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Hexaxim®
Hexaxim is a hexavalent vaccine that provides immunization against six infectious diseases by stimulating the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b.
Hexaxim is a hexavalent vaccine that provides immunization against six infectious diseases by stimulating the immune system to produce antibodies against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b. Used for Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.
At a glance
| Generic name | Hexaxim® |
|---|---|
| Also known as | Hexyon®, Hexacima® |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Hexavalent vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Hexaxim combines antigens from six pathogens in a single formulation to induce protective immunity. The vaccine contains inactivated poliovirus, diphtheria and tetanus toxoids, acellular pertussis components, hepatitis B surface antigen, and Haemophilus influenzae type b conjugate, allowing simultaneous protection against multiple diseases with a single injection.
Approved indications
- Primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability
- Drowsiness
- Loss of appetite
Key clinical trials
- Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
- Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (PHASE3)
- Anti-Hep B Antibodies at Age 9 to 10 Years After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine. (PHASE3)
- DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants (PHASE3)
- 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 (PHASE3)
- Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hexaxim® CI brief — competitive landscape report
- Hexaxim® updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI