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Hexaxim

Phase 3

Diphtheria | Monoclonal antibody | Infectious Disease |Sanofi|Trials Updated: Apr 5, 2022

Hexaxim development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Apr 2015

Hexaxim target and mechanism

ModalityMonoclonal antibody

Also known as Hexyon vaccine, Hexaxim Vaccine, Hexyon®, Hexacima®

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment354

FDA Designations

No designations recorded

Hexaxim clinical trials

Hexaxim · 1 trial · 6 indications

Phase 3 1
NCT02428491Immunogenicity 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 BirthDiphtheria
COMPLETED354 Analytics
PHASE3COMPLETED
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
DiphtheriaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Reporting Solicited Injection Site Reactions or Solicited Systemic Reactions
Within 7 days after vaccination

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

Secondary Endpoints

Number of Subjects With Seroprotection/Seroconversion/Vaccine Response After Infant Series in Cohort 1
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
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
Day 90 (1 month after third dose)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
DTaP-IPV-HB-PRP~T VaccineEXPERIMENTALAll 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).

Interventions

NameTypeDescription
Hexaxim®BIOLOGICALDTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
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Eligibility Criteria

Age Range61 Days to 91 Days
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:Vietnam
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Frequently asked questions about Hexaxim

What is Hexaxim used for?

Hexaxim is a combined vaccine developed by Sanofi for protection against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b. It is given as a primary vaccination series in infants, followed by a booster dose, and is studied in the infectious disease therapeutic area.

Who makes Hexaxim?

Hexaxim is developed by Sanofi, which trades under the ticker SNY. Sanofi Pasteur, the company's vaccines unit, conducted the clinical program for the product.

What phase is Hexaxim in?

Hexaxim has been evaluated in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The program enrolled 354 participants in total.

What clinical trials is Hexaxim in?

Hexaxim has been studied in the completed Phase 3 trial NCT02428491, which assessed immunogenicity and safety of the combined vaccine given as a three-dose primary series at 2, 3, and 4 months of age, followed by a booster dose at 16 to 17 months, in Vietnamese infants.

Is Hexaxim the same as Hexyon vaccine?

Yes, Hexaxim is also known as Hexyon vaccine. Other names used for the same product include Hexaxim Vaccine and Hexaxim with a registered trademark symbol. These names refer to the same Sanofi combined vaccine.