Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00444457

First received: March 5, 2007

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Results First Received: June 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Vaccines, Pneumococcal
Interventions:	Biological: 13-valent Pneumococcal Conjugate Vaccine Biological: 7vPnC

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
7vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Participant Flow for 3 periods

Period 1: Infant Series

	13vPnC (Pilot Lot 1)	13vPnC (Pilot Lot 2)	13vPnC (Manufacturing Lot)	7vPnC
STARTED	489	488	489	246
Vaccinated Dose 1	486	484	485	244
Vaccinated Dose 2	455	447	455	228
Vaccinated Dose 3	442	435	438	225
COMPLETED	435	427	428	218
NOT COMPLETED	54	61	61	28
Unknown	0	1	0	0
Parent or legal guardian request	18	29	34	14
Lost to Follow-up	10	11	7	6
Protocol Violation	16	8	6	3
Failed to return	5	4	4	2
Investigator request	4	3	3	2
Unspecified	0	2	4	0
Adverse Event	1	2	2	0
Death	0	1	1	1

Period 2: After Infant Series

	13vPnC (Pilot Lot 1)	13vPnC (Pilot Lot 2)	13vPnC (Manufacturing Lot)	7vPnC
STARTED	435	427	427	218
COMPLETED	415 ^[1]	397 ^[1]	408 ^[1]	208 ^[1]
NOT COMPLETED	20	30	19	10
Unknown	0	1	1	1
Parent or legal guardian request	4	11	6	3
Failed to return	7	6	5	1
Lost to Follow-up	5	5	5	2
Protocol Violation	2	4	2	2
Adverse Event	2	2	0	0
Investigator request	0	0	0	1
Unspecified	0	1	0	0

[1]	Not completed=Withdrawn after infant series

Period 3: Toddler Dose

	13vPnC (Pilot Lot 1)	13vPnC (Pilot Lot 2)	13vPnC (Manufacturing Lot)	7vPnC
STARTED	415 ^[1]	397 ^[1]	408 ^[1]	208 ^[1]
COMPLETED	408	391	404	200
NOT COMPLETED	7	6	4	8
Lost to Follow-up	4	1	1	3
Failed to return	2	2	1	3
Parent or legal guardian request	0	3	2	1
Protocol Violation	1	0	0	1

[1]	Vaccinated toddler dose

Baseline Characteristics

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Reporting Groups

	Description
13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
7vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
Total	Total of all reporting groups

Baseline Measures

	13vPnC (Pilot Lot 1)	13vPnC (Pilot Lot 2)	13vPnC (Manufacturing Lot)	7vPnC	Total
Number of Participants [units: participants]	489	488	489	246	1712
Age [units: months] Mean ± Standard Deviation	2.2 ± 0.3	2.2 ± 0.3	2.2 ± 0.3	2.2 ± 0.3	2.2 ± 0.3
Gender, Customized [units: participants]
Female	230	226	213	115	784
Male	259	260	275	131	925
Unknown	0	2	1	0	3

Outcome Measures

Show All Outcome Measures

1. Primary:

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series [ Time Frame: 1 Month after the infant series (7 Months of age) ]

Show Outcome Measure 1

2. Primary:

Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 2

3. Primary:

Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 3

4. Primary:

Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 4

5. Secondary:

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 5

6. Secondary:

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Show Outcome Measure 6

7. Secondary:

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

Show Outcome Measure 7

8. Secondary:

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Show Outcome Measure 8

9. Secondary:

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

Hide Outcome Measure 9

Measure Type	Secondary
Measure Title	Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose
Measure Description	Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Time Frame	1 month after the toddler dose (13 months of age)
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.
Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.

Reporting Groups

	Description
13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Measured Values

	13vPnC (Pilot Lot 1)	13vPnC (Pilot Lot 2)	13vPnC (Manufacturing Lot)
Number of Participants Analyzed [units: participants]	415	397	408
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose [units: GMC mcg/mL] Geometric Mean ( 95% Confidence Interval )
Common serotypes - serotype 4 (n=364,342,355)	2.29 ( 2.11 to 2.48 )	2.25 ( 2.07 to 2.44 )	3.06 ( 2.79 to 3.35 )
Common serotypes - serotype 6B (n=368,341,357)	11.14 ( 10.24 to 12.11 )	9.33 ( 8.55 to 10.19 )	9.92 ( 9.15 to 10.75 )
Common serotypes - serotype 9V (n=368,342,357)	1.91 ( 1.76 to 2.06 )	1.95 ( 1.80 to 2.10 )	1.99 ( 1.84 to 2.15 )
Common serotypes - serotype 14 (n=366,344,358)	6.61 ( 6.06 to 7.22 )	7.05 ( 6.42 to 7.74 )	6.91 ( 6.32 to 7.56 )
Common serotypes - serotype 18C (n=362,341,354)	1.95 ( 1.78 to 2.12 )	2.20 ( 2.01 to 2.41 )	2.48 ( 2.27 to 2.71 )
Common serotypes - serotype 19F (n=362,342,353)	4.51 ( 4.05 to 5.03 )	4.67 ( 4.23 to 5.14 )	6.51 ( 5.91 to 7.18 )
Common serotypes - serotype 23F (n=362,340,353)	3.35 ( 3.02 to 3.71 )	3.46 ( 3.14 to 3.82 )	3.10 ( 2.81 to 3.43 )
Additional serotypes - serotype 1 (n=367,344,357)	2.75 ( 2.53 to 2.99 )	2.95 ( 2.68 to 3.24 )	3.01 ( 2.75 to 3.30 )
Additional serotypes - serotype 3 (n=366,343,356)	0.75 ( 0.69 to 0.81 )	0.71 ( 0.65 to 0.77 )	0.80 ( 0.74 to 0.87 )
Additional serotypes - serotype 5 (n=368,343,357)	3.11 ( 2.87 to 3.37 )	2.63 ( 2.42 to 2.87 )	2.80 ( 2.60 to 3.02 )
Additional serotypes - serotype 6A (n=366,342,355)	7.52 ( 6.93 to 8.17 )	6.97 ( 6.41 to 7.59 )	6.83 ( 6.30 to 7.41 )
Additional serotypes - serotype 7F (n=366,343,358)	4.35 ( 4.01 to 4.72 )	4.24 ( 3.86 to 4.66 )	4.58 ( 4.21 to 4.98 )
Additional serotype - serotype 19A (n=362,341,353)	8.41 ( 7.73 to 9.14 )	8.32 ( 7.66 to 9.04 )	8.60 ( 7.91 to 9.36 )

Statistical Analysis 1 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.02
95% Confidence Interval	( -0.10 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 4
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 2 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.29
95% Confidence Interval	( -0.41 to -0.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 4
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 3 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.31
95% Confidence Interval	( -0.43 to -0.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 4
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 4 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.18
95% Confidence Interval	( 0.06 to 0.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 6B
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 5 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.12
95% Confidence Interval	( -0.00 to 0.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 6B
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 6 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.06
95% Confidence Interval	( -0.18 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 6B
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 7 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.02
95% Confidence Interval	( -0.13 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 9V
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 8 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.04
95% Confidence Interval	( -0.15 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 9V
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 9 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.02
95% Confidence Interval	( -0.13 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 9V
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 10 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.06
95% Confidence Interval	( -0.19 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 14
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 11 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.04
95% Confidence Interval	( -0.17 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 14
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 12 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.02
95% Confidence Interval	( -0.11 to 0.15 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 14
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 13 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.12
95% Confidence Interval	( -0.25 to 0.00 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 18C
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 14 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.24
95% Confidence Interval	( -0.37 to -0.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 18C
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 15 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.12
95% Confidence Interval	( -0.25 to 0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 18C
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 16 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.03
95% Confidence Interval	( -0.18 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 19F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 17 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.37
95% Confidence Interval	( -0.51 to -0.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 19F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 18 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.33
95% Confidence Interval	( -0.47 to -0.20 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 19F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 19 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.03
95% Confidence Interval	( -0.17 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 23F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 20 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.08
95% Confidence Interval	( -0.07 to 0.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 23F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 21 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.11
95% Confidence Interval	( -0.03 to 0.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Common serotypes - serotype 23F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 22 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	-0.07
95% Confidence Interval	( -0.20 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 1
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 23 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.09
95% Confidence Interval	( -0.21 to 0.03 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 1
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 24 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.02
95% Confidence Interval	( -0.15 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 1
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 25 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.06
95% Confidence Interval	( -0.06 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 3
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 26 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.07
95% Confidence Interval	( -0.18 to 0.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 3
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 27 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.13
95% Confidence Interval	( -0.25 to -0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 3
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 28 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.17
95% Confidence Interval	( 0.05 to 0.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 5
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 29 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.10
95% Confidence Interval	( -0.00 to 0.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 5
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 30 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.06
95% Confidence Interval	( -0.17 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 5
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 31 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.08
95% Confidence Interval	( -0.04 to 0.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 6A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 32 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.10
95% Confidence Interval	( -0.02 to 0.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 6A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 33 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	0.02
95% Confidence Interval	( -0.10 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 6A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 34 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.03
95% Confidence Interval	( -0.10 to 0.15 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 7F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 35 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.05
95% Confidence Interval	( -0.17 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 7F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 36 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.08
95% Confidence Interval	( -0.20 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 7F
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 37 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Pilot Lot 2)
Difference in log-transformed GM ^[2]	0.01
95% Confidence Interval	( -0.11 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 19A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 38 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 1) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.02
95% Confidence Interval	( -0.14 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 19A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

Statistical Analysis 39 for Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Groups ^[1]	13vPnC (Pilot Lot 2) vs. 13vPnC (Manufacturing Lot)
Difference in log-transformed GM ^[2]	-0.03
95% Confidence Interval	( -0.15 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotypes - serotype 19A
[2]	Other relevant estimation information:
	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.

10. Other Pre-specified:

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 7 days after dose (2 months of age) ]

Show Outcome Measure 10

11. Other Pre-specified:

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 7 days after dose (4 months of age) ]

Show Outcome Measure 11

12. Other Pre-specified:

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 7 days after dose (6 months of age) ]

Show Outcome Measure 12

13. Other Pre-specified:

Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) [ Time Frame: Within 7 days after dose (12 months of age) ]

Show Outcome Measure 13

14. Other Pre-specified:

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 7 days after dose (2 months of age) ]

Show Outcome Measure 14

15. Other Pre-specified:

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 7 days after dose (4 months of age) ]

Show Outcome Measure 15

16. Other Pre-specified:

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 7 days after dose (6 months of age) ]

Show Outcome Measure 16

17. Other Pre-specified:

Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age) [ Time Frame: Within 7 days after dose (12 months of age) ]

Show Outcome Measure 17

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella) was not available as planned; the alternate of a commercially available MMR and a commercially available varicella vaccine was administered in separate injections.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:

Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00444457 History of Changes
Other Study ID Numbers:	6096A1-3005
Study First Received:	March 5, 2007
Results First Received:	June 11, 2010
Last Updated:	October 10, 2012
Health Authority:	United States: Food and Drug Administration

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