Trial Outcomes & Findings for Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years (NCT NCT00346073)

Last Updated: 2018-08-07

Results Overview

A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2337 participants

Primary outcome timeframe

At Month 1

Results posted on

2018-08-07

Participant Flow

A total of 2337 subjects were enrolled into the study. Of these, 53 subjects were allocated subject numbers, but did not receive study vaccination.

Participant milestones

Participant milestones
Measure	Boostrix Group Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Overall Study STARTED	1522	762
Overall Study COMPLETED	1481	738
Overall Study NOT COMPLETED	41	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Boostrix Group Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Overall Study Serious Adverse Event	2	0
Overall Study Lost to Follow-up	39	24

Baseline Characteristics

Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boostrix Group n=1522 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=762 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Total n=2284 Participants Total of all reporting groups
Age, Continuous	39.9 Years STANDARD_DEVIATION 13.64 • n=93 Participants	40.1 Years STANDARD_DEVIATION 13.51 • n=4 Participants	39.97 Years STANDARD_DEVIATION 13.59 • n=27 Participants
Sex: Female, Male Female	946 Participants n=93 Participants	479 Participants n=4 Participants	1425 Participants n=27 Participants
Sex: Female, Male Male	576 Participants n=93 Participants	283 Participants n=4 Participants	859 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · African heritage/African American	126 Participants n=93 Participants	61 Participants n=4 Participants	187 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan native	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian heritage	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian heritage	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese heritage	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - South East Asian heritage	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Native Hawaiian or other Pacific islander	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African heritage	19 Participants n=93 Participants	13 Participants n=4 Participants	32 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European heritage	1281 Participants n=93 Participants	635 Participants n=4 Participants	1916 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Not specified	72 Participants n=93 Participants	41 Participants n=4 Participants	113 Participants n=27 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 0.1 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Boostrix Group n=1445 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=728 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-D	1418 Participants	717 Participants
Number of Seroprotected Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibodies Anti-T	1439 Participants	728 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to 1.0 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Boostrix Group n=1445 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=728 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Seropositive Subjects With Anti-tetanus (Anti-T) Antibodies	1420 Participants	723 Participants

PRIMARY outcome

Timeframe: At Month 1

Concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=726 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	63.6 EL.U/mL Interval 60.1 to 67.4	32.2 EL.U/mL Interval 29.6 to 35.1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	624.4 EL.U/mL Interval 593.9 to 656.6	368.4 EL.U/mL Interval 344.3 to 394.2
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	401.0 EL.U/mL Interval 368.5 to 436.3	351.9 EL.U/mL Interval 315.7 to 392.2

PRIMARY outcome

Timeframe: At Month 1

Booster responses for anti-PT, anti-FHA and anti-PRN antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (\<) 5 EU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥) 20 EU/mL), one month after vaccination; for initially seropositive subjects with pre-vaccination concentration ≥ 5 EU/mL and \< 20 EU/mL: an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EU/mL: an increase in antibody concentrations of at least two times the pre-vaccination concentration, one month after vaccination.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1441 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=725 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PT	1095 Participants	338 Participants
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-FHA	1388 Participants	671 Participants
Number of Subjects With Booster Responses for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies Anti-PRN	1343 Participants	665 Participants

SECONDARY outcome

Timeframe: At Month 1

A seropositive subject was a subject whose antibody concentration was greater than or equal to the cut-off value. Cut-off values assessed were greater than or equal to (≥) 1.0 international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=727 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Seropositive Subjects With Anti-diphteria (Anti-D) Antibodies	1269 Participants	669 Participants

SECONDARY outcome

Timeframe: At Month 1

Booster responses for anti-D and anti-T antibodies were defined as: for initially seronegative subjects (pre-vaccination concentration below cut-off: smaller than (\<) 0.1 IU/mL): antibody concentrations at least four times the cut-off (post-vaccination concentration greater than or equal to (≥ 0.4 IU/mL), one month after vaccination; and for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration one month after vaccination.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=727 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-D	1116 Participants	566 Participants
Number of Subjects With Booster Responses for Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Anti-T	704 Participants	441 Participants

SECONDARY outcome

Timeframe: At Month 1

Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Boostrix Group n=1445 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=728 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D	4.7 EL.U/mL Interval 4.4 to 5.1	5.0 EL.U/mL Interval 4.6 to 5.4
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T	8.5 EL.U/mL Interval 8.1 to 8.9	13.3 EL.U/mL Interval 12.5 to 14.1

SECONDARY outcome

Timeframe: During the 15-day period (Day 0-14) following vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1480 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=741 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Any	903 Participants	513 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Pain, Grade 3	24 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, Any	313 Participants	201 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Redness, ≥ 50 mm	23 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, Any	260 Participants	190 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Swelling, ≥ 50 mm	21 Participants	21 Participants

SECONDARY outcome

Timeframe: During the 15-day period (Day 0-14) following vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.

Assessed solicited general symptoms were fatigue, fever \[defined as temperature measured orally, greater than or equal to (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[gastro sympt.\] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1480 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=741 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Any	416 Participants	214 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Grade 3	37 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fatigue, Related	251 Participants	151 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), ≥37.5 °C	82 Participants	59 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever (orally), ≥39 °C	1 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Fever, Related	40 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Any	235 Participants	130 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Grade 3	18 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Gastro sympt., Related	125 Participants	67 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Any	445 Participants	230 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Grade 3	32 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Headache, Related	245 Participants	143 Participants

SECONDARY outcome

Timeframe: During the 31-day period (Days 0-30) following vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1522 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=762 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Any Unsolicited Adverse Events (AEs)	271 Participants	169 Participants

SECONDARY outcome

Timeframe: During the active phase of the study (Day 0 - Day 30)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1522 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=762 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Serious Adverse Events (SAEs).	9 Participants	2 Participants

SECONDARY outcome

Timeframe: During the extended safety follow-up (ESFU) phase (Day 31 - Month 6)

Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed. Two subjects were not contacted after the active phase of study, but had SAEs reported in the ESFU period.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1445 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=719 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects With Serious Adverse Events (SAEs)	12 Participants	11 Participants

SECONDARY outcome

Timeframe: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.

Hospitalization signified that the subject had been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out patient setting.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=718 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects Reporting Hospitalizations	13 Participants	10 Participants

SECONDARY outcome

Timeframe: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.

Emergency room visits refer to AEs requiring immediate medical attention.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=718 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects Reporting Emergency Room Visits	13 Participants	6 Participants

SECONDARY outcome

Timeframe: During the extended safety follow-up (ESFU) period (from Day 31 to Month 6)

Population: The analysis was performed on the Extended Safety Follow Up (ESFU) cohort, which included all the subjects for whom the ESFU contact was completed.

New onset chronic illnesses include diabetes, asthma, allergies, autoimmune diseases.

Outcome measures

Outcome measures
Measure	Boostrix Group n=1444 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=718 Participants Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Number of Subjects Reporting the Onset of New Chronic Illnesses	2 Participants	3 Participants

Adverse Events

Boostrix Group

Serious events: 21 serious events

Other events: 1108 other events

Deaths: 1 deaths

Adacel Group

Serious events: 13 serious events

Other events: 595 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Boostrix Group n=1522 participants at risk Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Boostrix® vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.	Adacel Group n=762 participants at risk Subjects, male or female, between, and including, 19 and 64 years of age received a single dose of Adacel™ vaccine administered intramuscularly in the deltoid region of the non-dominant upper arm at Day 0.
Skin and subcutaneous tissue disorders Erythema	20.6% 313/1522 • Number of events 313 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	26.4% 201/762 • Number of events 201 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
General disorders Fatigue	27.5% 419/1522 • Number of events 420 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	28.1% 214/762 • Number of events 214 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
Gastrointestinal disorders Gastrointestinal disorder	15.4% 235/1522 • Number of events 235 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	17.1% 130/762 • Number of events 130 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
Nervous system disorders Headache	29.4% 448/1522 • Number of events 450 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	30.2% 230/762 • Number of events 232 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
General disorders Pain	59.5% 905/1522 • Number of events 917 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	67.7% 516/762 • Number of events 530 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
General disorders Pyrexia	5.4% 82/1522 • Number of events 82 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	7.9% 60/762 • Number of events 61 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).
General disorders Swelling	17.1% 261/1522 • Number of events 261 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).	24.9% 190/762 • Number of events 191 • Solicited local and general symptoms: during the 15-day (Day 0-14) follow-up period after vaccination; Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination; SAEs: during the entire study period, including the ESFU phase (Month 0 - Month 6).

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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.
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