Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Hepatitis A Virus
Interventions:	Biological: Comparator: VAQTA™ (Hepatitis A vaccine) Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
39 clinical sites in the United States Date first participant visit: 14-Apr-2006 Date last participant visit: 25-Mar-2008

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
STARTED	330	323
Visit 1	330	323
Visit 2	305	294
Visit 3	273	261
Visit 4	262	240
COMPLETED	262	230
NOT COMPLETED	68	93
Adverse Event	0	1
Lost to Follow-up	25	42
Protocol Violation	3	8
Withdraw by Participant	20	20
Participant Moved	11	10
Unspecified	9	12

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	Total
Number of Participants [units: participants]	330	323	653
Age [units: years] Mean ± Standard Deviation	12.4 ± 0.80	12.5 ± 0.89	12.4 ± 0.85
Gender [units: participants]
Female	156	166	322
Male	174	157	331

Outcome Measures

1. Primary:

Antibody Response to Hepatitis A - Participants With a Serological Response [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]

Measure Type	Primary
Measure Title	Antibody Response to Hepatitis A - Participants With a Serological Response
Measure Description	Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Time Frame	4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	182	159
Antibody Response to Hepatitis A - Participants With a Serological Response [units: Participants]	182	158

Statistical Analysis 1 for Antibody Response to Hepatitis A - Participants With a Serological Response

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Miettinen and Nurminen
P Value ^[4]	<0.001
Risk Difference (RD) ^[5]	0.7
Standard Deviation	± 2.1
95% Confidence Interval	( -1.4 to 3.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	For testing the non-inferiority of 2 proportions. Stratified by investigator.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Difference in estimated response rates of Arm 1 – Arm 2.

2. Primary:

Antibody Response to Varicella - Participants With a Serological Response [ 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]

Measure Type	Primary
Measure Title	Antibody Response to Varicella - Participants With a Serological Response
Measure Description	Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Time Frame	6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	225	232
Antibody Response to Varicella - Participants With a Serological Response [units: Participants]
Number of participants ≥1.25 gpELISA units/mL	222	231
Number of participants ≥5 gpELISA units/mL	210	228

Statistical Analysis 1 for Antibody Response to Varicella - Participants With a Serological Response

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Miettinen and Nurminen
P Value ^[4]	0.013
Risk Difference (RD) ^[5]	-5.1
Standard Deviation	± 4.2
95% Confidence Interval	( -9.3 to -1.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2 for participants with initial serostatus <1.25 gpELISA units/mL
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	For testing the non-inferiority of 2 proportions. Stratified by investigator.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.
[5]	Other relevant estimation information:
	Difference in estimated response rates of Arm 1 – Arm 2.

3. Primary:

Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 4
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	246	247
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response [units: Participants]	241	237

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response

4. Primary:

Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 6B
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	246	246
Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response [units: Participants]	242	245

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response

5. Primary:

Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 9V
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response [units: Participants]	243	245

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response

6. Primary:

Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 14
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	248	247
Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response [units: Participants]	245	244

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response

7. Primary:

Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 18C
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response [units: Participants]	245	243

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response

8. Primary:

Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 19F
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	248	248
Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response [units: Participants]	245	244

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response

9. Primary:

Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response
Measure Description	Number of participants with postvaccination titer ≥0.2 mcg/mL for S. Pneumoniae serotype 23F
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response [units: Participants]	245	246

No statistical analysis provided for Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response

10. Primary:

Participants With 1 or More Systemic Adverse Experience [ 6 weeks post dose 1 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Systemic Adverse Experience
Measure Description	Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Time Frame	6 weeks post dose 1
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	311	274
Participants With 1 or More Systemic Adverse Experience [units: Participants]	178	80

No statistical analysis provided for Participants With 1 or More Systemic Adverse Experience

11. Primary:

Participants With 1 or More Systemic Adverse Experience [ 4 weeks post dose 2 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Systemic Adverse Experience
Measure Description	Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Time Frame	4 weeks post dose 2
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	263	251
Participants With 1 or More Systemic Adverse Experience [units: Participants]	88	77

No statistical analysis provided for Participants With 1 or More Systemic Adverse Experience

12. Primary:

Participants With 1 or More Systemic Adverse Experience. [ 6 months ]

Measure Type	Primary
Measure Title	Participants With 1 or More Systemic Adverse Experience.
Measure Description	Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	330	286
Participants With 1 or More Systemic Adverse Experience. [units: Participants]	204	133

No statistical analysis provided for Participants With 1 or More Systemic Adverse Experience.

13. Primary:

Participants With 1 or More Injection-site Adverse Experience [ 6 weeks post dose 1 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Injection-site Adverse Experience
Measure Description	Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame	6 weeks post dose 1
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	311	274
Participants With 1 or More Injection-site Adverse Experience [units: Participants]	83	61

No statistical analysis provided for Participants With 1 or More Injection-site Adverse Experience

14. Primary:

Participants With 1 or More Injection-site Adverse Experience [ 4 weeks post dose 2 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Injection-site Adverse Experience
Measure Description	Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame	4 weeks post dose 2
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	263	251
Participants With 1 or More Injection-site Adverse Experience [units: Participants]	54	66

No statistical analysis provided for Participants With 1 or More Injection-site Adverse Experience

15. Primary:

Participants With 1 or More Injection-site Adverse Experience [ 6 months ]

Measure Type	Primary
Measure Title	Participants With 1 or More Injection-site Adverse Experience
Measure Description	Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	330	286
Participants With 1 or More Injection-site Adverse Experience [units: Participants]	105	95

No statistical analysis provided for Participants With 1 or More Injection-site Adverse Experience

16. Primary:

Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 6 weeks post dose 1 ]

Measure Type	Primary
Measure Title	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Measure Description	Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame	6 weeks post dose 1
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	285	243
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [units: Participants]	10	5

No statistical analysis provided for Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

17. Primary:

Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 4 weeks post dose 2 ]

Measure Type	Primary
Measure Title	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Measure Description	Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame	4 weeks post dose 2
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	237	221
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [units: Participants]	6	5

No statistical analysis provided for Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

18. Primary:

Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ 6 months ]

Measure Type	Primary
Measure Title	Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Measure Description	Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	293	257
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [units: Participants]	16	10

No statistical analysis provided for Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

19. Primary:

Participants With 1 or More Serious Vaccine-related Adverse Experience [ 6 weeks post dose 1 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Serious Vaccine-related Adverse Experience
Measure Description	Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame	6 weeks post dose 1
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	311	274
Participants With 1 or More Serious Vaccine-related Adverse Experience [units: Participants]	0	1

No statistical analysis provided for Participants With 1 or More Serious Vaccine-related Adverse Experience

20. Primary:

Participants With 1 or More Serious Vaccine-related Adverse Experience [ 4 weeks post dose 2 ]

Measure Type	Primary
Measure Title	Participants With 1 or More Serious Vaccine-related Adverse Experience
Measure Description	Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame	4 weeks post dose 2
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	263	251
Participants With 1 or More Serious Vaccine-related Adverse Experience [units: Participants]	0	0

No statistical analysis provided for Participants With 1 or More Serious Vaccine-related Adverse Experience

21. Primary:

Participants With 1 or More Serious Vaccine-related Adverse Experience [ 6 months ]

Measure Type	Primary
Measure Title	Participants With 1 or More Serious Vaccine-related Adverse Experience
Measure Description	Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	330	286
Participants With 1 or More Serious Vaccine-related Adverse Experience [units: Participants]	0	1

No statistical analysis provided for Participants With 1 or More Serious Vaccine-related Adverse Experience

22. Primary:

Antibody Response to Hepatitis A – Geometric Mean Titer [ 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ]

Measure Type	Primary
Measure Title	Antibody Response to Hepatitis A – Geometric Mean Titer
Measure Description	Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
Time Frame	4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	182	159
Antibody Response to Hepatitis A – Geometric Mean Titer [units: mIU/mL] Geometric Mean ( 95% Confidence Interval )	4976.6 ( 4067.6 to 6088.6 )	6123.2 ( 4825.6 to 7769.7 )

No statistical analysis provided for Antibody Response to Hepatitis A – Geometric Mean Titer

23. Primary:

Antibody Response to Varicella - Geometric Mean Titer [ 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ]

Measure Type	Primary
Measure Title	Antibody Response to Varicella - Geometric Mean Titer
Measure Description	Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL
Time Frame	6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	225	232
Antibody Response to Varicella - Geometric Mean Titer [units: gpELISA units/mL] Geometric Mean ( 95% Confidence Interval )	14.6 ( 13.3 to 16.1 )	16.4 ( 15.1 to 17.7 )

No statistical analysis provided for Antibody Response to Varicella - Geometric Mean Titer

24. Primary:

Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 4
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes in Prevnar™.

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	246	247
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	1.8 ( 1.6 to 2.1 )	1.6 ( 1.4 to 1.8 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.1
Standard Deviation	± 0.2
95% Confidence Interval	( 0.9 to 1.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

25. Primary:

Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 6B
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	246	246
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	9.5 ( 8.3 to 11.0 )	9.6 ( 8.5 to 10.8 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.0
Standard Deviation	± 0.2
95% Confidence Interval	( 0.8 to 1.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

26. Primary:

Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 9V
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	3.7 ( 3.2 to 4.2 )	4.1 ( 3.7 to 4.7 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	0.9
Standard Deviation	± 0.1
95% Confidence Interval	( 0.8 to 1.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

27. Primary:

Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 14
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	248	247
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	7.7 ( 6.8 to 8.8 )	7.4 ( 6.5 to 8.4 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.0
Standard Deviation	± 0.2
95% Confidence Interval	( 0.9 to 1.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

28. Primary:

Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 18C
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	2.9 ( 2.6 to 3.3 )	2.6 ( 2.3 to 3.0 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.1
Standard Deviation	± 0.2
95% Confidence Interval	( 0.9 to 1.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

29. Primary:

Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 19F
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	248	248
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	4.0 ( 3.5 to 4.5 )	3.8 ( 3.3 to 4.3 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.1
Standard Deviation	± 0.1
95% Confidence Interval	( 0.9 to 1.2 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

30. Primary:

Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer [ 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ]

Measure Type	Primary
Measure Title	Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer
Measure Description	Postvaccination observed Geometric Mean Titer of antibody to S. Pneumoniae serotype 23F
Time Frame	6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes in Prevnar™

Reporting Groups

	Description
Arm 1: VAQTA™ + ProQuad™ + Prevnar™	VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™	VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.

Measured Values

	Arm 1: VAQTA™ + ProQuad™ + Prevnar™	Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Number of Participants Analyzed [units: participants]	247	247
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer [units: mcg/mL] Geometric Mean ( 95% Confidence Interval )	4.9 ( 4.3 to 5.6 )	4.5 ( 3.9 to 5.1 )

Statistical Analysis 1 for Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	ANCOVA
P Value ^[4]	<0.001
Mean difference in log titer ^[5]	1.1
Standard Deviation	± 0.2
95% Confidence Interval	( 1.0 to 1.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Comparison of the fold-difference of estimated GMTs of Arm 1 and Arm 2.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the fold-difference of GMTs excluding a decrease of 2 fold or more (lower bound >0.5).
[3]	Other relevant information, such as adjustments or degrees of freedom:
	Estimated responses and their fold-difference were based on statistical analysis models adjusting for combined study center and prevaccination titer.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Similarity (non-inferiority) indicated that the fold difference was statistically significantly less than the prespecified clinically relevant 2-fold difference at the 1-sided α=0.025 level.
[5]	Other relevant estimation information:
	Fold-difference of estimated GMTs of Arm 1 and Arm 2.

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_075, V251-067
Study First Received:	April 7, 2006
Results First Received:	March 24, 2009
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00312858 History of Changes
Health Authority:	United States: Food and Drug Administration