Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00546572

First received: October 18, 2007

Last updated: July 12, 2011

Last verified: July 2011

History of Changes

Results First Received: April 29, 2011

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:	Pneumococcal Infections
Interventions:	Biological: 13 valent Pneumococcal Conjugate Vaccine Biological: 23vPS

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 / 13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
23vPS / 13vPnC	23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)

Participant Flow for 2 periods

Period 1: Vax 1 / Year 0

	13vPnC / 13vPnC	23vPS / 13vPnC
STARTED	464	474
Received Vax 1	463	473
COMPLETED	391	404
NOT COMPLETED	73	70
Randomized, not treated	1	1
Withdrawal by Subject	3	2
Protocol Violation	3	4
Death	2	2
Adverse Event	0	1
Lost to Follow-up	0	1
6-Month Contact; withdraw before Vax 2	64	59

Period 2: Vax 2 / Year 1

	13vPnC / 13vPnC	23vPS / 13vPnC
STARTED	391	404
Received Vax 2	391	404
COMPLETED	387	402
NOT COMPLETED	4	2
Unspecified	1	1
Adverse Event	1	0
Vax 2; withdraw before 6-Month Contact	2	1

Baseline Characteristics

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Reporting Groups

	Description
13vPnC	13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
23vPS	23vPS 0.5 mL dose IM at Year 0 (Vax 1)
Total	Total of all reporting groups

Baseline Measures

	13vPnC	23vPS	Total
Number of Participants [units: participants]	463	473	936
Age [units: years] Mean ± Standard Deviation	76.7 ± 4.6	76.7 ± 4.5	76.7 ± 4.6
Gender [units: participants]
Female	221	235	456
Male	242	238	480

Outcome Measures

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1. Primary:

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0 ]

Show Outcome Measure 1

2. Primary:

Percentage of Participants Achieving a ≥ 4-fold Rise for Serotype 6A OPA Titer for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: Baseline, 1 month after Vax 1 / Year 0 ]

Show Outcome Measure 2

3. Secondary:

Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0 ]

Show Outcome Measure 3

4. Secondary:

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 13vPnC (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]

Show Outcome Measure 4

5. Secondary:

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]

Show Outcome Measure 5

6. Secondary:

Pneumococcal OPA Geometric Mean Titer (GMT) for Serotype 6A for 13vPnC / 13vPnC (Vax 2 / Year 1) Relative to 23vPS (Vax 1 / Year 0) [ Time Frame: 1 month after Vax 1 / Year 0, 1 month after Vax 2 / Year 1 ]

Show Outcome Measure 6

7. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) [ Time Frame: Days 1 through 14 / Year 0 ]

Show Outcome Measure 7

8. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

Show Outcome Measure 8

9. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

Show Outcome Measure 9

10. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1 ) [ Time Frame: Days 1 through 14 / Year 1 ]

Show Outcome Measure 10

11. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

Show Outcome Measure 11

12. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC and 23vPS (Vax 1 / Year 0) [ Time Frame: Days 1 through 14 / Year 0 ]

Show Outcome Measure 12

13. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

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Measure Type	Other Pre-specified
Measure Title	Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Measure Description	Systemic events reported using electronic diary. Fever scaled as Any (≥38 degrees Celsius [C]); Mild (≥38 but <38.5 degrees C); Moderate (≥38.5 but <39 degrees C); Severe (≥39 but ≤40 degrees C); Potentially life-threatening (>40 degrees C). Other systemic events include Fatigue, Headache, Chills, Rash, Vomiting, Decreased appetite, New generalized muscle pain (New muscle pain), Aggravated generalized muscle pain (Aggravated muscle pain), New generalized joint pain (New joint pain), and Aggravated generalized joint pain (Aggravated joint pain).
Time Frame	Days 1 through 14 / Year 0, Days 1 through 14 / Year 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.
Safety population; N=number of participants who reported any systemic reactogenicity events; (n)=number of participants with known values for 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1). Participants may be represented in more than 1 category.

Reporting Groups

	Description
13vPnC	13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
13vPnC / 13vPnC	13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)

Measured Values

	13vPnC	13vPnC / 13vPnC
Number of Participants Analyzed [units: participants]	259	259
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) [units: percentage of participants]
Fever: Any ≥38 degrees C (n=179, 179)	1.7	2.2
Fever: Mild ≥38 but <38.5 degrees C (n=179, 179)	1.7	0.6
Fever: Moderate ≥38.5 but <39 degrees C(n=177,177)	0.0	0.0
Fever: Severe ≥39 but ≤40 degrees C (n=177, 177)	0.0	0.6
Potentially life-threatening >40C (n=177, 177)	0.0	1.1
Fatigue (n=215, 215)	33.5	28.4
Headache (n=200, 200)	23.0	19.0
Chills (n=182, 182)	9.3	4.4
Rash (n=183, 183)	8.2	6.0
Vomiting (n=178, 178)	1.1	0.0
Decreased appetite (n=190, 190)	8.4	7.9
New muscle pain (n=219, 219)	37.9	35.6
Aggravated muscle pain (n=198, 198)	20.7	16.2
New joint pain (n=187, 187)	11.2	7.5
Aggravated joint pain (n=188, 188)	11.2	10.1

No statistical analysis provided for Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)

14. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 23vPS (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

Show Outcome Measure 14

15. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 1 ]

Show Outcome Measure 15

16. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination for 13vPnC (Vax / Year 0) and 23vPS / 13vPnC (Vax 2 / Year 1) [ Time Frame: Days 1 through 14 / Year 0, Days 1 through 14 / Year 1 ]

Show Outcome Measure 16

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: Wyeth 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
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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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00546572 History of Changes
Other Study ID Numbers:	6115A1-3005, B1851024
Study First Received:	October 18, 2007
Results First Received:	April 29, 2011
Last Updated:	July 12, 2011
Health Authority:	United States: Food and Drug Administration

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