Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (PILOT)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00824850

First received: January 16, 2009

Last updated: October 5, 2011

Last verified: October 2011

History of Changes

Results First Received: August 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Pneumococcal Conjugate Vaccine
Intervention:	Biological: 13-valent Pneumococcal Conjugate Vaccine

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
Participants were previously enrolled in Prevnar protocol D118-P8 (study duration 1995 to 1998) and were randomized to receive either 7-valent pneumococcal conjugate vaccine or meningococcal C conjugate vaccine in that study.

Pre-Assignment Details

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

Reporting Groups

	Description
7vPnC / 13vPnC	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
MnCC / 13vPnC	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.

Participant Flow: Overall Study

	7vPnC / 13vPnC	MnCC / 13vPnC
STARTED	38	37
Received Vaccination 13vPnC	38	36
COMPLETED	38	36
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Baseline Characteristics

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Reporting Groups

	Description
7vPnC / 13vPnC	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
MnCC / 13vPnC	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
Total	Total of all reporting groups

Baseline Measures

	7vPnC / 13vPnC	MnCC / 13vPnC	Total
Number of Participants [units: participants]	38	37	75
Age [units: years] Mean ± Standard Deviation	12.6 ± 1.1	13.1 ± 0.9	12.8 ± 1.0
Gender [units: participants]
Female	15	16	31
Male	23	21	44

Outcome Measures

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1. Primary:

Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) [ Time Frame: Day 28 (Visit 5) ]

Show Outcome Measure 1

2. Primary:

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3. Primary:

Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) [ Time Frame: Day 28 (Visit 5) ]

Show Outcome Measure 3

4. Primary:

Show Outcome Measure 4

5. Primary:

Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5) [ Time Frame: Day 28 (Visit 5) ]

Show Outcome Measure 5

6. Primary:

Show Outcome Measure 6

7. Secondary:

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 [ Time Frame: Baseline (Visit 1), Day 28 (Visit 5) ]

Show Outcome Measure 7

8. Secondary:

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 [ Time Frame: Baseline (Visit 1), Day 28 (Visit 5) ]

Show Outcome Measure 8

9. Secondary:

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 [ Time Frame: Baseline (Visit 1), Day 7 (Visit 4) ]

Show Outcome Measure 9

10. Secondary:

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 [ Time Frame: Baseline (Visit 1), Day 7 (Visit 4) ]

Show Outcome Measure 10

11. Secondary:

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 [ Time Frame: Baseline (Visit 1), Day 28 (Visit 5) ]

Hide Outcome Measure 11

Measure Type	Secondary
Measure Title	Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
Measure Description	Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution.
Time Frame	Baseline (Visit 1), Day 28 (Visit 5)
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; GMTs calculated using all participants with available data at both the prevaccination and postvaccination blood draws.

Reporting Groups

	Description
7vPnC / 13vPnC Prevaccination Visit 1	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
7vPnC / 13vPnC Postvaccination Visit 5	13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.

Measured Values

	7vPnC / 13vPnC Prevaccination Visit 1	7vPnC / 13vPnC Postvaccination Visit 5
Number of Participants Analyzed [units: participants]	38	38
Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 [units: Titer] Geometric Mean ( 95% Confidence Interval )
7vPnC serotype 4	22 ( 6.3 to 80.7 )	4535 ( 2836.5 to 7251.3 )
7vPnC serotype 6B	1024 ( 488.4 to 2148.4 )	11939 ( 8748.1 to 16293.9 )
7vPnC serotype 9V	43 ( 13.4 to 137.3 )	6709 ( 5097.5 to 8829.4 )
7vPnC serotype 14	159 ( 63.7 to 396.0 )	5946 ( 4361.1 to 8107.6 )
7vPnC serotype 18C	54 ( 19.5 to 149.5 )	5067 ( 3375.1 to 7607.2 )
7vPnC serotype 19F	33 ( 15.1 to 73.3 )	1623 ( 995.2 to 2647.9 )
7vPnC serotype 23F	87 ( 34.1 to 223.4 )	2799 ( 2048.5 to 3823.2 )
Additional serotype 1	6 ( 4.3 to 7.4 )	440 ( 301.8 to 641.2 )
Additional serotype 3	11 ( 6.9 to 16.6 )	111 ( 87.1 to 141.1 )
Additional serotype 5	4 ( 3.6 to 5.6 )	277 ( 145.2 to 526.4 )
Additional serotype 6A	17 ( 7.1 to 39.7 )	9029 ( 6255.0 to 13034.0 )
Additional serotype 7F	60 ( 17.7 to 205.3 )	7036 ( 4886.0 to 10131.8 )
Additional serotype 19A	76 ( 36.7 to 157.5 )	1869 ( 1099.8 to 3177.3 )

Statistical Analysis 1 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	201.8
95% Confidence Interval	( 55.11 to 739.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 4: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 2 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	11.7
95% Confidence Interval	( 5.20 to 26.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 6B: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 3 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	156.4
95% Confidence Interval	( 48.72 to 501.86 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 9V: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 4 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	37.4
95% Confidence Interval	( 13.71 to 102.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 14: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 5 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	93.9
95% Confidence Interval	( 30.99 to 284.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 18C: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 6 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	48.7
95% Confidence Interval	( 23.27 to 101.97 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 19F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 7 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	32.1
95% Confidence Interval	( 11.99 to 85.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	7vPnC serotype 23F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 8 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	78.1
95% Confidence Interval	( 50.42 to 120.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 1: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 9 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	10.3
95% Confidence Interval	( 6.80 to 15.72 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 3: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 10 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	61.7
95% Confidence Interval	( 32.75 to 116.34 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 5: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 11 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	536.5
95% Confidence Interval	( 212.04 to 1357.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 6A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 12 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	116.9
95% Confidence Interval	( 33.28 to 410.33 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 7F: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Statistical Analysis 13 for Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Groups ^[1]	All groups
geometric mean fold rise ^[2]	24.6
95% Confidence Interval	( 11.30 to 53.42 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Additional serotype 19A: GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all participants with available data from both the prevaccination and postvaccination blood draws.
[2]	Other relevant estimation information:
	CIs for the GMRFs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

12. Secondary:

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5 [ Time Frame: Baseline (Visit 1), Day 28 (Visit 5) ]

Show Outcome Measure 12

13. Secondary:

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 [ Time Frame: Baseline (Visit 1), Day 7 (Visit 4) ]

Show Outcome Measure 13

14. Secondary:

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4 [ Time Frame: Baseline (Visit 1), Day 7 (Visit 4) ]

Show Outcome Measure 14

15. Secondary:

Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) [ Time Frame: Day 28 (Visit 5) ]

Show Outcome Measure 15

16. Secondary:

Show Outcome Measure 16

17. Secondary:

Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5) [ Time Frame: Day 28 (Visit 5) ]

Show Outcome Measure 17

18. Secondary:

Show Outcome Measure 18

19. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination [ Time Frame: Baseline up to 4 days after vaccination on Day 1 ]

Show Outcome Measure 19

20. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination [ Time Frame: Baseline up to 4 days after vaccination on Day 1 ]

Show Outcome Measure 20

Serious Adverse Events

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Other Adverse Events

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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
No text entered.

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

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00824850 History of Changes
Other Study ID Numbers:	6096A1-3016, B1851014
Study First Received:	January 16, 2009
Results First Received:	August 4, 2011
Last Updated:	October 5, 2011
Health Authority:	United States: Food and Drug Administration

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