Trial Outcomes & Findings for Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination. (NCT NCT00610168)

NCT ID: NCT00610168

Last Updated: 2018-06-06

Results Overview

The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: At Month 0
• Results posted on: 2018-06-06

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 I Group Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Study STARTED	75	7
Overall Study COMPLETED	73	7
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Boostrix I Group Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination.

Baseline characteristics by cohort

Measure	Boostrix I Group n=75 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Total n=82 Participants Total of all reporting groups
Age, Continuous	21.1 Years STANDARD_DEVIATION 0.31 • n=5 Participants	21.1 Years STANDARD_DEVIATION 0.38 • n=7 Participants	21.1 Years STANDARD_DEVIATION 0.33 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	6 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.

Outcome measures

Measure	Boostrix I Group n=74 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-diphtheria ≥ 0.1 IU/mL	61 Subjects	5 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-diphtheria ≥ 1 IU/mL	17 Subjects	0 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-tetanus ≥ 0.1 IU/mL	72 Subjects	7 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-tetanus ≥ 1 IU/mL	44 Subjects	4 Subjects

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

The antibody concentrations cut-offs assessed were: equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.

Outcome measures

Measure	Boostrix I Group n=73 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-diphtheria ≥ 0.1 IU/mL	73 Subjects	7 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-diphtheria ≥ 1 IU/mL	68 Subjects	7 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-tetanus ≥ 0.1 IU/mL	73 Subjects	7 Subjects
Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Above the Cut-offs Anti-tetanus ≥ 1 IU/mL	71 Subjects	7 Subjects

SECONDARY outcome

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

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

Concentrations are presented as international units per millilitre (IU/mL).

Outcome measures

Measure	Boostrix I Group n=74 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-diphtheria Pre [N=74;7]	0.318 IU/mL Interval 0.24 to 0.421	0.196 IU/mL Interval 0.068 to 0.568
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-diphtheria Post [N=73;7]	5.994 IU/mL Interval 4.679 to 7.68	3.226 IU/mL Interval 1.741 to 5.975
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-tetanus Pre [N=74;7]	1.246 IU/mL Interval 0.956 to 1.623	0.989 IU/mL Interval 0.498 to 1.961
Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations Anti-tetanus Post [N=73;7]	9.596 IU/mL Interval 7.986 to 11.531	8.975 IU/mL Interval 5.277 to 15.264

SECONDARY outcome

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

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)

Outcome measures

Measure	Boostrix I Group n=75 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT Pre [N=75;7]	46 Subjects	7 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT Post [N=73;7]	73 Subjects	7 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA Pre [N=75;7]	75 Subjects	7 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA Post [N=73;7]	73 Subjects	7 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN Pre [N=75;7]	72 Subjects	7 Subjects
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN Post [N=73;7]	73 Subjects	7 Subjects

SECONDARY outcome

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

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

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

Outcome measures

Measure	Boostrix I Group n=75 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT Pre [N=75;7]	9.1 EL.U/mL Interval 6.9 to 11.9	12.5 EL.U/mL Interval 8.8 to 17.9
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PT Post [N=73;7]	90.3 EL.U/mL Interval 73.9 to 110.5	116.5 EL.U/mL Interval 56.5 to 240.5
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA Pre [N=75;7]	63.8 EL.U/mL Interval 53.1 to 76.8	118.8 EL.U/mL Interval 80.6 to 175.1
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-FHA Post [N=73;7]	793.4 EL.U/mL Interval 670.3 to 939.2	584.3 EL.U/mL Interval 248.3 to 1374.9
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN Pre [N=75;7]	36.9 EL.U/mL Interval 27.7 to 49.2	41.8 EL.U/mL Interval 20.3 to 85.9
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Anti-PRN Post [N=73;7]	548.1 EL.U/mL Interval 456.9 to 657.5	685.3 EL.U/mL Interval 243.5 to 1928.4

SECONDARY outcome

Timeframe: At Month 1

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had received the booster dose of Boostrix™ vaccine and for whom immunogenicity data were available.

Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.

Outcome measures

Measure	Boostrix I Group n=73 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group n=7 Participants Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PT [N=73;7]	72 Subjects	7 Subjects
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-FHA [N=73;7]	71 Subjects	6 Subjects
Number of Subjects With Booster Response to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Anti-PRN [N=73;7]	68 Subjects	7 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available 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

Measure	Boostrix I Group n=81 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any pain	76 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 pain	8 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any redness	48 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 redness	14 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any swelling	46 Subjects	—
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 swelling	15 Subjects	—

SECONDARY outcome

Timeframe: During the 4-day (Day 0-3) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled in.

Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. 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

Measure	Boostrix I Group n=81 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	44 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	2 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	36 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	7 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	0 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	7 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal symptoms	14 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal symptoms	1 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal symptoms	8 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	27 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	0 Subjects	—
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	22 Subjects	—

SECONDARY outcome

Timeframe: During the 31-day (Day 0-30) follow-up period after booster vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

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.

Outcome measures

Measure	Boostrix I Group n=82 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	26 Subjects	—

SECONDARY outcome

Timeframe: For safety assessment Boostrix I Group and Boostrix II Group were pooled (Pooled Group)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

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 I Group n=82 Participants Subjects, who had received Boostrix vaccine in the primary study (263855/004), received one additional booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.	Boostrix II Group Subjects, who had received Wyeth's (formerly Lederle) combined adult diphtheria and tetanus vaccine and GSK Biologicals' acellular pertussis vaccine in the primary study (263855/004), received one booster dose of Boostrix vaccine in this study, administered as an intramuscular injection into the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	1 Subjects	—

Adverse Events

Boostrix Pooled Group

Serious events: 1 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Boostrix Pooled Group n=82 participants at risk Boostrix I and Boostrix II Groups pooled together.
Respiratory, thoracic and mediastinal disorders Hyperventilation	1.2% 1/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).

Other adverse events

Measure	Boostrix Pooled Group n=82 participants at risk Boostrix I and Boostrix II Groups pooled together.
General disorders Pain	92.7% 76/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Redness	58.5% 48/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Swelling	56.1% 46/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Fatigue	53.7% 44/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Fever (Axillary)	8.5% 7/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Gastrointestinal symptoms	17.1% 14/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
General disorders Headache	32.9% 27/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
Infections and infestations Influenza	7.3% 6/82 • Solicited local/general symtopms: during the 4-day post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to 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