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Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

2014-08-27 03:16:51 | BioPortfolio

Summary

This study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Haemophilus Influenzae Type b (Hib) Infection

Intervention

Haemophilus influenzae type b (Hib) vaccine

Location

Hebei Province
China

Status

Not yet recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:51-0400

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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.

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.

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.-.

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