23-valent PPV / Sinovac - LARVOL DELTA

Lot-to-lot consistency, immunogenicity, and safety of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in healthy adults aged 40-65 years: A randomized, double-blind, controlled, phase IV clinical trial. (PubMed, Hum Vaccin Immunother) - P4 | "This study confirmed that the three manufacturing lots of PPV23 (Sinovac Biotech Co. Ltd.) demonstrated manufacturing consistency and can elicit satisfactory immune responses for all 23 serotypes and no safety concerns were identified.Trial registration: ClinicalTrial.gov identifier: NCT05731115."

Clinical • Journal • P4 data • Infectious Disease • Pneumococcal Infections

Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in Chinese Children, Adults and the Elderly: A Phase 4, Randomized, Double-Blind, Active-Controlled Clinical Trial. (PubMed, Vaccines (Basel)) - "The PPSV23 vaccine administered among individual aged ≥2 years was safe, well tolerated and immunogenic, eliciting an immune response either comparable to or higher than control vaccine. These findings support its use as a safe and effective option for pneumococcal immunization."

Clinical • Journal • P4 data • Infectious Disease • Pneumococcal Infections

The immunogenicity and safety of an inactivated quadrivalent influenza vaccine and a 23-valent pneumococcal polysaccharide vaccine in individuals with chronic diseases. (PubMed, Front Immunol) - "No serious adverse events were observed. The immunogenicity and safety profiles of IIV4 and PPSV23, particularly when administered simultaneously, in individuals with chronic diseases were comparable to those in healthy individuals, supporting the vaccination strategy of IIV4 and PPSV23 in chronic disease population."

Journal • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population (clinicaltrials.gov) - P=N/A | N=19267 | Completed | Sponsor: Sinovac Biotech Co., Ltd

New trial • Infectious Disease • Pneumococcal Infections

Immune persistence of a single dose of 23-valent pneumococcal polysaccharide vaccine: A 6-year follow-up. (PubMed, Hum Vaccin Immunother) - P3 | "The results suggested PPV23 could provide protection 6 years after vaccination. Considering the significant decrease of antibody level, the revaccination in high-risk population may be needed.Trial registration: ClinicalTrial.gov identifier: NCT03480763."

Journal • Infectious Disease • Pneumococcal Infections

Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Administered Concomitantly with a 23-Valent Pneumococcal Polysaccharide Vaccine in Adults Aged 60 Years and Older. (PubMed, Vaccines (Basel)) - "No serious adverse events were observed. In conclusion, the immunogenicity of the concomitant administration of IIV4 and PPSV23 was non-inferior to that of the separate administration, and the safety profile was favorable in adults aged 60 years and older in China."

Journal • Infectious Disease • Influenza • Pneumococcal Infections • Respiratory Diseases

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=1800 | Completed | Sponsor: Sinovac Biotech Co., Ltd | Recruiting ➔ Completed | Trial completion date: Nov 2024 ➔ Apr 2023 | Trial primary completion date: Nov 2024 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=1800 | Completed | Sponsor: Sinovac Biotech Co., Ltd | Not yet recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ May 2023

Trial completion • Trial completion date • Infectious Disease • Pneumococcal Infections

Safety evaluation of simultaneous administration of quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine in adults aged 60 years and older (PubMed, Zhonghua Yu Fang Yi Xue Za Zhi) - "The incidence of local adverse reactions in the two groups was 1.62% (9/554) and 0.79% (15/1 907), respectively, and the incidence of systemic adverse reactions was 1.44% (8/554) and 1.42% (27/1 907), respectively, with no statistically significant differences between them (all P>0.05). It is safe for adults aged 60 years and older to receive quadrivalent influenza split virion vaccine and 23-valent pneumococcal polysaccharide vaccine at the same time."

Journal • Infectious Disease • Influenza • Pain • Pneumococcal Infections • Respiratory Diseases

Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial. (PubMed, Front Immunol) - "In this randomized, controlled, open-label phase IV clinical trial, 270 participants including 135 adults aged 18-59 years and 135 adults aged 60 years or older, were enrolled and randomized to the CoronaVac group or to the control group in a 2:1 ratio and received two doses of CoronaVac or one dose of the 23-valent pneumococcal polysaccharide vaccine and one dose of inactivated hepatitis A vaccine on days 0 and 28, respectively...However, the D-dimer in the CoronaVac group decreased on day 14 compared to the value at baseline, while a higher D-dimer value, instead of a decreased D-dimer value, was a risk factor for TTS. CoronaVac showed a good safety profile and could induce a humoral response against the prototype and VOCs of SARS-CoV-2 in adults 18 years or older, with no abnormal effects on laboratory parameters of blood glucose and coagulation function."

Journal • P4 data • Cardiovascular • Hematological Disorders • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumococcal Infections • Respiratory Diseases • Thrombocytopenia • Thrombosis

Lot-to-lot Consistency of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=1800 | Not yet recruiting | Sponsor: Sinovac Biotech Co., Ltd

New P4 trial • Infectious Disease • Pneumococcal Infections

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=1800 | Recruiting | Sponsor: Sinovac Biotech Co., Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: May 2023 ➔ Nov 2024 | Trial primary completion date: Nov 2022 ➔ Nov 2024

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=600 | Completed | Sponsor: Sinovac Biotech Co., Ltd | Not yet recruiting ➔ Completed | Trial completion date: Mar 2022 ➔ Sep 2021 | Trial primary completion date: Dec 2021 ➔ Sep 2021

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=1800 | Not yet recruiting | Sponsor: Sinovac Biotech Co., Ltd

New P4 trial • Infectious Disease • Pneumococcal Infections

Study on Combined Vaccination With Quadrivalent Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine (clinicaltrials.gov) - P4 | N=3000 | Completed | Sponsor: Sinovac Biotech Co., Ltd

New P4 trial • Infectious Disease • Pneumococcal Infections • Pneumonia • Respiratory Diseases