Trial Outcomes & Findings for Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years (NCT NCT00871117)

NCT ID: NCT00871117

Last Updated: 2018-08-22

Results Overview

Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 478 participants
• Primary outcome timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
• Results posted on: 2018-08-22

Participant Flow

478 subjects were enrolled, but 2 subjects who received a subject number were not vaccinated. Therefore the total amount of subjects used for the analysis was 476.

Participant milestones

Measure	Kinrix + M-M-R II + Varivax Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Overall Study STARTED	239	237
Overall Study COMPLETED	234	227
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Measure	Kinrix + M-M-R II + Varivax Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Overall Study Lost to Follow-up	5	6
Overall Study Other	0	4

Baseline Characteristics

Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

Baseline characteristics by cohort

Measure	Kinrix + M-M-R II + Varivax n=239 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=237 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.	Total n=476 Participants Total of all reporting groups
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	109 Participants n=5 Participants	107 Participants n=7 Participants	216 Participants n=5 Participants
Race/Ethnicity, Customized Unspecified	42 Participants n=5 Participants	32 Participants n=7 Participants	74 Participants n=5 Participants
Age, Continuous	4.2 Years STANDARD_DEVIATION 0.41 • n=5 Participants	4.2 Years STANDARD_DEVIATION 0.37 • n=7 Participants	4.2 Years STANDARD_DEVIATION 0.39 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	123 Participants n=7 Participants	252 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants	114 Participants n=7 Participants	224 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as:

• initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of < 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL)
• initially seropositive subjects (sero+) (pre-booster antibody concentration ≥0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=211 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=209 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Booster Responses to Diphteria and Tetanus Anti-D	209 Participants	207 Participants
Number of Subjects With Booster Responses to Diphteria and Tetanus Anti-T	208 Participants	203 Participants

PRIMARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

anti-PT, anti-FHA and anti-PRN booster response :

• initially sero- (pre-booster antibody concentration below cut-off < 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL)
• initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and < 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster
• initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=220 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) Anti-PT	207 Participants	201 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) Anti-FHA	213 Participants	209 Participants
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL) Anti-PRN	220 Participants	209 Participants

PRIMARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Titers are expressed as GMTs.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=219 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 Anti-Polio 1	1638.4 titer Interval 1441.0 to 1863.0	1789.9 titer Interval 1559.0 to 2054.9
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 Anti-Polio 2	1572.9 titer Interval 1387.8 to 1782.7	1902.6 titer Interval 1678.6 to 2156.5
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3 Anti-Polio 3	2588.4 titer Interval 2282.7 to 2935.0	3189.6 titer Interval 2798.2 to 3635.7

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Cut-off value was defined as greater than or equal to 1.0 international units per milliliter (IU/mL).

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=217 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value Anti-D	217 Participants	212 Participants
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value Anti-T	217 Participants	209 Participants

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations were expressed as GMCs in IU/mL.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=217 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies Anti-D	14.273 IU/mL Interval 12.989 to 15.684	14.809 IU/mL Interval 13.397 to 16.371
Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies Anti-T	8.658 IU/mL Interval 7.888 to 9.504	8.138 IU/mL Interval 7.323 to 9.045

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Concentrations are expressed as GMCs in Enzyme-Linked Immunosorbent Assay (ELISA) Units per milliliter (EL.U/mL).

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=220 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies Anti-PRN	627.1 EL.U/mL Interval 543.2 to 724.0	620.4 EL.U/mL Interval 530.3 to 725.8
GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies Anti-PT	96.5 EL.U/mL Interval 85.8 to 108.6	101.3 EL.U/mL Interval 89.2 to 115.1
GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies Anti-FHA	968.9 EL.U/mL Interval 886.9 to 1058.4	968.2 EL.U/mL Interval 876.0 to 1070.1

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Anti-poliovirus 1, anti-poliovirus 2 and anti-poliovirus 3 booster response:

• initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ≥ 32 ED50 one month after vaccination
• initially seropositive subjects (pre-booster antibody titers ≥ 8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination.

ED50 is defined here as the reverse of the dilution resulting in 50% inhibition. The lowest dilution at which serum samples were tested is 1:8 from which a test was considered positive.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=215 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=211 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With an Anti-polio 1, 2, 3 Booster Response Anti-polio 1	211 Participants	202 Participants
Number of Subjects With an Anti-polio 1, 2, 3 Booster Response Anti-polio 2	204 Participants	207 Participants
Number of Subjects With an Anti-polio 1, 2, 3 Booster Response Anti-polio 3	213 Participants	207 Participants

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection status was defined as:

• anti-D antibody concentration greater than or equal to 0.1 IU/mL
• anti-T antibody concentration greater than or equal to 0.1 IU/mL

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=217 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects Seroprotected Against Diphteria and Tetanus Anti-D	217 Participants	212 Participants
Number of Subjects Seroprotected Against Diphteria and Tetanus Anti-T	217 Participants	212 Participants

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Seroprotection was defined:

• anti-poliovirus type 1, 2 or 3 antibody titer greater than or equal to 8 ED50.

ED50 is defined here as the reverse of the dilution resulting in 50% inhibition.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=219 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects Protected Against Poliovirus 1, 2 and 3 Anti-Polio 1	219 Participants	211 Participants
Number of Subjects Protected Against Poliovirus 1, 2 and 3 Anti-Polio 2	218 Participants	212 Participants
Number of Subjects Protected Against Poliovirus 1, 2 and 3 Anti-Polio 3	219 Participants	212 Participants

SECONDARY outcome

Timeframe: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.

Population: Analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine antigen component after vaccination.

Seropositivity was defined as a concentration greater than or equal to 5.0 EL.U/mL

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=220 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=212 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies anti-PT	220 Participants	212 Participants
Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies anti-FHA	220 Participants	212 Participants
Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies anti-PRN	220 Participants	212 Participants

SECONDARY outcome

Timeframe: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax

Population: The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.

Solicited local symptoms included pain, redness and swelling at the injection site. Any was defined as incidence of a particular symptom regardless of intensity grade.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=230 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=230 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Any Solicited Local Symptoms Any Pain	156 Participants	166 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness	115 Participants	114 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling	95 Participants	84 Participants

SECONDARY outcome

Timeframe: Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax

Population: The analysis was performed on the total vaccinated cohort, which included subjects with at least one vaccine administration documented, only on subjects with their symptom sheets completed.

Solicited general symptoms included fever [temperature equal to or greater than 37.5 degrees Celsius (°C)], drowsiness and loss of appetite. Any was defined as incidence of a particular symptom regardless of intensity grade.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=230 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=230 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Any Solicited General Symptoms Any Drowsiness	61 Participants	66 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite	60 Participants	57 Participants
Number of Subjects With Any Solicited General Symptoms Any Temperature (Axillary)	58 Participants	68 Participants

SECONDARY outcome

Timeframe: Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax

Population: Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) 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 will be reported as an unsolicited adverse event.

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=239 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=237 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Unsolicited Adverse Events	75 Participants	72 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 to 6 months post-vaccination)

Population: Analysis was performed on the total vaccinated cohort, which included all subjects with at least one vaccine administration documented and for whom data was available.

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

Outcome measures

Measure	Kinrix + M-M-R II + Varivax n=239 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.	Kinrix + M-M-R II -> Varivax n=237 Participants Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	1 Participants

Adverse Events

Kinrix + M-M-R II + Varivax

Serious events: 0 serious events

Other events: 228 other events

Deaths: 0 deaths

Kinrix + M-M-R II -> Varivax

Serious events: 1 serious events

Other events: 230 other events

Deaths: 0 deaths

Serious adverse events

Measure	Kinrix + M-M-R II + Varivax n=230 participants at risk；n=239 participants at risk Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.	Kinrix + M-M-R II -> Varivax n=230 participants at risk；n=237 participants at risk Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Infections and infestations Croup infectious	0.00% 0/239 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	0.42% 1/237 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.

Other adverse events

Measure	Kinrix + M-M-R II + Varivax n=230 participants at risk；n=239 participants at risk Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.	Kinrix + M-M-R II -> Varivax n=230 participants at risk；n=237 participants at risk Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
General disorders Pain	67.8% 156/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	72.2% 166/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.
General disorders Redness	50.0% 115/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	49.6% 114/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.
General disorders Swelling	41.3% 95/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	36.5% 84/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.
General disorders Drowsiness	26.5% 61/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	28.7% 66/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.
General disorders Loss of appetite	26.1% 60/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	24.8% 57/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.
General disorders Fever	25.2% 58/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.	29.6% 68/230 • Solicited local/general Adverse Events (AEs) during the first 4 days (Day 0-3) post vaccination ; unsolicited AEs during the 31 days (Days 0-30) post vaccination and SAEs during the entire study period (from Day 0 to 6 months post-vaccination). Solicited local/general Adverse Events (AEs) were only collected from subjects with their symptom sheets completed.

Additional Information

GSK Response Center

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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.
• Publication restrictions are in place

Restriction type: OTHER