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Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam

2014-08-27 03:12:31 | BioPortfolio

Summary

The purpose of the study is to evaluate the safety and reactogenicity of Synflorix™ (GSK 1024850A) given as a 3-dose primary immunization course when co-administered with Infanrix hexa™ vaccine at 2, 3 and 4 months of age in infants in Vietnam.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Pneumococcal Disease

Intervention

Synflorix™( GSK1024850A), Infanrix hexa™

Status

Not yet recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:31-0400

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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.

A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.

Infections with bacteria of the species STREPTOCOCCUS PNEUMONIAE.

An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)

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

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