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

REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).

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.

Study Overview

• Status: Completed
• Conditions: Invasive Pneumococcal Disease
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Procedure: Blood draw

Detailed Description

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iceland
  • Reykjavik, Iceland, 109
    • Midstod Heilsuverndar barna
  • Reykjavik
    • Hringbraut, Reykjavik, Iceland, 101
      • Landspitali University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single; All subjects will receive a single dose of 13vPnC	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); 0.5 mL intramuscular injection; Procedure: Blood draw; Collection of 10 mL of blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28
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.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 28
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.	Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination	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.	Day 28
Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination	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.	Day 1 through Day 4
Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination	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.	Day 1 through Day 4

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2009
• Primary Completion (Actual): December 16, 2009
• Study Completion (Actual): December 16, 2009

Study Registration Dates

• First Submitted: February 19, 2009
• First Submitted That Met QC Criteria: February 27, 2009
• First Posted (Estimate): March 2, 2009

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Immune response; pneumococcal conjugate vaccine; polysaccharide
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-3013; B1851012 (Other Identifier: Alias Study Number); 2008-006194-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.