Trial Outcomes & Findings for Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds (NCT NCT00892775)

Last Updated: 2019-11-15

Results Overview

Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

501 participants

Primary outcome timeframe

At 42-56 days after the first dose of study vaccine (Week 6)

Results posted on

2019-11-15

Participant Flow

Out of the 501 enrolled participants, 3 were not administered any vaccine and hence were not considered as having started the study.

Participant milestones

Participant milestones
Measure	Priorix-Tetra New WS Group Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Overall Study STARTED	332	166
Overall Study COMPLETED	327	165
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Priorix-Tetra New WS Group Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Overall Study Protocol Violation	1	0
Overall Study Subject difficulties with blood drawing	1	0
Overall Study Disclaimer/ Withdrawal caused by H1N1	1	0
Overall Study Migrated/ moved from study area	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Priorix-Tetra New WS Group n=332 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.	Total n=498 Participants Total of all reporting groups
Age, Continuous	13 Months STANDARD_DEVIATION 1.94 • n=5 Participants	12.9 Months STANDARD_DEVIATION 1.7 • n=7 Participants	12.97 Months STANDARD_DEVIATION 1.86 • n=5 Participants
Sex: Female, Male Female	166 Participants n=5 Participants	84 Participants n=7 Participants	250 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	82 Participants n=7 Participants	248 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian heritage	165 Participants n=5 Participants	83 Participants n=7 Participants	248 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian heritage	162 Participants n=5 Participants	81 Participants n=7 Participants	243 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European heritage	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 42-56 days after the first dose of study vaccine (Week 6)

Population: The According-to-protocol (ATP) cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received vaccine according to their random assignment, who had not received a vaccine forbidden in the protocol and for whom pre/ post-vaccination serology results were available.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=314 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=157 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. Anti-measles ≥ 150 mIU/mL	312 Participants	157 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. Anti-mumps ≥ 231 U/ML	279 Participants	142 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. Anti-rubella ≥ 4 IU/mL	313 Participants	157 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. IgG varicella antibodies ≥ 1:4 dilution	284 Participants	131 Participants

SECONDARY outcome

Timeframe: At 42-56 days after the second dose of study vaccine (Week 18)

Population: The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.

Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=308 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=156 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. Anti-measles ≥ 150 mIU/mL	308 Participants	156 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. Anti-mumps ≥ 231 U/ML	307 Participants	155 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. Anti-rubella ≥ 4 IU/mL	308 Participants	156 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. IgG varicella antibodies ≥ 1:4 dilution	286 Participants	138 Participants

SECONDARY outcome

Timeframe: At 42-56 days after the first and second dose of study vaccine(s).

Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=314 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=157 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Measles (mIU/mL); Dose 1	3291.2 Titres Interval 3054.0 to 3546.8	3460.1 Titres Interval 3145.6 to 3806.0
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Mumps (U/mL); Dose 1	924.4 Titres Interval 821.9 to 1039.7	994.4 Titres Interval 851.7 to 1161.0
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Rubella (IU/mL); Dose 1	71.7 Titres Interval 66.1 to 77.9	66.6 Titres Interval 59.3 to 74.9
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Varicella (1/dil); Dose 1	104.8 Titres Interval 90.8 to 120.9	69.6 Titres Interval 53.6 to 90.2
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Measles (mIU/mL); Dose 2	4247.6 Titres Interval 3911.5 to 4612.6	4297.1 Titres Interval 3867.9 to 4774.0
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Mumps (U/mL); Dose 2	3379.5 Titres Interval 3121.3 to 3659.0	3216.2 Titres Interval 2870.9 to 3603.0
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Rubella (IU/mL); Dose 2	125.7 Titres Interval 117.4 to 134.5	115.2 Titres Interval 104.2 to 127.4
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses Anti-Varicella (1/dil); Dose 2	6570.6 Titres Interval 5746.7 to 7512.7	5134.8 Titres Interval 4153.8 to 6347.4

SECONDARY outcome

Timeframe: Within 4 days after each vaccination (Days 0-3)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, 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 = cried when limb was moved/ spontaneously painful. Grade 3 redness/ swelling = redness/ swelling spreading beyond 20 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=330 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 1	62 Participants	28 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 1	92 Participants	44 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 1	2 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 1	22 Participants	11 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 2	46 Participants	24 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 2	79 Participants	43 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 2	4 Participants	5 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 2	37 Participants	25 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 2	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Days 0-42) after each vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects,with the symptom sheet filled-in.

Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=330 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Any Meningism; Dose 1	2 Participants	1 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Grade 3 Meningism; Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Any Parotid gland; Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Grade 3 Parotid gland; Dose 1	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Any Meningism; Dose 2	2 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Grade 3 Meningism; Dose 2	1 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Any Parotid gland; Dose 2	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms Grade 3 Parotid gland; Dose 2	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43 days (Days 0-42) after each vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.

Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (\>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=330 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any, Grade 3 and Related Fever Any temperature; Dose 1	231 Participants	104 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 temperature; Dose 1	54 Participants	23 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Related temperature; Dose 1	160 Participants	70 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Any temperature; Dose 2	115 Participants	62 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 temperature; Dose 2	31 Participants	13 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Related temperature; Dose 2	29 Participants	28 Participants

SECONDARY outcome

Timeframe: Within 43 days (Days 0-42) after each vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects, with the symptom sheet filled-in.

Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=330 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Any, rash type; Dose 1	88 Participants	42 Participants
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Grade 3 rash type; Dose 1	9 Participants	6 Participants
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Related rash type; Dose 1	37 Participants	23 Participants
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Any, rash type; Dose 2	40 Participants	17 Participants
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Grade 3 rash type; Dose 2	6 Participants	1 Participants
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes Related rash type; Dose 2	12 Participants	7 Participants

SECONDARY outcome

Timeframe: Within 43 days (Days 0-42) after first vaccination dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

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. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=332 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Any AE(s)	165 Participants	73 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Grade 3 AE(s)	8 Participants	5 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Related AE(s)	21 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 43 days (Days 86-128) after second vaccination dose

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=332 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Any AE(s)	146 Participants	76 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Grade 3 AE(s)	6 Participants	6 Participants
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) Related AE(s)	10 Participants	6 Participants

SECONDARY outcome

Timeframe: From first study dose (Day 0) until study end (Week 18)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	Priorix-Tetra New WS Group n=332 Participants Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 Participants Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Number of Subjects With Serious Adverse Events (SAEs)	27 Participants	12 Participants

Adverse Events

Priorix-Tetra New WS Group

Serious events: 27 serious events

Other events: 246 other events

Deaths: 0 deaths

Priorix-Tetra Current WS Group

Serious events: 12 serious events

Other events: 117 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Priorix-Tetra New WS Group n=332 participants at risk Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.	Priorix-Tetra Current WS Group n=166 participants at risk Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea; Dose 1	9.3% 31/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.0% 10/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Cough; Dose 1	7.2% 24/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.0% 10/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Cough; Dose 2	7.2% 24/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	7.2% 12/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea; Dose 2	7.2% 24/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.0% 10/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pain; Dose 1	18.8% 62/330 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	16.9% 28/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Redness; Dose 1	27.9% 92/330 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	26.5% 44/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Swelling; Dose 1	6.7% 22/330 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.6% 11/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Pain; Dose 2	14.1% 46/327 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	14.6% 24/164 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Redness; Dose 2	24.2% 79/327 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	26.2% 43/164 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
General disorders Swelling; Dose 2	11.3% 37/327 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	15.2% 25/164 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Gastrointestinal disorders Diarrhoea; Dose 1	5.1% 17/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	6.6% 11/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Skin and subcutaneous tissue disorders Rash; Dose 1	26.7% 88/330 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	25.3% 42/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Skin and subcutaneous tissue disorders Rash; Dose 2	12.2% 40/327 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	10.4% 17/164 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Fever; Dose 1	70.0% 231/330 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	62.7% 104/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Fever; Dose 2	35.2% 115/327 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	37.8% 62/164 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Upper respiratory tract infection; Dose 1	15.1% 50/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	13.3% 22/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
Infections and infestations Upper respiratory tract infection; Dose 2	9.0% 30/332 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.	18.7% 31/166 • Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.