Safety and Immunogenicity of an Investigational Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Adsorbed (Tdap) Vaccine in Young Adults

The primary objectives of this study are:
To describe the safety profile of each of the investigational vaccine formulations for all participants
To describe the humoral and cell-mediated immune responses to all of the investigational vaccine formulations
To evaluate the dose response to vaccine components
To describe the magnitude, quality, and longevity of immune responses to each of the investigational vaccine formulations

Start Date26 Jun 2019

Sponsor / Collaborator

Sanofi Pasteur

NCT01337167

/ CompletedPhase 3

A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.

Start Date19 Apr 2011

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

NCT01346293

/ CompletedPhase 3

Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age

The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.
Primary Objectives:
To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose.
To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose .
To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
Observational Objectives:
To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.

Start Date01 Apr 2011

Sponsor / Collaborator

Sanofi Pasteur

100 Clinical Results associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

100 Translational Medicine associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

100 Patents (Medical) associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

Literatures (Medical) associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

01 Dec 2018·BMC Public HealthQ3 · MEDICINE

Impact of vaccine delays at the 2, 4, 6 and 12 month visits on incomplete vaccination status by 24 months of age in Quebec, Canada

Q3 · MEDICINE

ArticleOA

Author: Guay, Maryse ; Boulianne, Nicole ; Kiely, Marilou ; Landry, Monique ; Sauvageau, Chantal ; De Serres, Gaston ; Talbot, Denis ; Ouakki, Manale

BACKGROUNDTimeliness in the administration of recommended vaccines is often evaluated using vaccine delays and provides more information regarding the susceptibility of children to vaccine-preventable diseases compared with vaccine coverage at a given age. The importance of on-time administration of vaccines scheduled at the first visit is well documented, but data are scarce about the impact of vaccine delays at other visits on vaccination status by 24 months of age. Using vaccine delays for the first three doses of DTaP-containing vaccines and for the first dose of measles-containing vaccines as markers of timeliness at the 2, 4, 6 and 12 month visits, we estimated the proportion of incomplete vaccination status by 24 months of age attributable to a vaccine delay at each of these visits.METHODSWe used the data from six cross-sectional coverage surveys conducted in the Province of Quebec from 2006 to 2016 which included 7183 children randomly selected from the universal health insurance database. A vaccine dose was considered delayed if received 30 days or more after the recommended age. The impact of new vaccine delays at each visit on incomplete vaccination status by 24 months of age was estimated with the attributable risk in the population.RESULTSThe proportion of children with vaccine delay was 5.4% at 2 months, 13.3% at 4 months, 23.1% at 6 months and 23.6% at 12 months. Overall, 72.5% of all 2-year-old children with an incomplete status by 24 months were attributable with a vaccine delay, of which 16.1% were attributable with a first vaccine delay at 2 months, 10.6% at 4 months, 14.0% at 6 months and 31.8% at 12 months.CONCLUSIONSWhile great emphasis has been put on vaccine delays at the first vaccination visit, the prevalence of vaccine delays was greater with later visits and most children with an incomplete vaccination status by 24 months had a vaccine delay occurring during these later visits. Interventions to improve timeliness should address vaccine delays at each visit and not only focus on the first visit.

01 Dec 2018·Journal of Microbiology, Immunology and InfectionQ2 · MEDICINE

Immunogenicity and protective efficacy of a newly developed tri-component diphtheria, tetanus, and acellular pertussis vaccine in a murine model

Q2 · MEDICINE

ArticleOA

Author: Ahn, Dong Ho ; Shin, Hye Jo ; Kang, Kyu Ri ; Han, Seung Beom ; Choi, Gi Sub ; Kang, Jin Han ; Huh, Dong Ho ; Kim, Bo Ram

BACKGROUND/PURPOSEAlthough assessing the immunogenicity and protective efficacy of acellular pertussis (aP) vaccines via murine model studies faces limitations, preliminary assessments have been achieved by evaluating respiratory challenge and humoral and cellular immunity.METHODSWe performed a long-term intranasal respiratory challenge with reference and clinically isolated strains of Bordetella pertussis. Simultaneously, we assessed humoral and cellular immunity for evaluating the immunogenicity of a newly developed tri-component diphtheria-tetanus-aP (DTaP) vaccine. Moreover, comparative assessment was made by performing the same evaluations with a commercially available tri-component DTaP vaccine as the positive control.RESULTSBoth groups showed significantly increased levels of antibodies against pertussis toxin, filamentous hemagglutinin and pertactin, and the levels of interferon-γ and interleukin-10 were significantly increased after two doses of vaccination. Furthermore, since cross cell-mediated immune reactivity between the two vaccines was detected, the possibility of interchangeability was indirectly suggested. Although the positive control group showed significantly higher titers in antibody responses for filamentous hemagglutinin and pertactin compared to the experimental group, anti-pertussis toxin antibody titers of the two groups were not significantly different and the protective efficacy against the clinical and reference strains was maintained in both groups for 18 weeks.CONCLUSIONThe results showed inferior immunogenicity of the new DTaP vaccine compared to a commercial vaccine despite comparable cellular immunity and protective efficacy. Some efforts are necessary for improving immunogenicity against filamentous hemagglutinin and pertactin before conducting human clinical trials.

01 Feb 2018·VaccineQ3 · MEDICINE

Conventional influenza vaccines influence the performance of a universal influenza vaccine in mice

Q3 · MEDICINE

Article

Author: Price, Graeme E ; Lo, Chia-Yun ; Epstein, Suzanne L ; Misplon, Julia A ; Garcia, Mayra ; Rowell, Janelle

Universal influenza vaccines are designed to protect against diverse strains of influenza virus. Preclinical testing of new vaccine candidates is usually done in naïve animals, despite intended use in the human population with its varied immune history including responses to previous vaccinations. As an approach more relevant to human use, we tested a candidate universal influenza vaccine in mice with a history of conventional vaccination. Female BALB/c mice were given two intramuscular doses of inactivated influenza vaccine (IIV) or diphtheria and tetanus toxoids vaccine (DT), one month apart. Another group was given two intranasal doses of live attenuated influenza virus (LAIV). One month after the second dose, mice were given the universal influenza vaccine: recombinant adenoviruses expressing influenza A nucleoprotein (A/NP) and matrix 2 (M2) (A/NP + M2-rAd). Immune responses to universal vaccine antigens A/NP and M2 were assessed by ELISA and interferon-γ ELISPOT. Protection was tested by challenge with mouse-adapted A/FM/1/47 (H1N1) and monitoring for weight loss and survival. Universal vaccine performance was enhanced, inhibited or unaffected by particular prior vaccinations. Mice given Afluria IIV and LAIV had greater antibody and T-cell response to A/NP than mice without prior vaccination, providing examples of enhanced A/NP + M2-rAd performance. Though Fluvirin IIV partially inhibited, the universal vaccine still provided considerable protection unlike conventional vaccination. Fluzone IIV and DT had no effect on A/NP + M2-rAd performance. Thus our results demonstrate that universal vaccine candidate A/NP + M2-rAd was at least partially effective in mice with diverse prior histories. However, the degree of protection and nature of the immune responses may be affected by a history of conventional vaccination and suggests that performance in humans would be influenced by immune history.

News (Medical) associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

28 Jun 2022

·www.prnewswire.com

United States Human Vaccines Markets, 2018-2021 & Forecast to 2028: Approval/launches of the New Vaccines / Rising Focus on Immunization Programs / Increasing Investments and Government Support

DUBLIN, June 28, 2022 /PRNewswire/ -- The "United States Human Vaccines Market Size, Share, Top 45 Human Vaccines Brand In-depth Analysis, Emerging Trends, Current Analysis, Growth, Demand, Opportunity, and Forecast 2022 - 2028" report has been added to ResearchAndMarkets.com's offering. Amid the COVID-19 crisis, the United States human vaccines market is poised to grow by US$ 31,517 million by 2028, accelerating at a CAGR of 7% during the forecast period. The prominent factors that are expected to contribute to the growth of the United States human vaccines market: Increased Disease Awareness Approval/launches of the New Vaccines Rising Focus on Immunization Programs Increasing Investments and Government Support for the Vaccines Development The report contains a deep analysis of the United States human vaccines market size in terms of value. The report provides a clear insight into current and future developments of the United States vaccines market. The report also explores the detailed analysis, insights of the top 45 vaccines market assessment in the United States from 2018 to 2021, and forecasts to 2028. The report also details the latest information about the vaccine's pricing analysis, insights, and trends, and the regulatory framework of the United States human vaccines market. After conducting thorough research on the historical and current growth parameters, the growth prospects of the United States human vaccines market are obtained with maximum precision. This new 2022 market report provides a holistic analysis of the entire United States human vaccines market. The report offers the most up-to-date industry data on the actual market situation and future outlook for the United States' human vaccines market. The report also tracks and analyses competitive developments, including collaboration, partnership deals, distribution, exclusive and licensing agreements, new vaccine developments, and R&D activities in the market. The report also delivers an in-depth analysis of evolving market trends, drivers, and restraining forces that influence the growth of the market. The report also analyses detailed profiles of innovative and leading players with information on business overview, companies' vaccines portfolio, promising vaccines in the clinical development, and the newest developments The report will serve as a source for a 360-degree analysis, thoroughly integrating different models. This Newest and Comprehensive the United States Human Vaccines Market Research Report 2022 Delivers: Comprehensive Research Methodology of the United States Human Vaccines Market Detailed and Extensive Market Overview with Key Analyst Insights Insights about Market Determinants that are Stimulating the United States Human Vaccines Market To Analyze the Historical Growth in the Market Size of the United States Human Vaccines Market from 2018 to 2021 To Estimate and Forecast the Market Size of the United States Human Vaccines Market from 2022 to 2028 and Growth Rate until 2028 Detailed Insights of the Top 45 Human Vaccines Market Value Used in the U.S. with Six Years Forecast An Insightful Analysis of the Top 45 Vaccines Brand Market Share and Y-o-Y Growth Rate Delivers All-inclusive Insights on the Latest Pricing Analysis, Insights, and Trends Delivers an In-Depth Analysis of Evolving Market Trends, Drivers, and Restraints of the United States Human Vaccines Market An Insightful Investigation has been done on Promising Human Vaccines in the Clinical Development Delivers Comprehensive Insights into the Regulatory Framework of the United States Human Vaccines Market Tracks Competitive Developments, Approaches, Recent Industry Developments, Partnership, Collaboration Deals, Distribution, Exclusive, and Licensing Agreement A Comprehensive List of the Leading Companies along with the Analysis of their Current Vaccines Portfolio, Promising Human Vaccines in the Clinical Development, and Present Development The Report Helps Answer the Following Questions: What is the current scenario of the United States human vaccines market? What is the total market size and forecast (until 2028) of the United States human vaccines market? How big is the United States human vaccines market? At what CAGR is the U.S. human vaccines market projected to grow in the forecast period (2022-2028)? What are the leading human vaccines? What are their revenue potentials to 2028? Which human vaccine brand provides the highest market share? What is the regulatory framework in the United States vaccines market? What are the key factors driving the United States human vaccines market? What are the key challenges of the United States human vaccines market? What are the major deals and agreement happenings in the United States human vaccines market? What are the United States human vaccines pricing trends and analysis? What are the various human vaccines available in the United States? Who are the topmost market players? What are their happenings, current developments, and scenarios? How is the market predicted to develop in the future? Key Topics Covered: 1. Executive Summary 2. United States Human Vaccines Market Size and Forecast (2018 - 2028) 3. United States Human Vaccines Brand Market Share and Y-o-Y Growth (%), 2018 - 2028 4. Key Market Growth Drivers and Challenges in the United States Human Vaccines Market 4.1 Key Market Growth Drivers 4.2 Key Market Challenges 5. United States Top 45 Human Vaccines Market Value Analysis, Insights and Forecasts, 2018 - 2028 5.1 Daptacel 5.2 Quadracel 5.3 Kinrix 5.4 Vaxelis 5.5 IPOL 5.6 Vaqta 5.7 Havrix 5.8 Twinrix 5.9 Engerix B 5.10 PedvaxHIB 5.11 ActHIB 5.12 Hiberix 5.13 MenQuadfi 5.14 Tenivac 5.15 Imovax 5.16 FluMist Quadrivalent 5.17 Prevnar 13 5.18 Gardasil 9 5.19 Fluzone Quadrivalent 5.20 Flublok 5.21 Flucelvax Quadrivalent 5.22 Afluria Quadrivalent 5.23 Fluad 5.24 Varivax 5.25 Menactra 5.26 Proquad 5.27 Pneumovax 23 5.28 Fluarix 5.29 FluLaval 5.30 M-M-R II 5.31 Adacel 5.32 Boostrix 5.33 Bexsero 5.34 Menveo 5.35 Trumenba 5.36 Shingrix 5.37 Pentacel 5.38 Recombivax HB 5.39 Rotateq 5.40 Rotarix 5.41 Pediarix 5.42 Infanrix 5.43 Heplisav-B 5.44 TDVAX 5.45 BioThrax 5.46 Other Vaccines 6. United States Human Vaccines Pricing Analysis, Insights and Trends 7. Regulatory Framework of the United States Human Vaccines Market 8. Major Deals and Agreement Happenings in the Human Vaccines Market 8.1 Merger & Acquisitions 8.2 Collaboration Deals 8.3 Licensing Agreement 8.4 Exclusive Agreement 8.5 Distribution Agreement 8.6 Partnership Deals 9. Leading Companies in the United States Human Vaccines Market 9.1 Sanofi Pasteur 9.1.1 Business Overview 9.1.2 Human Vaccines Portfolio 9.1.3 Promising Human Vaccines in the Clinical Development 9.1.4 Recent Development 9.3 Merck 9.4 Pfizer 9.5 Seqirus (CSL Limited) 9.6 AstraZeneca 9.7 Dynavax Technologies Corporation 9.8 Emergent BioSolutions Inc. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

VaccineAcquisition

100 Deals associated with Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AJ52	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diphtheria	US	Sanofi Pasteur, Inc.	14 May 2002
Tetanus	US	Sanofi Pasteur, Inc.	14 May 2002
Whooping Cough	US	Sanofi Pasteur, Inc.	14 May 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Discovery	PR	Sanofi Pasteur	01 Apr 2011
Measles	Discovery	PR	Sanofi Pasteur	01 Apr 2011
Measles	Discovery	US	Sanofi Pasteur	01 Apr 2011
Tetanus	Discovery	PR	Sanofi Pasteur	01 Apr 2011
Whooping Cough	Discovery	PR	Sanofi Pasteur	01 Apr 2011
Meningitis, Meningococcal	Discovery	US	Sanofi	01 Oct 2006
Haemophilus Infections	Discovery	US	Sanofi	01 May 2001
Poliomyelitis	Discovery	US	Sanofi	01 May 2001

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01337167 (V419-005, CTgov)	Phase 3	Bacterial Infections \| Virus Diseases	1,473	DAPTACEL™+V419+PedvaxHIB™+RotaTeq™+Prevnar 13™ (V419)	dieiejtlrq(fwetydzcdx) = bhhvlrztci obwccjcbcx (cvxgzbhald, bwgykcxjve - lxaiifkevh) View more	-	16 Mar 2016
				ActHIB™+DAPTACEL™+PENTACEL™+Recombivax HB vaccine+RotaTeq™+Prevnar 13™ (Control)	dieiejtlrq(fwetydzcdx) = tfmpobfdvc obwccjcbcx (cvxgzbhald, vrbelmaqxe - pkvubeqtoh) View more
NCT01346293 (CTgov)	Phase 3	Diphtheria \| Measles \| Whooping Cough \| Tetanus \| Poliomyelitis	3,372	DAPTACEL+Pentacel vaccines+DTaP-IPV (DTaP-IPV)	dkaqvnbpjs(ilailsmjjc) = tqybzfqcid felkmbosrk (dnsdjatttw, krgrrkihbk - llorkusnbk) View more	-	29 May 2015
				DAPTACEL+IPOL (DAPTACEL®+IPOL®)	dkaqvnbpjs(ilailsmjjc) = xuunvtjjlh felkmbosrk (dnsdjatttw, mewcvirazq - bjlttldvvf) 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)	ursfbrivtn(whnbsuhtnh) = uckhpjlaai eilowsyavh (xjvwawdtra, famlnlwhzm - goejuseqee) View more	-	23 Aug 2011
				DAPTACEL+Menactra (Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30)	ursfbrivtn(whnbsuhtnh) = ukayfnvugm eilowsyavh (xjvwawdtra, bpcgeszavd - mngfpucjnm) View more
NCT00258895 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	649	DAPTACEL (DAPTACEL®-Primed)	qucgvatspu(htqzkrenrf) = xjhmqctgfq uzyiqhvsek (ooowczmgcr, xwpmiquhze - pupzbkogtn) View more	-	28 Sep 2009
				Pentacel (Pentacel®-Primed)	qucgvatspu(htqzkrenrf) = wqnomerzah uzyiqhvsek (ooowczmgcr, ykxojryyxo - ljgfhgdqhe) View more

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Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Sanofi Pasteur)

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