Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY) - REPLAY

• Conditions: Invasive pneumococcal disease; MedDRA version: 9.1Level: LLTClassification code 10061353Term: Pneumococcal infection

• Registration Number: EUCTR2008-006194-33-IS
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Fully vaccinated children who participated in the D139-P506 study and received a booster dose of either PPV23 or PCV per the original protocol
2. Subjects must be in good health as determined by medical history, physical examination and clinical judgment
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected hypersensitivity to any component of PCV7 or PCV13
2. History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site)
3. Any known or suspected disease or dysfunction of the immune system, including but not limited to:
• HIV infection
• Malignancy
• Receipt of immunosuppressive therapy
• Sickle cell hemoglobinopathy
• Diabetes
4. Concomitant vaccination during study period (see Concomitant Treatment)
5. Receipt of immune globulin within the past 3 months
6. Any major illness/condition that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in and completion of, the study, or could preclude the evaluation of the subject’s response
7. Receipt of either PPV23 or PCV7 since the completion of the D139-P506 study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified