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

COMPLETEDPHASE3

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

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

NCT04429295•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

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

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Aged ≥ 2 months (age range of 8 weeks \<12 weeks) on the day of the first vaccination
•Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or medically stable prematurely born infants (born after a gestational period of 27-36 weeks)
•Infants who have received the birth dose of Bacille Calmette-Guérin vaccine (BCG) at least 4 weeks before the first trial vaccination
•Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and comply with all study procedures

Exclusion Criteria

•Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine within the period of 4 weeks before to 4 weeks after each trial vaccination, except for oral polio vaccine (OPV) and influenza vaccination. OPV may be received any time during the study while influenza vaccination may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
•Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B (except the dose of Hep B vaccine given at birth or at least 4 weeks before the first trial vaccination), Haemophilus influenzae type b, poliomyelitis (except OPV), rotavirus, and Streptococcus pneumoniae with either the trial vaccines or another vaccine
•Receipt of immune globulins, blood or blood-derived products since birth
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent at ≥ 0.5 mg/kg/day for more than 2 consecutive weeks since birth)
•Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] positive)
•Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
•History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, rotavirus, or pneumococcal infection(s) confirmed either clinically, serologically, or microbiologically
•History of any neurologic disorders, including encephalopathy, seizures (febrile and non-febrile) and progressive neurologic disorders
•History of intussusception
+10 more criteria

Locations (3)

Investigational Site Number 7640003

Bangkok, Thailand

Investigational Site Number 7640001

Bangkok, Thailand

Investigational Site Number 7640002

Khon Kaen, Thailand

Key Dates

Start Date

June 28, 2020

Primary Completion Date

February 26, 2021

Completion Date

November 20, 2021

Last Updated

September 22, 2025

Enrollment

460

ACTUAL participants

Conditions

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

Interventions

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

BIOLOGICAL

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

BIOLOGICAL

Inactivated Poliomyelitis Vaccine

BIOLOGICAL

Poliomyelitis Vaccine bivalent types 1 and 3

BIOLOGICAL

Human Rotavirus, live attenuated

BIOLOGICAL

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

BIOLOGICAL

Safety and Immunogenicity of Intranasal BPZE1 Vaccination in Healthy Adults

NCT03541499

PertussisPertussis Immunisation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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