Trial Outcomes & Findings for Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents (NCT NCT01362322)

NCT ID: NCT01362322

Last Updated: 2018-08-10

Results Overview

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 671 participants
• Primary outcome timeframe: At Month 1
• Results posted on: 2018-08-10

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Boostrix New Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Study STARTED	335	336
Overall Study COMPLETED	330	329
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Boostrix New Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Overall Study Withdrawal by Subject	3	1
Overall Study Lost to Follow-up	2	6

Baseline Characteristics

Immunogenicity and Safety of BoostrixTM Using a New Syringe in 10 to 15-year Old Adolescents

Baseline characteristics by cohort

Measure	Boostrix New Group n=335 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=336 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.	Total n=671 Participants Total of all reporting groups
Age, Continuous	11.9 Years STANDARD_DEVIATION 1.59 • n=93 Participants	11.9 Years STANDARD_DEVIATION 1.61 • n=4 Participants	11.9 Years STANDARD_DEVIATION 1.6 • n=27 Participants
Sex: Female, Male Female	179 Participants n=93 Participants	178 Participants n=4 Participants	357 Participants n=27 Participants
Sex: Female, Male Male	156 Participants n=93 Participants	158 Participants n=4 Participants	314 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 for whom data concerning immunogenicity outcome measures were available.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D	6.784 IU/mL Interval 6.178 to 7.45	6.493 IU/mL Interval 5.915 to 7.128
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T	18.937 IU/mL Interval 17.313 to 20.713	18.515 IU/mL Interval 16.851 to 20.342

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 for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT	140.2 EL.U/mL Interval 126.0 to 156.1	125.9 EL.U/mL Interval 112.7 to 140.7
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA	1080.2 EL.U/mL Interval 995.2 to 1172.5	1013.7 EL.U/mL Interval 940.0 to 1093.2
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN	652.4 EL.U/mL Interval 572.1 to 743.9	619.2 EL.U/mL Interval 546.0 to 702.2

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-D	0.472 IU/mL Interval 0.403 to 0.553	0.456 IU/mL Interval 0.392 to 0.53
Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Anti-T	0.956 IU/mL Interval 0.835 to 1.095	0.899 IU/mL Interval 0.789 to 1.026

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

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

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT PRE	7.5 EL.U/mL Interval 6.6 to 8.7	7.2 EL.U/mL Interval 6.3 to 8.2
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA PRE	48.9 EL.U/mL Interval 43.3 to 55.2	49.4 EL.U/mL Interval 43.6 to 56.0
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN PRE	14 EL.U/mL Interval 12.3 to 15.9	13.4 EL.U/mL Interval 11.9 to 15.0

SECONDARY outcome

Timeframe: At Day 0 (PRE) and at Month 1 (POST)

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-D PRE	284 Participants	286 Participants
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-D POST	320 Participants	319 Participants
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-T PRE	311 Participants	314 Participants
Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-T POST	321 Participants	319 Participants

SECONDARY outcome

Timeframe: At Day 0 (PRE) vaccine and at Month 1 (POST)

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome 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 ( ≥) 1 international units per milliliter (IU/mL).

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-D PRE	83 Participants	89 Participants
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-D POST	315 Participants	310 Participants
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-T PRE	151 Participants	143 Participants
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-T POST	321 Participants	319 Participants

SECONDARY outcome

Timeframe: At Day 0 (PRE) vaccine and at Month 1 (POST)

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-PRN POST	321 Participants	318 Participants
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-PT PRE	175 Participants	175 Participants
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-PT POST	316 Participants	315 Participants
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-FHA PRE	310 Participants	310 Participants
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-FHA POST	319 Participants	319 Participants
Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations) Anti-PRN PRE	269 Participants	272 Participants

SECONDARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=319 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies Anti-D	257 Participants	252 Participants
Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies Anti-T	266 Participants	270 Participants

SECONDARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); for initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.

Outcome measures

Measure	Boostrix New Group n=321 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=318 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. Anti-PT	298 Participants	295 Participants
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. Anti-FHA	305 Participants	304 Participants
Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens. Anti-PRN	315 Participants	317 Participants

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine 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.

Outcome measures

Measure	Boostrix New Group n=330 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=329 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With Any Solicited Local Symptoms Any Pain	237 Participants	248 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	113 Participants	94 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	98 Participants	90 Participants

SECONDARY outcome

Timeframe: Within 31 days (Days 0-30) post

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.

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

Measure	Boostrix New Group n=335 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=336 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With Unsolicited Adverse Events (AEs)	44 Participants	45 Participants

SECONDARY outcome

Timeframe: Within 4 days (Days 0-3) post vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.

Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Measure	Boostrix New Group n=330 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=329 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With Any Solicited General Symptoms Any Fatigue	83 Participants	86 Participants
Number of Subjects With Any Solicited General Symptoms Any Gastrointestinal symptoms	32 Participants	42 Participants
Number of Subjects With Any Solicited General Symptoms Any Headache	88 Participants	108 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature	9 Participants	6 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 - Month 1)

Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.

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

Measure	Boostrix New Group n=335 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=336 Participants Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	0 Participants

Adverse Events

Boostrix New Group

Serious events: 1 serious events

Other events: 263 other events

Deaths: 0 deaths

Boostrix Prev Group

Serious events: 0 serious events

Other events: 279 other events

Deaths: 0 deaths

Serious adverse events

Measure	Boostrix New Group n=335 participants at risk Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=336 participants at risk Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Injury, poisoning and procedural complications Injury	0.30% 1/335 • Number of events 1 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	0.00% 0/336 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).

Other adverse events

Measure	Boostrix New Group n=335 participants at risk Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.	Boostrix Prev Group n=336 participants at risk Subjects, aged 10 to 15 years, received one dose of Boostrix™ vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
Skin and subcutaneous tissue disorders Erythema	33.7% 113/335 • Number of events 113 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	28.0% 94/336 • Number of events 94 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
General disorders Fatigue	24.8% 83/335 • Number of events 83 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	25.6% 86/336 • Number of events 86 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
Gastrointestinal disorders Gastrointestinal disorder	9.6% 32/335 • Number of events 32 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	12.5% 42/336 • Number of events 42 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
Nervous system disorders Headache	26.6% 89/335 • Number of events 90 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	32.4% 109/336 • Number of events 110 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
General disorders Pain	70.7% 237/335 • Number of events 237 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	73.8% 248/336 • Number of events 248 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
General disorders Swelling	29.3% 98/335 • Number of events 98 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).	26.8% 90/336 • Number of events 90 • Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).

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.
• Publication restrictions are in place

Restriction type: OTHER