Trial Outcomes & Findings for Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B (NCT NCT02901951)
NCT ID: NCT02901951
Last Updated: 2020-01-02
Results Overview
Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to \[≥\]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration \< 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
106 participants
Primary outcome timeframe
7 days after the challenge dose (Day 7)
Results posted on
2020-01-02
Participant Flow
Subjects aged between and including 40 to 60 years were enrolled in this study, in compliance with the inclusion criteria, which required the documented evidence of previous vaccination with three or four consecutive doses of Engerix-B administered in adulthood (i.e. at least 18 years of age).
106 subjects were enrolled in the study but 3 subjects were withdrawn before vaccine administration. Therefore, the number of subjects started is 103.
Participant milestones
| Measure |
HBV Group
Subjects aged 40 to 60 years old who received 3 or 4 doses of Engerix-B (HBV vaccine) 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Persistence of Immunity to Hepatitis B in Adults Vaccinated With GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine (HBV), Engerix-B
Baseline characteristics by cohort
| Measure |
HBV Group
n=103 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European Heritage
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days after the challenge dose (Day 7)Population: Analysis was performed on the According-to-protocol (ATP) cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.
Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to \[≥\]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration \< 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.
Outcome measures
| Measure |
HBV Group
n=101 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose
< 6.2 mIU/mL
|
66.7 Percentage of subjects
Interval 22.3 to 95.7
|
|
Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose
≥ 6.2 mIU/mL
|
85.3 Percentage of subjects
Interval 76.5 to 91.7
|
PRIMARY outcome
Timeframe: 30 days after the challenge dose (Day 30)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.
Anamnestic response to the challenge dose was defined as: At least (i.e. ≥ 4-fold rise in one month post-vaccination anti-HBs antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration \< 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.
Outcome measures
| Measure |
HBV Group
n=101 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose
< 6.2 mIU/mL
|
100 Percentage of subjects
Interval 54.1 to 100.0
|
|
Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose
≥ 6.2 mIU/mL
|
100 Percentage of subjects
Interval 96.2 to 100.0
|
SECONDARY outcome
Timeframe: At the pre-challenge dose time-point (Day 0), at 7 days post-challenge time-point (Day 7) and at 30 days post-challenge time-point (Day 30)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.
Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.
Outcome measures
| Measure |
HBV Group
n=101 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 6.2 mIU/mL [Day 0]
|
94.1 Percentage of subjects
Interval 87.5 to 97.8
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 10 mIU/mL [Day 7]
|
97.0 Percentage of subjects
Interval 91.6 to 99.4
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 100 mIU/mL [Day 7]
|
92.1 Percentage of subjects
Interval 85.0 to 96.5
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 6.2 mIU/mL [Day 30]
|
100 Percentage of subjects
Interval 96.4 to 100.0
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 10 mIU/mL [Day 30]
|
100 Percentage of subjects
Interval 96.4 to 100.0
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 100 mIU/mL [Day 30]
|
98.0 Percentage of subjects
Interval 93.0 to 99.8
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 10 mIU/mL [Day 0]
|
90.1 Percentage of subjects
Interval 82.5 to 95.1
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 100 mIU/mL [Day 0]
|
61.4 Percentage of subjects
Interval 51.2 to 70.9
|
|
Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values
≥ 6.2 mIU/mL [Day 7]
|
98.0 Percentage of subjects
Interval 93.0 to 99.8
|
SECONDARY outcome
Timeframe: At the pre-challenge dose time-point (Day 0), at 7 days post-challenge dose time-point (Day 7) and at 30 days post-challenge dose time-point (Day 30)Population: Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.
Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Outcome measures
| Measure |
HBV Group
n=101 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Anti-HBs Antibody Concentrations
At Day 0
|
184.6 mIU/mL
Interval 121.5 to 280.3
|
|
Anti-HBs Antibody Concentrations
At Day 7
|
3840.0 mIU/mL
Interval 2330.0 to 6328.6
|
|
Anti-HBs Antibody Concentrations
At Day 30
|
48999.1 mIU/mL
Interval 33572.7 to 71513.7
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after the challenge dosePopulation: Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects who received the challenge dose.
Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBV Group
n=103 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Pain
|
40 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Redness (mm)
|
4 Participants
|
|
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Any Swelling (mm)
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after the challenge dosePopulation: Analysis was performed on the TVC which included all subjects who received the challenge dose.
Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius \[°C\]) , gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain) and headache. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBV Group
n=103 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Number of Subjects With Any Solicited General AEs
Any Fatigue
|
27 Participants
|
|
Number of Subjects With Any Solicited General AEs
Any Gastrointestinal symptoms
|
10 Participants
|
|
Number of Subjects With Any Solicited General AEs
Any Headache
|
20 Participants
|
|
Number of Subjects With Any Solicited General AEs
Any Fever
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after the challenge dosePopulation: Analysis was performed on the TVC which included all subjects who received the challenge dose.
An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBV Group
n=103 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Number of Subjects With Any Unsolicited AEs
|
41 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 30)Population: Analysis was performed on the TVC which included all subjects who received the challenge dose.
SAEs assessed included any untoward medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
HBV Group
n=103 Participants
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Number of Subjects With Any Serious Adverse Events (SAEs)
|
0 Participants
|
Adverse Events
HBV Group
Serious events: 0 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HBV Group
n=103 participants at risk
Subjects aged 40 to 60 years old who received 3 or 4 doses of HBV vaccine 20 to 30 years ago and were administered with a single challenge dose of HBV vaccine in this study at Day 0 (Visit 1).
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.9%
4/103 • Number of events 4 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Bronchitis
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
3/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Eye disorders
Eye pruritus
|
1.9%
2/103 • Number of events 2 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Fatigue
|
28.2%
29/103 • Number of events 30 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Gastroenteritis
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
9.7%
10/103 • Number of events 10 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Nervous system disorders
Headache
|
24.3%
25/103 • Number of events 26 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Vascular disorders
Hypertension
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Injection site erythema
|
3.9%
4/103 • Number of events 4 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Injection site pain
|
38.8%
40/103 • Number of events 40 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Injection site pruritus
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Injection site swelling
|
2.9%
3/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Psychiatric disorders
Insomnia
|
1.9%
2/103 • Number of events 2 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Eye disorders
Lacrimation increased
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Lip swelling
|
0.97%
1/103 • Number of events 2 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
2/103 • Number of events 2 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
2/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Nausea
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
2/103 • Number of events 2 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Pain
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.9%
3/103 • Number of events 4 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.9%
3/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
General disorders
Pyrexia
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.9%
2/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Sinusitis
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Toothache
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
3/103 • Number of events 3 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • Number of events 1 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
6/103 • Number of events 6 • Solicited local & general AEs: during 4-day (Days 0-3) follow-up period after challenge dose; Unsolicited AEs: during 31-day (Days 0-30) follow-up period after challenge dose; SAEs: during the entire study period (Day 0 to Day 30).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER