Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
NCT ID: NCT04429295
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2020-06-28
2021-11-20
Brief Summary
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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
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A - Intervention regimen
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
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
Human Rotavirus, live attenuated
Pharmaceutical form:Oral suspension Route of administration: Oral
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Group B - Control regimen
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
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
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
Inactivated Poliomyelitis Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Poliomyelitis Vaccine bivalent types 1 and 3
Pharmaceutical form:Oral suspension Route of administration: Oral
Human Rotavirus, live attenuated
Pharmaceutical form:Oral suspension Route of administration: Oral
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Interventions
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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
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
Inactivated Poliomyelitis Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Poliomyelitis Vaccine bivalent types 1 and 3
Pharmaceutical form:Oral suspension Route of administration: Oral
Human Rotavirus, live attenuated
Pharmaceutical form:Oral suspension Route of administration: Oral
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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
* Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 38.0 C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
* Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
8 Weeks
11 Weeks
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number 7640003
Bangkok, , Thailand
Investigational Site Number 7640001
Bangkok, , Thailand
Investigational Site Number 7640002
Khon Kaen, , Thailand
Countries
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References
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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.
Related Links
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SH600009 Plain Language Results Summary
Other Identifiers
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U1111-1233-9694
Identifier Type: OTHER
Identifier Source: secondary_id
SH600009
Identifier Type: -
Identifier Source: org_study_id
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