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Hexaxim Vaccine
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 Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.
At a glance
| Generic name | Hexaxim Vaccine |
|---|---|
| Also known as | Hexaxim® |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Hexavalent vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated or recombinant antigens from six pathogens formulated to trigger both humoral and cellular immune responses. Upon administration, these antigens stimulate B cells to produce specific antibodies and T cells to develop memory responses, providing protection against infection by these six disease-causing organisms. The hexavalent formulation combines multiple vaccines into a single injection, improving compliance and reducing the number of injections needed during childhood immunization schedules.
Approved indications
- Active 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)
- Study to Evaluate the Immunogenicity of LR20062 Compared to Control When Administered Intramuscularly in Healthy Infants At 2, 4, 6 Months of Age (PHASE2)
- 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 |