Delving into the Latest Updates on SHAN6 with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

DTP-HepB-Polio-Hib vaccine, SHAN 6

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

DiphtheriaHemophilus influenza infectionHepatitis B+ [3]

Originator Organization

Sanofi Pasteur SA

Active Organization-

Inactive Organization

Sanofi Pasteur SA

License Organization-

Drug Highest PhasePendingPhase 3

First Approval Date-

Regulation-

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Phase III, multi-center, randomized, active-controlled, open-label, three-arm, study in 690 infants who will receive a 3-dose primary series at 6, 10 and 14 weeks of age, of either 3-dose SHAN6™ or SHAN6™ – SHAN 5® + bOPV – SHAN6™ or SHAN 5® + bOPV – SHAN 5® + bOPV – SHAN 5® + bOPV + IPV, and a booster dose of either SHAN6™ or SHAN 5® + bOPV at 18 months of age

Start Date24 Aug 2020

Sponsor / Collaborator

Sanofi Pasteur Europe

NCT04429295

/ CompletedPhase 3

Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (Shan6™) Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand

Primary Objective:
To demonstrate the non-inferiority of the SHAN6™ vaccine to the licensed SHAN5™ given with bOPV and IPV vaccines when coadministered with PCV and ORV
Secondary Objective:
* To describe the immunogenicity profile of the SHAN6™ vaccine 3-dose primary infant vaccination and that of the control vaccines (SHAN5™ given with bOPV and IPV)
* To describe the immune response to co-administered ORV-1 (Rotarix™) in a subset of participants from each group
* To describe the immune response to co-administered PCV-13 (Prevnar 13®) in a subset of participants from each group
* To describe the persistence of the antibodies against SHAN6™ antigens following a 3-dose primary series of SHAN6™ or SHAN5™ given with bOPV and IPV
* To describe the immunogenicity profile of SHAN6™ 28 days after the single booster dose of SHAN6™
* To describe the safety profile of the SHAN6™ vaccine and the control vaccines (SHAN5™ given with bOPV and IPV), when administered concomitantly with routine pediatric vaccines

Start Date28 Jun 2020

Sponsor / Collaborator

Sanofi Pasteur SA

CTRI/2018/04/013375

/ CompletedPhase 2

Safety and Immunogenicity of booster dose of a Hexavalent Vaccine SHAN6â?¢ (DTwP-HepB-Hib-IPV) with or without co-administration of MMR vaccine in Toddlers

Start Date13 May 2018

Sponsor / Collaborator-

100 Clinical Results associated with SHAN6

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100 Translational Medicine associated with SHAN6

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100 Patents (Medical) associated with SHAN6

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100 Deals associated with SHAN6

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diphtheria	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020
Hemophilus influenza infection	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020
Hepatitis B	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020
Poliomyelitis	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020
Tetanus	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020
Whooping Cough	Phase 3	Thailand	Sanofi Pasteur SA	28 Jun 2020