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-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [2]

Active Indication

DiphtheriaHaemophilus InfectionsHepatitis B+ [4]

Inactive Indication

HIV InfectionsInfluenza, Human

Originator Organization

Sanofi Pasteur

Active Organization

Sanofi Pasteur

Sanofi Winthrop Industrie SA

Inactive Organization

Sanofi

Drug Highest PhaseApproved

First Approval Date

European Union (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

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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76

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

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 ; Lambeth, Courtney ; Chen, Ziqiang ; 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 2023·Expert review of vaccines

A review of the DTaP-IPV-HB-PRP-T Hexavalent vaccine in pediatric patients

Review

Author: Dakin, Andrew ; Arkwright, Peter D. ; Borrow, Ray

INTRODUCTION:

Hexaxim is a hexavalent vaccine approved as primary and booster vaccination in infants 6 weeks and older, protecting against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenzae type b.

AREAS COVERED:

To evaluate the immunogenicity and reactogenicity (safety) of Hexaxim (Hexyon, Hexacima) in primary and booster vaccine schedules; long-term antibody persistence; concomitant use with other childhood vaccines and use in immunocompromised infants. Hexaxim was found to be noninferior to other licensed hexavalent vaccines, being highly immunogenic for all toxoids/antigens and with an acceptable safety profile. It can be administered concomitantly with other childhood vaccines. Hexaxim can be given as a booster for infants primed with Infanrix Hexa and given in a pentavalent-hexavalent-pentavalent series. Hexaxim elicits a similar immune response and safety profile in human immunodeficiency virus (HIV) positive infants. It has the benefit of being a ready-to-use liquid formulation, minimizing dosage errors and preparation time.

EXPERT OPINION:

Hexaxim has an acceptable safety profile and provides immunity against all six targeted diseases. It is an acceptable alternative to other hexavalent vaccines on the market. Further studies are required on the use of immunocompromised patients as well as the antibody persistence of each of the vaccine components.

31 Dec 2023·Expert Review of Vaccines

DTaP-IPV-HB-Hib vaccine (Hexaxim): an update 10 years after first licensure

Review

Author: Macina, Denis ; Manson, Christine ; Serradell, Laurence ; Boisnard, Florence

INTRODUCTION:

Hexaxim® is fully liquid, hexavalent, combination vaccine that provides immunization against diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and invasive diseases caused by Haemophilus influenzae type b. Combination vaccines such as Hexaxim reduce the number of injections needed, improving both vaccination compliance and operational efficiency.

AREAS COVERED:

Safety and immunogenicity data were reviewed from >25 clinical trials involving approximately 7200 infants/toddlers, identified using PubMed searches to April 2023. These trials have evaluated a diverse range of primary series and booster schedules, including antibody persistence, co-administration of Hexaxim with other routine pediatric vaccines, and specific populations (born to Tdap-vaccinated women, preterm, and immunocompromised infants). Lastly, post-marketing surveillance and real-world effectiveness data were assessed.

EXPERT OPINION:

An extensive program of clinical development prior to licensure demonstrated favorable vaccine safety and good immunogenicity of each antigen, and Hexaxim was first approved for use in 2012. In the 10 years since licensure, Hexaxim has been adopted widely, with more than 180 million doses distributed worldwide. The widespread use of this hexavalent vaccine is a crucial tool in the ongoing and future control of six pediatric infectious diseases globally.

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
-	-	J07CA09	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	European Union	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	Iceland	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	Liechtenstein	Sanofi Winthrop Industrie SA	17 Apr 2013
Diphtheria	Norway	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	European Union	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	Iceland	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	Liechtenstein	Sanofi Winthrop Industrie SA	17 Apr 2013
Haemophilus Infections	Norway	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	European Union	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	Iceland	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	Liechtenstein	Sanofi Winthrop Industrie SA	17 Apr 2013
Hepatitis B	Norway	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	European Union	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	Iceland	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	Liechtenstein	Sanofi Winthrop Industrie SA	17 Apr 2013
Poliomyelitis	Norway	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	European Union	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	Iceland	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	Liechtenstein	Sanofi Winthrop Industrie SA	17 Apr 2013
Tetanus	Norway	Sanofi Winthrop Industrie SA	17 Apr 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningococcal Infections	Phase 3	United States	Sanofi Pasteur	17 Sep 2018
Meningococcal Infections	Phase 3	Puerto Rico	Sanofi Pasteur	17 Sep 2018
HIV Infections	Phase 3	South Africa	Sanofi Pasteur	14 Jul 2016
Influenza, Human	Phase 3	Philippines	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


NCT03547271 (CTgov)	Phase 3	Meningococcal Infections	1,660	Pneumococcal vaccine (10-valent)+MenACYW conjugate vaccine+DTaP-IPV-HB-Hib vaccine+MMR vaccine (Group 1: MenACYW)	pwymwcxokn(oqbueveotz) = zdizzmyqqt hbewkceiiz (dchlrepxww, mlgzattcdz - iblfuafdnw) View more	-	22 Jan 2025
				Pneumococcal vaccine (10-valent)+DTaP-IPV-HB-Hib vaccine+Y conjugate vaccine+MMR vaccine (Group 2: Nimenrix)	pwymwcxokn(oqbueveotz) = rlwtiflkuc hbewkceiiz (dchlrepxww, ynoluxtsqg - pbhczinvys) View more
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)	weluwbvazy = qhltpjwdwm qhsoozdusa (npkcjbrpcj, hubopteoia - vasdxsysup) 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®)	weluwbvazy = pynrqmiemx qhsoozdusa (npkcjbrpcj, ywnrjdnwtq - tlqvfoczne) 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	nhkudzfsah = zzusehtaav spiyixaifw (gzumeieeog, bnqxpynmwx - dtqgwfvcsx) 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)	xjsvbipijv = zzyydrqjuf srrialyleq (tlldfdsrsj, zhqxevpevy - amxzgxmjxy) 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)	xjsvbipijv = dkcyhaumpm srrialyleq (tlldfdsrsj, hmsfkqfhge - looxijvuxq) 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)	jhwswmfblh = xivmcsgrjn xevdizispe (snhloqwrkr, qxjcodgftx - hbylforsil) View more	-	09 May 2014
				DTaP-IPV-HB-PRP~T (DTaP-IPV-HB-PRP~T Batch 2)	jhwswmfblh = uicdoftbrx xevdizispe (snhloqwrkr, jihygobbju - danbrbotet) 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)	rtbqtrzvsw(usmwtooutl) = fgfqtripoq qhbovxudho (vhmulkaxbh, foozqdjpeq - bdqmzpenmt) View more	-	05 May 2014
				DTaP-IPV-Hep B-PRP~T (DTaP-IPV-Hep B-PRP~T Batch B)	rtbqtrzvsw(usmwtooutl) = cymcxvjmny qhbovxudho (vhmulkaxbh, armbllzreh - ixuhyxzcla) 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)	tryzxtwfxm = ehkamyzeux eaawyfegux (qhdznloigb, vfurirtdic - nzfrosxaxi) View more	-	02 May 2014
				CombAct-Hib+Engerix B+OPV (CombAct-Hib™ + Engerix B™ + OPV Group)	tryzxtwfxm = dmbeziidfh eaawyfegux (qhdznloigb, rbtxybodtj - marojqpylt) View more
NCT00619502 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	254	DTaP-IPV-HepB-PRP~T (DTaP-IPV-HepB-PRP~T)	xufsgdsijs = tgngyvzbza zrhhwebyzh (edfdemjeii, roadfzwmyg - evyoersbuo) View more	-	03 Apr 2014
				Engerix B+Pentaxim (Pentaxim™ + Engerix B™)	xufsgdsijs = gkyqzzykmu zrhhwebyzh (edfdemjeii, bjvrqiupoq - mdeatdvopj) 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™)	cxvhombmpp = yufcxhgliv uktmbwuceg (ufvcnmnprz, hfqplxxxbj - lyrvttsljp) View more	-	01 Apr 2014
				Infanrix Hexa (Infanrix Hexa™ + Prevnar™)	cxvhombmpp = ouncjhgxjh uktmbwuceg (ufvcnmnprz, hasaexlyou - aliormfxzs) View more
NCT00315055 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Whooping Cough ... View more	310	DTaP-IPV-Hep B-PRP~T (DTaP-IPV-Hep B-PRP~T)	bxjbvdhuty = smtfznznmd ewsymptjlf (qrwuvrqblh, opaenclwcb - vnrqrtzvsk) View more	-	04 Feb 2014
				ENGERIX+PENTAXIM (PENTAXIM™ and ENGERIX® PEDIATRIC)	bxjbvdhuty = swhskfkgah ewsymptjlf (qrwuvrqblh, xhjseavsvs - vtbnjhekcc)