Last reviewed 2026-06-02 · How we verify

Comparator: PedvaxHIB™

Comparator: PedvaxHIB™ is a Conjugate vaccine Biologic drug developed by Merck Sharp & Dohme LLC. It is currently FDA-approved for Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children. Also known as: One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study, visit in all treatment groups in the study..

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 vaccine used to prevent Haemophilus influenzae type b infections. It is a small molecule vaccine, specifically a conjugate vaccine, used in combination with other vaccines to protect against various bacterial and viral infections.

At a glance

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 polysaccharide into a T-cell-dependent antigen, enabling robust antibody responses and immunological memory in infants and young children. The resulting antibodies provide protection against invasive Hib disease including meningitis, bacteremia, and epiglottitis.

Approved indications

• Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children

Common side effects

• Injection site erythema
• Injection site swelling
• Fever
• Irritability
• Drowsiness

Key clinical trials

• Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005) (PHASE3)
• Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068) (PHASE4)
• Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED) (PHASE3)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Comparator: PedvaxHIB™ CI brief — competitive landscape report
• Comparator: PedvaxHIB™ updates RSS · CI watch RSS
• Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about Comparator: PedvaxHIB™

Related

• Drug class: All Conjugate vaccine drugs
• Target: All drugs targeting Haemophilus influenzae type b polyribosylribitol phosphate (PRP) capsular polysaccharide
• Manufacturer: Merck Sharp & Dohme LLC — full pipeline
• Therapeutic area: All drugs in Immunology / Infectious Disease
• Indication: Drugs for Prevention of invasive disease caused by Haemophilus influenzae type b in infants and children
• Also known as: One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study, visit in all treatment groups in the study.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing