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Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

2014-08-27 03:44:54 | BioPortfolio

Summary

This protocol posting deals with objectives & outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives & outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050 ) The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrolment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Study Design

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

Conditions

Haemophilus Influenzae Type b Disease

Intervention

Engerix-B, Infanrix™ hexa, Meningitec™, Infanrix™ IPV/HIB, Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta, NeisVac-C™

Location

GSK Investigational Site
Almería
Spain
04009

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:54-0400

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Medical and Biotech [MESH] Definitions

A type of H. influenzae isolated most frequently from biotype I. Prior to vaccine availability, it was a leading cause of childhood meningitis.

A species of HAEMOPHILUS found on the mucous membranes of humans and a variety of animals. The species is further divided into biotypes I through VIII.

BACTERIAL INFECTIONS of the nervous system caused by HAEMOPHILUS organisms, and marked by prominent inflammation of the meninges. HAEMOPHILUS INFLUENZAE TYPE B is the most common causative organism. The condition primarily affects children under 6 years of age but may occur in adults. Clinical manifestations include fever; nuchal rigidity; PHOTOPHOBIA; SEIZURES; HEARING LOSS, SENSORINEURAL; COMA; and cerebrovascular thrombosis. The organism tends to enter the central nervous system following infections of adjacent structures, including the middle ear (see also OTITIS MEDIA), sinuses, and pharynx. (From Menkes, Textbook of Child Neurology, 5th ed, pp396-7)

One of the Type II site-specific deoxyribonucleases (EC 3.1.21.4). It recognizes and cleaves the sequence A/AGCTT at the slash. HindIII is from Haemophilus influenzae R(d). Numerous isoschizomers have been identified. EC 3.1.21.-.

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.

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