Last reviewed · How we verify
DTaP-IPV-Hep B-PRP-T Vaccine
DTaP-IPV-Hep B-PRP-T Vaccine is a vaccine Biologic drug developed by Sanofi Pasteur, a Sanofi Company. It is currently in Phase 3 development for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children.
This pentavalent vaccine stimulates the immune system to produce antibodies and cellular immunity against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b.
This pentavalent vaccine stimulates the immune system to produce antibodies and cellular immunity 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 | DTaP-IPV-Hep B-PRP-T Vaccine |
|---|---|
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
DTaP-IPV-Hep B-PRP-T is a combination vaccine containing inactivated toxoids (diphtheria and tetanus), acellular pertussis antigens, inactivated poliovirus, hepatitis B surface antigen, and polyribosylribitol phosphate conjugate from Haemophilus influenzae type b. Upon administration, these antigens trigger both humoral (antibody) and cell-mediated immune responses, providing protection against six serious infectious diseases. The conjugate technology for the Hib component enhances immunogenicity in infants by linking the polysaccharide capsule to a protein carrier.
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
- 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)
- 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)
- Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™ (PHASE3)
- Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DTaP-IPV-Hep B-PRP-T Vaccine CI brief — competitive landscape report
- DTaP-IPV-Hep B-PRP-T Vaccine updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI
Frequently asked questions about DTaP-IPV-Hep B-PRP-T Vaccine
What is DTaP-IPV-Hep B-PRP-T Vaccine?
How does DTaP-IPV-Hep B-PRP-T Vaccine work?
What is DTaP-IPV-Hep B-PRP-T Vaccine used for?
Who makes DTaP-IPV-Hep B-PRP-T Vaccine?
What drug class is DTaP-IPV-Hep B-PRP-T Vaccine in?
What development phase is DTaP-IPV-Hep B-PRP-T Vaccine in?
What are the side effects of DTaP-IPV-Hep B-PRP-T Vaccine?
Related
- Drug class: All vaccine drugs
- Manufacturer: Sanofi Pasteur, a Sanofi Company — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and Haemophilus influenzae type b in infants and children
- Compare: DTaP-IPV-Hep B-PRP-T Vaccine vs similar drugs
- Pricing: DTaP-IPV-Hep B-PRP-T Vaccine cost, discount & access