Hib Vaccine Clinical Trials — Placebo Data

Was the Hib vaccine tested with a placebo before approval? This page documents the pre-licensure clinical trial evidence for each Haemophilus influenzae type b conjugate vaccine licensed in the US.

Clinical trial data for the three Haemophilus influenzae type b vaccines on the US childhood schedule. ActHIB's package insert documents a 3.4% serious adverse event rate in 50 of 1,455 infants — a rate the manufacturer's own paid researchers determined was unrelated to vaccination. PedvaxHIB was licensed against an unlicensed experimental form of itself.

ActHIB (Sanofi)

Source: FDA-approved package insert: "within 30 days … 50 of 1,455 (3.4%) participants [babies] experienced a serious adverse event."

Investigator Self-Attribution

The package insert further states: "[n]one was assessed by the investigators [Sanofi] as related to the study of vaccines."

The determination that zero of the 50 serious adverse events were vaccine-related was made by Sanofi's own paid researchers. There was no independent review. No placebo group existed to compare baseline SAE rates against. Aaron Siri: "Case closed."

Pyramid Position

ActHIB's safety control was an unspecified hepatitis B vaccine — itself licensed with no control and 4–5 days of safety monitoring. The Hib safety chain therefore traces back to a Hep B vaccine with minimal monitoring and no validated baseline.

Hiberix (GSK)

Source: FDA-approved package insert.

Pyramid Position

Hiberix → ActHIB → unspecified Hep B vaccine → no control. Three levels of "as safe as" comparisons, none anchored to a placebo.

PedvaxHIB (Merck)

Source: FDA-approved package insert.

The Self-Comparison Trial

PedvaxHIB was licensed by comparing it against an unlicensed, experimental version of itself — a different formulation of the same vaccine. No outside comparator. No placebo. The "control" was the same product in a different lyophilized form. The 3-day safety window is among the shortest of any vaccine on the US childhood schedule.

Summary Table

Pharma Self-Reporting Problem

ActHIB's 3.4% SAE rate illustrates a structural flaw across all vaccine trials: in the absence of a placebo control, the determination of whether any adverse event is "vaccine-related" is made by the pharmaceutical company's own paid investigators. No independent body reviews these assessments. The FDA accepts the company's determination at face value.

Fifty serious adverse events in 1,455 babies — all deemed unrelated by Sanofi — were reported in the package insert as footnote-level information.

Schedule

Schedule varies by brand:

Disease Context

Haemophilus influenzae type b causes invasive infection — meningitis, epiglottitis, sepsis, pneumonia — primarily in children under 5. Before the vaccine, Hib was a leading cause of bacterial meningitis in young children. The disease became uncommon following widespread vaccination, though incidence had been declining before the vaccine was introduced.

See Also

Hib Vaccines (Post-Licensure), Pre-Licensure Safety Testing, Hepatitis B Vaccines (Pre-Licensure), Combination Vaccines (Pre-Licensure), Childhood Vaccine Schedule, Sanofi, GSK, Merck

Frequently Asked Questions

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