Trial Outcomes & Findings for Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects (NCT NCT03311659)

Last Updated: 2020-10-27

Results Overview

A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations \<0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

448 participants

Primary outcome timeframe

At Day 31

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	dTpa Group Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Overall Study STARTED	447
Overall Study COMPLETED	446
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	dTpa Group Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Overall Study Protocol Violation	1

Baseline Characteristics

Evaluation of Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Boostrix Vaccine Administered as a Booster Dose in Healthy Russian Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dTpa Group n=447 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Age, Continuous	32.7 Years STANDARD_DEVIATION 27.29 • n=5 Participants
Sex: Female, Male Female	241 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	447 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 31

Population: The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.

Outcome measures

Outcome measures
Measure	dTpa Group n=441 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). Anti-D antibody ≥ 0.1 IU/ml	437 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D). Neutralizing anti-D antibody ≥ 0.01 IU/ml	1 Participants

PRIMARY outcome

Timeframe: At Day 31

A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.

Outcome measures

Outcome measures
Measure	dTpa Group n=441 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Seroprotected Subjects for Anti-tetanus (Anti-T).	439 Participants

PRIMARY outcome

Timeframe: At Day 31

A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.

Outcome measures

Outcome measures
Measure	dTpa Group n=442 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). Anti-PT antibody	430 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). Anti-FHA antibody	442 Participants
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN). Anti-PRN antibody	431 Participants

SECONDARY outcome

Timeframe: At Day 31

Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration: 1. for subjects with values \<0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations of at least ≥0.4 IU/ml, one month after vaccination; and 2. for subjects with values ≥0.1 IU/ml (i.e. equal to or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (\<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination.

Outcome measures

Outcome measures
Measure	dTpa Group n=441 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-D antibody, S-	26 Participants
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-D antibody, S+	282 Participants
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-D antibody, Overall	308 Participants
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-T antibody, S-	38 Participants
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-T antibody, S+	338 Participants
Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens Anti-T antibody, Overall	376 Participants

SECONDARY outcome

Timeframe: At Day 31

Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations: 1. for subjects with pre-vaccination values below (\<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and 2. for subjects with pre-vaccination values between the assay cut-off and \<4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration. Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN respectively.

Outcome measures

Outcome measures
Measure	dTpa Group n=442 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PRN antibody, S-	57 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PRN antibody, S+ (< 4*assay cut-off)	114 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PRN antibody, S+ (≥ 4*assay cut-off)	225 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PRN, Overall	396 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PT antibody, S-	138 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PT antibody, S+ (< 4*assay cut-off)	140 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PT antibody, S+ (≥ 4*assay cut-off)	97 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-PT antibody, Overall	375 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-FHA antibody, S-	8 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-FHA antibody, S+ (< 4*assay cut-off)	57 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-FHA antibody, S+ (≥ 4*assay cut-off)	345 Participants
Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens. Anti-FHA antibody, Overall	410 Participants

SECONDARY outcome

Timeframe: At Day 31

Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively.

Outcome measures

Outcome measures
Measure	dTpa Group n=442 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. Anti-T antibody	13.507 IU/mL Interval 12.138 to 15.031
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. Anti-D antibody	6.287 IU/mL Interval 5.643 to 7.004
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. Anti-PT antibody	59.279 IU/mL Interval 52.907 to 66.418
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. Anti-FHA antibody	396.938 IU/mL Interval 362.876 to 434.197
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination. Anti-PRN antibody	249.638 IU/mL Interval 213.233 to 292.258

SECONDARY outcome

Timeframe: During the 4-day (Day 1-4) follow-up period after vaccination.

Population: Analysis was performed on Total Vaccinated Cohort (TVC) which included all subjects with the study vaccine administration and solicited symptoms documented.

Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as \> 0 millimeters (mm) diameter for all subjects.

Outcome measures

Outcome measures
Measure	dTpa Group n=447 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With Solicited Local Symptoms. Pain	284 Participants
Number of Subjects With Solicited Local Symptoms. Redness	207 Participants
Number of Subjects With Solicited Local Symptoms. Swelling	174 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 1-4) follow-up period after vaccination.

Population: Analysis was performed on subset of TVC which included subjects aged below 6 years, with the study vaccine administration documented and had solicited symptoms documented.

Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥ 38.0 degrees Celsius (°C). The location for measuring temperature was the axilla.

Outcome measures

Outcome measures
Measure	dTpa Group n=18 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects Aged Below 6 Years With Solicited General Symptoms. Drowsiness	1 Participants
Number of Subjects Aged Below 6 Years With Solicited General Symptoms. Irritability/Fussiness	5 Participants
Number of Subjects Aged Below 6 Years With Solicited General Symptoms. Loss of appetite	3 Participants
Number of Subjects Aged Below 6 Years With Solicited General Symptoms. Fever ( ≥ 38°C)	0 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 1-4) follow-up period after vaccination.

Population: Analysis was performed on subset of TVC which included subjects aged above and equal to 6 years, with the study vaccine administration documented and had solicited symptoms documented.

Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 °C.

Outcome measures

Outcome measures
Measure	dTpa Group n=429 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. Fatigue	126 Participants
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. Gastrointestinal symptoms	34 Participants
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. Headache	107 Participants
Number of Subjects Aged 6 Years and Above With Solicited General Symptoms. Fever ( ≥ 38°C), Overall	10 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 1-4) follow-up period after vaccination.

Population: Analysis was performed on TVC which included all subjects with the study vaccine administration and solicited symptoms documented.

Large injection site reaction for subjects \< 6 years of age defined as a swelling with a diameter of \> 50 mm and for subjects ≥ 6 years of age swelling with a diameter of \> 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination.

Outcome measures

Outcome measures
Measure	dTpa Group n=447 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With Large Swelling Reactions.	1 Participants

SECONDARY outcome

Timeframe: During the 31-day (Day 1-31) follow-up period after vaccination

Population: Analysis was performed on TVC which included all subjects with the study vaccine administration documented.

Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.

Outcome measures

Outcome measures
Measure	dTpa Group n=447 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With Unsolicited Adverse Events (AEs)	52 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 31

Population: Analysis was performed on TVC which included all subjects with the study vaccine administration documented.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	dTpa Group n=447 Participants Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants

Adverse Events

dTpa Group

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	dTpa Group n=447 participants at risk Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Infections and infestations Pneumonia bacterial	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.

Other adverse events

Other adverse events
Measure	dTpa Group n=447 participants at risk Healthy female and male subjects aged 4 years and above, who received a single dose of Boostrix vaccine at Day 1.
Gastrointestinal disorders Abdominal pain	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Gastrointestinal disorders Abdominal pain upper	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Gastrointestinal disorders Diarrhoea	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Gastrointestinal disorders Nausea	0.67% 3/447 • Number of events 3 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Chest pain	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Chills	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Fatigue	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Induration	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Injection site lymphadenopathy	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Injection site oedema	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Injection site pruritus	0.45% 2/447 • Number of events 2 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Pyrexia	0.67% 3/447 • Number of events 3 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Vaccination site erythema	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
General disorders Vaccination site haematoma	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Bronchitis	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Conjunctivitis	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Ear infection	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Nasopharyngitis	0.67% 3/447 • Number of events 3 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Oral herpes	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Pharyngitis	0.45% 2/447 • Number of events 2 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Pneumonia bacterial	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Respiratory tract infection viral	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Rhinitis	1.6% 7/447 • Number of events 7 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Sinusitis	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Tonsillitis	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Tracheitis	0.67% 3/447 • Number of events 3 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Infections and infestations Varicella	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Injury, poisoning and procedural complications Joint injury	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Investigations Blood pressure increased	0.22% 1/447 • Number of events 2 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Investigations Body temperature increased	0.45% 2/447 • Number of events 2 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Musculoskeletal and connective tissue disorders Arthropathy	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Musculoskeletal and connective tissue disorders Muscular weakness	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Musculoskeletal and connective tissue disorders Myalgia	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Nervous system disorders Headache	2.7% 12/447 • Number of events 12 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Nervous system disorders Somnolence	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Psychiatric disorders Irritability	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 6/447 • Number of events 6 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 6/447 • Number of events 6 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.45% 2/447 • Number of events 2 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Respiratory, thoracic and mediastinal disorders Sneezing	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Skin and subcutaneous tissue disorders Erythema	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
Skin and subcutaneous tissue disorders Rash	0.22% 1/447 • Number of events 1 • Unsolicited adverse events (AEs) were reported during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31). Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years of age and subjects 6 years of age and above), and then, analyzed per age stratum. Please refer to the outcomes section for the results.

Additional Information

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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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