CompletedNCT02428491Updated Apr 5, 2022

Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth

A Phase 3 interventional study of Hexaxim® in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 1 site in Vietnam. Open to participants aged 61 Days to 91 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 354
Allocation: Not applicable
Ages: 61 Days to 91 Days
Sex: All

Study summary

The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth.

Primary Objective:

To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers.

Secondary Objective:

To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam.
To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series.
To describe the persistence of all antibodies before receipt of the booster vaccination.
To evaluate the immunogenicity of the study vaccine one month after the booster.

Read the detailed description

Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's hexavalent vaccine given as primary series at 2, 3, and 4 months of age and then a booster dose at 16 to 17 months of age, to comply with Vietnamese vaccination recommendations.

Conditions studied

Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Influenzae Type b

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Keywords

Diphtheria
Tetanus
Pertussis
Poliomyelitis
Hepatitis B
Haemophilus Influenzae Type b
DTaP-IPV-Hep B-PRP-T Combined Vaccine (Hexaxim®)

In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 354 is above the median of 100 across 1,887 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 61 Days to 91 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Aged 61 to 91 days on the day of the first study visit
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg
Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
Have received one dose of Hep B vaccine at birth or within 1 week after birth (documented according to the national recommendations).

Exclusion criteria

Exclusion Criteria:

Participation 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 other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination except for Bacille Calmette Guerin (BCG) vaccination (any administration of oral poliovirus vaccine (OPV) in the context of oral poliovirus vaccine-national immunization days (NIDs) does not fall within the scope of this exclusion criterion)
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth or within 1 week after birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine (any administration of OPV in the context of OPV-NIDs does not fall within the scope of this exclusion criterion)
Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
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 for more than 2 consecutive weeks since birth)
History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
Known personal or maternal history of Human Immunodeficiency Virus (HIV), or hepatitis C seropositivity
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
Known thrombocytopenia, as reported by the parent/legally acceptable representative
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
History of seizures
In an emergency setting, or hospitalized involuntarily
Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 354 participants (actual)

Study arms

Experimental
DTaP-IPV-HB-PRP~T Vaccine
All participants will receive 3 doses of 0.5 mL DTaP-IPV-HB-PRP\~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (primary series), followed by a booster dose approximately 12 months after the completion of the primary series (at 16 to 17 months of age).
Biological: Hexaxim®

Interventions

BiologicalHexaxim®
DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
Also known as: Hexyon®, Hexacima®

What researchers measure

Primary outcomes

Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions
Solicited injection site reactions: tenderness, erythema, and swelling (and extensive limb swelling for booster dose). Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability
Time frame: Within 7 days after vaccination

Secondary outcomes

Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1
Seroconversion:4-fold increase in anti-Pertussis(PT)\& anti-Filamentous hemagglutinin(FHA) antibody(Ab) concentrations from pre-vaccination to one month after first dose.Vaccine response:anti-PT/anti-FHA Ab concentrations in Enzyme Linked Immunosorbent Assay(ELISA) units(EU)/mL\>=4\*Lower Limit of Quantitation(LLOQ) if pre-vaccination concentration \<4\*LLOQ/\>=pre-vaccination concentration if prevaccination concentrations\>=4\*LLOQ. Seroprotection:anti-Diphtheria \&anti-Tetanus\>=0.01 International Units(IU)/mL\&\>=0.1 IU/mL;anti-PT \&anti-FHA\>=2 EU/mL \&\>=8 EU/mL;anti-Polyribosyl Ribitol Phosphate(PRP)\>=0.15 microgram per milliliter(mcg/mL) \&\>=1.0mcg/mL;anti-Polio types 1,2,\&3\>=8(1/dilution),anti-Hepatitis B\>=10 mili-international units per mililiter(mIU/mL)\&\>=100 mIU/mL
Time frame: Day 90 (1 month after third dose)
Number of Subjects With Seroprotection/Seroconversion/Vaccine and Booster Response Before and After Booster Vaccination in Cohort 1
Seroconversion:4-fold increase in anti-PT \& anti-FHA Ab concentrations from pre-booster vaccination to 1 month after booster dose.Vaccine response post-booster vaccination:post-booster Ab concentrations\>=4\*LLOQ if pre-dose 1 Ab concentrations\<4\*LLOQ/post-booster Ab concentrations\>=predose 1 Ab concentrations if pre-dose 1\>=4\*LLOQ. Booster response:\>=4 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if one-month post-dose 3\<4\*LLOQ/\>=2 fold Ab concentrations increase from pre-dose 4 to one-month post-dose 4 if pre-dose 4\>=4\*LLOQ.Seroprotection:anti-Diphtheria \& anti-Tetanus\>=0.01 IU/mL \&\>=0.1 IU/mL \&\>=1.0 IU/mL;anti-PRP \>=0.15 mcg/mL \&\>=1.0 mcg/mL;anti-Polio types 1, 2, \& 3\>=8 (1/dilution),anti-Hepatitis B\>=10 mIU/mL \&\>=100 mIU/mL
Time frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Infant Series in Cohort
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
Time frame: Day 90 (1 month after third dose)
Geometric Mean Titers or Geometric Mean Concentrations of DTaP-IPV-HB-PRP~T Antibodies Before and After Booster Vaccination in Cohort 1
Geometric mean of concentrations of antibodies against PT, FHA, diphtheria, tetanus, PRP, poliovirus 1, 2 and 3, and Hep B
Time frame: Day 425 (pre-booster) and Day 455 (1 month after booster dose)
Percentage of Subjects With Seroprotection/Seroconversion Rates after Infant Series in Cohort 1 and Group 3 of A3L15 (NCT01105559)
Seroconversion defined as 4-fold increase in anti-PT \& anti-FHA Ab concentrations from pre-vaccination to one month after first dose. Seroprotection defined as following: anti-Diphtheria \& anti-Tetanus \>=0.01 IU/mL; anti-PT \& anti-FHA \>=4EU/mL; anti-PRP \>=0.15 mcg/mL; anti-Polio types 1, 2, \& 3 \>=8 (1/dilution), anti-Hepatitis B \>=10 mIU/mL. Results observed in Group 3 of Study A3L15 (NCT00362336), a study conducted in South Africa where participants had been given DTaP-IPV-HB-PRP\~T at 6, 10, and 14 weeks of age following Hep B vaccination at birth, were used as the non-inferiority reference value
Time frame: Day 90 (1 month after third dose)

Study locations

1 site

Preventive Medicine Centre of Thai Binh Province
Thai Binh, Vietnam

References and documents

Individual participant data

Plan to share: 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02428491
Lead sponsor: Sanofi Pasteur, a Sanofi Company
Responsible party: Sponsor
First posted: Apr 28, 2015
Start date: Apr 20, 2015
Primary completion: Jan 11, 2017
Completion: Jan 11, 2017
Last update: Apr 5, 2022

Study contacts

Medical Director

study director · Sanofi Pasteur SA

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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