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

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

Conditions

• Pertussis Immunisation
• Diphtheria Immunisation
• Polio Immunisation
• Hepatitis B Immunisation
• Haemophilus Influenzae Type B Immunisation
• Tetanus Immunisation
• Rotavirus Immunisation
• Pneumococcal Immunisation

Interventions

BIOLOGICAL

DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b)

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Inactivated Poliomyelitis Vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Poliomyelitis Vaccine bivalent types 1 and 3

Pharmaceutical form:Oral suspension Route of administration: Oral

BIOLOGICAL

Human Rotavirus, live attenuated

Pharmaceutical form:Oral suspension Route of administration: Oral

BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Weeks

Max Age

11 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-28

Primary Completion

2021-02-26

Completion

2021-11-20

Countries

• Thailand

Study Locations