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GSK Biologicals' Hiberix™
Hiberix is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by linking the bacterial polysaccharide capsule to a protein carrier.
Hiberix is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by linking the bacterial polysaccharide capsule to a protein carrier. Used for Prevention of invasive Haemophilus influenzae type b disease in infants and children.
At a glance
| Generic name | GSK Biologicals' Hiberix™ |
|---|---|
| Also known as | Hib |
| Sponsor | GlaxoSmithKline |
| Drug class | Conjugate vaccine |
| Target | Haemophilus influenzae type b polysaccharide capsule (PRP) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains purified polyribosylribitol phosphate (PRP) polysaccharide from the Hib capsule conjugated to meningococcal outer membrane protein complex (OMPC). This conjugation enhances immunogenicity by converting the T-cell-independent polysaccharide antigen into a T-cell-dependent response, resulting in stronger and more durable antibody production and immunological memory against Hib infection.
Approved indications
- Prevention of invasive Haemophilus influenzae type b disease in infants and children
Common side effects
- Injection site erythema
- Injection site swelling
- Fever
- Irritability
Key clinical trials
- Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine (PHASE4)
- Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine (PHASE3)
- Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers (PHASE3)
- Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants (PHASE2)
- Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination (PHASE3)
- 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)
- Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine (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:
- GSK Biologicals' Hiberix™ CI brief — competitive landscape report
- GSK Biologicals' Hiberix™ updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI