Trial Outcomes & Findings for Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years (NCT NCT01153685)

NCT ID: NCT01153685

Last Updated: 2018-06-08

Results Overview

The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: At Day 0 before vaccination
• Results posted on: 2018-06-08

Participant Flow

Participant milestones

Measure	Fluviral A Group Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Overall Study STARTED	50	70
Overall Study COMPLETED	50	70
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunogenicity & Safety Study of Fluviral® (2010 - 2011 Season) in Adults Aged 18 to 60 Years and Over 60 Years

Baseline characteristics by cohort

Measure	Fluviral A Group n=50 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Total n=120 Participants Total of all reporting groups
Age, Continuous	34.8 Years STANDARD_DEVIATION 13.72 • n=5 Participants	66.6 Years STANDARD_DEVIATION 4.73 • n=7 Participants	50.7 Years STANDARD_DEVIATION 9.23 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	39 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	31 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 before vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	14.1 Titer Interval 10.1 to 19.8	13.0 Titer Interval 9.8 to 17.3
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	39.2 Titer Interval 24.0 to 63.8	15.2 Titer Interval 11.1 to 21.0
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. B/Brisbane	22.7 Titer Interval 15.2 to 34.0	28.0 Titer Interval 21.5 to 36.5

PRIMARY outcome

Timeframe: At Day 21 after vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

The Fluviral vaccine strains were A/California (H1N1), A/Victoria (H3N2) and B/Brisbane

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	390.1 Titer Interval 293.8 to 518.1	142.1 Titer Interval 105.1 to 192.0
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	185.6 Titer Interval 140.9 to 244.5	183.7 Titer Interval 139.6 to 241.8
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Fluviral Vaccine Strains. B/Brisbane	260.6 Titer Interval 184.6 to 368.0	248.6 Titer Interval 185.9 to 332.3

PRIMARY outcome

Timeframe: At Day 0 before vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	29 Subjects	22 Subjects
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	15 Subjects	17 Subjects
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. B/Brisbane	21 Subjects	35 Subjects

PRIMARY outcome

Timeframe: At Day 21 after vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

A Seroprotected subject was defined as a subject with a serum haemagglutination inhibition (HI) antibody titer greater than or equal to 1:40.

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	49 Subjects	62 Subjects
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	48 Subjects	65 Subjects
Number of Seroprotected Subjects for Antibodies Against Fluviral Vaccine Strains. B/Brisbane	47 Subjects	69 Subjects

PRIMARY outcome

Timeframe: At Day 21 after vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

A subject seroconverted for haemagglutination inhibition (HI) antibodies was defined as a subject with either a prevaccination (Day 0) HI antibody titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a prevaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	41 Subjects	57 Subjects
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	35 Subjects	50 Subjects
Number of Seroconverted Subjects for Antibodies Against Fluviral Vaccine Strains. B/Brisbane	33 Subjects	51 Subjects

PRIMARY outcome

Timeframe: At Day 21 after vaccination

Population: The analyses were based on the According-To-Protocol (ATP) cohort for immunogenicity.

Seroconversion Factor (SCF) is defined as the fold increase in serum HI antibody GMTs post-vaccination (Day 21) compared to prevaccination (Day 0).

Outcome measures

Measure	Fluviral A Group n=49 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains. A/California (H1N1)	10.0 Fold increase Interval 6.3 to 15.7	9.3 Fold increase Interval 6.8 to 12.8
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains. A/Victoria (H3N2)	13.1 Fold increase Interval 9.3 to 18.5	14.1 Fold increase Interval 10.2 to 19.5
Seroconversion Factor for Antibodies Against Fluviral Vaccine Strains. B/Brisbane	11.5 Fold increase Interval 7.0 to 18.7	8.9 Fold increase Interval 6.3 to 12.4

SECONDARY outcome

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

Population: The analysis was performed on the Total Vaccinated Cohort on subjects with available results.

Solicited local symptoms assessed were pain, redness and swelling at the injection site. Solicited general symptoms assessed were bronchospasm, chills, cough, fatigue, headache, joint pain at other location, muscle aches, red eyes, sore throat, swelling of the face and temperature (defined as orally temperature equal or above 38.0 degrees Celcius)

Outcome measures

Measure	Fluviral A Group n=50 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=69 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Headache	13 Subjects	6 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Pain	41 Subjects	18 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Redness	0 Subjects	0 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Swelling	2 Subjects	1 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Bronchospasm	0 Subjects	3 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Chills	2 Subjects	0 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Cough	2 Subjects	0 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Fatigue	15 Subjects	7 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Joint pain at other location	6 Subjects	3 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Muscle aches	17 Subjects	6 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Red eyes	4 Subjects	1 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Sore throat	8 Subjects	2 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Swelling of the face	1 Subjects	0 Subjects
Number of Subjects With Solicited Local and General Symptoms After Administration of Fluviral. Temperature	1 Subjects	1 Subjects

SECONDARY outcome

Timeframe: Within the 21-day post-vaccination period

Population: The analysis was performed on the Tota Vaccinated Cohort.

Unsolicited adverse events (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptoms with onset outside the specified period of follow-up for solicited symptoms.

Any = occurrence of any adverse event regardless of intensity grade or relationship to vaccination.

Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = event assessed by the investigator as causally related to the vaccination.

Outcome measures

Measure	Fluviral A Group n=50 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related	8 Subjects	3 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any	16 Subjects	17 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: Within the 21-day post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort.

Unsolicited AE covers any AE 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	Fluviral A Group n=50 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Cough	0 Subjects	2 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Breast pain	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Ear pain	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Epididymitis	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Fatigue	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Folliculitis	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Gingival pain	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Headache	1 Subjects	3 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Nausea	3 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Diarrhoea	3 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Dizziness	1 Subjects	2 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Abdominal pain	2 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Back pain	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Conjunctivitis	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Contusion	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Crohn's disease	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Depression	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Dysmenorrhoea	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Injection site haematoma	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Injection site pain	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Injection site paraesthesia	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Insomnia	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Localized infection	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Menorrhagia	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Metrorrhagia	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Mouth ulceration	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Musculoskeletal chest pain	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Musculoskeletal pain	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Nasopharyngitis	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Ocular hyperaemia	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Pain	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Procedural pain	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Renal colic	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Sedation	1 Subjects	0 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Sinus headache	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Sleep apnoea syndrome	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Tooth fracture	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Urinary tract infection	0 Subjects	1 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs). Vomiting	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the entire study period

Population: The analysis was performed on the Total Vaccinated Cohort.

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

Outcome measures

Measure	Fluviral A Group n=50 Participants Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 Participants Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	2 Subjects	0 Subjects

Adverse Events

Fluviral A Group

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Fluviral B Group

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluviral A Group n=50 participants at risk Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 participants at risk Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
Gastrointestinal disorders Crohn's disease	2.0% 1/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	0.00% 0/70 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Renal and urinary disorders Renal colic	2.0% 1/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	0.00% 0/70 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)

Other adverse events

Measure	Fluviral A Group n=50 participants at risk Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.	Fluviral B Group n=70 participants at risk Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
General disorders Pain	82.0% 41/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	26.1% 18/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
General disorders Fatigue	30.0% 15/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	10.1% 7/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Nervous system disorders Headache	26.0% 13/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	8.7% 6/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
General disorders Joint pain at other location	12.0% 6/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	4.3% 3/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Musculoskeletal and connective tissue disorders Muscle aches	34.0% 17/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	8.7% 6/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Eye disorders Red eyes	8.0% 4/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	1.4% 1/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Infections and infestations Sore throat	16.0% 8/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	2.9% 2/69 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Gastrointestinal disorders Nausea	6.0% 3/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	1.4% 1/70 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)
Gastrointestinal disorders Diarrhoea	6.0% 3/50 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)	0.00% 0/70 • Solicited symptoms: during a 4-day follow-up period after vaccination. Unsolicited symptoms: during 21 days following the vaccination (Day 0-21). Serious adverse events: during the entire study period (21 days)

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