A Phase 3, Randomized, Blinded, Active-controlled Study to Evaluate the Immunogenicity and Safety of Walvax's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-TT) as Compared to Pfizer's 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Co-administered With EPI Vaccines at 2, 4, and 12-15 Months of Age, to Healthy Infants in Indonesia

The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI Vaccines at 2, 4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-TT as compared to PCV13 one month after the booster dose.

Start Date23 Nov 2023

Sponsor / Collaborator

Walvax Biotechnology Co., Ltd.

CTR20220983

/ CompletedPhase 4

采用随机、双盲、试验疫苗不同批次间相互对照的设计，比较和评价三个连续生产批次试验疫苗间的免疫原性和安全性的批间一致性。

[Translation] A randomized, double-blind, cross-comparison design was used to compare and evaluate the batch consistency of immunogenicity and safety among three consecutive production batches of the test vaccine.

通过考察2~5岁健康儿童接种不同批次13价肺炎球菌多糖结合疫苗后的免疫原性和安全性，比较和评价三个连续生产批次试验疫苗间的批间一致性。

[Translation]

The immunogenicity and safety of different batches of 13-valent pneumococcal polysaccharide conjugate vaccine were investigated in healthy children aged 2 to 5 years, and the batch consistency of the test vaccine among three consecutive production batches was compared and evaluated.

Start Date21 Sep 2022

Sponsor / Collaborator

Yuxi Walvax Biotechnology Co., Ltd.

[+1]

CTR20220707

/ CompletedPhase 4

采用单中心、随机、开放性的非劣效试验设计，评价13价肺炎球菌多糖结合疫苗与吸附无细胞百白破联合疫苗同时接种或间隔接种的免疫原性和安全性临床研究

[Translation] A single-center, randomized, open-label, non-inferiority trial was designed to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide conjugate vaccine and adsorbed acellular diphtheria, tetanus and pertussis combined vaccine administered simultaneously or at intervals.

评价13价肺炎球菌多糖结合疫苗在3月龄健康婴儿中和免疫规划吸附无细胞百白破联合疫苗同时接种或间隔接种的免疫原性和安全性。

[Translation]

To evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide conjugate vaccine administered simultaneously or at intervals with adsorbed acellular diphtheria, tetanus and pertussis combined vaccine in immunization schedule in healthy infants aged 3 months.

Start Date14 May 2022

Sponsor / Collaborator

Yuxi Walvax Biotechnology Co., Ltd.

[+1]

100 Clinical Results associated with 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Walvax Biotechnology)

100 Translational Medicine associated with 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Walvax Biotechnology)

100 Patents (Medical) associated with 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Walvax Biotechnology)

598

Literatures (Medical) associated with 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Walvax Biotechnology)

31 Dec 2025·Emerging Microbes & Infections

Serotype epidemiology and case-fatality risk of invasive pneumococcal disease: a nationwide population study from Switzerland, 2012–2022

Article

Author: Hilty, Markus ; Just, Nicolaj ; Casanova, Carlo ; Kahlert, Christian ; Baty, Florent ; Albrich, Werner C

In Switzerland, thirteen-valent pneumococcal conjugate vaccine (PCV13) has been introduced in 2011. During the COVID-19 pandemic, cases of invasive pneumococcal disease (IPD) have decreased but consequences on the serotype epidemiology are less clear. The objective of the study has been to analyse the impact of PCV13 introduction and the COVID-19 pandemic on the IPD epidemiology and investigate the changes in the case fatality risk (CFR). We analysed data from the Swiss nationwide surveillance for the period 2012-2022. Poisson and logistic regression analyses were performed allowing us to inspect trends over time and to define serotypes that are associated with case fatality. In total, 8747 IPD cases were included from 2012 to 2022. IPD incidence dropped in the years 2020 (6.0/100,000) and 2021 (5.5/100,000) but recovered in 2022 (9.1/100,000). While the incidence numbers of patients >65 years did not reach the pre-pandemic level, numbers significantly increased in infants <1 year in 2022 (IRR 1.08, 95%CI: 1.01-1.16). The incidence of PCV13 serotypes among all IPD cases decreased until 2019 before increasing again during the pandemic (in 2022). Logistic regression analyses revealed that the PCV20 serotype 11A (OR: 1.76, 95%CI: 1.14-2.64), and the PCV13 serotypes 3 (OR: 1.26, 95% CI: 1.04-1.53) and 19F (OR: 1.76, 95%CI: 1.14-2.65) were significantly associated with increased CFR. In conclusion, the COVID-19 pandemic has had only minor temporary effects on the serotype distribution. Continued use of vaccines with extended serotype coverage may further reduce IPD disease burden and mortality.

31 Dec 2025·Human Vaccines & Immunotherapeutics

PCV20 for the prevention of invasive pneumococcal disease in the Mexican pediatric population: A cost-effectiveness analysis

Article

Author: Huang, Liping ; Wannaadisai, Warisa ; Torres, Gustavo Ivan ; Ta, An ; Huerta, José Luis ; Vinand, Elizabeth

The introduction of a pneumococcal conjugate vaccine (PCV) covering 13 serotypes (PCV13) into the Mexican pediatric national immunization program (NIP) has substantially reduced the burden of pneumococcal disease (PD) since 2010. This study aimed to estimate the impact of replacing either PCV13 or 15valent PCV (PCV15) with 20-valent PCV (PCV20) in the Mexican pediatric NIP. A decision-analytic Markov model was developed to compare the cost-effectiveness of PCV20 versus lower-valent vaccines from a Mexican public health sector (payer) perspective over 10 years. Epidemiological and cost inputs were sourced from Mexican data. Direct and indirect vaccine effects were estimated using PCV13 clinical effectiveness, 7-valent PCV efficacy studies, and PCV13 impact data in Mexico. The estimated disease and cost impact of PCV20 was compared with PCV13 and PCV15, all under a 2 + 1 dosing schedule. A discount rate of 5% per annum was applied to costs and health outcomes. Model robustness was evaluated through sensitivity analyses, including deterministic sensitivity analysis (DSA), probabilistic sensitivity analysis (PSA), and additional scenario assessments. PCV20 was estimated to provide considerably more health benefits than both comparators by averting more cases of PD compared with both PCV13 and PCV15, as well as a total cost saving of over 10 billion Mexican pesos. The DSA, PSA, and scenario assessments confirmed minimal deviation from the base case. Therefore, the introduction of PCV20 (2 + 1) into the Mexican pediatric NIP is expected to reduce the burden of PD and medical costs compared with lower-valent alternatives.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Back to the future? Drastic drop in serotype 19A carriage in daycare centers within two years after a second switch to PCV13 in Belgium

Article

Author: Van den Bosch, Eline ; Van Damme, Pierre ; Theeten, Heidi ; Lammens, Christine ; Goossens, Herman ; Maertens, Kirsten ; Van Heirstraeten, Liesbet ; Malhotra-Kumar, Surbhi ; Verhaegen, Jan ; Ekinci, Esra ; Desmet, Stefanie ; Beutels, Philippe

Pneumococcal conjugate vaccines (PCVs) reduce Streptococcus pneumoniae infection and carriage. After switching from PCV13 to PCV10 in 2015-2016, Belgium switched back to PCV13 in 2019. Building on our systematic monitoring of childhood nasopharyngeal carriage since 2016, here, we analyze the serotypes of S. pneumoniae and other pathogens in children attending daycare centers (DCCs) from 2018 to 2021. From the period of 2018-2019 to 2020-2021, we included a total of 2,741 nasopharyngeal swabs collected from children aged 6 to 30 months. We identified S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus and conducted serotyping and antimicrobial susceptibility assessments of S. pneumoniae strains using culture methods and real-time PCR. S. pneumoniae carriage was frequent and quite stable over the three study years. H. influenzae and M. catarrhalis were more frequently carried than S. pneumoniae. Frequency of all PCV13-serotypes together among S. pneumoniae carriers decreased significantly from 19.4% in 2018-2019 to 9.9% in 2020-2021 (p < .001), largely due to the decreased serotype 19A carriage. Resistance of pneumococcal strains to penicillin increased significantly over the three study years. Two years after the second switch to PCV13 in 2019, pneumococcal serotype 19A carriage decreased again significantly in Belgian children attending daycare centers.

100 Deals associated with 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine (Walvax Biotechnology)

R&D Status

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Indication	Country/Location	Organization	Date
Pneumococcal Infections	China	Yuxi Walvax Biotechnology Co., Ltd.	30 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pneumonia	Discovery	China	Walvax Biotechnology Co., Ltd.	08 Apr 2016
Pneumonia, Pneumococcal	Discovery	-	Walvax Biotechnology Co., Ltd.	08 Apr 2016

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