Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine (REPLAY)

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00853749

First received: February 19, 2009

Last updated: December 16, 2010

Last verified: December 2010

History of Changes

Results First Received: December 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Invasive Pneumococcal Disease
Interventions:	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC) Procedure: Blood draw

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

PCV/23vPS/13vPnC

For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).

PCV/PCV/13vPnC

For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).

Participant Flow: Overall Study

	PCV/23vPS/13vPnC	PCV/PCV/13vPnC
STARTED	50	39
Vaccinated	50	39
COMPLETED	50	38
NOT COMPLETED	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
PCV/23vPS/13vPnC	For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
PCV/PCV/13vPnC	For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
Total	Total of all reporting groups

Baseline Measures

	PCV/23vPS/13vPnC	PCV/PCV/13vPnC	Total
Number of Participants [units: participants]	50	39	89
Age [units: years] Mean ± Standard Deviation	7.6 ± 0.2	7.6 ± 0.2	7.6 ± 0.2
Gender [units: Participants]
Female	25	20	45
Male	25	19	44

Outcome Measures

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1. Primary:

Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination [ Time Frame: Day 28 ]

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2. Primary:

Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination [ Time Frame: Day 28 ]

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3. Secondary:

Antibody Response Measured 1 Month After Vaccination (Avidity Assay) [ Time Frame: Day 28 ]

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4. Secondary:

Antibody Response Measured 1 Month After Vaccination (OPA) [ Time Frame: Day 28 ]

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5. Other Pre-specified:

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination [ Time Frame: Day 28 ]

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6. Other Pre-specified:

Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination [ Time Frame: Day 1 through Day 4 ]

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7. Other Pre-specified:

Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination [ Time Frame: Day 1 through Day 4 ]

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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
In protocol, primary analysis based on All Available Immunogenicity Population and later modified to Evaluable Immunogenicity Population in Statistical Analysis Plan based on subsequent similar studies and suitability for primary objective.

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
ClinicalTrials.gov Identifier:	NCT00853749 History of Changes
Other Study ID Numbers:	6096A1-3013, B1851012
Study First Received:	February 19, 2009
Results First Received:	December 16, 2010
Last Updated:	December 16, 2010
Health Authority:	Iceland: Ministry of Health and Social Security

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