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

NCT04429295 | Completed Phase 3

• 2 other identifiers: SH600009U1111-1233-9694
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (2)

• Number of participants with antibodies (Ab) above predefined threshold against diphtheria (D), tetanus (T), hepatitis B (Hep B), Haemophilus influenzae type b (Hib) and poliovirus (Polio) antigens

  Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered

  28 days after the third dose (Day 148)

• Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens

  Ab against pertussis antigens will be measured

  28 days after the third dose (Day 148)

Secondary Outcomes (17)

• Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens

  At baseline (Day 0) and 28 days after the third dose (Day 148)

• Number of participants with a vaccine response for pertussis antigens

  At baseline (Day 0) and 28 days after the third dose (Day 148)

• Pertussis antigens vaccine seroconversion

  At baseline (Day 0) and 28 days after the third dose (Day 148)

• Geometric Mean Concentrations Ratios (GMCRs) of Ab against all the antigens, including anti-rotavirus and anti-S. pneumoniae in a subset of participants

  At baseline (Day 0) and 28 days after the third dose (Day 148)

• GMCs of Ab against each antigen, including anti-rotavirus and anti-pneumococcal serotypes, in a subset of participants

  At baseline (Day 0) and 28 days after the third dose (Day 148)

Study Arms (2)

Group A - Intervention regimen

EXPERIMENTAL

SHAN6™ + routine pediatric vaccines pneumococcal 13-valent conjugate vaccine \[PCV\] \[Prevnar 13®\] and oral rotavirus vaccine \[ORV-1\] \[Rotarix™\] at age of 2, 4 months; SHAN6™ + Prevnar 13® at age of 6 months; SHAN6™ administered alone as a booster dose at age of 15-18 months

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); Biological: Human Rotavirus, live attenuated; Biological: Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Group B - Control regimen

ACTIVE COMPARATOR

SHAN5™ + bivalent oral polio vaccine (bOPV), co-administered with Prevnar 13® and Rotarix™ at 2, 4 months of age and with inactivated polio vaccine \[IPV\] at 4 months of age; SHAN5™ + bOPV, co-administered with Prevnar 13® at 6 months of age SHAN6™ administered alone as a booster dose at 15-18 months of age

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); 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)

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

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Also known as: SHAN6™

Group A - Intervention regimen; Group B - Control regimen

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

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Also known as: SHAN5™

Group B - Control regimen

Inactivated Poliomyelitis Vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Also known as: IMOVAX Polio

Group B - Control regimen

Poliomyelitis Vaccine bivalent types 1 and 3 BIOLOGICAL

Pharmaceutical form:Oral suspension Route of administration: Oral

Group B - Control regimen

Human Rotavirus, live attenuated BIOLOGICAL

Pharmaceutical form:Oral suspension Route of administration: Oral

Also known as: Rotarix™

Group A - Intervention regimen; Group B - Control regimen

Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Also known as: Prevnar 13®, PCV-13

Group A - Intervention regimen; Group B - Control regimen

Eligibility Criteria

• Age: 8 Weeks - 11 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• In an emergency setting, or hospitalized
• Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
• Thrombocytopenia, as reported by the parent/legally acceptable representative, contraindicating intramuscular vaccination in the Investigator's opinion
• Chronic illness that, in the Investigator's opinion, is at a stage where it might interfere with trial conduct or completion
• Any condition which, in the Investigator's opinion, might interfere with the evaluation of the study objectives

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Investigational Site Number 7640003

Bangkok, 10330, Thailand

Location

Investigational Site Number 7640001

Bangkok, 10700, Thailand

Location

Investigational Site Number 7640002

Khon Kaen, 4002, Thailand

Location

Related Publications (1)

• Sanchez L, Rungmaitree S, Kosalaraksa P, Jantarabenjakul W, Leclercq J, Yaiprayoon Y, Midde VJ, Varghese K, Mangarule S, Noriega F. Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand. Pediatr Infect Dis J. 2023 Aug 1;42(8):711-718. doi: 10.1097/INF.0000000000003975. Epub 2023 Apr 27.

  PMID: 37257121 DERIVED

Related Links

• SH600009 Plain Language Results Summary

MeSH Terms

Interventions

Diphtheria Toxoid; Tetanus Toxoid; Hepatitis B Surface Antigens; Poliovirus Vaccine, Inactivated; RIX4414 vaccine; 13-valent pneumococcal vaccine

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Vaccines, Inactivated; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: June 28, 2020
• Primary Completion: February 26, 2021
• Study Completion: November 20, 2021
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

TH (3)