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ActHIB®
ActHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) bacteria.
ActHIB is a conjugate vaccine that stimulates the immune system to produce antibodies against Haemophilus influenzae type b (Hib) bacteria. Used for Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children.
At a glance
| Generic name | ActHIB® |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Conjugate vaccine |
| Target | Haemophilus influenzae type b polyribosylribitol phosphate (PRP) capsular antigen |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
ActHIB contains purified polyribosylribitol phosphate (PRP) capsular polysaccharide from Hib conjugated to tetanus toxoid as a carrier protein. This conjugation enhances immunogenicity by promoting T-cell dependent B-cell responses, resulting in 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
- Exploratory Clinical Study of MT-2301 (PHASE2)
- Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (PHASE3)
- Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
- 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)
- Phase 3 Study of BK1310 in Healthy Infants (PHASE3)
- Confirmatory Study of BK1310 in Healthy 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:
- ActHIB® CI brief — competitive landscape report
- ActHIB® updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI