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

Primary Purpose

Invasive Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
Iceland
Study Type
Interventional
Intervention
13-valent pneumococcal conjugate vaccine (13vPnC)
Blood draw
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Invasive Pneumococcal Disease focused on measuring Immune response, pneumococcal conjugate vaccine, polysaccharide

Eligibility Criteria

5 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
  • Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Exclusion Criteria:

  • Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
  • History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
  • Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
  • Receipt of immune-globulin within the past 3 months.
  • Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.

Sites / Locations

  • Landspitali University Hospital
  • Midstod Heilsuverndar barna

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single

Arm Description

All subjects will receive a single dose of 13vPnC

Outcomes

Primary Outcome Measures

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
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Secondary Outcome Measures

Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Antibody Response Measured 1 Month After Vaccination (OPA)
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Full Information

First Posted
February 19, 2009
Last Updated
October 14, 2021
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00853749
Brief Title
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Acronym
REPLAY
Official Title
REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2009 (Actual)
Primary Completion Date
December 16, 2009 (Actual)
Study Completion Date
December 16, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Detailed Description
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Pneumococcal Disease
Keywords
Immune response, pneumococcal conjugate vaccine, polysaccharide

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Other
Arm Description
All subjects will receive a single dose of 13vPnC
Intervention Type
Biological
Intervention Name(s)
13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention Description
0.5 mL intramuscular injection
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
Collection of 10 mL of blood
Primary Outcome Measure Information:
Title
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
Description
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame
Day 28
Title
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Description
Percentage of participants achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Description
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Time Frame
Day 28
Title
Antibody Response Measured 1 Month After Vaccination (OPA)
Description
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Time Frame
Day 28
Other Pre-specified Outcome Measures:
Title
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
Description
Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all participants with available data for the specified blood draw.
Time Frame
Day 28
Title
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination
Description
Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category.
Time Frame
Day 1 through Day 4
Title
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
Description
Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Participants may have been represented in more than 1 category.
Time Frame
Day 1 through Day 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study. Subjects must be in good health as determined by medical history, physical examination and clinical judgment. Exclusion Criteria: Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC). History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site). Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy. Receipt of immune-globulin within the past 3 months. Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Landspitali University Hospital
City
Hringbraut
State/Province
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Facility Name
Midstod Heilsuverndar barna
City
Reykjavik
ZIP/Postal Code
109
Country
Iceland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
24300594
Citation
Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-3013&StudyName=Immune%20Response%20In%20Children%20Revaccinated%20With%20Pneumococcal%20Conjugate%20Vaccine
Description
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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

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