Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Human Challenge Model
Phase: PHASE2
Conditions: H1N1 Influenza Healthy Volunteers
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)



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B (TK@MGDKD?@HD<M@LPDMDIBH@?D><GOC@M<KTK@M>PMM@IO!H@MD><I#JGG@B@JA
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 5MDI<GTNDNJPOND?@JAOC@.)($,-IJMH<GM@A@M@I>@M<IB@<I??@@H@?>GDID><GGT
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4@NO0&4	
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Participant ID: _________________ Participant Initials: _______ Date: ____/______/______ 

 
Monday, August 27, 2012, FLU-PRO Version 1.0 
 
Research Tool in Development: Do NOT copy or distribute 
Page 1 of 2 
 
Influenza Symptom Questionnaire 
 
 
 
What time is it? ______  AM / PM  (please circle) 
Please rate the extent to which you had each symptom during the past 24 hours.  
 
Not at all A little bit 
Somewhat 
Quite a bit 
Very much 
Runny or dripping nose 
 
 
 
 
 
Congested or stuffy nose 
 
 
 
 
 
 
 
 
 
 
 
Scratchy or itchy throat 
 
 
 
 
 
Sore or painful throat 
 
 
 
 
 
Swollen throat 
 
 
 
 
 
Difficulty swallowing 
 
 
 
 
 
 
 
 
 
 
 
Teary or watery eyes 
 
 
 
 
 
Sore or painful eyes 
 
 
 
 
 
Eyes sensitive to light 
 
 
 
 
 
 
 
 
 
 
 
Trouble breathing 
 
 
 
 
 
Chest congestion 
 
 
 
 
 
Chest tightness 
 
 
 
 
 
Dry or hacking cough 
 
 
 
 
 
Wet or loose cough 
 
 
 
 
 
 
 
 
 
 
 
Headache 
 
 
 
 
 
Head congestion 
 
 
 
 
 
Sinus pressure 
 
 
 
 
 
Felt dizzy  
 
 
 
 
 
Felt lightheaded 
 
 
 
 
 
 
 
 
 
 
 
 
 
People experience the flu in different ways. We would like to know about the symptoms you 
have been experiencing during the past 24 hours. For each symptom, please mark one box  
under the response that best matches your experience. Mark the “Not at all” box, if you did not 
have that symptom in the past 24 hours. 
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Participant ID: _________________ Participant Initials: _______ Date: ____/______/______ 

 
Monday, August 27, 2012, FLU-PRO Version 1.0 
 
Research Tool in Development: Do NOT copy or distribute 
Page 2 of 2 
 
Please rate the extent to which you had each symptom during the past 24 hours.  
 
Not at all A little bit 
Somewhat 
Quite a bit 
Very much 
Lack of appetite (did not feel like 
eating) 
 
 
 
 
 
Felt nauseous (feeling like you 
wanted to throw-up) 
 
 
 
 
 
Stomach ache 
 
 
 
 
 
 
 
 
 
 
 
Sleeping more than usual 
 
 
 
 
 
Difficulty staying asleep 
 
 
 
 
 
Difficulty falling asleep 
 
 
 
 
 
 
 
 
 
 
 
Body aches or pains 
 
 
 
 
 
Weak or tired 
 
 
 
 
 
Chills or shivering 
 
 
 
 
 
Felt cold 
 
 
 
 
 
Felt hot 
 
 
 
 
 
Sweating 
 
 
 
 
 
Felt uncomfortable (general 
discomfort) 
 
 
 
 
 
 
 
 
 
 
 
In the past 24 hours, how often have you had any of the following symptoms? 
 
0 times 
1 time 
2 times 
3 times 
4 or more 
times 
How many times did you vomit?  
 
 
 
 
 
How many times did you have 
diarrhea? 
 
 
 
 
 
 
 
 
 
 
 
 
Never 
Rarely 
Sometimes 
Often 
Always 
Sneezing 
 
 
 
 
 
Coughing 
 
 
 
 
 
Coughed up mucus or phlegm 
 
 
 
 
 
 
















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ADDITIONAL DAILY DIARY ITEMS FOR FLU-PRO VALIDATION STUDY 
Items to be asked in the daily diary through to Day 14 along with the FLU-PRO items. 
1.  Did you take any medication for your flu symptoms today? (Please select one response only) 
1  Yes 
0  No 
 
2.  Do you have asthma, COPD (chronic obstructive pulmonary disease) or both? 
1  Yes 
0  No 
 
3. 
[Only asked if answer to the question above is “yes”].  Did you use any rescue medication 
today for your asthma or COPD? (Please select one response only) 
1  Yes 
0  No 
 
4.  Overall, how severe were your flu symptoms today? (Please select one response only) 
0  No flu symptoms today 
1  Mild 
2  Moderate 
3  Severe 
4  Very severe 
 
5.  Overall, how were your flu symptoms today compared to yesterday? (Please select one 
response only) 
1  Much better 
2  Somewhat better 
3  A little better 
4  About the same 
5  A little worse 
6  Somewhat worse 
7  Much worse 
 
6.  How much did your flu symptoms interfere with your usual activities today? (Please select 
one response only) 
1  Not at all 
2  A little bit 
3  Somewhat 
4  Quite a bit 
5  Very much 
 
7.  Have you returned to your usual activities today? 
1  Yes 
















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8.  In general, how would you rate your physical health today? (Please select one response only) 
5  Excellent 
4  Very Good 
3  Good 
2  Fair 
1  Poor 
 
9.  Have you returned to your usual health today? 
1  Yes 
0  No