To demonstrate non-inferiority of the 2 vaccination regimens versus the control in terms of seroconversion rates, defined as a group difference with a lower bound of the 95% CI >−10% for each antigen, 43 days postdose 2. Parents/guardians recorded solicited local and general symptoms for a 4-day and 43-day period after each vaccine dose, respectively.
Participants maintained the memory aid following vaccination, and for 6 days thereafter, on which they recorded solicited local and systemic reactions graded as none, mild, moderate, or severe.
Two of FIFA's 24 executive committee members were barred after they were recorded soliciting money for their votes.
Memory aid worksheets were provided to record solicited symptoms, AEs, and concomitant medication use for 14 days after dosing.
All participants were provided with diary cards to record solicited and unsolicited AEs.
Subjects used diary cards to record solicited injection site symptoms (pain, redness, and swelling/induration) and general symptoms (chest tightness or difficulty in breathing, chills, cough, fatigue, headache, joint pain, muscle pain, red eyes, sore throat/hoarseness/pain on swallowing, swelling of the face, fever), and rated each symptom for severity.
Safety was assessed via recording solicited local and systemic symptoms within 7 days and unsolicited symptoms within 30 days after each vaccination.
They caught Spitzer with a wire, recording him soliciting a prostitute.
Livestock records were solicited from individual households, which included the type (e.g. cattle, goat, sheep) and equivalent number of each livestock head.
Centers identified potential participant families based on clinic records and solicited their participation by mail which included information about the study along with a consent form.
The following adverse events were solicited and recorded routinely during the 14 days after immunisation: injection site pain, redness and swelling, systemic fatigue, fever, headache, malaise, myalgia, joint pain, gastrointestinal symptoms and contralateral local reactions.
