Local Symptoms (at injection sites)
Fill in entire item group once per vaccine The 10Pn-PD-DiT vaccine is administered at Visits 1 (all cohorts), 2 (all cohorts except the 2+1 schedule HIV-neg. cohort), 3 (all cohorts) and 5 (all cohorts except the EPI/3+0 schedule HIV-neg. cohort). The DTPw-HBV/Hib vaccine is administered at Visits 1, 2, 3 and 8 (all cohorts).
integer
For investigator only: Could you please tick the appropriate box (side / site) for assessment.
text
For investigator only: Could you please tick the appropriate box (side / site) for assessment.
text
Fill in entire item group once per symptom Record either Size on Days 0-3 for Redness and Swelling or Pain Intensity on Days 0-3 for Pain.
integer
for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
integer
for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
integer
for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
integer
for Redness and Swelling Measure and record the greatest diameter (in mm). The original PDF file contains a printed 0-100 mm scale. The following comment is included in the Diary Cards of the Booster Doses: In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.
integer
Intensity: 0 / 1 / 2 / 3
integer
Intensity: 0 / 1 / 2 / 3
integer
Intensity: 0 / 1 / 2 / 3
integer
Intensity: 0 / 1 / 2 / 3
integer
if yes, give last day of symptoms in next item
boolean
Last Day of Symptoms
date
Other local symptoms
Local symptom description
text
Symptom Intensity
integer
Symptom start date
date
If no, record end date
boolean
if not continuing
date
General Symptoms
Fill in entire item group once per symptom Diarrhoea and Vomiting are only applicable if HRV has been administered (Visit 2 and 3)
integer
Please record the temperature every day in the evening. Should additional temperature measurements be performed at other times of the day, the highest temperature is to be recorded.
text
Body Temperature on Day 0
float
Body Temperature on Day 1
float
Body Temperature on Day 2
float
Body Temperature on Day 3
float
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
integer
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
integer
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
integer
For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all
integer
For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.
integer
For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.
integer
For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.
integer
For Diarrhoea, record the number of looser than normal stools per day. For Vomiting, record the number of vomiting episodes per day.
integer
if yes, give last day of symptoms in next item
boolean
Last Day of Symptoms
date
Other General Symptoms
General symptom description
text
Symptom Intensity
integer
Symptom start date
date
If no, record end date
boolean
if not continuing
date
Medication
Concomitant Medication name
text
Concomitant Medication Reason
text
Concomitant Medication Daily Dose
text
Concomitant Medication start date
date
if not continuing
date
If no, specify end date
boolean