Clinical Trials associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

NCT06647407 / RecruitingPhase 1/2

A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Start Date05 Nov 2024

Sponsor / Collaborator

Sanofi Pasteur

CTRI/2024/08/073010 / Not yet recruitingNot Applicable

A Prospective Randomized Single Center Two Arm Open Label Parallel GroupComparative Study to Evaluate the Safety of Needle Free Injection System(N-FIS TM) andImmunogenicity of Hexavalent Vaccine (HEXASIIL) in Healthy Infants Aged 15 to 18Months - NIL

Start Date02 Sep 2024

Sponsor / Collaborator-

TCTR20240723005 / Not yet recruitingNot ApplicableIIT

Antibody persistence against diphtheria, tetanus, pertussis, hepatitis B, measles, mumps and rubella in 9-12-year-old Thai children following immunization with pentavalent and hexavalent vaccines, and the immunogenicity of Tdap administered at 11 years of age

Start Date01 Sep 2024

Sponsor / Collaborator-

100 Clinical Results associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

100 Translational Medicine associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

100 Patents (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

184

Literatures (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Disparate kinetics in immune response of two different Haemophilus influenzae type b conjugate vaccines: Immunogenicity and safety observations from a randomized controlled phase IV study in healthy infants and toddlers using a 2+1 schedule

Article

Author: Virk, Navpreet ; Bosis, Samantha ; Cheuvart, Brigitte ; Horn, Michael ; Duchenne, Maurine ; Salamanca de la Cueva, Ignacio ; Westerholt, Soeren ; Martinón-Torres, Federico ; Meyer, Nadia ; Van den Steen, Peter ; Jakes, Rupert W

Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL. One month after the booster vaccination, the anti-PRP antibody GMC ratio (Ih group/Va group) was 0.917 (95% CI: 0.710-1.185), meeting the non-inferiority criteria. The difference in percentage of participants (Ih group - Va group) reaching GMCs ≥5 µg/mL was -6.3% (95% CI: -14.1% to 1.5%), not reaching the predefined non-inferiority threshold. Interestingly, a slightly higher post-booster antibody avidity was observed in the Ih group versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. This study illustrates the different kinetics of the anti-PRP antibody response post-primary and post-booster using the two vaccines containing different Hib conjugates and indicates a potential differential impact of concomitant vaccinations on the anti-PRP responses. The clinical implications of these differences should be further studied.

31 Dec 2024·Human Vaccines & Immunotherapeutics

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016)

Article

Author: Lumley, Jessie ; Chen, Ziqiang ; Costantino, Claudio ; Johnson, David ; Westerholt, Soeren ; Martinon-Torres, Federico ; Lambeth, Courtney ; Guerra, Andrea ; Marcek, Tomas ; Wilck, Marissa

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Switching between HVs during the childhood vaccination series is sometimes necessary due to, for example, vaccine availability, health-care provider preference, and/or tender awards. The purpose of this study was to describe the safety, tolerability, and immunogenicity of a booster dose of Vaxelis® in participants who previously received a primary infant series of either DTaP2-HBV-IPV-Hib (Hexyon®) or Vaxelis®. Healthy participants approximately 11-13 months of age who previously received a two-dose primary series of Hexyon® (HHV group) or Vaxelis® (VVV group) all received a Vaxelis® booster dose. Immunogenicity was evaluated by measuring antibody levels to individual vaccine antigens approximately 30 days following booster vaccination. Safety was evaluated as the proportion of participants with adverse events (AEs). The proportions of participants with antibody-specific responses for antigens contained in both Vaxelis® and Hexyon® at 30 days post-toddler-booster vaccination with Vaxelis® were comparable between groups, and higher in the VVV group for Vaxelis® antigens PRN and FIM2/3. The overall proportions of participants with AEs were generally comparable between groups. Following a booster dose of Vaxelis®, immune responses were comparable between groups for all shared antigens, and higher in the VVV group for antigens found only in Vaxelis®. The booster was well tolerated in both groups. These data support the use of Vaxelis® as a booster in mixed HV regimens.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Acceptance and willingness to pay for DTaP-HBV-IPV-Hib hexavalent vaccine among parents: A cross-sectional survey in China

Article

Author: Zhang, Bingling ; Tang, Lin ; Liu, Jiajie ; Huang, Lifang ; Wang, Yu ; Wang, Lei ; Xu, Xia ; Wang, Fuzhen ; Li, Jun ; Zhang, Xue ; Zhou, Yang ; Liu, Qianqian ; Huang, Aodi ; Zhang, Qian ; Liu, Siyu ; Zhou, Zemei ; Yin, Zundong ; Wang, Xiaoqi

DTaP-HBV-IPV-Hib hexavalent vaccine has been used in high-income countries for many years to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b disease. Currently, no hexavalent vaccines have been approved for use in China. Evidence of parental acceptance and interest in hexavalent vaccines can help policy makers and manufacturers make decisions about entering the vaccine market and the immunization program in China. We measured parental acceptance and willingness-to-pay (WTP) for a hexavalent vaccine to provide such evidence. We conducted a cross-sectional survey of children's caregivers in 16 vaccination clinics in seven cities in China and obtained information on socio-demographics, knowledge of disease, confidence in vaccines, previous vaccination experience, and acceptance of and WTP for hexavalent vaccine. Multivariate logistic regression was used to determine factors influencing acceptance, and multivariate tobit regression was used to identify factors impacting WTP. Between April 28 and June 30, 2023, a total of 581 parents of children aged 0-6 years participated in the survey; 435 (74.87%, 95% CI:71.3%-78.4%) parents indicated acceptance of hexavalent vaccine. Residence location, parents' education level, experience paying for vaccination, and disease knowledge scores were key factors affecting parents' choices for vaccination. Mean (SD) and median (IQR) willingness to pay for full 4-dose course vaccination were 2266.66 (1177.1) CNY and 2400 (1600-2800) CNY. Children's age (p < .001), parents' education level (p = .024), and perceived price barriers (p < .001) were significantly associated with WTP. Parents have high acceptance and willingness to pay for hexavalent vaccine. The less money parents have to pay out of pocket, the more willing they can be to accept the vaccine. Therefore, acceptance may increase even further if the vaccine is covered by medical insurance, provided free of charge by the government, or if its price is reduced. Our results provide reference for optimizing and adjusting immunization strategies in China.

News (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

02 Jul 2024

·www.prnewswire.com

INOVIO Announces Appointment of Steven Egge as Chief Commercial Officer

Mr. Egge brings over 25 years of biopharmaceutical experience building commercial organizations and successfully launching novel therapeutic products INOVIO poised to become a commercial-stage company with plans to submit a Biologics License Application for INO-3107 in second half of 2024 under U.S. Food and Drug Administration's Accelerated Approval Pathway PLYMOUTH MEETING, Pa., July 2, 2024 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced the appointment of Steven Egge as Chief Commercial Officer. Mr. Egge will lead the company's commercial strategy and operations as it prepares to potentially launch its first DNA medicine product, INO-3107 as a treatment for recurrent respiratory papillomatosis (RRP). "We are delighted to welcome Steve to INOVIO and look forward to adding his expertise to our leadership team as we continue advancing our preparations to commercially launch INO-3107 in 2025, should it receive approval by the FDA as a treatment for RRP," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "Steve joins us at an exciting time, as we prepare to become a commercial-stage company, while advancing multiple product candidates targeting unmet medical needs. His expertise launching new products, driving market share in competitive environments, and growing overall therapeutic areas will be advantageous to the development and implementation of our commercial plans, as will his experience across immunology and vaccines, HPV, and rare diseases." "This is a great time to join INOVIO as the company has the opportunity to market the first therapeutic option for patients suffering from RRP, a rare and debilitating HPV-related disease that significantly impacts quality of life," said Mr. Egge. "I look forward to working with the talented team at INOVIO and continuing the ongoing efforts to build out the company's commercial strategies and capabilities." Mr. Egge comes to INOVIO from Sumitomo Pharma (formerly Myovant Sciences, acquired by Sumitovant Biopharma, a subsidiary of Sumitomo Pharma, in 2023), where as Senior Vice President and General Manager for Women's Health he was responsible for building the commercial leadership team, accelerating the launch of Myfembree® and helping lead the company's expansion into new indications. Mr. Egge was at Merck for twenty years, where he held a number of senior commercial leadership roles, including leading Merck's HPV Vaccines Franchise as well as Chief Marketing Officer for the Vaccine Division, where he oversaw launches for new indications for GARDASIL®, a re-launch of ZOSTAVAX®, and launch planning for GARDASIL9® and VAXELIS®. Mr. Egge also served as Global Commercial Head for Merck's Fertility Franchise, where he oversaw the launch of ELONVA® in ex-U.S. markets. After Merck, Mr. Egge served as Senior Vice President at Genfit Corp., a French biotech company focused on liver diseases, where he led commercial planning and business development. About INOVIO's DNA Medicines Platform INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA®. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA® delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms. About INOVIO INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit . CELLECTRA® is a trademark of INOVIO. GARDASIL®, GARDASIL9®, ZOSTAVAX® and ELONVA® are trademarks of Merck and Co., Inc. VAXELIS® is trademark of The MSP Vaccine Company. Myfembree® is trademark of Sumitomo Pharma Switzerland GmbH. Forward-Looking Statements This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and expectations regarding our research and development programs, including the planned submission of a BLA in the second half of 2024 and the planned commercial launch of INO-3107 if regulatory approval is obtained. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2023, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law. Contacts Media: Jennie Willson (267) 429-8567 [email protected] Investors: Thomas Hong (267) 440-4298 [email protected] SOURCE INOVIO Pharmaceuticals, Inc.

Executive ChangeVaccine

30 Mar 2023

·endpts.com

Aspen looks to rebound in production and revenue after Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around. Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales. However, things were not all negative as Aspen said it was in negotiations with customers seeking to “secure a portion of Aspen’s sterile manufacturing capabilities.” Aspen CEO Steven Saad said in a release: Aspen had initially invested in three sterile manufacturing lines at its production site in Gqeberha, South Africa, and had plans to invest in two more production lines. The intention was to transition the manufacturing of its own anesthetic products from third-party producers to enhance the supply, Hill told Endpoints News in an email. “The COVID pandemic, however, fast-tracked our plans to manufacture vaccines as we pivoted and re-prioritized in-housing our anesthetic products to manufacture the COVID vaccine,” Hill said. Hill stated that in August of last year, Aspen entered a long-term agreement with India’s Serum Institute for Aspen to manufacture, market and eventually distribute four vaccines in Africa. The Serum Institute deal will also help Aspen gain further entry into the routine vaccine market, which has “sustainable” demand and can diversify the manufacturer’s portfolio, Hill told Endpoints. “This is an important milestone as Aspen seeks to optimize our sterile manufacturing capacity in Gqeberha. The four products are Pneumococcal vaccine, Rotavirus vaccine, Polyvalent Meningococcal Vaccine and the Hexavalent Vaccine with transfer activities currently underway,” Hill said. The company also secured agreements with the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations in the meantime. Hill added that the grant funding from these deals has helped to offset the production costs related to starting production of the Serum Institute vaccines. Saad added in the release that Aspen expects the new manufacturing business to bring in around R 2 billion ($112 million) in 2024.

VaccineFinancial Statement

02 Feb 2023

·www.sanofi.com

Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone

Strong sales performance and double digit EPS growth marking the achievement of the 2022 profitability milestone Paris, February 3, 2023 Q4 2022 sales growth of 2.6% at CER and business EPS (1) growth of 17.4% at CER Specialty Care grew 18.1% driven by Dupixent ® (€2,402 million, +42.1%) and new product launches Vaccines sales (-16.3%) reflecting influenza and PPH sales phasing (Q3 influenza sales: up 32.4%) as well as ramp up of non-consolidated Vaxelis ® sales General Medicines core assets up 8.0% while GBU sales were lower (-3.7%) mainly due to Lantus ® and spin-off of EUROAPI CHC sales increased 6.6% driven by double-digit growth of Digestive Wellness, Cough & Cold and Allergy categories Full-year 2022 delivered 7.0% sales growth and 17.1% business EPS growth at CER Sales grew to €42,997 million driven by Dupixent ® (€8,293 million, +43.8%), adding €3 billion of incremental sales, Vaccines up 6.3% in line with the mid-term growth objective as well as CHC strategy execution (+8.6%) Mid-term BOI margin target of 30% and cost savings objective of €2.5 billion achieved Business EPS (1) of €8.26 up 25.9% on a reported basis and 17.1% at CER IFRS EPS of €5.37 (up 8.0%) Board held on February 2, proposes annual dividend of €3.56, an increase of 6.9% Progress on Corporate Social Responsibility strategy in Q4 Positive phase 2/3 results of acoziborole with the potential to further transform the treatment of sleeping sickness Accelerating our ambition towards net zero emissions by 5 years, now targeting 2045 Key R&D milestones and regulatory achievements in Q4 Dupixent ® approved in Europe for prurigo nodularis and CHMP positive opinion for eosinophilic esophagitis Beyfortus ® ( nirsevimab) approved in Europe for the prevention of RSV disease in all infants VidPrevtyn ® Beta approved in Europe as a booster for the prevention of COVID-19 in adults Enjaymo ® approved in Europe in adult patients with cold agglutinin disease (CAD) Full-year 2023 business EPS guidance Sanofi expects 2023 business EPS (1) to grow low single digit (2) at CER, barring unforeseen major adverse events. Applying average January 2023 exchange rates, the currency impact on 2023 business EPS is estimated between -3.5% to -4.5% Sanofi Chief Executive Officer, Paul Hudson, commented: “We closed 2022, marking the successful execution of the first chapter of our 6-year ‘Play to Win’ strategy. Specialty Care delivered the highest sales among our businesses. Dupixent ® and Vaccines continue to be our leading growth drivers. We are particularly proud of the progress we made in R&D transformation with multiple approvals of transformative medicines and new product launches across Specialty Care. At the same time, we keep delivering strong proof points of our improved financial performance underpinned by the achievement of the 30% BOI margin. Moving to the next chapter of our strategy, we are looking forward to the planned launches of Altuviiio ® and Beyfortus ® as well as key pivotal readouts, including the COPD indication for Dupixent ® . With the view on the expected entrants of generic competition for Aubagio ® in the coming months, we remain confident in our outstanding commercial capabilities, including the ambition to reach sales of 10 billion euros for Dupixent ® in 2023, enabling us to guide to low single-digit EPS growth for the year.” Q4 2022 Change Change at CER 2022 Change Change at CER IFRS net sales reported €10,725m +7.3% +2.6% €42,997m +13.9% +7.0% IFRS net income reported €1,460m +29.1% _ €6,720m +8.0% — IFRS EPS reported €1.16 +28.9% _ €5.37 +8.0% — Free cash flow (3) €2,546m +0.2% _ €8,483m +4.8% — Business operating income €2,724m +20.7% +15.0% €13,040m +21.7% +13.3% Business net income (1) €2,141m +23.8% +17.6% €10,341m +25.9% +17.0% Business EPS (1) €1.71 +23.9% +17.4% €8.26 +25.9% +17.1% Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 9). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q4 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2022 business EPS was €8.26; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9). Attachment Press Release

Drug ApprovalBiosimilar

100 Deals associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)	J07CA09	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	EU	MCM Vaccine BV	15 Feb 2016
Diphtheria	NO	MCM Vaccine BV	15 Feb 2016
Diphtheria	IS	MCM Vaccine BV	15 Feb 2016
Diphtheria	LI	MCM Vaccine BV	15 Feb 2016
Haemophilus Infections	LI	MCM Vaccine BV	15 Feb 2016
Haemophilus Infections	NO	MCM Vaccine BV	15 Feb 2016
Haemophilus Infections	EU	MCM Vaccine BV	15 Feb 2016
Haemophilus Infections	IS	MCM Vaccine BV	15 Feb 2016
Hepatitis B	IS	MCM Vaccine BV	15 Feb 2016
Hepatitis B	LI	MCM Vaccine BV	15 Feb 2016
Hepatitis B	NO	MCM Vaccine BV	15 Feb 2016
Hepatitis B	EU	MCM Vaccine BV	15 Feb 2016
Tetanus	LI	MCM Vaccine BV	15 Feb 2016
Tetanus	NO	MCM Vaccine BV	15 Feb 2016
Tetanus	EU	MCM Vaccine BV	15 Feb 2016
Tetanus	IS	MCM Vaccine BV	15 Feb 2016
Whooping Cough	EU	MCM Vaccine BV	15 Feb 2016
Whooping Cough	LI	MCM Vaccine BV	15 Feb 2016
Whooping Cough	IS	MCM Vaccine BV	15 Feb 2016
Whooping Cough	NO	MCM Vaccine BV	15 Feb 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis	Preclinical	-	MCM Vaccines B.V.	30 Mar 2012
Bacterial Infections	Preclinical	-	Merck Sharp & Dohme Corp.	19 Apr 2011
Virus Diseases	Preclinical	-	Merck Sharp & Dohme Corp.	19 Apr 2011
Diphtheria	Preclinical	CA	Sanofi Pasteur	01 Aug 2006
Poliomyelitis	Preclinical	CA	Sanofi Pasteur	01 Aug 2006
Tetanus	Preclinical	CA	Sanofi Pasteur	01 Aug 2006
Whooping Cough	Preclinical	CA	Sanofi Pasteur	01 Aug 2006
Hepatitis B	Preclinical	-	Merck Sharp & Dohme Corp.	01 May 2001

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04978818 (CTgov)	Phase 4	Haemophilus Infections	333	PedvaxHIB (PedvaxHIB Arm)	pmwzreguzu(nebrjkcjsm) = halanctamg cqhhhhztmj (khhjdrepkc, ctshsvzvso - bfjgarfznh) View more	-	24 Jun 2024
				Vaxelis (Vaxelis)	pmwzreguzu(nebrjkcjsm) = uyzujbsbhu cqhhhhztmj (khhjdrepkc, wqcrckeyjv - nexdknhbzr) View more
NCT05289271 (CTgov)	Phase 4	-	168	Vaxelis™ (Group 1: V, V, V)	lvfdheswpg(vblybxmssu) = pxywcnjpty qivyyknnik (bpyxtfdimx, umbxlvgusq - iumzscpxnd) View more	-	06 Sep 2023
				Vaxelis™ (Group 2: H, H, V)	lvfdheswpg(vblybxmssu) = lpuiznhnlf qivyyknnik (bpyxtfdimx, xcndsekrjm - nqdmblihps) View more
NCT04016714 (V114-026 \| PNEU-PED-EU-2, CTgov)	Phase 3	Pneumococcal Infections	1,191	VARIVAX™+Vaxelis™+V114+M-M-R®II (V114)	(zyomygjdru) = vixchsvwuf psdlemxfxq (ltfmvtpjsb, qdhzppcnkz - ealtrsjxtj) View more	-	01 Dec 2022
				VARIVAX™+Vaxelis™+Prevenar 13™+M-M-R®II (Prevenar 13™)	(zyomygjdru) = grneaswkcj psdlemxfxq (ltfmvtpjsb, mzojhzrlit - mnazxnjsip) View more
NCT01341639 (V419-007, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	1,250	ProQuad™+V419+Prevenar 13+RotaTeq (PR5I)	jxwrkdojjr(tsatqvndzb) = niwubkdegr xelhydtesv (gxtpbdkwuh, qxtecgvfur - nrwaqchsre) View more	-	10 Apr 2019
				ProQuad™+INFANRIX™ hexa+Prevenar 13+RotaTeq (INFANRIX™ Hexa)	puvmdemyeo(kfffmhjzsy) = gglwbljmmi gzayogbygi (isnylgrdlu, gtcviaympr - kjfftnhpjr) View more
NCT01480258 (V419-008, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	1,315	PR5I+Prevenar 13™+Rotavirus vaccine (PR5I)	ekpbgdakwe(lgxfdfomaa) = wavlmquiyg oifebwedqi (qfxwylgyvc, empniocjch - ucyrijvztk) View more	-	02 Apr 2019
				INFANRIX™ hexa+Prevenar 13™+Rotavirus vaccine (INFANRIX™ Hexa)	ipjaupcnmh(vimbhxnath) = vqodfbdvfu hxjlqnqtry (wsxuusotif, ukxiylkxoj - xmuqdklaxk) View more
NCT01553279 (V419-011, CTgov)	Phase 3	Bacterial Infections \| Meningitis \| Virus Diseases	284	Hib-MCC+V419+PREVNAR 13®+MCC-TT+MMR Vaccine (V419 and MCC-TT)	pmnmnskluu(intlcpnfug) = mrvouovvkd vyqgliuxee (rwumnssuge, ktfhbmjwok - mkqibwpkjv) View more	-	28 Mar 2019
				Hib-MCC+MCC-CRM+V419+PREVNAR 13®+MMR Vaccine (V419 and MCC-CRM)	pmnmnskluu(intlcpnfug) = xxqhcsqtta vyqgliuxee (rwumnssuge, cfmzrfbgdu - qxxjxnvfmm) View more
NCT01839188 (V419-010, CTgov)	Phase 3	Meningococcal Infections \| Virus Diseases	385	NeisVac-C®+Pediacel®+PR5I+Prevenar 13®+RotaTeq®	nojcfdutgv(unonrefhsm) = gmdvslebhs uinktfrczg (iqkvhkhflk, pbpvrgbdte - azmvewoayd) View more	-	25 Feb 2019
NCT01839188 \| EUCTR2012-004221-25-ES (V419-010, Pubmed \| Vaccine)	Phase 3	Bacterial Infections \| Virus Diseases	385	DTaP5-IPV-HB-Hib	lfzawvssfu(wipkxkguia) = qhrsaioowa liengbemwk (whfqdpgxvh )	-	27 Jun 2017
NCT01340937 (V419-006, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	2,808	PENTACEL™+V419+RotaTeq™+Prevnar 13™ (V419 Lot A)	neibgectpo(pvzbecpeqk) = oujqhnvpth wufqvtyqry (ftzzhpbfxd, vbkosyhbnt - ovmwgemcie) View more	-	02 May 2016
				PENTACEL™+V419+RotaTeq™+Prevnar 13™ (V419 Lot B)	neibgectpo(pvzbecpeqk) = zthgqqerfr wufqvtyqry (ftzzhpbfxd, zbkgyaoyne - deoyrvynkz) View more
NCT01337167 (V419-005, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	1,473	DAPTACEL™+V419+PedvaxHIB™+RotaTeq™+Prevnar 13™ (V419)	ctnhxabjxb(tsdyaseplk) = oyvjelwmqk qafxxozael (eeeujwvqdx, bwulobscil - qkzxjhmorx) View more	-	16 Mar 2016
				ActHIB™+DAPTACEL™+PENTACEL™+Recombivax HB vaccine+RotaTeq™+Prevnar 13™ (Control)	ctnhxabjxb(tsdyaseplk) = shurxnbxmg qafxxozael (eeeujwvqdx, shiizbejgc - iecnhhfzgb) View more

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Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine(Sanofi)

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