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

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Toxoid vaccine

Synonyms

SP-306, Adacel, Repevax

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesOther Diseases

Active Indication

DiphtheriaTetanusWhooping Cough

Inactive Indication-

Originator Organization

Sanofi Pasteur

Active Organization

Shenzhen Sanofi Pasteur Biological Products Co. Ltd.Sanofi Pasteur, Inc.

Sanofi Pasteur

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (10 Jun 2005),

DiphtheriaTetanusWhooping Cough

Regulation-

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The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are:
Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years?
What is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study?
Participants will receive a Tdap vaccination every 3 months ±2 weeks for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.

Start Date01 May 2023

Sponsor / Collaborator

ABO Holdings, Inc.

NCT04490018 / CompletedPhase 3

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly With 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents

Primary Objective:
To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2).
Secondary Objective:
To describe:
the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine [adsorbed, reduced antigen(s) content] (Tdap-IPV) vaccines (Group 3).
the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.
the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.
the safety profile in each group after each and any vaccination.

Start Date16 Mar 2021

Sponsor / Collaborator

Sanofi Pasteur

NCT04142983 / CompletedPhase 2/3

A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine

This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.

Start Date03 Feb 2020

Sponsor / Collaborator

GCAM Inc

100 Clinical Results associated with DTaP vaccine(Sanofi)

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100 Translational Medicine associated with DTaP vaccine(Sanofi)

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100 Patents (Medical) associated with DTaP vaccine(Sanofi)

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51

Literatures (Medical) associated with DTaP vaccine(Sanofi)

01 Aug 2023·Infectious diseases and therapy

Safety and Clinical Benefits of Adacel^® and Adacel^®-Polio Vaccination in Pregnancy: A Structured Literature Review.

Review

Author: Clark, Liana R ; Johnson, David R

Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel^®/Adacel-Polio^® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91-93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.

01 May 2023·Vaccine

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis

Article

Author: Monfredo, Celine ; Vargas-Zambrano, Juan C. ; Pool, Vitali ; Li, Lin ; Bouvet, Paul-Edouard ; Blangero, Yoann ; Clark, Liana R. ; Macina, Denis ; Johnson, David R.

OBJECTIVE:

To evaluate the effectiveness of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine containing five pertussis components (Tdap5; Adacel®, Sanofi) when given during pregnancy at preventing pertussis in infants less than 2 months of age.

METHODS:

The US Centers for Disease Control and Prevention (CDC), in collaboration with the Emerging Infections Program (EIP) Network, undertook a case-control study evaluating the effectiveness of Tdap vaccination in pregnancy against pertussis in infants less than 2 months of age based on data collected by the EIP Network from 2011 through 2014. The dataset from the CDC/EIP Network study was used to conduct this product-specific vaccine effectiveness analysis of Tdap5 vaccination in pregnancy to prevent disease in young infants. The main outcome of interest was vaccine effectiveness in infants whose pregnant parents were vaccinated with Tdap5 between 27 and 36 weeks' gestation, in accordance with the ideal timing for Tdap vaccination in pregnancy recommended by the US Advisory Committee on Immunization Practices. Odd ratios (ORs) and 95 % confidence intervals (CIs) were estimated using conditional logistic regression, and vaccine effectiveness was calculated as (1-OR) × 100 %.

RESULTS:

There were 160 infant pertussis cases and 302 matched controls included in this Tdap5-specific study. Tdap5 effectiveness in preventing pertussis in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation was 92.5 % (95 % CI, 38.5 %-99.1 %). Effectiveness of Tdap5 against pertussis-related hospitalization in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation could not be calculated due to lack of discordance among matched cases and controls. Vaccination of the parents after pregnancy or less than 14 days before delivery did not protect infants from pertussis.

CONCLUSIONS:

Tdap5 vaccination in pregnancy between 27 and 36 weeks' gestation is highly effective at protecting young infants from pertussis.

STUDY REGISTRATION:

ClinicalTrials.gov, NCT05040802.

01 Feb 2023·Vaccine

Effect of maternal immunisation with multivalent vaccines containing inactivated poliovirus vaccine (IPV) on infant IPV immune response: A phase 4, multi-centre randomised trial

Article

Author: Stephens, Laura ; Jones, Christine E ; Heath, Paul T ; Cooper, Gillian ; Southern, Jo ; Waight, Pauline ; Andrews, Nick ; Miller, Elizabeth ; Calvert, Anna ; Martin, Javier ; Grassly, Nicholas C

Multivalent diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP/IPV) has been offered to pregnant women in the United Kingdom since 2012. To assess the impact of maternal DTaP/IPV immunisation on the infant immune response to IPV, we measured poliovirus-specific neutralising antibodies at 2, 5 and 13 months of age in a randomised, phase 4 study of Repevax or Boostrix/IPV in pregnancy and in a non-randomised group born to women not given DTaP/IPV in pregnancy. Infants whose mothers received DTaP/IPV were less likely to seroconvert after three IPV doses than those whose mothers did not receive DTaP/IPV. At 13 months of age, 63/110 (57.2 %), 46/108 (42.6 %) and 40/108 (37.0 %) were seropositive to types 1 to 3, compared with 20/22 (90.9 %), 20/22 (90.9 %) and 14/20 (70.0 %) (p-values 0.003, <0.001 and 0.012). UK infants whose mothers are given DTaP/IPV in pregnancy may be insufficiently protected against poliomyelitis until their pre-school booster.

100 Deals associated with DTaP vaccine(Sanofi)

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	US	Sanofi Pasteur, Inc.	10 Jun 2005
Tetanus	US	Sanofi Pasteur, Inc.	10 Jun 2005
Whooping Cough	US	Sanofi Pasteur, Inc.	10 Jun 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04142983 (CTgov)	Phase 2/3	Tetanus	110	Tdap Vaccine	rjbkbjmora(stqotsegaj) = gvfctrulbi ljzgvgiqaj (dolouvktth, oxmzjjsney - cwlouvbuis) View more	-	06 Dec 2022
NCT01439165 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	1,330	Adacel Vaccine (Adacel Vaccine)	tzovikzhsq(vdwpwxlhhu) = joyzzmzteh qeqvvwtvxb (wcmefesndh, fofzajuufn - ljyzhxupbs) View more	-	09 Oct 2017
				Td (Td Adsorbed Vaccine)	tzovikzhsq(vdwpwxlhhu) = dyedcivqqg qeqvvwtvxb (wcmefesndh, dflzxhjtzd - xffxztumrv) View more
NCT01311557 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	1,302	Adacel (Participants 10 to <11 Years of Age)	suocpzocdq(tsohhprlkc) = zwoehgzskw exabcrqxse (ncflvwlgki, vmjynjnzfh - cwlduymjlv) View more	-	08 Apr 2016
				Adacel (Participants 11 to <12 Years of Age)	suocpzocdq(tsohhprlkc) = bcndmpqwab exabcrqxse (ncflvwlgki, jigupwvdgz - jweslagtti) View more
NCT02089347 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	534	acellular pertussis vaccine adsorbed (SP306 Group)	ctmimowazc(ylqpulujnh) = cmmtndpvrv mmvlwnwlad (nofcbwytjg, ncmuqfxrhx - lowylubvhg) View more	-	08 Oct 2015
				Diphtheria (DT Group)	ctmimowazc(ylqpulujnh) = ffkuyfawev mmvlwnwlad (nofcbwytjg, wborrjrzue - hgcffgrnft) View more
NCT00712959 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	769	Acellular Pertussis (ADACEL®) (Group 1: Previous Tdap or Tdap-IPV Recipients)	mefhgucoiq(oveiwnjjad) = tisesoxafl elxytjkfcg (ydbsftbfoh, yhoxsgxhjb - gqknktqcjl) View more	-	30 Apr 2014
				Tetanus, Reduced Diphtheria Toxoid (Group 2: Tdap Vaccine-naïve)	mefhgucoiq(oveiwnjjad) = irjddnjvpw elxytjkfcg (ydbsftbfoh, krwuzwykqc - jtjdnrdwsh) View more
NCT01933776 (CTgov)	Phase 1	Diphtheria \| Whooping Cough \| Tetanus	40	ADACEL™ Vaccine (ADACEL™ Vaccine Group 1)	mofubgybnw(kwswyehqts) = lbqjkitmuf backmcflyi (combjqskzb, ionsavvnol - bgcrilelvf) View more	-	21 Apr 2014
				ADACEL™ Vaccine (ADACEL™ Vaccine Group 2)	mofubgybnw(kwswyehqts) = qodqbzkwiy backmcflyi (combjqskzb, jkhamzngua - mkjcpuibnm) View more
NCT01629589 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	423	Tetanus Toxoid, Reduced Diphtheria Toxoid (Adacel® Vaccine Group)	tisegdjlns(rauaggcixd) = ydnygbyodx mebtbtiabu (tqpyspuvjc, rjfdjtkfjz - ljmkqzcvel) View more	-	21 Oct 2013
				Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) (BOOSTRIX® Vaccine Group)	tisegdjlns(rauaggcixd) = hkzaghqfna mebtbtiabu (tqpyspuvjc, xrtavxeirv - zappselgvv) View more
NCT00457249 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	1,564	ADACEL (ADACEL® Vaccine Group)	femucmckvd(epadskdwvi) = hmmgetaptu iqsthhgvmn (nffxlzqpwr, ucygnlgpsl - mjegvoiztn) View more	-	19 Oct 2012
				DECAVAC (DECAVAC® Vaccine Group)	femucmckvd(epadskdwvi) = rskuigxuxs iqsthhgvmn (nffxlzqpwr, zrhxczlzju - wkfmmrdsjq) View more
NCT00319553 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus	647	Acellular Pertussis Adsorbed (Adacel® Vaccine Group)	biewxclgjm(lwnjkempmy) = mxyqhqvdww aulefyfrch (cwdznpshxf, vhqfscofre - rzhglbnqdp) View more	-	21 Oct 2010
				Acellular Pertussis Adsorbed (Boostrix® Vaccine Group)	biewxclgjm(lwnjkempmy) = tuleihbxlg aulefyfrch (cwdznpshxf, eitudgdwod - ppdzydiytf) View more
NCT00777257 (CTgov)	Phase 4	Diphtheria \| Meningitis \| Meningococcal Infections ... View more	1,345	Tdap (Tdap + Placebo Vaccines Day 0)	giqntvujgz(mtvolhnteu) = qaguoywcsz ogdfflslza (nkxiomihbf, hnekffgsfh - dqnxswmjvp) View more	-	31 Dec 2009
				Tdap+Menactra (Tdap + Menactra® Vaccines Day 0)	giqntvujgz(mtvolhnteu) = mxfblbftpy ogdfflslza (nkxiomihbf, slwjicvlru - qsuvitchom) View more