Trial Outcomes & Findings for Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299) (NCT NCT00637195)

NCT ID: NCT00637195

Last Updated: 2020-01-03

Results Overview

A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 152 participants
• Primary outcome timeframe: Month 3
• Results posted on: 2020-01-03

Participant Flow

Participant milestones

Measure	Cervarix™ & Engerix™ Group Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Overall Study STARTED	76	76
Overall Study COMPLETED	73	75
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Cervarix™ & Engerix™ Group Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Overall Study Lost to Follow-up	1	0
Overall Study Other	2	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)

Baseline characteristics by cohort

Measure	Cervarix™ & Engerix™ Group n=76 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).	Total n=152 Participants Total of all reporting groups
Age, Continuous	22.4 years STANDARD_DEVIATION 1.51 • n=5 Participants	22.1 years STANDARD_DEVIATION 1.32 • n=7 Participants	22.3 years STANDARD_DEVIATION 1.42 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	76 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination .

A subject seroprotected against hepatitis B is a subject with anti-hepatitis B surface antigen (HBs) antibody titers greater than or equal to 10 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=72 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Seroprotected Against Hepatitis B Following 3 Doses of Engerix	70 Participants	73 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.

Titers are given as Geometric Mean Titers (GMTs) expressed as milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=72 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Anti-hepatitis B Surface Antigen (HBs) Antibody Titers Following 3 Doses of Engerix	156.1 mIU/mL Interval 83.7 to 291.3	146.2 mIU/mL Interval 86.6 to 246.9

SECONDARY outcome

Timeframe: Months 2 and 7

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine and with available data.

Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination.

Cut-off values assessed include 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=68 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies Anti-HPV-18, Month 2	68 Participants	—
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies Anti-HPV-16, Month 2	62 Participants	—
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies Anti-HPV-16, Month 7	61 Participants	—
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibodies Anti-HPV-18, Month 7	67 Participants	—

SECONDARY outcome

Timeframe: Months 2 and 7

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, only for subjects receiving Cervarix™ vaccine with available data.

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=68 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Anti-HPV-16/18 Antibody Titers Anti-HPV-16, Month 2	3497.2 EL.U/mL Interval 2902.3 to 4214.1	—
Anti-HPV-16/18 Antibody Titers Anti-HPV-16, Month 7	8725.2 EL.U/mL Interval 7105.7 to 10714.0	—
Anti-HPV-16/18 Antibody Titers Anti-HPV-18, Month 2	2775.6 EL.U/mL Interval 2306.5 to 3340.1	—
Anti-HPV-16/18 Antibody Titers Anti-HPV-18, Month 7	4664.4 EL.U/mL Interval 3709.9 to 5864.3	—

SECONDARY outcome

Timeframe: Months 2, 3 and 13

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.

Anti-HBs seroconversion is defined as the appearance [i.e. titer greater than or equal to the cut-off value of 3.3 milli-international units/milliliter (mIU/mL)] of anti-HBs antibodies in the sera of subjects seronegative (with titers below the cut-off value) before vaccination.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=55 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=64 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies Month 2	46 Participants	54 Participants
Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies Month 3	55 Participants	63 Participants
Number of Subjects Seroconverted for Anti-hepatitis B (HBs) Antibodies Month 13	52 Participants	63 Participants

SECONDARY outcome

Timeframe: Months 2 and 13

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.

A subject seroprotected against Hepatitis B is a subject with anti-HBs antibody titers greater than or equal to 10 mIU/mL.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=72 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course Month 2	63 Participants	65 Participants
Number of Subjects Seroprotected Against Anti-Hepatitis B (HBs) Antibodies Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course Month 13	69 Participants	74 Participants

SECONDARY outcome

Timeframe: At Months 2 and 13

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, in subjects with available data and who were negative for anti-hepatitis B core antigen (anti-HBc) before vaccination.

Titers are given as Geometric Mean Titers (GMTs) expressed as mIU/mL.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=72 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course Month 2	34.4 mIU/mL Interval 17.1 to 69.5	35.7 mIU/mL Interval 18.9 to 67.1
Anti-HBs Antibody Titers Following 2 Doses of Engerix and After Completing the 4-dose Engerix Vaccination Course Month 13	19888.4 mIU/mL Interval 13042.6 to 30327.5	16927.5 mIU/mL Interval 11854.1 to 24172.3

SECONDARY outcome

Timeframe: During the 7-day period following any vaccination

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Solicited local symptoms assessed include injection site pain, redness and swelling.

Data are presented across doses.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=76 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Solicited Local Symptoms Pain	76 Participants	62 Participants
Number of Subjects Reporting Solicited Local Symptoms Redness	26 Participants	12 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling	26 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 7-day period following the 4th dose of HBV vaccine

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Solicited local symptoms assessed include injection site pain, redness and swelling.

Data are presented across doses.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=74 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Solicited Local Symptoms Redness	8 Participants	13 Participants
Number of Subjects Reporting Solicited Local Symptoms Pain	36 Participants	44 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling	12 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 7-day period following any vaccination

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

Data are presented across doses.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=76 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Solicited General Symptoms Arthralgia	9 Participants	10 Participants
Number of Subjects Reporting Solicited General Symptoms Fatigue	49 Participants	52 Participants
Number of Subjects Reporting Solicited General Symptoms Gastro-intestinal symptoms	24 Participants	31 Participants
Number of Subjects Reporting Solicited General Symptoms Headache	49 Participants	42 Participants
Number of Subjects Reporting Solicited General Symptoms Myalgia	28 Participants	33 Participants
Number of Subjects Reporting Solicited General Symptoms Rash	3 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Temperature ≥ 37.5°C	9 Participants	5 Participants
Number of Subjects Reporting Solicited General Symptoms Urticaria	1 Participants	3 Participants

SECONDARY outcome

Timeframe: During the 7-day period following the 4th dose of HBV vaccine

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Solicited general symptoms assessed include arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [axillary route, ≥ 37.5 degree Celsius (°C)] and urticaria.

Data are presented across doses.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=74 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Solicited General Symptoms Arthralgia	1 Participants	4 Participants
Number of Subjects Reporting Solicited General Symptoms Fatigue	26 Participants	34 Participants
Number of Subjects Reporting Solicited General Symptoms Gastro-intestinal symptoms	3 Participants	13 Participants
Number of Subjects Reporting Solicited General Symptoms Headache	21 Participants	25 Participants
Number of Subjects Reporting Solicited General Symptoms Myalgia	4 Participants	18 Participants
Number of Subjects Reporting Solicited General Symptoms Rash	1 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Temperature ≥ 37.5°C	3 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms Urticaria	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 30-day period following any vaccination

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Unsolicited adverse event covers any adverse event 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	Cervarix™ & Engerix™ Group n=76 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Unsolicited Adverse Events	56 Participants	47 Participants

SECONDARY outcome

Timeframe: During the 30-day period following the 4th dose of HBV vaccine

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Unsolicited adverse event covers any adverse event 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	Cervarix™ & Engerix™ Group n=74 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Unsolicited Adverse Events	20 Participants	22 Participants

SECONDARY outcome

Timeframe: Up to study end (Month 13)

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

SAEs assessed include medical occurrences that result 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	Cervarix™ & Engerix™ Group n=76 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Serious Adverse Events (SAE)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to study end (Month 13)

Population: Analysis was performed on the Total Vaccinated cohort, which consisted of all vaccinated subjects for whom data were available.

Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

Outcome measures

Measure	Cervarix™ & Engerix™ Group n=74 Participants Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=75 Participants Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Number of Subjects Reporting Medically Significant Conditions	37 Participants	32 Participants

Adverse Events

Cervarix™ & Engerix™ Group

Serious events: 2 serious events

Other events: 76 other events

Deaths: 0 deaths

Engerix™ Group

Serious events: 2 serious events

Other events: 73 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cervarix™ & Engerix™ Group n=76 participants at risk Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 participants at risk Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous complete	1.3% 1/76 • From Month 0 up to Month 13.	0.00% 0/76 • From Month 0 up to Month 13.
Endocrine disorders Graves-Basedow's disease	1.3% 1/76 • From Month 0 up to Month 13.	0.00% 0/76 • From Month 0 up to Month 13.
Reproductive system and breast disorders Endometriosis	1.3% 1/76 • From Month 0 up to Month 13.	0.00% 0/76 • From Month 0 up to Month 13.
Infections and infestations Gastroenteritis viral	0.00% 0/76 • From Month 0 up to Month 13.	1.3% 1/76 • From Month 0 up to Month 13.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/76 • From Month 0 up to Month 13.	1.3% 1/76 • From Month 0 up to Month 13.

Other adverse events

Measure	Cervarix™ & Engerix™ Group n=76 participants at risk Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™) (Months 0, 1 \& 6) and 4 doses of Hepatitis B (Engerix™) vaccine (Months 0, 1, 2 \& 12).	Engerix™ Group n=76 participants at risk Subjects received 4 doses of Hepatitis B (HBV) vaccine (Months 0, 1, 2 \& 12).
General disorders Pain at injection site	100.0% 76/76 • From Month 0 up to Month 13.	81.6% 62/76 • From Month 0 up to Month 13.
General disorders Redness at injection site	34.2% 26/76 • From Month 0 up to Month 13.	15.8% 12/76 • From Month 0 up to Month 13.
General disorders Swelling at injection site	34.2% 26/76 • From Month 0 up to Month 13.	13.2% 10/76 • From Month 0 up to Month 13.
General disorders Arthralgia	11.8% 9/76 • From Month 0 up to Month 13.	13.2% 10/76 • From Month 0 up to Month 13.
General disorders Fatigue	64.5% 49/76 • From Month 0 up to Month 13.	68.4% 52/76 • From Month 0 up to Month 13.
General disorders Gastrointestinal symptom	31.6% 24/76 • From Month 0 up to Month 13.	40.8% 31/76 • From Month 0 up to Month 13.
Gastrointestinal disorders Headache	64.5% 49/76 • From Month 0 up to Month 13.	55.3% 42/76 • From Month 0 up to Month 13.
General disorders Myalgia	36.8% 28/76 • From Month 0 up to Month 13.	43.4% 33/76 • From Month 0 up to Month 13.
General disorders Rash	3.9% 3/76 • From Month 0 up to Month 13.	6.6% 5/76 • From Month 0 up to Month 13.
General disorders Temperature	11.8% 9/76 • From Month 0 up to Month 13.	6.6% 5/76 • From Month 0 up to Month 13.
Nervous system disorders Headache	15.8% 12/76 • From Month 0 up to Month 13.	17.1% 13/76 • From Month 0 up to Month 13.
Infections and infestations Upper respiratory tract infection	9.2% 7/76 • From Month 0 up to Month 13.	6.6% 5/76 • From Month 0 up to Month 13.
Reproductive system and breast disorders Dysmenorrhoea	9.2% 7/76 • From Month 0 up to Month 13.	7.9% 6/76 • From Month 0 up to Month 13.
Infections and infestations Cystitis	6.6% 5/76 • From Month 0 up to Month 13.	5.3% 4/76 • From Month 0 up to Month 13.
Infections and infestations Nasopharyngitis	7.9% 6/76 • From Month 0 up to Month 13.	3.9% 3/76 • From Month 0 up to Month 13.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	9.2% 7/76 • From Month 0 up to Month 13.	2.6% 2/76 • From Month 0 up to Month 13.
Respiratory, thoracic and mediastinal disorders Rhinitis	7.9% 6/76 • From Month 0 up to Month 13.	1.3% 1/76 • From Month 0 up to Month 13.
Gastrointestinal disorders Abdominal pain	0.00% 0/76 • From Month 0 up to Month 13.	6.6% 5/76 • From Month 0 up to Month 13.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 4/76 • From Month 0 up to Month 13.	1.3% 1/76 • From Month 0 up to Month 13.
General disorders Influenza like illness	1.3% 1/76 • From Month 0 up to Month 13.	5.3% 4/76 • From Month 0 up to Month 13.
Immune system disorders Pharyngitis	1.3% 1/76 • From Month 0 up to Month 13.	5.3% 4/76 • From Month 0 up to Month 13.

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