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Example 1.2 Parallel two‐group design – hepatitis B

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Levie, Gjorup, Skinhøj and Stoffel (2002) compared a 2‐dose regimen of recombinant hepatitis B vaccine including the immune stimulant AS04 with the standard 3‐dose regimen of HbsAg in healthy adults. The rationale behind testing a 2‐dose regimen was that fewer injections would improve compliance.

Key features include the following:

 Design: Two centres, open‐label randomised two‐group comparison,

 Endpoint: Seroprotection rate,

 Size: 340 healthy adults aged between 15 and 40 years,

 Analysis: Fisher's exact test,

 Conclusion: The 2‐dose regimen compared favourably with the standard.

Randomised Clinical Trials

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