Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults (NCT NCT01738477)

NCT ID: NCT01738477

Last Updated: 2018-06-06

Results Overview

A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 165 participants
• Primary outcome timeframe: At Month 1
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	Boostrix Group 1 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Study STARTED	37	128
Overall Study COMPLETED	36	124
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Boostrix Group 1 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Overall Study Lost to Follow-up	1	4

Baseline Characteristics

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Previously Boosted Young Adults

Baseline characteristics by cohort

Measure	Boostrix Group 1 n=37 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=128 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.	Total n=165 Participants Total of all reporting groups
Age, Continuous	23.3 Years STANDARD_DEVIATION 2.4 • n=5 Participants	23.5 Years STANDARD_DEVIATION 2.1 • n=7 Participants	23.5 Years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	57 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	71 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Oriental	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White/caucasian	31 Participants n=5 Participants	114 Participants n=7 Participants	145 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). Anti-D	35 Participants	115 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). Anti-T	35 Participants	115 Participants

PRIMARY outcome

Timeframe: At Month 1

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Concentrations were expressed in geometric mean concentrations (GMCs).

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-PT	66.2 IU/mL Interval 50.8 to 86.2	87.3 IU/mL Interval 74.5 to 102.4
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-FHA	336.2 IU/mL Interval 250.0 to 452.2	290.5 IU/mL Interval 252.5 to 334.2
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-PRN	425.5 IU/mL Interval 281.9 to 642.3	463.3 IU/mL Interval 390.8 to 549.3

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). Anti-D	35 Participants	115 Participants
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T). Anti-T	35 Participants	115 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

The cut-off of the assay was ≥ 1.0 IU/mL.

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. Anti-D at Month 0	23 Participants	70 Participants
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. Anti-D at Month 1	34 Participants	115 Participants
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. Anti-T at Month 0	27 Participants	86 Participants
Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off. Anti-T at Month 1	35 Participants	115 Participants

SECONDARY outcome

Timeframe: At Month 0 and Month 1

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Concentrations were expressed as GMCs.

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Anti-D and Anti-T Antibody Concentrations. Anti-D at Month 0	1.6 IU/mL Interval 1.1 to 2.3	1.6 IU/mL Interval 1.3 to 2.1
Anti-D and Anti-T Antibody Concentrations. Anti-D at Month 1	6.8 IU/mL Interval 5.4 to 8.6	6.0 IU/mL Interval 5.3 to 6.9
Anti-D and Anti-T Antibody Concentrations. Anti-T at Month 0	1.8 IU/mL Interval 1.4 to 2.4	1.8 IU/mL Interval 1.5 to 2.2
Anti-D and Anti-T Antibody Concentrations. Anti-T at Month 1	9.9 IU/mL Interval 7.9 to 12.5	9.7 IU/mL Interval 8.5 to 11.0

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Concentrations were expressed in geometric mean concentrations (GMCs).

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-PT	5.3 IU/mL Interval 3.4 to 8.2	9.9 IU/mL Interval 8.1 to 12.2
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-FHA	21.7 IU/mL Interval 13.4 to 35.4	36.9 IU/mL Interval 31.5 to 43.3
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN). anti-PRN	27.8 IU/mL Interval 13.7 to 56.3	71.6 IU/mL Interval 56.7 to 90.6

SECONDARY outcome

Timeframe: At Month 1

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Booster response to anti-D and anti-T antigens was defined as:

• for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,
• for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination.

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With a Booster Response to Anti-D and Anti-T. Anti-D	14 Participants	47 Participants
Number of Subjects With a Booster Response to Anti-D and Anti-T. Anti-T	21 Participants	64 Participants

SECONDARY outcome

Timeframe: At Month 1.

Population: The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.

Booster response to pertussis antigens was defined as:

• for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;
• for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;
• for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination.

Outcome measures

Measure	Boostrix Group 1 n=35 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=115 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-PT	33 Participants	106 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA	34 Participants	104 Participants
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN	29 Participants	79 Participants

SECONDARY outcome

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

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

The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.

Outcome measures

Measure	Boostrix Group 1 n=36 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=125 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With Solicited Local Symptoms. Any Pain	21 Participants	97 Participants
Number of Subjects With Solicited Local Symptoms. Any Redness	15 Participants	47 Participants
Number of Subjects With Solicited Local Symptoms. Any Swelling	7 Participants	30 Participants

SECONDARY outcome

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

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

The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.

Outcome measures

Measure	Boostrix Group 1 n=36 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=125 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With Solicited General Symptoms. Any Fatigue	8 Participants	38 Participants
Number of Subjects With Solicited General Symptoms. Any Gastrointestinal Symptoms	1 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. Any Headache	8 Participants	40 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	1 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 31 days (Day 0 - 30) after vaccination.

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

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Outcome measures

Measure	Boostrix Group 1 n=37 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=128 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With Unsolicited Adverse Events (AEs).	10 Participants	33 Participants

SECONDARY outcome

Timeframe: From Day 0 to 31 days post-vaccination.

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

SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Boostrix Group 1 n=37 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=128 Participants Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Number of Subjects With Serious Adverse Events (SAEs).	0 Participants	0 Participants

Adverse Events

Boostrix Group 1

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Boostrix Group 2

Serious events: 0 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Boostrix Group 1 n=37 participants at risk Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who received Massachusetts Public Health Biologic Laboratories combined tetanus and diphtheria vaccine in study NCT00109330, received the first dose of Boostrix in this study.	Boostrix Group 2 n=128 participants at risk Healthy male of female subjects, aged 19 to 30 years of age at the time of booster vaccination, who were randomized to the Lot A, Lot B or Lot C groups in study NCT00109330, received a second dose of Boostrix in this study.
Musculoskeletal and connective tissue disorders Myalgia	5.4% 2/37 • Number of events 2 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	0.78% 1/128 • Number of events 1 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
General disorders Pain	56.8% 21/37 • Number of events 21 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	75.8% 97/128 • Number of events 97 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
General disorders Swelling	18.9% 7/37 • Number of events 7 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	23.4% 30/128 • Number of events 30 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Reproductive system and breast disorders Dysmenorrhoea	5.4% 2/37 • Number of events 2 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	1.6% 2/128 • Number of events 2 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Skin and subcutaneous tissue disorders Erythema	40.5% 15/37 • Number of events 15 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	36.7% 47/128 • Number of events 47 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
General disorders Fatigue	21.6% 8/37 • Number of events 8 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	29.7% 38/128 • Number of events 38 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Gastrointestinal disorders Gastrointestinal disorder	2.7% 1/37 • Number of events 1 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	8.6% 11/128 • Number of events 11 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.
Nervous system disorders Headache	29.7% 11/37 • Number of events 15 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): from Month 0 to Month 1.	35.9% 46/128 • Number of events 56 • Solicited local/general symptoms: during the 4-days (Days 0-3) post-vaccination period; Unsolicited AE(s): during the 31-day (Days 0-30) post-vaccination period; SAE(s): 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