Trial Outcomes & Findings for Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG) (NCT NCT01311674)

NCT ID: NCT01311674

Last Updated: 2024-03-18

Results Overview

The primary endpoint for study HB-012 is area under the anti-HBs antibody concentration-time curve (AUC0-t) through Day 210. This endpoint was chosen because it allowed for the assessment of changes in anti HBs antibody concentration over time, and addressed one of the study objectives: to determine the effectiveness of Engerix-B booster vaccinations in the production of high anti-HBs titer plasma. By comparing AUC0-t between the two dosing schedules, the primary endpoint of AUC0-t also addressed the study objective to determine the optimal vaccination schedule to obtain high anti-HBs titer plasma for the manufacture of HepaGam B.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

141 participants

Primary outcome timeframe

Day 0 to Day 210

Results posted on

2024-03-18

Participant Flow

This reporting only covers the interim analysis data collected within a 12 month period between enrolment of the first subject on 9 September 2009 and the interim analysis report cut off date of 1 September 2010 hence the enrollment number being less than the number of participants specified in the protocol.

Participant milestones

Participant milestones
Measure
Schedule 1 - Standard Dose Primary Vaccination Series
hepatitis B vaccine: Primary vaccination series 20 ug/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 ug/1.0 mL every 4 months
Schedule 2 - High Dose Primary Vaccination Series
hepatitis B vaccine: Primary vaccination series 40 ug/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 ug/1.0 mL every 4 months
Overall Study
STARTED
72
69
Overall Study
COMPLETED
28
29
Overall Study
NOT COMPLETED
44
40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=72 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=69 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Total
n=141 Participants
Total of all reporting groups
Age, Continuous
34.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
36.5 years
STANDARD_DEVIATION 9.5 • n=7 Participants
35.5 years
STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
23 Participants
n=7 Participants
44 Participants
n=5 Participants
Sex: Female, Male
Male
51 Participants
n=5 Participants
46 Participants
n=7 Participants
97 Participants
n=5 Participants
Race/Ethnicity, Customized
White
56 Participants
n=5 Participants
54 Participants
n=7 Participants
110 Participants
n=5 Participants
Race/Ethnicity, Customized
Black/African American
8 Participants
n=5 Participants
8 Participants
n=7 Participants
16 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Race/Ethnicity, Customized
Multiple races
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Hepatitis B vaccination status at Baseline
No vaccination previously
34 Participants
n=5 Participants
32 Participants
n=7 Participants
66 Participants
n=5 Participants
Hepatitis B vaccination status at Baseline
Previously vaccinated
38 Participants
n=5 Participants
37 Participants
n=7 Participants
75 Participants
n=5 Participants
BMI
27.4 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
27.7 kg/m^2
STANDARD_DEVIATION 3.9 • n=7 Participants
27.6 kg/m^2
STANDARD_DEVIATION 3.7 • n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 210

Population: The efficacy analysis population was used to assess the primary endpoint and to generate study conclusions. The efficacy analysis population included all subjects who were vaccinated prior to the interim analysis cut-off date of 1 September 2010 and assessed on visit Day 210.

The primary endpoint for study HB-012 is area under the anti-HBs antibody concentration-time curve (AUC0-t) through Day 210. This endpoint was chosen because it allowed for the assessment of changes in anti HBs antibody concentration over time, and addressed one of the study objectives: to determine the effectiveness of Engerix-B booster vaccinations in the production of high anti-HBs titer plasma. By comparing AUC0-t between the two dosing schedules, the primary endpoint of AUC0-t also addressed the study objective to determine the optimal vaccination schedule to obtain high anti-HBs titer plasma for the manufacture of HepaGam B.

Outcome measures

Outcome measures
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=28 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=29 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Comparison Between Vaccination Schedules Using Day 210 Anti-HBs Antibody Titers AUC(0-t)
1675.8 IU*days/mL
Standard Deviation 3065.6
4124.8 IU*days/mL
Standard Deviation 1097.3

SECONDARY outcome

Timeframe: Day 210

Population: The population used for this analysis, efficacy population responders, includes any subject who reached Day 210 (with the exception of subjects with all anti-HBs titer results \< 2 IU/mL who were considered non-responders), 14 in Schedule 1 and 21 in Schedule 2. However, four subjects (1 in schedule 1 and 3 in schedule 2) were excluded due to missing day 210 titers.

Anti-HBs titers on Day 210 were assessed as a measure of the anti-HBs level attained following completion of the primary vaccination series; the final primary-series vaccination was administered for both Schedules on Day 180.

Outcome measures

Outcome measures
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=13 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=18 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Comparison Between Vaccination Schedules Using Anti-HBs Titers on Day 210
14.2 IU/mL
Standard Deviation 14
31.1 IU/mL
Standard Deviation 47.3

SECONDARY outcome

Timeframe: up to Day 258

Population: The efficacy population responder subset was used. If a subject's anti-HBs titer levels did not reach 55 IU/mL on or before the cut-off date September 1, 2010, the subject was included as a censored observation. The last anti-HBs assessment date or interim analysis cut-off date, whichever was later, was used as the censoring date. In schedule 1, 3 subjects reached anti-HBs titer level of 55 IU/mL. In schedule 2, 4 subjects reached a titer of 55 IU/mL.

Time to reach 55 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 55 IU/mL using Kaplan - Meier methods.

Outcome measures

Outcome measures
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=14 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=21 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Comparison Between Vaccination Schedules Using Time to Reach 55 IU/mL Anti-HBs Plasma Titer Level
NA Days
Interval 133.0 to
Insufficient number of patients with events.
NA Days
Insufficient number of patients with events.

SECONDARY outcome

Timeframe: 0-12 months

Population: The efficacy population responder subset was used. If a subject's anti-HBs titer levels did not reach 80 IU/mL on or before the cut-off date September 1, 2010, the subject was included as a censored observation. The last anti-HBs assessment date or interim analysis cut-off date, whichever was later, was used as the censoring date. In schedule 1, no subjects reached anti-HBs titer level of 80 IU/mL. In schedule 2, 2 subjects reached a titer of 80 IU/mL.

Time to reach 80 IU/mL was calculated based on the actual time, in days, from the baseline visit (Day 0) to the first time to reach an anti-HBs titer of 80 IU/mL.

Outcome measures

Outcome measures
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=14 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=21 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Time to Reach Anti-HBs Level of 80 IU/mL
NA Days
Insufficient number of patients with events.
NA Days
Insufficient number of patients with events.

SECONDARY outcome

Timeframe: Up to Day 258

Population: The efficacy population responder subset was used. The interim analysis cut-off date was used as the censoring date, except in the case where the subject was lost to follow-up or withdrawn prior to the interim analysis cut off date.

Time to reach peak anti-HBs plasma titer was calculated based on the actual times in days, from the baseline visit (Day 0) to the peak titer using Kaplan-Meier methods.

Outcome measures

Outcome measures
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=14 Participants
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=21 Participants
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Comparison Between Vaccination Schedules Using Time to Peak Anti-HBs Titer
119.2 days
Standard Deviation 88.0
153.3 days
Standard Deviation 86.9

Adverse Events

Schedule 1- Standard Dose Primary Vaccination Series

Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths

Schedule 2 - High Dose Primary Vaccination Series

Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=72 participants at risk
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=69 participants at risk
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Hepatobiliary disorders
Hepatomegaly and elevated liver enzymes
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.

Other adverse events

Other adverse events
Measure
Schedule 1- Standard Dose Primary Vaccination Series
n=72 participants at risk
Schedule 1 subjects will receive 20 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
Schedule 2 - High Dose Primary Vaccination Series
n=69 participants at risk
Schedule 2 subjects will receive 40 µg/1.0 mL of Engerix-B® on Day 0, Day 30, Day 60, Day 180 with booster of 20 µg/1.0 mL of Engerix-B® every 120 days (4 months) (after Day 180 vaccination) hepatitis B vaccine: Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
Blood and lymphatic system disorders
EOSINOPHILIA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Blood and lymphatic system disorders
HYPOCHROMIC ANAEMIA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Ear and labyrinth disorders
CERUMEN IMPACTION
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
ABDOMINAL PAIN
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
DYSPEPSIA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
NAUSEA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Gastrointestinal disorders
TOOTHACHE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
CHEST DISCOMFORT
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
FATIGUE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
INFLUENZA LIKE ILLNESS
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
INJECTION SITE INFLAMMATION
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
INJECTION SITE PAIN
12.5%
9/72 • Number of events 12 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
17.4%
12/69 • Number of events 19 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
General disorders
PYREXIA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Hepatobiliary disorders
HEPATITIS
2.8%
2/72 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Immune system disorders
ALLERGY TO ANIMAL
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Immune system disorders
DRUG HYPERSENSITIVITY
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Immune system disorders
HYPERSENSITIVITY
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
4.3%
3/69 • Number of events 3 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Immune system disorders
MULTIPLE ALLERGIES
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
BRONCHITIS
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
GASTROENTERITIS
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
GASTROENTERITIS VIRAL
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
INFLUENZA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
NASOPHARYNGITIS
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
OTITIS EXTERNA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
SINUSITIS
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
VIRAEMIA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Infections and infestations
VIRAL INFECTION
4.2%
3/72 • Number of events 3 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Injury, poisoning and procedural complications
ANIMAL BITE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Injury, poisoning and procedural complications
LIMB INJURY
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
BLOOD GLUCOSE DECREASED
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
BLOOD GLUCOSE INCREASED
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
CARBON DIOXIDE DECREASED
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
EOSINOPHIL COUNT INCREASED
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
HEPATITIS B SURFACE ANTIGEN POSITIVE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
HIV TEST NEGATIVE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
NEUTROPHIL COUNT INCREASED
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
TREPONEMA TEST FALSE POSITIVE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Investigations
WHITE BLOOD CELL COUNT INCREASED
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Metabolism and nutrition disorders
HYPERGLYCAEMIA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Musculoskeletal and connective tissue disorders
BACK PAIN
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Musculoskeletal and connective tissue disorders
MYALGIA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
HEADACHE
6.9%
5/72 • Number of events 7 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
13.0%
9/69 • Number of events 11 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
MIGRAINE
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
PARAESTHESIA
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
PRESYNCOPE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
SINUS HEADACHE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Nervous system disorders
SYNCOPE
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Psychiatric disorders
ANXIETY
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
2.9%
2/69 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Psychiatric disorders
DEPRESSION
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Psychiatric disorders
INSOMNIA
1.4%
1/72 • Number of events 2 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Psychiatric disorders
STRESS
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Renal and urinary disorders
CHROMATURIA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Renal and urinary disorders
URINARY TRACT PAIN
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Reproductive system and breast disorders
DYSMENORRHOEA
0.00%
0/72 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
1.4%
1/69 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
1.4%
1/72 • Number of events 1 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.
0.00%
0/69 • Adverse events were collected for a total of 7 days using diary cards after each vaccination, for the duration of the study until the interim reporting cut off date of 1 September 2010 (approximately 357 days).
Adverse events were elicited by the investigator (or designate) asking the patient non leading questions at each study visit, and at plasmapheresis visits that fall within 7 days of vaccination. Subjects were questioned about SAEs throughout the study.

Additional Information

Christine Hall, Sr. Director Clinical Research

Emergent Biosolutions

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place