Trial Outcomes & Findings for Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM (NCT NCT00969436)

NCT ID: NCT00969436

Last Updated: 2018-06-08

Results Overview

Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 450 participants
• Primary outcome timeframe: At 42 - 56 days after the second vaccination dose at week 30
• Results posted on: 2018-06-08

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Priorix-Tetra Group Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Overall Study STARTED	180	180	90
Overall Study COMPLETED	155	159	79
Overall Study NOT COMPLETED	25	21	11

Reasons for withdrawal

Measure	Priorix-Tetra Group Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Overall Study Protocol Violation	1	3	0
Overall Study Migrated/moved from study area	12	10	2
Overall Study Father - serious health problem	0	0	1
Overall Study Parents personal problem	0	0	1
Overall Study Subject eliminated (other vaccine)	1	0	0
Overall Study Withdrawal by Subject	3	0	2
Overall Study Lost to Follow-up	8	8	5

Baseline Characteristics

Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM

Baseline characteristics by cohort

Measure	Priorix-Tetra Group n=180 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=180 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=90 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.	Total n=450 Participants Total of all reporting groups
Age, Continuous	9 Months STANDARD_DEVIATION 0 • n=5 Participants	9 Months STANDARD_DEVIATION 0.11 • n=7 Participants	9 Months STANDARD_DEVIATION 0 • n=5 Participants	9 Months STANDARD_DEVIATION 0.07 • n=4 Participants
Sex: Female, Male Female	79 Participants n=5 Participants	89 Participants n=7 Participants	49 Participants n=5 Participants	217 Participants n=4 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	91 Participants n=7 Participants	41 Participants n=5 Participants	233 Participants n=4 Participants
Race/Ethnicity, Customized Asian - central/ south Asian heritage	177 Participants n=5 Participants	175 Participants n=7 Participants	88 Participants n=5 Participants	440 Participants n=4 Participants
Race/Ethnicity, Customized Asian - south east Asian heritage	2 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: At 42 - 56 days after the second vaccination dose at week 30

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.

Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.

Outcome measures

Measure	Priorix-Tetra Group n=150 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=153 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=73 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Anti-measles ≥ 150 mIU/mL	149 Participants	153 Participants	72 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Anti-mumps ≥ 231 U/ML	149 Participants	152 Participants	72 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Anti-rubella ≥ 4 IU/mL	150 Participants	152 Participants	73 Participants
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies IgG varicella antibodies ≥ 1:4	138 Participants	141 Participants	69 Participants

SECONDARY outcome

Timeframe: Approximately 42 to 56 days after the first vaccine dose at week 6

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.

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

Outcome measures

Measure	Priorix-Tetra Group n=149 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=153 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=73 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies Anti-measles ≥ 150 mIU/mL	138 Participants	135 Participants	63 Participants
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies Anti-mumps ≥ 231 U/ML	124 Participants	128 Participants	60 Participants
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies Anti-rubella ≥ 4 IU/mL	147 Participants	151 Participants	73 Participants
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies IgG varicella antibodies ≥ 1:4	130 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose

Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.

Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).

Outcome measures

Measure	Priorix-Tetra Group n=150 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=153 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=73 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-measles; Week 6	2013.6 mIU/mL Interval 1662.2 to 2439.3	1180.4 mIU/mL Interval 963.0 to 1446.7	1200 mIU/mL Interval 887.9 to 1621.8
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-mumps; Week 6	991.9 mIU/mL Interval 819.7 to 1200.3	746.6 mIU/mL Interval 628.0 to 887.6	775.1 mIU/mL Interval 600.9 to 999.7
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-rubella; Week 6	45.4 mIU/mL Interval 38.3 to 53.7	63.8 mIU/mL Interval 55.9 to 72.8	62 mIU/mL Interval 51.3 to 74.9
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses IgG varicella antibodies; Week 6	120.5 mIU/mL Interval 90.8 to 160.0	2.2 mIU/mL Interval 2.0 to 2.4	2.2 mIU/mL Interval 1.8 to 2.6
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-measles; Week 30	4471.3 mIU/mL Interval 3975.3 to 5029.2	3358.7 mIU/mL Interval 3017.5 to 3738.4	2495 mIU/mL Interval 2064.5 to 3015.2
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-mumps; Week 30	6428 mIU/mL Interval 5774.9 to 7154.9	10108.5 mIU/mL Interval 9223.9 to 11078.0	4925.3 mIU/mL Interval 4200.9 to 5774.7
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses Anti-rubella; Week 30	148.4 mIU/mL Interval 136.1 to 161.8	164.8 mIU/mL Interval 152.1 to 178.6	173 mIU/mL Interval 153.0 to 195.6
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses IgG varicella antibodies; Week 30	5318.5 mIU/mL Interval 4318.7 to 6549.8	198 mIU/mL Interval 158.2 to 247.7	128 mIU/mL Interval 91.7 to 178.7

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)

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

Measure	Priorix-Tetra Group n=174 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=172 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=84 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 1	20 Participants	12 Participants	9 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 1	15 Participants	8 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 1	8 Participants	5 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Pain; Dose 2	9 Participants	10 Participants	3 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Pain; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Redness; Dose 2	10 Participants	6 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Redness; Dose 2	3 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Any Swelling; Dose 2	9 Participants	6 Participants	0 Participants
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling; Dose 2	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

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 or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Priorix-Tetra Group n=174 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=172 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=83 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Meningism; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Meningism; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Meningism; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Parotid gland swelling; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Parotid gland swelling; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Parotid gland swelling; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Meningism; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Meningism; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Meningism; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Any Parotid gland swelling; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Grade 3 Parotid gland swelling; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Related Parotid gland swelling; Dose 2	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

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 ≥ 38.0°C and grade 3 fever was defined as fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Priorix-Tetra Group n=174 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=172 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=83 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Reporting Any, Grade 3 and Related Fever Any temperature; Dose 1	76 Participants	70 Participants	27 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 temperature; Dose 1	11 Participants	5 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Related temperature; Dose 1	53 Participants	48 Participants	15 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Any temperature; Dose 2	41 Participants	37 Participants	22 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Grade 3 temperature; Dose 2	2 Participants	6 Participants	2 Participants
Number of Subjects Reporting Any, Grade 3 and Related Fever Related temperature; Dose 2	22 Participants	21 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)

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

Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination

Outcome measures

Measure	Priorix-Tetra Group n=174 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=172 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=83 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Reporting Any, Grade 3 and Related Rash Any Rash; Dose 1	1 Participants	2 Participants	1 Participants
Number of Subjects Reporting Any, Grade 3 and Related Rash Grade 3 Rash; Dose 1	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Rash Related Rash; Dose 1	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Rash Any Rash; Dose 2	0 Participants	1 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Rash Grade 3 Rash; Dose 2	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Any, Grade 3 and Related Rash Related Rash; Dose 2	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 43-day (Days 0-42) after the first and second vaccination dose

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

An unsolicited Adverse Event (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 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.

Outcome measures

Measure	Priorix-Tetra Group n=180 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=180 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=90 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects Reporting Any Unsolicited Adverse Event Any AE(s); Dose 1	37 Participants	39 Participants	18 Participants
Number of Subjects Reporting Any Unsolicited Adverse Event Any AE(s); Dose 2	19 Participants	18 Participants	11 Participants

SECONDARY outcome

Timeframe: From the first study dose up to study end (Month 0 to Month 7.5 approximately)

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

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Priorix-Tetra Group n=180 Participants Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=180 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=90 Participants Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Number of Subjects With Serious Adverse Events (SAEs)	7 Participants	6 Participants	0 Participants

Adverse Events

Priorix-Tetra Group

Serious events: 7 serious events

Other events: 114 other events

Deaths: 0 deaths

Priorix/ Priorix-Tetra Group

Serious events: 6 serious events

Other events: 116 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Measure	Priorix-Tetra Group n=180 participants at risk Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=180 participants at risk Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=90 participants at risk Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Respiratory, thoracic and mediastinal disorders Wheezing	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Nervous system disorders Febrile convulsion	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Pyrexia	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Metabolism and nutrition disorders Dehydration	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Gastroenteritis	1.1% 2/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	1.7% 3/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Lower respiratory tract infection	1.1% 2/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Viral infection	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Bronchiolitis	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Pneumonia	0.00% 0/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.56% 1/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.

Other adverse events

Measure	Priorix-Tetra Group n=180 participants at risk Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.	Priorix/ Priorix-Tetra Group n=180 participants at risk Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.	Control Group n=90 participants at risk Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
Respiratory, thoracic and mediastinal disorders Cough; Dose 1	3.3% 6/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	5.6% 10/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	6.7% 6/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Pain; Dose 1	11.1% 20/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	6.7% 12/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	10.0% 9/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Redness; Dose 1	8.6% 15/174 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	4.7% 8/172 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.6% 3/84 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Pain; Dose 2	5.8% 9/155 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	6.3% 10/159 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.8% 3/79 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Redness; Dose 2	6.5% 10/155 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.8% 6/159 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/79 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Swelling; Dose 2	5.8% 9/155 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.8% 6/159 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	0.00% 0/79 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Fever; Dose 1	43.7% 76/174 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	40.7% 70/172 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	32.5% 27/83 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
General disorders Fever; Dose 2	26.5% 41/155 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	23.3% 37/159 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	27.8% 22/79 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Rhinitis; Dose 1	3.9% 7/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	5.0% 9/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	6.7% 6/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Nasopharyngitis; Dose 1	2.2% 4/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	4.4% 8/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	6.7% 6/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Upper respiratory tract infection; Dose 1	5.6% 10/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.9% 7/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	1.1% 1/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
Infections and infestations Rhinitis; Dose 2	3.3% 6/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	3.9% 7/180 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.	5.6% 5/90 • Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.

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