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DTaP-HBV-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 Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children.
At a glance
| Generic name | DTaP-HBV-IPV vaccine |
|---|---|
| Also known as | INFANRIX®HEXA |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
DTaP-HBV-IPV is a pentavalent inactivated vaccine that contains antigens from five pathogens: diphtheria and tetanus toxoids, acellular pertussis components, hepatitis B surface antigen, and inactivated poliovirus types 1, 2, and 3. Upon administration, these antigens trigger both humoral (antibody) and cell-mediated immune responses, conferring protection against these five vaccine-preventable diseases.
Approved indications
- Active immunization against diphtheria, tetanus, pertussis, hepatitis B, and poliomyelitis in infants and children
Common side effects
- Injection site reactions (pain, redness, swelling)
- Fever
- Irritability or fussiness
- Drowsiness
- Loss of appetite
Key clinical trials
- 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)
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants (PHASE2)
- Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe (PHASE3)
- The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination (NA)
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US (PHASE3)
- Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines (PHASE4)
- Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DTaP-HBV-IPV vaccine CI brief — competitive landscape report
- DTaP-HBV-IPV vaccine updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI