Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

NCT00853749 | Completed Phase 3 Results

• 3 other identifiers: 6096A1-3013B18510122008-006194-33
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

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.

Conditions

Invasive Pneumococcal Disease

Keywords

Immune response; pneumococcal conjugate vaccine; polysaccharide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Antibody Response Measured 1 Month After Vaccination (Avidity Assay)

  Day 28

• Antibody Response Measured 1 Month After Vaccination (OPA)

  Day 28

Other Outcomes (3)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination

  Day 28

• Percentage of Participants Reporting Prespecified Local Reactions Within 4 Days of Vaccination

  Day 1 through Day 4

• Percentage of Participants Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination

  Day 1 through Day 4

Study Arms (1)

Single

OTHER

All subjects will receive a single dose of 13vPnC

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Procedure: Blood draw

Interventions

13-valent pneumococcal conjugate vaccine (13vPnC) BIOLOGICAL

0.5 mL intramuscular injection

Single

Blood draw PROCEDURE

Collection of 10 mL of blood

Single

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead
• Pfizer: collaborator

Study Sites (2)

Landspitali University Hospital

Hringbraut, Reykjavik, 101, Iceland

Location

Midstod Heilsuverndar barna

Reykjavik, 109, Iceland

Location

Related Publications (1)

• 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.

  PMID: 24300594 DERIVED

Related Links

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

Primary analysis based on evaluable immunogenicity population as per analysis plan change.Data for a participant reported in PCV/23vPS/13vPnC instead of PCV/PCV/13vPnC due to data entry error on case report form;this did not affect result conclusion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: March 2, 2009
• Study Start: May 5, 2009
• Primary Completion: December 16, 2009
• Study Completion: December 16, 2009
• Last Updated: November 11, 2021
• Results First Posted: January 5, 2011

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

IC (2)