PedvaxHIB: side effects, ingredients & package insert

PedvaxHIB ingredients (FDA package insert, Section 11)

Per-dose composition as stated in the prescribing information; verified 2026-07-09. Click an ingredient for every vaccine that contains it.

Source: Manufacturer prescribing information. Formulations change — re-verify before clinical use.

PedvaxHIB side effects: where the data is

Reported reactions for PedvaxHIB and the other Hib products are compiled on the Hib vaccine page: pre-licensure trial reactogenicity, VAERS report counts, and international databases (Canada Vigilance, EudraVigilance, Lareb, VigiAccess). Those counts are spontaneous reports with no denominator — a report does not establish that the vaccine caused the event.

• Pre-licensure clinical trial data
• Post-licensure surveillance (VAERS and international)
• Documented adverse events and causality assessment
• Vaccine Injury Table (VICP) — compensable injuries

PedvaxHIB lot number lookup

PedvaxHIB vs ActHIB vs Hiberix

All licensed Hib vaccine products side by side. Differences in platform, adjuvant and route are the usual reasons one is chosen over another; efficacy and safety comparisons belong to the trial and surveillance sections of the Hib vaccine page.

Schedule and age range

Licensed ages and the recommended series for Hib vaccines are on the Hib vaccine page; how 31 countries schedule it is on Hib schedule by country. Always confirm the product-specific age range in the current package insert.

Common questions about PedvaxHIB

What are the side effects of PedvaxHIB?

Common reactions listed in the PedvaxHIB package insert are injection-site pain, redness or swelling and short-lived systemic symptoms such as fever, tiredness or irritability. Rarer events and the reported counts from VAERS and international databases are on the Hib vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.

What is in PedvaxHIB?

PedvaxHIB contains Haemophilus b PRP conjugated to Neisseria meningitidis OMPC (PRP-OMP) as antigen; adjuvant: Amorphous aluminum hydroxyphosphate sulfate; it is preservative-free. Excipients: Sodium chloride, Sodium borate. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).

Where is the PedvaxHIB package insert?

The FDA-licensed prescribing information for PedvaxHIB is published by Merck Sharp & Dohme LLC and the FDA; the source used for this page is https://www.merck.com/product/usa/pi_circulars/p/pedvax_hib/pedvax_pi.pdf. Formulations change, so re-verify the current insert before clinical use.

How does PedvaxHIB compare with ActHIB?

PedvaxHIB (Merck Sharp & Dohme LLC) uses a conjugate platform with adjuvant Amorphous aluminum hydroxyphosphate sulfate, given intramuscular; ActHIB (Sanofi Pasteur) uses conjugate with adjuvant none. Both are licensed Hib vaccines; the comparison table above lists every product.