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DTaP-Hep B-IPV Vaccine
This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and polio viruses.
This combination vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, hepatitis B, and polio viruses. Used for Prevention of diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children.
At a glance
| Generic name | DTaP-Hep B-IPV Vaccine |
|---|---|
| Also known as | Infanrix hexa™ |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
DTaP-Hep B-IPV is a pentavalent inactivated vaccine that contains antigens from five pathogens. It works by presenting these antigens to the immune system, triggering both humoral (antibody) and cell-mediated immune responses that provide protection against infection. The vaccine components are either inactivated toxins (diphtheria and tetanus toxoids), inactivated bacterial cells (pertussis), inactivated viral particles (hepatitis B surface antigen and poliovirus), enabling safe immunization without causing disease.
Approved indications
- Prevention of diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability or fussiness
- Drowsiness
- Loss of appetite
Key clinical trials
- Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
- 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)
- 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)
- Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) (PHASE3)
- Analgesic Properties of Oral Sucrose During Immunizations (NA)
- 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)
- DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants (PHASE3)
- Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants (PHASE3)
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 |
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