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. 2007 Jul 18;2007(3):CD004913. doi: 10.1002/14651858.CD004913.pub2

Frey 2002a.

Methods Generation of allocation sequence: not described
Allocation concealment: unclear
Blinding: single (participants)
Inclusion of all randomized participants: adequate; see 'Participants'
Length of follow up: 56 days
Participants Number: 680 enrolled and vaccinated; 665 developed a positive reaction ("take") at vaccination site and this number (665) used in trial report as denominator of analysis of adverse events
Inclusion criteria: healthy adults aged 18 to 32 years
Exclusion criteria: vaccinia scar; vaccinia vaccination; human immunodeficiency virus (HIV)‐AB; vaccination contraindications according to package insert (ie pregnancy, immunosuppression, and eczema), and protocol‐specified (history of live‐attenuated virus vaccination within 60 days before trial, receipt of blood products or immunoglobulin within 6 months before trial, household contact, sexual contact, or occupational exposure to someone with 1 or more of exclusion criteria listed in package insert); contact with infants < 12 months
Interventions Dryvax smallpox vaccine:
 1. Undiluted (108.1 plaque‐forming units (PFU)/mL)
 2. Dilution 1:5
 3. Dilution 1:10
Outcomes 1. Success rate 
 2. Humoral response (60% PFU reduction) and cellular response 
 3. Adverse events
Notes Location: USA