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PedvaxHIB®
PedvaxHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by presenting the bacterial polysaccharide capsule linked to a protein carrier.
PedvaxHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) by presenting the bacterial polysaccharide capsule linked to a protein carrier. Used for Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children.
At a glance
| Generic name | PedvaxHIB® |
|---|---|
| Also known as | Comparator, Monovalent Hib conjugate vaccine. |
| Sponsor | GlaxoSmithKline |
| Drug class | Conjugate vaccine |
| Target | Haemophilus influenzae type b polyribosylribitol phosphate (PRP) capsular polysaccharide |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains the polyribosylribitol phosphate (PRP) capsular polysaccharide of Haemophilus influenzae type b 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 antigen, enabling robust antibody production and immunological memory against Hib infection.
Approved indications
- Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children
Common side effects
- Local injection site reactions (erythema, swelling, induration)
- Fever
- Irritability
- Drowsiness
Key clinical trials
- Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
- Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children (PHASE2)
- Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age (PHASE3)
- Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines (PHASE2)
- Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar® (PHASE2)
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:
- PedvaxHIB® CI brief — competitive landscape report
- PedvaxHIB® updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI