Delving into the Latest Updates on Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine(Sanofi) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Combination vaccine, Prophylactic vaccine

+ [1]

Synonyms

DTaP-IPV, DTaP-poliovirus vaccine paediatric, Quadracel

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Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesRespiratory Diseases+ [1]

Active Indication

DiphtheriaPoliomyelitisTetanus+ [1]

Inactive Indication

Measles

Originator Organization

Sanofi

Active Organization

Sanofi Pasteur, Inc.

Inactive Organization

Sanofi Pasteur

Drug Highest PhaseApproved

First Approval Date

US (24 Mar 2015),

DiphtheriaPoliomyelitisTetanus+ [1]

Regulation-

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Assessment of time course of changes in antibody titers after vaccination with a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Salk vaccine): DTap-wIPV to consider necessity of booster vaccinations. - DTap-wIPV to consider necessity of booster vaccinations.

Start Date01 Mar 2015

Sponsor / Collaborator-

NCT01437423 / CompletedPhase 4

Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)

The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Start Date01 Jun 2011

Sponsor / Collaborator

Sanofi Pasteur

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 adsorbed and inactivated poliovirus vaccine(Sanofi)

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

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

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135

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

31 Dec 2024·Human Vaccines & Immunotherapeutics

Adverse events following immunization of co- and separate administration of DTaP-IPV/Hib vaccines: A real-world comparative study

Article

Author: Li, Jing ; Zhu, Yiqing ; Wang, Yihan ; Wang, Jinghui ; Wang, Yafei ; Guo, Yu ; Wang, Lina ; Sun, Li

To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.

01 Jun 2024·Vaccine: X

Changes in vaccination practices among infants after the introduction of DTaP-IPV/Hib combination vaccines

Article

Author: Choi, Nam-Kyong ; Kim, Hee-Jin ; Park, Suvin ; Jeong, Na-Young

Background:

Diphtheria-tetanus-acellular pertussis, polio, and Haemophilus influenza type B (DTaP-IPV/Hib) combination vaccine was introduced as a part of the Korea National Immunization Program (NIP) on June 19, 2017. Combination vaccines can improve vaccination rates by simplifying the vaccination schedule.

Objective:

To explain how the introduction of DTaP-IPV/Hib in the NIP has changed vaccination practices for infants.

Methods:

Using a nationwide vaccine registry, the proportion of infants who completed the full recommended doses of the primary series of DTaP, IPV, and Hib (D-I-H) within 12 months of age was estimated among those born between 2013 and 2019. Among those, the proportions of those who received the same DTaP components for all 3 doses during the primary series were calculated for the 2013-2016 and the 2017-2019 birth cohorts. Those who received the same component of DTaP throughout the entire primary vaccination schedule were categorized into 3 groups by DTaP components to compare the average frequency of medical visits for vaccination.

Results:

A total of 2,703,822 infants were born between 2013 and 2019, of which 96.7% completed full doses of the primary D-I-H series within 12 months of age. For the 2013-2016 birth cohorts, most received DTaP-IPV-only (75.4%), while most of the 2017-2019 birth cohorts received DTaP-IPV/Hib-only (81.0%) to complete the 3 doses for primary D-I-H series. The average frequency of medical visits for vaccination showed a significant difference across the 3 groups classified by DTaP components in every birth cohort (p < 0.001).

Conclusions:

After the introduction of DTaP-IPV/Hib, most infants completed the primary D-I-H series with the combination vaccine and there was a significant reduction in the average number of medical visits for vaccination. Our findings provide important insights for countries considering the introduction of combination vaccines into their NIP.

01 Aug 2023·Vaccine: X

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India

Article

Author: Rao, Harish ; Parekh, Sameer ; Shaligram, Umesh ; Desai, Shivani ; Pujari, Pramod ; Shewale, Sunil ; Patel, Akash ; Marthak, Kiran ; Gairola, Sunil ; Sharma, Hitt

Background:

To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Haemophilus influenza type B conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults.

Methods:

Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes.

Results:

All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported.

Conclusion:

SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.Clinical Trial Registration: CTRI/2017/07/009034.

100 Deals associated with Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine(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	US	Sanofi Pasteur, Inc.	24 Mar 2015
Poliomyelitis	US	Sanofi Pasteur, Inc.	24 Mar 2015
Tetanus	US	Sanofi Pasteur, Inc.	24 Mar 2015
Whooping Cough	US	Sanofi Pasteur, Inc.	24 Mar 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Measles	Phase 3	US	Sanofi Pasteur	01 Apr 2011
Measles	Phase 3	PR	Sanofi Pasteur	01 Apr 2011

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01437423 (CTgov)	Phase 4	Diphtheria \| Whooping Cough \| Tetanus ... View more	600	TETRAXIM	eqqpakhbyy(bahtenrqzj) = lwsnvoxtyy avlvivrhdd (yiskugjhig, omcxtqpmsy - qotjpstnyf) View more	-	04 Jan 2017
NCT01346293 (CTgov)	Phase 3	Diphtheria \| Measles \| Whooping Cough ... View more	3,372	DAPTACEL+Pentacel vaccines+DTaP-IPV (DTaP-IPV)	ijpkvjjlfe(ovswxynpiq) = scohlnsgvu kxufikzozn (ldbaqztrtj, fllbbahjps - pujlzruifp) View more	-	29 May 2015
				DAPTACEL+IPOL (DAPTACEL®+IPOL®)	ijpkvjjlfe(ovswxynpiq) = kdudquhjtt kxufikzozn (ldbaqztrtj, shehzfwaxl - vouvmefvfb) View more
NCT00255047 (CTgov)	Phase 3	Diphtheria \| Whooping Cough	2,167	Pentacel®: DTaP-IPV/Hib combined (Study Group 2: Pentacel®)	jhoimxvdvx(yefkkdzfmr) = yphdjglbxd ldxotaczoo (fabrozfkbi, uagkxofrpn - iyslgqkkjw) View more	-	10 Nov 2010
				ActHIB®+DTaP-IPV (Study Group 3: DTaP-IPV and ActHIB®)	jhoimxvdvx(yefkkdzfmr) = rmgthaxfau ldxotaczoo (fabrozfkbi, jyrttqvmrd - jdbxhwddfu) View more