Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00689351

First received: May 29, 2008

Last updated: June 24, 2011

Last verified: June 2011

History of Changes

Results First Received: December 10, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Caregiver, Investigator); Primary Purpose: Prevention
Condition:	Pneumococcal Vaccine
Interventions:	Biological: 13-valent pneumococcal conjugate vaccine Biological: 7-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
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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	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).

Participant Flow for 3 periods

Period 1: Infant Series of Dosing

	13vPnC	7vPnC
STARTED	91	89
Vaccinated Dose 1	88	89
Vaccinated Dose 2	86	88
Vaccinated Dose 3	85	88
COMPLETED	85	88
NOT COMPLETED	6	1
Parent/legal guardian request	5	0
Adverse Event	1	0
Lost to Follow-up	0	1

Period 2: After Infant Series

	13vPnC	7vPnC
STARTED	85	88
COMPLETED	84	88
NOT COMPLETED	1	0
Parent/legal guardian request	1	0

Period 3: Toddler Dose

	13vPnC	7vPnC
STARTED	84	88
COMPLETED	84	88
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
13vPnC	13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
7vPnC	7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
Total	Total of all reporting groups

Baseline Measures

	13vPnC	7vPnC	Total
Number of Participants [units: participants]	91	89	180
Age [units: months] Mean ± Standard Deviation	2.1 ± 0.3	2.1 ± 0.2	2.1 ± 0.2
Gender [units: participants]
Female	45	39	84
Male	46	50	96

Outcome Measures

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1. Primary:

Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

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2. Secondary:

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

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3. Other Pre-specified:

Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series [ Time Frame: 1 month after the infant series (7 months of age) ]

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4. Other Pre-specified:

Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose [ Time Frame: 1 month after the Toddler Dose (13 months of age) ]

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5. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

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6. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

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7. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

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8. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

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9. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) [ Time Frame: Within 4 days after dose 1 (2 months of age) ]

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10. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) [ Time Frame: Within 4 days after dose 2 (4 months of age) ]

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11. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) [ Time Frame: Within 4 days after dose 3 (6 months of age) ]

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12. Other Pre-specified:

Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) [ Time Frame: Within 4 days after toddler dose (12 months of age) ]

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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
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Results Point of Contact:

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Wyeth, Inc
ClinicalTrials.gov Identifier:	NCT00689351 History of Changes
Other Study ID Numbers:	6096A1-010, B1851001
Study First Received:	May 29, 2008
Results First Received:	December 10, 2010
Last Updated:	June 24, 2011
Health Authority:	Korea: Food and Drug Administration

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