Delving into the Latest Updates on Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Conjugated vaccine

Synonyms

6-in-1 paediatric vaccine - Sanofi, 6-in-1 paediatric vaccine - sanofi pasteur, diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)

+ [13]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [2]

Active Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Inactive Indication

HIV InfectionsInfluenza, Human

Originator Organization

Sanofi Pasteur

Active Organization

Sanofi Winthrop Industrie SA

Inactive Organization

Sanofi Pasteur

Sanofi

Drug Highest PhaseApproved

First Approval Date

EU (17 Apr 2013),

DiphtheriaHaemophilus InfectionsHepatitis B+ [3]

Regulation-

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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

NCT05794230 / Active, not recruitingPhase 3

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers.
It will be conducted in India and the RSA in 2 cohorts:
* Cohort I: Infants and toddlers 6 months to 16 months of age (Cohort I)
* Cohort II: Infants and toddlers 6 weeks to 15 months of age (Cohort II) In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines.
In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8).
The primary objectives of this study are:
* To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA)
* To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA
The secondary objectives of this study are:
* To describe the antibody titers to the meningococcal serogroups A, C, Y, and W:
* before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine:
* in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA.
* To describe the safety profile of MenACYW conjugate vaccine and that of licensed Menactra vaccine in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with other age-recommended vaccines.
* To describe the safety profile of age-recommended vaccines:
* in infants 6 weeks to 15 months of age (Cohort II) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
* in infants and toddlers 6 months to 16 months of age (Cohort I) in India and the RSA when administered concomitantly with MenACYW conjugate vaccine.
The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

Start Date27 Mar 2023

Sponsor / Collaborator

Sanofi Pasteur

ChiCTR2200064991 / SuspendedPhase 3

A randomized, blinded, parallel-controlled phase III clinical study to evaluate the safety and immunogenicity of healthy infants aged 2 and 3 months with DTacp

Start Date26 Oct 2022

Sponsor / Collaborator

Henan Center For Disease Control & Prevention

100 Clinical Results associated with Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA)

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100 Translational Medicine associated with Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA)

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100 Patents (Medical) associated with Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA)

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102

Literatures (Medical) associated with Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA)

31 Dec 2024·Human Vaccines & Immunotherapeutics

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

Letter

Author: Amimo, Floriano

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

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

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.

100 Deals associated with Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b conjugate vaccine(Sanofi Pasteur SA)

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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	EU	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	IS	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	LI	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	NO	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	EU	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	IS	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	LI	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	NO	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	EU	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	IS	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	LI	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	NO	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	EU	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	IS	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	LI	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	NO	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	EU	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	IS	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	LI	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	NO	Sanofi Winthrop Industrie SA	17 Apr 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	ZA	Sanofi Pasteur	14 Jul 2016
Influenza, Human	Phase 3	PH	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


NCT03673462 (MET41, CTgov)	Phase 3	Meningococcal Infections	2,797	W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 1: MenACYW Conjugate Vaccine)	kfpbpnefax(lkvwuvkndq) = alrxypwfty ozyiughsru (oihjgfcabb, usjqpuhgle - cekqqajivn) View more	-	05 Oct 2023
				W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)+Diphtheria, Tetanus, Acellular Pertussis, Poliovirus+Varicella Virus Vaccine+Hepatitis B Vaccine+Pneumococcal 13-valent Conjugate Vaccine (Group 2: MENVEO®)	kfpbpnefax(lkvwuvkndq) = uwfyguqngx ozyiughsru (oihjgfcabb, vjfuqslhbs - qoicoukxwe) View more
NCT01948193 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections ... View more	177	recombinant Hepatitis B monovalent vaccine+DTaP-IPV-HB-PRP-T combined vaccine	kxxncqajko(bpgbrkyuok) = fsjcbuirhf quuthzlqya (egokfuzhas, ihdsvbbfcu - cmgammacdt) View more	-	25 Sep 2015
NCT01444781 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	1,106	DTaP IPV Hep B PRP T+Prevenar (Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster)	zdrfyfcdwe(hdazpajnjd) = nbflpvulhh guztszxgdy (yslcgcucbp, hkdagkufzz - wjgexkhafg) View more	-	16 Jul 2014
				IPV Hep B PRP T Primary+Infanrix Hexa+PCV7 (Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster)	zdrfyfcdwe(hdazpajnjd) = qbmvypvtur guztszxgdy (yslcgcucbp, vuawkmkwym - ttiknystdp) View more
NCT00404651 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	1,189	DTaP-IPV-HB-PRP~T (DTaP-IPV-HB-PRP~T Batch 1)	jicitzijzq(jntsxreqhc) = oyntrhaahv dqzljozroz (pldrmbmfly, uayknuhjwj - dqycdcrsai) View more	-	09 May 2014
				DTaP-IPV-HB-PRP~T (DTaP-IPV-HB-PRP~T Batch 2)	jicitzijzq(jntsxreqhc) = fjvezgagqr dqzljozroz (pldrmbmfly, wqihmserlf - fxicyqtrtf) View more
NCT01177722 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	1,375	DTap-IPV-Hep B-PRP~T (DTap-IPV-Hep B-PRP~T Batch A)	yybbvhlzfe(npronxsvpw) = aomoscbyio ddrvioqqxu (wziabxhbka, cskoovcrer - sodwbxlquc) View more	-	05 May 2014
				DTaP-IPV-Hep B-PRP~T (DTaP-IPV-Hep B-PRP~T Batch B)	yybbvhlzfe(npronxsvpw) = ljltipinoc ddrvioqqxu (wziabxhbka, zhuoacafub - yhdmdqwotw) View more
NCT00362336 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections ... View more	622	DTaP+DTaP-IPV-Hep B-PRP~T (DTaP-IPV-Hep B-PRP~T Group)	lvpomroujz(guwxkodlrk) = qdeodppibu unboqfkgom (sxqqncllzc, otvjzhztvr - zwmkgbemow) View more	-	02 May 2014
				CombAct-Hib+Engerix B+OPV (CombAct-Hib™ + Engerix B™ + OPV Group)	lvpomroujz(guwxkodlrk) = jozchruqak unboqfkgom (sxqqncllzc, sebjhlgtvr - tuyygufabu) View more
NCT00619502 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	254	DTaP-IPV-HepB-PRP~T (DTaP-IPV-HepB-PRP~T)	jacnmqurtg(plhuviietq) = msukbtmtxb qusozzcwvd (fqpbrvgswo, lcbrcwmrvr - hjbfedytaf) View more	-	03 Apr 2014
				Engerix B+Pentaxim (Pentaxim™ + Engerix B™)	jacnmqurtg(plhuviietq) = zmaadwczan qusozzcwvd (fqpbrvgswo, ystgjuskca - rhdvxxiglr) View more
NCT00401531 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections ... View more	412	Prevnar+DTaP-IPV-Hep B-PRP-T (DTaP-IPV-Hep B-PRP-T + Prevnar™)	okubjdlhti(lbwgwqrfxo) = veulkugugv raglrlnaxj (ywnurunokp, wrjerpsmtt - gppuikmkgg) View more	-	01 Apr 2014
				Infanrix Hexa (Infanrix Hexa™ + Prevnar™)	okubjdlhti(lbwgwqrfxo) = dsxgvqplzm raglrlnaxj (ywnurunokp, jvjvtebxwy - syjhogsucw) View more
NCT00315055 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough	310	DTaP-IPV-Hep B-PRP~T (DTaP-IPV-Hep B-PRP~T)	tjfnolksww(gbzgxzlxuf) = uajtlghndr jsoazlqzog (wzgptxcuyz, djawqyrilq - pkzepwipja) View more	-	04 Feb 2014
				ENGERIX+PENTAXIM (PENTAXIM™ and ENGERIX® PEDIATRIC)	tjfnolksww(gbzgxzlxuf) = olrzhxtblc jsoazlqzog (wzgptxcuyz, hkooaqhtsn - cxkytmavmh)
NCT00343889 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections ... View more	379	DTaP-Hep B-PRP~T+OPV (Group 1: DTaP-Hep B-PRP~T + OPV)	knagumygve(iyfaoepyqr) = khfpzltyxa pluumectye (qvcjfqklhd, tadbqgrbkw - lxppfczpom) View more	-	10 Dec 2013
				Tritanrix-Hep B+OPV (Group 2: Tritanrix-Hep B/ Hib™ + OPV)	knagumygve(iyfaoepyqr) = tanwypxgiz pluumectye (qvcjfqklhd, ljvuqkxvwf - iaxjfozshm) View more