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August 13, 1992New England Journal of MedicineOpen Access

A Controlled Trial of a Formalin-Inactivated Hepatitis A Vaccine in Healthy Children

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Why the study?

Does a formalin-inactivated hepatitis A vaccine prevent clinically apparent hepatitis A in healthy children?

Population

1037 healthy seronegative children 2 to 16 years of age in an Hasidic Jewish community in upstate New York

Comparison

One intramuscular injection of a highly… vs Placebo

Design

RCT, randomly assigned, double-blind, placebo-controlled

Follow-up

mean of 103 days

Authors

AWAlan WerzbergerColumbia UniversityBMBarbara MenschPopulation CouncilBKBarbara J. KuterChildren's Hospital of Philadelphia

Discussion

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Implication

Supports routine childhood immunization against hepatitis A; confirms high efficacy of formalin-inactivated vaccine in RCT.

Structured PICO

Does a formalin-inactivated hepatitis A vaccine prevent clinically apparent hepatitis A in healthy children?

P
Population
1037 healthy seronegative children 2 to 16 years of age in an Hasidic Jewish community in upstate New York
I
Intervention
One intramuscular injection of a highly purified, formalin-inactivated hepatitis A vaccine
C
Comparator
Placebo
O
Outcome
Clinically apparent hepatitis A (defined by typical signs and symptoms, diagnostic increase in IgM antibody to hepatitis A, and serum ALT at least twice the upper limit of normal) occurring greater than or equal to 50 days after the injectionhard clinical

A single dose of formalin-inactivated hepatitis A vaccine is highly protective against clinically apparent hepatitis A in healthy children.

Cite This Study

Werzberger et al. (1992) studied this question.

synapsesocial.com/papers/6a7051205671bbf00bc2b017https://doi.org/10.1056/nejm199208133270702
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Safety and Immunogenicity of a Live Attenuated Hepatitis A Virus Vaccine in Seronegative Volunteers1991 · 102 citations
  2. 2Epidemiologic Patterns of Wild-Type Hepatitis A Virus Determined by Genetic Variation1991 · 143 citations
  3. 3An inactivated hepatitis A viral vaccine of cell culture origin1986 · 112 citations
  4. 4HEPATITIS A VIRUS INFECTION IN HOUSEHOLDS1982 · 80 citations
  5. 5Propagation of Human Hepatitis A Virus in Cell Culture in Vitro1979 · 392 citations