Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00824655

First received: January 16, 2009

Last updated: August 4, 2011

Last verified: August 2011

History of Changes

Results First Received: June 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Pneumococcal Vaccines
Intervention:	Biological: 13vPnC

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
Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.

Reporting Groups

	Description
13vPnC/13vPnC	Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
13vPnC	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.

Participant Flow for 3 periods

Period 1: Infant Series (5 Months of Age)

	13vPnC/13vPnC	13vPnC
STARTED	118	0
COMPLETED	118	0
NOT COMPLETED	0	0

Period 2: After Infant Dose (6 Months of Age)

	13vPnC/13vPnC	13vPnC
STARTED	118	0
COMPLETED	118	0
NOT COMPLETED	0	0

Period 3: Toddler Dose (12 Months of Age)

	13vPnC/13vPnC	13vPnC
STARTED	118	116
COMPLETED	116	116
NOT COMPLETED	2	0
Adverse Event	1	0
Parent/legal guardian request	1	0

Baseline Characteristics

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Reporting Groups

	Description
13vPnC/13vPnC	Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
13vPnC	Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Total	Total of all reporting groups

Baseline Measures

	13vPnC/13vPnC	13vPnC	Total
Number of Participants [units: participants]	118	116	234
Age [units: months] Mean ± Standard Deviation	5.1 ± 0.37	11.9 ± 0.52	8.5 ± 3.42
Gender, Customized [units: participants]
Female	50	60	110
Male	68	56	124

Outcome Measures

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1. Primary:

Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose (13 months of age) ]

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2. Secondary:

Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose [ Time Frame: 1 Month after the infant series (6 months of age) ]

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3. Secondary:

GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose [ Time Frame: 1 Month after the infant series (6 months of age) ]

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4. Secondary:

GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose [ Time Frame: 12 months of age (prior to toddler dose) ]

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5. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) [ Time Frame: Day 1 through Day 7 after vaccination ]

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6. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) [ Time Frame: Day 1 through Day 7 after vaccination ]

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7. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) [ Time Frame: Day 1 through 7 after vaccination ]

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8. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) [ Time Frame: Day 1 through 7 after vaccination ]

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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:	Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier:	NCT00824655 History of Changes
Other Study ID Numbers:	6096A1-3012
Study First Received:	January 16, 2009
Results First Received:	June 17, 2011
Last Updated:	August 4, 2011
Health Authority:	Sweden: Medical Products Agency Sweden: Regional Ethical Review Board

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