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Study Evaluating Antibody Response of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children Previously Given PnC

2014-08-27 03:17:31 | BioPortfolio

Summary

This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Pneumococcal Vaccines

Intervention

13-valent pneumococcal conjugate vaccine

Location

Ancenis
France
44150

Status

Recruiting

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:31-0400

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Medical and Biotech [MESH] Definitions

A pneumococcal vaccine which 7 pneumococcal serotypes (6B, 14, 19F, 23F, 18C, 4, 9V), each conjugated individually to the outer membrane protein complex of NEISSERIA MENINGITIDIS.

Vaccines or candidate vaccines used to prevent infections with STREPTOCOCCUS PNEUMONIAE.

Vaccines or candidate vaccines containing antigenic polysaccharides from Haemophilus influenzae and designed to prevent infection. The vaccine can contain the polysaccharides alone or more frequently polysaccharides conjugated to carrier molecules. It is also seen as a combined vaccine with diphtheria-tetanus-pertussis vaccine.

Semisynthetic vaccines consisting of polysaccharide antigens from microorganisms attached to protein carrier molecules. The carrier protein is recognized by macrophages and T-cells thus enhancing immunity. Conjugate vaccines induce antibody formation in people not responsive to polysaccharide alone, induce higher levels of antibody, and show a booster response on repeated injection.

A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.

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