the study is to evaluate the immunogenicity and safety of Sinovac PCV13.

Start Date12 Oct 2024

Sponsor / Collaborator

Beijing Kexing Zhongwei Biotech Co. Ltd.

100 Clinical Results associated with 13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

100 Translational Medicine associated with 13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

100 Patents (Medical) associated with 13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

Literatures (Medical) associated with 13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

16 Feb 2023·Antimicrobial Agents and Chemotherapy

Frequent Transmission of Streptococcus pneumoniae Serotype 35B and 35D, Clonal Complex 558 Lineage, across Continents and the Formation of Multiple Clades in Japan

Article

Author: Nakano, Satoshi ; Ito, Yutaka ; Suga, Shigeru ; Chang, Bin ; Matsumura, Yasufumi ; Shinohara, Koh ; Sugai, Motoyuki ; Ohnishi, Makoto ; Yamamoto, Masaki ; Fujisawa, Takao ; Nagao, Miki

03 Jun 2021·Expert Review of VaccinesQ2 · MEDICINE

Vaccination coverage among health-care workers: pre–post intervention study to assess impact of an on-site vaccination-dedicated clinic

Q2 · MEDICINE

Article

Author: Cautela, Vincenza ; Nobile, Carmelo Giuseppe Angelo ; Pileggi, Claudia ; De Sarro, Caterina ; Pavia, Maria ; Papadopoli, Rosa

BACKGROUNDSeveral studies have revealed low vaccinations coverage among health-care workers (HCWs) for all vaccinations. The aim of our study was to evaluate the impact of the implementation of an on-site vaccination-dedicated clinic on the vaccination coverage rates of HCWs.RESEARCH DESIGN AND METHODSA quasi-experimental pre-post intervention study was carried out among undergraduate and postgraduate students attending medical and health-care professions schools.RESULTSWe enrolled 804 students, 404 in the control and 400 in the experimental group. A significantly higher increase of vaccination coverage in the experimental group than in the control group for all the investigated vaccinations (p < 0.001) was found. The odds of adherence to vaccinations in the experimental group, compared to the control group, ranged from 6.9-fold (95% CI 3.51-13.44) to 18.9-fold (95% CI 10.85-32.96). The increase in the coverage rate in the control group was between 2.5% and 3.5%, whereas in the experimental group, higher increases were found, ranging from 34.8% to 71%.CONCLUSIONSThe extraordinary increase in the adherence to HCWs recommended vaccinations found in the study seems to indicate a significant role of enabling factors in the complex process of decision-making and implementation of health-related behaviors.

100 Deals associated with 13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumococcal Infections	Phase 3	-	Beijing Kexing Zhongwei Biotech Co. Ltd.	12 Oct 2024
Pneumonia	Preclinical	CN	Sinovac Biotech Co. Ltd.	10 Apr 2018
Pneumonia	Preclinical	CN	Beijing Kexing Zhongwei Biotech Co. Ltd.	10 Apr 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| Pediatr Infect Dis J	Not Applicable	Pneumococcal Infections \| HIV Infections	-	13-Valent Pneumococcal Conjugate Vaccine (Children with HIV)	tfwbdfzrty(evxkrpjhft) = zowpkgfbpt grdlcvgcqe (zpuzsxusnm ) View more	-	01 May 2018
				13-Valent Pneumococcal Conjugate Vaccine (HIV-uninfected children)	tfwbdfzrty(evxkrpjhft) = njfzqhfodm grdlcvgcqe (zpuzsxusnm ) View more
Pubmed \| Pediatr Infect Dis J	Not Applicable	-	284	13-valent pneumococcal conjugate vaccine (Children between 15 months and 2 years of age)	tymdgghiuh(plzhgmyuba) = nhlhknozan tjgqkryupa (ugaagjazmw )	-	01 Dec 2011
				13-valent pneumococcal conjugate vaccine (Children between 2 and 5 years)	tymdgghiuh(plzhgmyuba) = mtxbtloriu tjgqkryupa (ugaagjazmw )

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13-valent pneumococcal conjugate vaccine(Sinovac Life Sciences)

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