NCT04429295 - Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand | Biotech Hunter

Enrollment

460

Participants

Timeline

Start Date

June 28, 2020

Primary Completion Date

February 26, 2021

Study Completion Date

November 20, 2021

Conditions

Pertussis ImmunisationDiphtheria ImmunisationPolio ImmunisationHepatitis B ImmunisationHaemophilus Influenzae Type B ImmunisationTetanus ImmunisationRotavirus ImmunisationPneumococcal 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

Trial Locations (3)

4002

Investigational Site Number 7640002, Khon Kaen

10330

Investigational Site Number 7640003, Bangkok

10700

Investigational Site Number 7640001, Bangkok

All Listed Sponsors

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY