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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: None posted in the registry

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

Other trials in Thailand

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

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 groups in NCT04429295
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.

28 Jun 202020 Nov 2021

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)

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

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04429295
Acronym / sponsor ID: SH600009
Conditions: Pertussis Immunisation, Diphtheria Immunisation, Polio Immunisation, Hepatitis B Immunisation, Haemophilus Influenzae Type B Immunisation, Tetanus Immunisation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 460 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 28 Jun 2020 (actual)
Primary completion: 26 Feb 2021 (actual)
Study completion: 20 Nov 2021 (actual)
First posted: 12 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A - Intervention regimen	Experimental	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)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
Group B - Control regimen	Active comparator	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)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

Who may qualify

Ages: 8 to 11 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (20 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)Also: SHAN6™Pharmaceutical form:Suspension for injection Route of administration: Intramuscular	Biological	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)Also: SHAN5™Pharmaceutical form:Suspension for injection Route of administration: Intramuscular	Biological	Group B - Control regimen
Inactivated Poliomyelitis VaccineAlso: IMOVAX PolioPharmaceutical form:Suspension for injection Route of administration: Intramuscular	Biological	Group B - Control regimen
Poliomyelitis Vaccine bivalent types 1 and 3Pharmaceutical form:Oral suspension Route of administration: Oral	Biological	Group B - Control regimen
Human Rotavirus, live attenuatedAlso: Rotarix™Pharmaceutical form:Oral suspension Route of administration: Oral	Biological	Group A - Intervention regimen, Group B - Control regimen
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)Also: Prevnar 13®, PCV-13Pharmaceutical form:Suspension for injection Route of administration: Intramuscular	Biological	Group A - Intervention regimen, Group B - Control regimen

Primary outcome

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
Time frame: 28 days after the third dose (Day 148)
Ab titers against D, T, Hep B, Hib and Polio antigens will be measured Threshold values will be considered
Adjusted Geometric Mean Concentrations (aGMCs) of Ab against pertussis antigens
Time frame: 28 days after the third dose (Day 148)
Ab against pertussis antigens will be measured

17 secondary outcomes

Number of participants with Ab titers above predefined thresholds against each antigen diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and poliovirus antigens
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Number of participants with a vaccine response for pertussis antigens
Time frame: At baseline (Day 0) and 28 days after the third dose (Day 148)
Pertussis antigens vaccine seroconversion
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
Pertussis antigens vaccine seroconversion
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCRs of Ab against all the antigens
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
GMCs of Ab against each antigen
Time frame: Before and 28 days after the booster dose (at Day 388-478 and Day 416-506)
aGMCs of Ab against pertussis antigens
Time frame: 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)
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site and systemic reactions
Time frame: Up to 7 days post-vaccination
Number of participants reporting unsolicited non-serious AEs
Time frame: Up to 28 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
Time frame: Up to Day 416-506

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Derived from this study: PubMed 37257121Sanchez 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.
SH600009 Plain Language Results SummaryLink provided by the sponsor.
Individual participant dataSharing planned: 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

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Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
Not yet recruitingPhase 4
Maternal Immunization With Tetanus Toxoid, Reduced Diphtheria Toxoid, Reduced-dose (2 µg) Recombinant Pertussis Vaccine (TdaP2gen) and Its Effect on the Immune Response in Thai Infants up to 15-18 Months Old
Pertussis, Diphtheria

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi Pasteur, a Sanofi Company

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 28 days after the third dose (Day 148)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04429295, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.