Study of DTwP-HepB-Hib-IPV (SHAN6 ) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand

  • STATUS
    Recruiting
  • participants needed
    460
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 28 March 2023
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vaccination
pneumococcal
prevnar
tetanus
blood draw
poliomyelitis
rotavirus
haemophilus influenzae type b
pediatric
pertussis immunisation

Summary

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

Description

The duration of each participant's active participation in the study will be approximately 17 months (506 days)

Details
Condition Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type B Immunisation, Tetanus Immunisation, Rotavirus Immunisation, Pneumococcal Immunisation
Age 1years - 1years
Treatment DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b), Inactivated Poliomyelitis Vaccine, Poliomyelitis Vaccine bivalent types 1 and 3, Human Rotavirus, live attenuated, Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Clinical Study IdentifierNCT04429295
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on28 March 2023

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pneumococcal
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