Pertussis ImmunisationPhase 3NCT04429295
Study of DTwP-HepB-Hib-IPV (SHAN6™) Vaccine Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in Thailand
A Phase 3 study testing DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) and Inactivated Poliomyelitis Vaccine in people with Pertussis Immunisation and Diphtheria Immunisation, run by Sanofi Pasteur, a Sanofi Company at 3 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 11 weeksHealthy volunteers can take part
- Conditions the study is for
- Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation
- What is being tested?
- DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b) and Inactivated Poliomyelitis Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 3 sitesThailand
- Study dates
- 28 Jun 2020to 20 Nov 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Investigational Site Number 7640003
Bangkok, 10330
Investigational Site Number 7640001
Bangkok, 10700
Investigational Site Number 7640002
Khon Kaen, 4002
About this study
Official title: 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
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
Read more
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
Read the 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
- Conditions
- Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type B Immunisation, Tetanus Immunisation
- Being tested
- DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus), DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b), Inactivated Poliomyelitis Vaccine, Poliomyelitis Vaccine bivalent types 1 and 3, Human Rotavirus, live attenuated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called SHAN6™
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)Biological
Also called SHAN5™
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Inactivated Poliomyelitis VaccineBiological
Also called IMOVAX Polio
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Poliomyelitis Vaccine bivalent types 1 and 3Biological
Pharmaceutical form:Oral suspension Route of administration: Oral
Human Rotavirus, live attenuatedBiological
Also called Rotarix™
Pharmaceutical form:Oral suspension Route of administration: Oral
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)Biological
Also called Prevnar 13®, PCV-13
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Ab titers against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
Measured: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with a vaccine response for pertussis antigens
Pertussis antigens vaccine response Threshold values will be considered
Measured: At baseline (Day 0) and 28 days after the third dose (Day 148)
Pertussis antigens vaccine seroconversion
Ab against pertussis antigens will be measured
Measured: 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
Ab concentrations against all the antigens, including anti-rotavirus and anti-S. pneumoniae for a subset of participants, will be measured The ratio calculated will be: (post dose 3/pre-primary)
Measured: 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
Ab concentrations against each antigen, including anti rotavirus and anti pneumococcal serotypes for a subset of participants, will be measured
Measured: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with anti-rotavirus Ab titers above predefined thresholds in a subset of participants
Ab against rotavirus will be measured in a subset of participants Threshold values will be considered
Measured: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with anti-pneumococcal Ab titers above predefined thresholds in a subset of participants
Anti-pneumococcal Ab will be measured in a subset of participants Threshold values will be considered
Measured: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with Ab titers above predefined threshold against diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
Ab against D, T, Hep B, Hib and polio antigens will be measured Threshold values will be considered
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Number of participants with a booster response for pertussis antigens
Pertussis antigens booster response Threshold values will be considered
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Pertussis antigens vaccine seroconversion
Ab against pertussis antigens will be measured
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCRs of Ab against all the antigens
Ab concentrations against all the antigens will be measured The ratio calculated will be: (post booster/pre-booster)
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCs of Ab against each antigen
Ab concentrations against each antigen will be measured
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
aGMCs of Ab against pertussis antigens
Ab against pertussis antigens will be measured, adjusted for baseline value
Measured: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Number of participants reporting immediate systemic adverse events (AEs)
Unsolicited (spontaneously reported) systemic AEs
Measured: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and systemic reactions
Solicited injection site reactions:
- tenderness, erythema and site swelling
Solicited systemic reactions:
- fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability
Measured: Up to 7 days post-vaccination
Number of participants reporting unsolicited non-serious AEs
Unsolicited non-serious AEs
Measured: Up to 28 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs
Measured: Up to Day 416-506
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start28 Jun 2020
- Primary completion26 Feb 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pertussis ImmunisationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429295
- Sponsor's protocol ID
- SH600009
- Other IDs
- U1111-1233-9694
- Status last verified
- Sep 2025
- First submitted
- 10 Jun 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
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.
PubMed 37257121