Trial Outcomes & Findings for A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. (NCT NCT02570126)

NCT ID: NCT02570126

Last Updated: 2019-11-25

Results Overview

Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1236 participants

Primary outcome timeframe

15-days (Days 0-14) post Dose 1 of varicella vaccination

Results posted on

2019-11-25

Participant Flow

Five vaccinated subjects for whom the data could not be used due to invalid informed consent were excluded.

Participant milestones

Participant milestones
Measure	VAR_HSA_F Group 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Overall Study STARTED	615	616
Overall Study COMPLETED	609	607
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Reasons for withdrawal
Measure	VAR_HSA_F Group 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Overall Study Lost to Follow-up	2	0
Overall Study Unable To Arrange Visit 3	1	0
Overall Study Violation Of Procedures GSK	0	1
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	3	7

Baseline Characteristics

A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VAR_HSA_F Group n=615 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=616 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	Total n=1231 Participants Total of all reporting groups
Age, Continuous	16.7 Months STANDARD_DEVIATION 3.3 • n=5 Participants	16.9 Months STANDARD_DEVIATION 3.4 • n=7 Participants	16.8 Months STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	318 Participants n=5 Participants	312 Participants n=7 Participants	630 Participants n=5 Participants
Sex: Female, Male Male	297 Participants n=5 Participants	304 Participants n=7 Participants	601 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	133 Participants n=5 Participants	135 Participants n=7 Participants	268 Participants n=5 Participants
Race/Ethnicity, Customized Other	94 Participants n=5 Participants	94 Participants n=7 Participants	188 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	379 Participants n=5 Participants	381 Participants n=7 Participants	760 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15-days (Days 0-14) post Dose 1 of varicella vaccination

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with administration of either Varilrix HSA-free or Varilrix™vaccine documented. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days (Days 0-14) post Dose 1 of varicella vaccination

Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F)

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Fever	24 Subjects	32 Subjects

SECONDARY outcome

Timeframe: 15 days post each dose of varicella vaccination

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days post each dose of varicella vaccination for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Fever Fever ≥ 38 °C following Dose 1	83 Subjects	92 Subjects
Number of Subjects Reporting Fever Fever ≥ 38 °C following Dose 2	83 Subjects	86 Subjects

SECONDARY outcome

Timeframe: At Day 42 and Day 84 post vaccination

Population: Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Immune response (in terms of GMC) was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84

Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=185 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=173 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) Post Dose 1 blood sample at Day 42	139.9 mIU/mL Interval 126.7 to 154.5	146.0 mIU/mL Interval 132.5 to 160.7
Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) Post Dose 2 blood sample at Day 84	931.8 mIU/mL Interval 841.1 to 1032.3	1102.4 mIU/mL Interval 996.1 to 1220.2

SECONDARY outcome

Timeframe: At Day 42 and Day 84 post vaccination

Population: Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Seropositivity was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84

For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (\< ) 25 mIU/mL) before vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=185 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=173 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) ≥ 25 mIU/mL (At Day 42)	184 Subjects	168 Subjects
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) ≥ 50 mIU/mL (At Day 42)	174 Subjects	166 Subjects
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) ≥ 25 mIU/mL (At Day 84)	180 Subjects	173 Subjects
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) ≥ 50 mIU/mL (At Day 84)	180 Subjects	173 Subjects

SECONDARY outcome

Timeframe: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 4 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (\>) 20 mm

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Solicited Local Symptoms Any Pain, Dose 1	75 Subjects	86 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain, Dose 1	2 Subjects	4 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Redness, Dose 1	149 Subjects	150 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness, Dose 1	3 Subjects	2 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Swelling, Dose 1	43 Subjects	42 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling, Dose 1	2 Subjects	1 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Pain, Dose 2	63 Subjects	80 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain, Dose 2	1 Subjects	1 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Redness, Dose 2	168 Subjects	185 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness, Dose 2	10 Subjects	8 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Swelling, Dose 2	69 Subjects	71 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling, Dose 2	1 Subjects	4 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Pain, Across Doses	101 Subjects	126 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Pain, Across Doses	3 Subjects	5 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Redness, Across Doses	224 Subjects	234 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Redness, Across Doses	13 Subjects	10 Subjects
Number of Subjects Reporting Solicited Local Symptoms Any Swelling, Across Doses	92 Subjects	94 Subjects
Number of Subjects Reporting Solicited Local Symptoms Grade 3 Swelling, Across Doses	3 Subjects	4 Subjects

SECONDARY outcome

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature \> 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Fever Fever (Axillary), Dose 1 : ≥ 38 °C	205 Subjects	188 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Dose 1 : > 39.5 °C	40 Subjects	27 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Dose 1 : Related	72 Subjects	51 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Dose 2 : ≥ 38 °C	172 Subjects	177 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Dose 2 : > 39.5 °C	23 Subjects	31 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Dose 2 : Related	51 Subjects	57 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Across Doses : ≥ 38 °C	301 Subjects	290 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Across Doses : > 39.5 °C	57 Subjects	53 Subjects
Number of Subjects Reporting Fever Fever (Axillary), Across Doses : Related	111 Subjects	95 Subjects

SECONDARY outcome

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Rash Any, Dose 1 : Localised or generalised	89 Subjects	104 Subjects
Number of Subjects Reporting Rash Any, Dose 1 : With fever	32 Subjects	27 Subjects
Number of Subjects Reporting Rash Any, Dose 1 : Varicella like	7 Subjects	9 Subjects
Number of Subjects Reporting Rash Any, Dose 1 : Grade 3	2 Subjects	4 Subjects
Number of Subjects Reporting Rash Any, Dose 1 : Related	16 Subjects	23 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Any	65 Subjects	74 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Administration site	4 Subjects	2 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Other site	63 Subjects	72 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : With fever	18 Subjects	12 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Varicella like	5 Subjects	4 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Grade 3	2 Subjects	1 Subjects
Number of Subjects Reporting Rash Localised, Dose 1 : Related	11 Subjects	13 Subjects
Number of Subjects Reporting Rash Generalised, Dose 1 : Any	29 Subjects	35 Subjects
Number of Subjects Reporting Rash Generalised, Dose 1 : With fever	14 Subjects	15 Subjects
Number of Subjects Reporting Rash Generalised, Dose 1 : Varicella like	2 Subjects	6 Subjects
Number of Subjects Reporting Rash Generalised, Dose 1 : Grade 3	0 Subjects	3 Subjects
Number of Subjects Reporting Rash Generalised, Dose 1 : Related	5 Subjects	11 Subjects
Number of Subjects Reporting Rash Any, Dose 2 : Localised or generalised	76 Subjects	78 Subjects
Number of Subjects Reporting Rash Any, Dose 2 : With fever	27 Subjects	34 Subjects
Number of Subjects Reporting Rash Any, Dose 2 : Varicella like	4 Subjects	5 Subjects
Number of Subjects Reporting Rash Any, Dose 2 : Grade 3	2 Subjects	5 Subjects
Number of Subjects Reporting Rash Any, Dose 2 : Related	15 Subjects	16 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Any	52 Subjects	57 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Administration site	1 Subjects	4 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Other site	51 Subjects	53 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : With fever	16 Subjects	23 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Varicella like	3 Subjects	2 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Grade 3	1 Subjects	1 Subjects
Number of Subjects Reporting Rash Localised, Dose 2 : Related	12 Subjects	9 Subjects
Number of Subjects Reporting Rash Generalised, Dose 2 : Any	25 Subjects	26 Subjects
Number of Subjects Reporting Rash Generalised, Dose 2 : With fever	11 Subjects	12 Subjects
Number of Subjects Reporting Rash Generalised, Dose 2 : Varicella like	1 Subjects	3 Subjects
Number of Subjects Reporting Rash Generalised, Dose 2 : Grade 3	1 Subjects	4 Subjects
Number of Subjects Reporting Rash Generalised, Dose 2 : Related	3 Subjects	8 Subjects
Number of Subjects Reporting Rash Any, Across Doses : Localised or generalised	144 Subjects	152 Subjects
Number of Subjects Reporting Rash Any, Across Doses : With fever	55 Subjects	59 Subjects
Number of Subjects Reporting Rash Any, Across Doses : Varicella like	11 Subjects	14 Subjects
Number of Subjects Reporting Rash Any, Across Doses : Grade 3	4 Subjects	9 Subjects
Number of Subjects Reporting Rash Any, Across Doses : Related	28 Subjects	37 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Any	106 Subjects	112 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Administration site	5 Subjects	6 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Other site	103 Subjects	107 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : With fever	32 Subjects	34 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Varicella like	8 Subjects	6 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Grade 3	3 Subjects	2 Subjects
Number of Subjects Reporting Rash Localised, Across Doses : Related	20 Subjects	21 Subjects
Number of Subjects Reporting Rash Generalised, Across Doses : Any	49 Subjects	57 Subjects
Number of Subjects Reporting Rash Generalised, Across Doses : With fever	24 Subjects	27 Subjects
Number of Subjects Reporting Rash Generalised, Across Doses : Varicella like	3 Subjects	9 Subjects
Number of Subjects Reporting Rash Generalised, Across Doses : Grade 3	1 Subjects	7 Subjects
Number of Subjects Reporting Rash Generalised, Across Doses : Related	8 Subjects	19 Subjects

SECONDARY outcome

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=612 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=614 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 1 : Any	1 Subjects	1 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 1 : Grade 3	0 Subjects	1 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 1 : Related	0 Subjects	0 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 2 : Any	0 Subjects	1 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 2 : Grade 3	0 Subjects	0 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Dose 2 : Related	0 Subjects	0 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Across Doses : Any	1 Subjects	2 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Across Doses : Grade 3	0 Subjects	1 Subjects
Number of Subjects Reporting Febrile Convulsions Febrile convulsion, Across Doses : Related	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)

Population: Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the administered dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group)

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. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=615 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=616 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Post Dose 1	270 Subjects	282 Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs) Post Dose 2	223 Subjects	220 Subjects

SECONDARY outcome

Timeframe: From Day 0 through the end of study (Day 84)

SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination

Outcome measures

Outcome measures
Measure	VAR_HSA_F Group n=615 Participants 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=616 Participants 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Number of Subjects Reporting Serious Adverse Events (SAEs)	13 Subjects	15 Subjects

Adverse Events

VAR_HSA_F Group

Serious events: 13 serious events

Other events: 489 other events

Deaths: 0 deaths

VAR Group

Serious events: 15 serious events

Other events: 491 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	VAR_HSA_F Group n=615 participants at risk 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm	VAR Group n=616 participants at risk 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm
Respiratory, thoracic and mediastinal disorders Cough	9.3% 57/615 • Number of events 71 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	8.0% 49/616 • Number of events 59 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Gastrointestinal disorders Diarrhoea	6.2% 38/615 • Number of events 44 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	6.3% 39/616 • Number of events 53 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
General disorders Injection site erythema	36.4% 224/615 • Number of events 319 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	38.5% 237/616 • Number of events 341 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
General disorders Injection site pain	16.4% 101/615 • Number of events 138 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	20.6% 127/616 • Number of events 167 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
General disorders Injection site swelling	15.0% 92/615 • Number of events 112 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	15.4% 95/616 • Number of events 114 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Infections and infestations Nasopharyngitis	14.1% 87/615 • Number of events 110 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	13.0% 80/616 • Number of events 102 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
General disorders Pyrexia	48.9% 301/615 • Number of events 377 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	47.1% 290/616 • Number of events 365 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Skin and subcutaneous tissue disorders Rash	23.4% 144/615 • Number of events 165 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	24.7% 152/616 • Number of events 182 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Infections and infestations Rhinitis	5.4% 33/615 • Number of events 40 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	4.1% 25/616 • Number of events 32 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Gastrointestinal disorders Teething	9.4% 58/615 • Number of events 130 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	8.9% 55/616 • Number of events 80 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Infections and infestations Upper respiratory tract infection	4.6% 28/615 • Number of events 35 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	6.0% 37/616 • Number of events 42 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed
Gastrointestinal disorders Vomiting	5.0% 31/615 • Number of events 34 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed	5.5% 34/616 • Number of events 39 • Solicited local AEs: During the 4-day post vaccination period after each dose. Solicited general and unsolicited AEs: During the 43-day post vaccination period after each dose. Serious adverse events: From Day 0 through the end of study (Day 84) For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed

Additional Information

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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.
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Restriction type: OTHER