Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
Condition: Pertussis Immunisation; Diphtheria Immunisation; Polio Immunisation; Hepatitis B Immunisation; Haemophilus Influenzae Type B Immunisation; Tetanus Immunisation; Rotavirus Immunisation; Pneumococcal Immunisation
MeSH terms: Hepatitis B; Diphtheria
Study type: Interventional
Phase: Phase 3

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
    

Detailed description: 
      The duration of each participant's active participation in the study will be approximately
      14-17 months (416-506 days)

      in addition to the 2 MedDRA terms: Polio immunisation 10054175 Hepatitis B immunisation
      10054181 Haemophilus influenzae type B immunisation 10069533 Tetanus immunisation 10054131
      Rotavirus immunisation 10076886 Pneumococcal immunisation 10069578
    

Intervention name(s): 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)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Oral suspension Route of administration: Oral; Pharmaceutical form:Oral suspension Route of administration: Oral; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other intervention name(s): SHAN6™; SHAN5™; IMOVAX Polio; Rotarix™; Prevnar 13®, PCV-13
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention