Delving into the Latest Updates on Poliovirus vaccine inactivated(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Inactivated Poliomyelitis Vaccine (Salk Vaccine)(Sanofi), 不活化ポリオワクチン

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

DiphtheriaPoliomyelitisTetanus

Inactive Indication

Hepatitis BInfluenza, HumanWhooping Cough

Originator Organization

Sanofi

Active Organization

Sanofi KKSanofi Pasteur Europe

Sanofi

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Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Germany (12 Oct 1999),

DiphtheriaPoliomyelitisTetanus

Regulation-

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This is a single site, phase 1 study of dmLT as a mucosal adjuvant to control fecal viral shedding when used in combination with intradermally administered fractional dose trivalent IPV (fIPV). It will be a 2-arm, randomized, double-blind controlled trial of intradermal fIPV versus fIPV+dmLT in healthy adults with a monovalent oral polio vaccine (OPV) challenge administered as a test of mucosal immunity. A maximum of 30 healthy subjects will be recruited, all of whom will have received IPV only as part of their primary childhood immunization series (cohort 1); they will be randomized 2:1 to receive fIPV-dmLT or fIPV alone. A maximum of 27 participants will be recruited from an earlier pilot study population exposed to fIPV+/-dmLT and will provide follow-up samples for immunologic studies only (cohort 2).

Start Date01 Apr 2022

Sponsor / Collaborator

University of Vermont

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NCT04481191

/ CompletedPhase 3

A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants

This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.

Start Date25 Aug 2020

Sponsor / Collaborator

Merck Sharp & Dohme LLC

CTRI/2017/12/010803

/ SuspendedPhase 2/3

A Phase II / III, prospective, randomised, active-controlled, open label, Parallel group, 2-arm, Multi-centric trial for evaluation of Efficacy, Safety, and Tolerability of DTaP plus Hib (Diphtheria, acellular Pertussis, Tetanus and Hemophilus influenza b) combination vaccine in Indian paediatric population in comparison with PentaximÂ® (Diphtheria, acellular Pertussis, Tetanus, Hemophilus influenza b and IPV) combination vaccine of Sanofi Pasteur

Start Date15 Dec 2017

Sponsor / Collaborator

Wockhardt Ltd.

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100 Clinical Results associated with Poliovirus vaccine inactivated(Sanofi)

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100 Translational Medicine associated with Poliovirus vaccine inactivated(Sanofi)

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100 Patents (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

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86

Literatures (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

24 Jan 2025·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Safety evaluation of tetravalent meningococcal conjugate vaccine in combination with the inactivated poliomyelitis vaccine and diphtheria-tetanus-acellular pertussis vaccine for infants].

Article

Author: Liu, X Y ; Zhang, C ; Li, S W ; Hu, W J ; Lyu, Y K ; Wang, R Z

Objective: To investigate the safety of the tetravalent meningococcal conjugate vaccine (MPCV-ACYW) in combination with the inactivated poliomyelitis (IPV) vaccine and diphtheria-tetanus-acellular pertussis (DTaP) vaccine for infants aged 3-5 months and provide real-world evidence for the immunization strategy of vaccine combination. Methods: From June to October 2023, a total of 600 3-month-old infants were selected and divided into three groups: control group, mono-vaccination group and combined vaccination group. They were simultaneously or individually vaccinated with MPCV-ACYW, IPV and DTaP vaccines at 3, 4, and 5 months of age, respectively. The incidence rate of adverse reactions within 30 days after each dose was observed. Results: All 600 infants completed at least one vaccination and entered the safety data analysis. The age of the control group (100 infants), the mono-vaccination group (250 infants), and the combination group (250 infants) was (101.20±7.88), (102.26±7.94), and (102.35±7.76) days, respectively. The body lengths were (63.00±3.02), (62.55±3.06), and (63.14±4.02) cm, respectively. The body weights were (6.90±0.77), (6.86±0.94), and (6.99±0.95) kg, respectively. Boys accounted for 49%, 50.4%, and 52.4%, respectively, with no statistically significant differences (all P>0.05). The overall incidence rates of adverse reactions in the control group, mono-vaccination group, and combined vaccination group were 4.00%, 2.80%, and 3.20%, respectively, with systemic adverse reaction rates of 3.00%, 2.40%, and 2.00%. The incidence rates of local adverse reactions were 1.00%, 0.40%, and 1.20%, with no statistically significant differences (all P>0.05). Adverse reactions were mainly grade 1, with incidence rates of grade 1 adverse reactions of 3.00%, 2.00%, and 1.60% in the three groups, and incidence rates of grade 2 adverse reactions of 1.00%, 0.80%, and 1.60%, respectively. No grade 3 or 4 serious adverse reactions occurred, and the differences were not statistically significant (all P>0.05). The adverse reaction symptoms of the three groups were mainly systemic reactions, among which fever and diarrhea symptoms were reported in individual cases in each group, with no statistically significant differences in the incidence rate (all P>0.05). The symptoms of adverse reactions were mostly transient and self-relieved, all of which were cured. Conclusion: The combination of MPCV-ACYW and IPV or DTaP vaccines is safe for infants aged 3-5 months.

31 Dec 2024·Human Vaccines & Immunotherapeutics

A phase 3 randomized, open-label study evaluating the immunogenicity and safety of concomitant and staggered administration of a live, pentavalent rotavirus vaccine and an inactivated poliomyelitis vaccine in healthy infants in China

Article

Author: Huang, Zhuhang ; Ou, Zhiqiang ; Tu, Yingmei ; Zhang, Yong ; Liao, Yuyi ; Li, Changgui ; Yu, Yebin ; Liao, Xueyan ; Liu, Guixiu ; Shou, Qiong ; Zhao, Weiwei ; Li, Yuan ; Chen, Shaomin ; Hartzel, Jonathan ; Zheng, Minghuan ; Fu, Rong ; Ying, Zhifang ; Stek, Jon ; Huang, Meilian ; Liu, Yan ; Zhang, Jikai

This open-label, randomized, phase 3 study in China (V260-074; NCT04481191) evaluated the immunogenicity and safety of concomitant and staggered administration of three doses of an oral, live, pentavalent rotavirus vaccine (RV5) and three doses of an intramuscular, inactivated poliomyelitis vaccine (IPV) in 400 healthy infants. The primary objective was the non-inferiority of neutralizing antibody (nAb) responses in the concomitant- versus the staggered-use groups. Antibody responses were measured at baseline and 1-month post-dose 3 (PD3). Parents/legal guardians recorded adverse events for 30 or 15 d after study vaccinations in the concomitant-use or staggered-use groups, respectively. At PD3, >98% of participants seroconverted to all three poliovirus types, and the primary objective was met as lower bounds of the two-sided 95% CI for between-group difference in nAb seroconversion percentages ranged from - 4.3% to - 1.6%, for all poliovirus types, p < .001. At PD3, geometric mean titers (GMTs) of nAb responses to poliovirus types 1, 2, and 3 in the concomitant-use group and the staggered-use group were comparable; 100% of participants had nAb titers ≥1:8 and ≥1:64 for all poliovirus types. Anti-rotavirus serotype-specific IgA GMTs and participants with ≥3-fold rise in postvaccination titers from baseline were comparable between groups. Administration of RV5 and IPV was well tolerated with comparable safety profiles in both groups. The immunogenicity of IPV in the concomitant-use group was non-inferior to the staggered-use group and RV5 was immunogenic in both groups. No safety concerns were identified. These data support the concomitant use of RV5 and IPV in healthy Chinese infants.

01 Dec 2022·Vaccine: X

Development of an animal component free production process for Sabin inactivated polio vaccine

Article

Author: Suarez-Zuluaga, Diego A ; van der Pol, Leo A ; van 't Oever, Aart G ; Thomassen, Yvonne E ; Bakker, Wilfried A M

Inactivated polio vaccine production using attenuated Sabin strains (sIPV) instead of wild type polio viruses (cIPV) is an initiative encouraged by the World Health Organization. This use of attenuated viruses is preferred as it reduces risks related to potential outbreaks during IPV production. Previously, an sIPV production process was set up based on the cIPV production process. Optimizing this process while using only animal component free (ACF) substances allows reduction of operational costs and mitigates risks of adverse effects related with animal derived compounds. Here, development of a process for production of sIPV using only ACF compounds, is described. The upstream process required a change in cell growth medium from serum-containing medium to ACF medium, while virus production media remained the same as the already used M199 medium was free of animal components. In the downstream process multiple modifications in existing unit operations were made including addition of a diafiltration step prior to inactivation. After optimizing each unit operation, robustness of the whole process was demonstrated using design of experiments (DoE) methodology. By using DoE we were able to vary different process parameters across unit operations to assess the impact on our quality attributes. The developed process was robust as the observed variation for quality attributes due to differences in process parameters remained within specification. The resulting pilot process showed not only to be robust, but also to have a considerable higher product yield when compared to the serum containing sIPV process. Product yields are now comparable to the cIPV process based on using wild type polio viruses. Moreover, the potency of the produced vaccine was comparable that of cIPV vaccine. The developed ACF sIPV process can be transferred to vaccine manufacturers at the end-of pre-clinical development phase, at lab- or pilot scale, before production of clinical trial material.

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News (Medical) associated with Poliovirus vaccine inactivated(Sanofi)

04 Apr 2024

·www.fiercepharma.com

Sanofi pledges to keep polio vaccine supplies afloat in India after new approval

“We wish to assure all stakeholders that there will be no shortage of IPV vaccines in India on our account,” a Sanofi India spokesperson told Fierce Pharma on Thursday. After press reports flagged the possibility of an inactivated polio vaccine (IPV) shortage in India, Sanofi says it's ready to supply the nation with a newly approved shot. Thursday, after the company gained an approval for a new polio vaccine, IMOVAX-Polio, Sanofi issued an assurance that it will be able to keep providing sufficient supplies. The developments come quickly on the heels of an Economic Times report alleging that a shortage crisis was looming following Sanofi’s decision to shut down certain vaccine manufacturing operations in the country. Last September, Sanofi revealed plans to discontinue its previous polio shot in India. Still, to hear Sanofi tell it, India shouldn’t be concerned. The company’s local branch remains “dedicated to supporting India’s public health program for polio,” a Sanofi India spokesperson told Fierce Pharma on Thursday. “To ensure that there is no interruption to the availability of IPV vaccines, we have already obtained approvals for our product IMOVAX-Polio,” she added. Regarding the company’s decision to discontinue its previous polio shot, Sanofi India’s spokesperson pointed to the rapidly shifting healthcare environment in the country following the COVID-19 pandemic. Amid rising demand for production capacity in India, Sanofi last year opted to discontinue its older polio shot. The company's spokesperson noted that the shot was only filled and packaged at the company’s factory in Hyderabad, while the antigens themselves were manufactured in France. Sanofi and its Indian affiliate Shantha Biotechnics pledged to supply polio vaccines for India’s universal immunization program through UNICEF back in 2015. Sanofi got its hands on Shantha in 2009 when the French drugmaker’s vaccine division agreed to pay 550 million euros ($784 million) for the Merieux Alliance’s controlling stake in the Indian shot maker. Elsewhere in India, Sanofi last week called on local drugmakers Cipla and Dr. Reddy’s Laboratories to help sell its central nervous system (CNS) drugs and vaccines in country. Cipla is slated to market six Sanofi CNS medicines, including the leading epilepsy therapy Frisium, which Sanofi will continue to own, import and manufacture. Dr. Reddy’s, for its part, is on deck to sell five Sanofi vaccines in the country.

VaccineDrug Approval

100 Deals associated with Poliovirus vaccine inactivated(Sanofi)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	Germany	Sanofi Pasteur Europe	12 Oct 1999
Poliomyelitis	Germany	Sanofi Pasteur Europe	12 Oct 1999
Tetanus	Germany	Sanofi Pasteur Europe	12 Oct 1999

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Preclinical	Philippines	Sanofi Pasteur	01 Sep 2007
Influenza, Human	Preclinical	Philippines	Sanofi Pasteur	01 Sep 2007
Diphtheria	Preclinical	France	Sanofi Pasteur	01 Jun 2006
Poliomyelitis	Preclinical	France	Sanofi Pasteur	01 Jun 2006
Tetanus	Preclinical	France	Sanofi Pasteur	01 Jun 2006
Whooping Cough	Preclinical	France	Sanofi Pasteur	01 Jun 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04481191 (V260-074, CTgov)	Phase 3	-	400	RotaTeq (V260)+IPV (Concomitant RotaTeq and IPV)	xnbplnvjrn(slywswyurx) = shbqdhfmme nosnafdikw (guoqwptjkz, plxvhtolpb - dfbsjymsxu) View more	-	17 Feb 2023
				RotaTeq (V260)+IPV (Staggered RotaTeq and IPV)	xnbplnvjrn(slywswyurx) = zdixmusxqu nosnafdikw (guoqwptjkz, xeoqmwpxkh - gimohxhbcf) View more
NCT01686503 (IDIPV, CTgov)	Phase 2	HIV Infections \| Poliomyelitis	231	IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (2/5 Dose Intradermal IPV)	fmohtmbcpt(nuldivwivj) = ezbgbnyhuj udqmtovwmi (abbxsyxaya, bshhwuuexn - mrklplbfbh) View more	-	05 Feb 2015
				IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose (Full Dose Intramuscular IPV)	fmohtmbcpt(nuldivwivj) = ndheomkbri udqmtovwmi (abbxsyxaya, voamylxdip - ritmmgbrxb) View more
NCT00355121 (CTgov)	Phase 2	Diphtheria \| Whooping Cough \| Tetanus \| Meningitis, Meningococcal \| Poliomyelitis	882	DAPTACEL+Menactra+IPOL (Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30)	kjvytvzuak(wplfgfnmip) = lvhycvmwlg bejvswoggb (cejjfteqsa, znyfgwysxo - hxfyjievms) View more	-	23 Aug 2011
				DAPTACEL+Menactra (Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30)	kjvytvzuak(wplfgfnmip) = uipggbcvjt bejvswoggb (cejjfteqsa, sognilumci - ftqbotzhbn) View more