A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days).
The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations.
• There will be 5 (for full-term infants) or 6 (for preterm infants) study visits:
* Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days.
* Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 months of age, V06 separated from V05 by 30 days.

Start Date22 May 2025

Sponsor / Collaborator

Sanofi

CTIS2023-507600-32-00

/ RecruitingPhase 3

A Phase 3, randomized, modified double-blind, active-controlled, parallel-group, 2-arm study to investigate the safety and immunogenicity of a 21-valent pneumococcal conjugate vaccine in healthy infants and toddlers - PSK04

Start Date22 May 2025

Sponsor / Collaborator

Sanofi Pasteur, Inc.

NCT06838000

/ RecruitingPhase 3

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group Study to Investigate the Safety and Immunogenicity of Catch-up Vaccination Regimens of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).

Start Date28 Feb 2025

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

100 Translational Medicine associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

100 Patents (Medical) associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

Literatures (Medical) associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Serotype distribution among adults with community-acquired pneumococcal pneumonia in Japan between 2019 and 2022: A multicenter observational study

Article

Author: Shirata, Masahiro ; Nakagawa, Atsushi ; Fujii, Hiroshi ; Ishida, Masayuki ; Tsukino, Mitsuhiro ; Okamura, Kayoko ; Nishiyama, Akira ; Nakahara, Yasuharu ; Niibayashi, Seisuke ; Sugita, Takakazu ; Ntiamoah, Desmond Opoku ; Hamao, Nobuyoshi ; Yamada, Takashi ; Toyoda, Yuko ; Sakai, Naoki ; Maeda, Haruka ; Nishioka, Kensuke ; Inoue, Taisei ; Asoh, Norichika ; Ito, Akihiro ; Kaji, Yusuke ; Morikawa, Toru ; Morimoto, Konosuke ; Oi, Issei ; Ushiki, Atsuhito ; Hasegawa, Yoshinori ; Fujii, Yuya ; Yagiuchi, Ai ; Dhoubhadel, Bhim Gopal ; Tsuchiya, Michiko ; Urata, Tomoyuki ; Sando, Eiichiro ; Ito, Isao

Streptococcus pneumoniae is a leading cause of community-acquired pneumonia (CAP) in adults. With the introduction of pneumococcal conjugate vaccines (PCVs) into pediatric national immunization programs, the serotype distribution of pneumococcal disease among adults has changed due to indirect effect. In Japan, PCV15 and PCV20 have been introduced, and PCV21 is under review for approval in adults. This multicenter observational study assessed pneumococcal serotypes in 583 adult patients with community-acquired, culture-positive pneumococcal pneumonia from May 2019 to December 2022. Pneumococcal isolates were serotyped using the Quellung reaction. The median patient age was 74 years (interquartile range: 66-82 years), 383 (65.7%) patients were male, 387 (66.4%) patients had one or more underlying medical conditions, 425 patients (72.9%) were hospitalized, and 305 (52.3%) had a CURB-65 score ≥2. The most common serotypes were serotype 3 (12.5%), 35B (12.0%), 15A (7.7%), 11A (6.7%), and 23A (6.3%). The proportion of serotypes covered by PCV13, PCV15, PCV20, PPSV23, and PCV21 were 24.0, 28.0, 43.7, 44.1, and 71.9%, respectively. The proportions of vaccine-covered serotypes were similar between patients aged <65 and ≥65 years. Serotype 3 was more prevalent among patients living in nursing homes (25.9%) compared with those living at home (11.2%). The proportions of PCV20- and PCV21-covered serotypes suggest that these new vaccines may offer additional protection against adult pneumococcal pneumonia. Given the availability of newly developed PCVs for adults in Japan, reassessing the optimal pneumococcal vaccination policy for adults is warranted.

31 Dec 2025·Emerging Microbes & Infections

The rise of serotype 8 is associated with lineages and mutations in the capsular operon with different potential to produce invasive pneumococcal disease

Article

Author: Sempere, Julio ; Domenech, Mirian ; Llamosí, Mirella ; García, Ernesto ; González-Díaz, Aída ; Yuste, Jose ; Úbeda, Aída ; Sanz, Juan Carlos ; Pérez-García, Covadonga ; Ardanuy, Carmen

Despite conjugate vaccine introduction to prevent invasive pneumococcal disease (IPD), serotype replacement by non-vaccine serotypes is a constant concern. In this study, we elucidate the rise of serotype 8 causing IPD in Spain. We evaluated isolates received during the period 2008-2023 including whole genome sequencing characterization and host-pathogen interaction studies. Serotype 8 has emerged as one of the most prevalent serotypes causing IPD in both children and adults. CC53/GPSC3 carrying pspC 6.11 was the dominant lineage in recent years, displaying increased adhesion to lung cells, enhanced biofilm formation, higher factor H recruitment, improved phagocytosis evasion, and greater virulence in a mice pneumonia model than other co-circulating lineages which could explain its predominance. Morphologically, serotype 8 strains exhibit two appearances on blood agar plates: mucoid colonies, and non-mucoid variants. Molecular characterization revealed that non-mucoid variants harbour mutations in the wchA gene and/or others within the capsular operon, leading to increased adhesion and biofilm formation, albeit with reduced immune evasion capacity. Serotype 8 has become a major cause of IPD, with CC53/GPSC3 as the dominant lineage due to its pathogenic advantages. The versatility of the capsular operon contributes to its success in causing IPD. The use of vaccines with broader coverage, such as PCV20 or PCV21, containing this serotype, may offer an effective strategy to ameliorate the impact on IPD by serotype 8.

31 Dec 2025·Human Vaccines & Immunotherapeutics

Global distribution and characteristics of pneumococcal serotypes in adults

Review

Author: Morimoto, Konosuke ; Maeda, Haruka

The introduction of pneumococcal conjugate vaccines (PCVs) into pediatric national immunization programs (NIP) has significantly reduced invasive pneumococcal diseases and pneumococcal pneumonia caused by PCV serotypes in adults due to herd immunity. However, diseases caused by PCV13 serotypes persist, mainly serotype 3, known for its severity. With the reduction in PCV13 serotypes, diseases caused by non-PCV13 serotypes increased. Residual and emerging serotypes vary regionally; serotype 8 in Europe and South Africa, and serotype 4 in the US and Canada. PCV20 and PCV21 were recently developed, which can prevent residual and emerging pneumococcal diseases where herd immunity is well-established. In countries that have not introduced PCV into pediatric NIP, the pneumococcal disease burden due to PCV serotypes is still marked. Given that serotype distribution varies by region and evolves over time, this review aimed to discuss serotype distribution and disease severity in adults across countries to support future pneumococcal vaccine strategies.

News (Medical) associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

21 May 2025

·www.prnewswire.com

SK bioscience Wins Patent Lawsuit Against Pfizer Over Pneumococcal Vaccine

No patent infringement found in exports of individual conjugate bulk substances and research-use finished products of PCV13 to Russia Company plans to export PCV13 vaccine components "We aim for the global PCV market with our 21-valent and next-generation pneumococcal vaccines currently under development." SEONGNAM, South Korea, May 21, 2025 /PRNewswire/ -- SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced that it the Supreme Court of Korea has ruled in its favor in a patent infringement lawsuit filed by large global pharmaceutical giant Pfizer over its 13-valent pneumococcal conjugate vaccine (PCV13). In 2020, Pfizer claimed that SK bioscience's export of PCV13 individual conjugate bulk substances and research-use finished products to Russia infringed on the composition patent of its vaccine, Prevnar 13. Continue Reading SK bioscience L HOUSE manufacturing plant However, the Supreme Court ruled that the individual conjugates comprising PCV13 do not fall within the scope of Pfizer's patent claims, thereby upholding the lower court's ruling in favor of SK bioscience. The Court also confirmed that the production and supply of PCV13 finished products for research purposes did not constitute patent infringement. SK bioscience successfully developed Korea's first 13-valent pneumococcal conjugate vaccine, SKYPneumo, in 2016. However, due to the ongoing patent dispute with Pfizer, the company has been prohibited from manufacturing and selling the vaccine in Korea until 2027, when the related patents set to expire. Following the ruling, SK bioscience now plans to initiate new business in pneumococcal conjugate vaccines by exporting individual components of PCV13 to countries with high vaccine demand, such as those in Southeast Asia and Latin America. Technology transfers through local partnerships are also being pursued in parallel. Looking ahead, SK bioscience aims to expand its presence in the global pneumococcal vaccine market. From 2027, the company will be able to manufacture and sell SKYPneumo domestically. In addition, the company is developing a 21-valent pneumococcal conjugate vaccine with global pharmaceutical company Sanofi, which entered Phase 3 global clinical in late 2024. Simultaneously, the two companies are also working on a next-generation pneumococcal vaccine that is expected to offer broader protection than current options. The global pneumococcal vaccine market continues to grow. According to Global Market Insights, the market is projected to grow at a compound annual rate of approximately 5.6% to reach USD 15.1 billion (approximately KRW 21.55 trillion) by 2034. This growth is driven by expanded vaccination programs and support from governments and international organizations like WHO and Gavi. SK bioscience's strong track record in public vaccine supply and cooperation with global health organizations positions it well for future expansion. Jaeyong Ahn, CEO of SK bioscience, said, "This latest court decision is meaningful in that it ensures a competitively developed vaccine in Korea does not go to waste but instead finds new opportunity. We will leverage this momentum to improve access to premium vaccines, contribute to a stable global vaccine supply, and achieve sustainable growth." Meanwhile, SK bioscience recently secured a definitive legal victory in a patent invalidation suit against Moderna, successfully challenging the biotech giant's Korean patent related to messenger RNA (mRNA) vaccine technology. The contested patent covers 'modified nucleosides, nucleotides, and nucleic acids and their uses.' This case, which invalidated the only registered mRNA manufacturing patent in Korea, regarded as a major step in reducing patent-related risks and removing barriers to innovation for domestic companies engaged in mRNA research and development. About SK bioscience SK bioscience is an innovative vaccine and biotech company, committed to vaccine development and manufacturing to enable more equitable access to vaccines around the world. Leveraging strengths on cutting-edge technologies, SK bioscience has been dedicated to promoting human health from prevention to cure across the globe. With the cooperation of domestic and international governments, regulatory agencies, healthcare providers, doctors, and medical experts, all of the SK colleagues are passionately committed to providing high-quality vaccines to those who need them and better public healthcare solutions. - SK bioscience Website - SK bioscience Linkedin Contact SK bioscience Communications Team Changhyun Jin ([email protected]) Jeannie S. Pak ([email protected]) SOURCE SK bioscience WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

VaccinePatent InfringementmRNAPhase 3

30 Jan 2025

·www.fiercebiotech.com

Sanofi cuts programs tied to multibillion-dollar deals from pipeline

Sanofi disclosed removals from its pipeline alongside the progress of other molecules. \n Sanofi has removed (PDF) a clutch of programs from its clinical pipeline, scratching out entries for its late-phase BTK inhibitor and phase 1 prospects linked to the multibillion-dollar takeovers of Ablynx, Principia Biopharma and Synthorx.The French drugmaker added the BTK inhibitor tolebrutinib to its pipeline by acquiring Principia for $3.7 billion. Facing down skepticism, Sanofi guided the asset to mixed phase 3 data last year, with the win in one form of multiple sclerosis offset by failures in another form of the disease. The company removed the relapsing multiple sclerosis program from its pipeline but plans to file for approval in another setting.Sanofi removed three assets from its phase 1 pipeline. Pegenzileukin, the IL-2 candidate Sanofi picked up through its $2.5 billion takeover of Synthorx, was one of the assets affected by the clearout. The molecule suffered a setback in 2022, triggering a 1.6 billion euro ($1.7 billion) impairment, but Sanofi kept going.The drugmaker began a phase 1/2 program in 2023 to optimize the dose schedule for the treatment of solid tumors. Sanofi listed the study of the candidate, which is also called SAR444245 and THOR-707, in “cancer, in combination” among the programs removed from phase 1 in the fourth quarter. The other two early-phase removals affected nanobodies, the platform technology Sanofi acquired in its 3.9 billion euro ($4.1 billion) takeover of Ablynx. One of the removed drug candidates, SAR445611, is an anti-CX3CR1 nanobody that Sanofi was developing in an inflammatory indication. The second jettisoned molecule is SAR444200, a GPC3-based nanobody T-cell engager that Sanofi was testing in solid tumors.\"Sanofi continues to prioritize our pipeline to focus on medicines and vaccines that deliver the greatest value for patients,\" a company spokesperson told Fierce Biotech in an emailed statement. \"That\'s why we\'ve made the decision to discontinue these select programs where we believe we cannot deliver meaningful value to patients.\"Sanofi disclosed the removals alongside the progress of other molecules. SP0202 advanced into phase 3, furthering Sanofi’s push to bring the SK bioscience-partnered 21-valent pneumococcal conjugate vaccine candidate to market. Sanofi recently agreed to pay 50 million euros ($52 million) upfront to expand its pneumococcal vaccine collaboration with SK.When it comes to dealmaking this year, Sanofi\'s CFO François Roger said the French pharma would be looking out for companies in the value range of 2 billion euros to 5 billion euros. “We will continue to explore external growth opportunities to strengthen our four existing therapeutic areas and potentially cover white spaces,” Roger said on an earnings call with analysts this morning. “We don\'t feel any pressure to go crazy on M&A and BD, so we will remain very disciplined while having the opportunity to compliment whatever we have in our pipeline.”Editor\'s note: This article has been updated with a statement from Sanofi.

AcquisitionVaccinePhase 3Phase 1

23 Dec 2024

·www.fiercebiotech.com

Sanofi pays SK bioscience €50M as children\'s pneumococcal vaccine enters phase 3

The partnership between Sanofi and SK bioscience dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.\n Sanofi is handing SK bioscience 50 million euros ($52 million) as the longtime partners take their next-gen pneumococcal conjugate vaccine program into phase 3.The move follows a phase 2 win last year for the candidate, a 21-valent pneumococcal conjugate vaccine previously called GBP410 and now renamed PCV21, which demonstrated comparable immunogenicity to a control vaccine.By including 21 serotypes, the partners aim to offer broader coverage than the current approved pneumococcal conjugate vaccines for children. Sanofi announced Monday morning that it has now launched the shot into a phase 3 study, making it the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter a late-stage study in infants and toddlers.Sanofi and SK will co-fund the research and development costs, with Sanofi also paying SK the 50 million euro upfront fee. An undisclosed amount of development and commercial milestone payments could follow. Should PCV21 make it to market, Sanofi will commercialize the vaccine worldwide, except for in SK’s home turf of South Korea.“Given the vast unmet public health needs in [invasive pneumococcal disease], we’re delighted to expand this collaboration and continue our pursuit of innovative work in PCV,” Thomas Triomphe, Sanofi\'s head of vaccines, said in the Dec. 23 release.“Our collaboration leverages SK bioscience’s capabilities and Sanofi’s expertise in developing and bringing innovative vaccines to people worldwide with the collective aim of reducing the global impact of pneumococcal disease,” Triomphe added. The partnership between Sanofi and SK dates back to 2014, when the French pharma paid $23 million upfront to get the ball rolling on vaccine development.There are currently two FDA-approved pneumococcal vaccines for children—Merck & Co.’s 15-valent Vaxneuvance and Pfizer’s 20-valent Prevnar 20.Sanofi isn’t the only Big Pharma hoping to expand the range of serotypes available in pneumococcal vaccines. GSK had been working on a 24-valent candidate acquired via its $2.1 billion acquisition of Affinivax but revealed in October that it had axed the asset. In June, Merck’s 21-valent Capvaxive became the first pneumococcal vaccine specifically designed for adults to receive FDA approval.Then, in September, Vaxcyte unveiled what analysts called “stunning” phase 1/2 data in adults for its 31-valent candidate that, if replicated in a large pivotal study, could pose a serious threat to Prevnar 20. A separate phase 2 trial of Vaxcyte’s shot in infants has recently launched.

$Sanofi pays SK bioscience €50M as children\'s pneumococcal vaccine enters phase 3$

Phase 2Phase 3VaccineAcquisitionClinical Result

100 Deals associated with Next-generation pneumococcal conjugate vaccine (Sanofi/SK Bioscience)

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Indication	Highest Phase	Country/Location	Organization	Date
Vaccination	Phase 3	United States	Sanofi	27 Feb 2025
Vaccination	Phase 3	Chile	Sanofi	27 Feb 2025
Vaccination	Phase 3	Philippines	Sanofi	27 Feb 2025
Pneumococcal Infections	Phase 3	Netherlands	Sanofi Pasteur SA	18 Dec 2024
Pneumococcal Infections	Phase 3	Norway	Sanofi Pasteur SA	18 Dec 2024
Pneumococcal Infections	Phase 3	Poland	Sanofi Pasteur SA	18 Dec 2024
Pneumococcal Infections	Phase 3	South Korea	Sanofi Pasteur SA	18 Dec 2024
Chickenpox	Phase 2	United States	Sanofi Pasteur SA	22 May 2020
Chickenpox	Phase 2	Canada	Sanofi Pasteur SA	22 May 2020
Chickenpox	Phase 2	Honduras	Sanofi Pasteur SA	22 May 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04398706 (CTgov)	Phase 2	Diphtheria \| Hepatitis B \| Pneumonia ... View more	852	Pentacel+SP0202-IIb+Prevnar 13 (Stage I: Group 1 SP0202-IIb)	xlmcgxqkkm = ytzlbvynro txoxkyklbq (kdczpmcgpv, xojvciyvvf - qstsbopjun) View more	-	12 Nov 2024
				Pentacel+SP0202-VI+Prevnar 13 (Stage I: Group 2 SP0202-VI)	xlmcgxqkkm = rkizefzyav txoxkyklbq (kdczpmcgpv, sbduxoiaxr - cqxjtbamwx) View more
NCT04583618 (CTgov)	Phase 2	Vaccination	750	SP0202-IIb (Group 1: SP0202-IIb)	wzggnaveja(muclkohvko) = dryypgcgmz tjudcajfve (wdxzuxvamm, takcczlmzg - otexajmicx) View more	-	27 Aug 2024
				SP0202-VI (Group 2: SP0202-VI)	wzggnaveja(muclkohvko) = zwhjpdpuql tjudcajfve (wdxzuxvamm, rzvzxaejhe - ypvgfcwwew) View more

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