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

Wyeth

Status and phase

Completed

Phase 3

Conditions

Invasive Pneumococcal Disease

Treatments

Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

Procedure: Blood draw

Study type

Interventional

Funder types

Industry

Identifiers

NCT00853749

B1851012

6096A1-3013

2008-006194-33 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

89 patients

Sex

All

Ages

5 to 7 years old

Volunteers

No 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.