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Tritanrix-HepB/Hib™
Tritanrix-HepB/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b.
Tritanrix-HepB/Hib is a combination vaccine that stimulates the immune system to produce antibodies against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b. Used for Prevention of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b infection in infants and children.
At a glance
| Generic name | Tritanrix-HepB/Hib™ |
|---|---|
| Also known as | DTPw-HBV/Hib |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Drug class | Combination vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
This pentavalent vaccine contains inactivated toxoids of diphtheria and tetanus, acellular pertussis antigens, hepatitis B surface antigen, and polyribosylribitol phosphate conjugate from Haemophilus influenzae type b. Upon administration, these antigens trigger both humoral and cellular immune responses, leading to the production of protective antibodies and memory cells against these five pathogens.
Approved indications
- Prevention of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b infection in infants and children
Common side effects
- Injection site pain, redness, or swelling
- Fever
- Irritability
- Drowsiness
Key clinical trials
- Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age (PHASE3)
- Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants (PHASE2)
- Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety & Immunogenicity in Children & Infants (PHASE2)
- Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines (PHASE3)
- Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine (PHASE3)
- Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age. (PHASE3)
- Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen (PHASE2)
- Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B. (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:
- Tritanrix-HepB/Hib™ CI brief — competitive landscape report
- Tritanrix-HepB/Hib™ updates RSS · CI watch RSS
- Sanofi Pasteur, a Sanofi Company portfolio CI