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Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

2014-08-27 03:45:08 | BioPortfolio

Summary

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) - GSK Biologicals' Tritanrix™-HepB/Hiberix™

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Conditions

Diphtheria

Intervention

DTPw-HBV/Hib-MenAC conjugate vaccine

Location

GSK Investigational Site
Muntinlupa
Philippines
1781

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:45:08-0400

Clinical Trials [2116 Associated Clinical Trials listed on BioPortfolio]

Response to GSK Biologicals’ Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24...

Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™ ...

Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.

The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single inje...

Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study ...

Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants

"The purpose of this study is to compare the immune response, safety and reactogenicity of Tritanrix™-HepB/Hib-MenAC vaccine given either with or without a birth dose of hepatitis B vacc...

PubMed Articles [1778 Associated PubMed Articles listed on BioPortfolio]

Development of nanoparticle adjuvants to potentiate the immune response against diphtheria toxoid.

Over the years, diphtheria was known as contagious fatal infection caused by Corynebacterium diphtheria that affects upper respiratory system. The spread of diphtheria epidemic disease is best preven...

Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine.

Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55years of age. The aim of this study was to assess the safety of MenACWY-D administered as part of routine clin...

Sex-differential effects of diphtheria-tetanus-pertussis vaccine for the outcome of paediatric admissions? A hospital based observational study from Guinea-Bissau.

In spite of protection against the targeted infections, a large volume of observational data indicates that diphtheria-tetanus-pertussis (DTP) vaccine may have a negative impact on overall childhood m...

Late Onset of Injection Site Reactions After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Adult Study Populations.

Injection site reactions (ISRs; redness, swelling and pain) commonly occur within 1-2 days after vaccination. After administration of toxoid vaccines including diphtheria toxoid, a later onset of ISR...

Randomized Controlled Trial of the Safety and Immunogenicity of Revaccination With Tetanus-Diphtheria-Acellular Pertussis Vaccine (Tdap) in Adults 10 Years After a Previous Dose.

Reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap) vaccine is recommended in many countries for boosting immunity in adolescents and adults. Although immunity to these antigen...

Medical and Biotech [MESH] Definitions

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.

The formaldehyde-inactivated toxin of Corynebacterium diphtheriae. It is generally used in mixtures with TETANUS TOXOID and PERTUSSIS VACCINE; (DTP); or with tetanus toxoid alone (DT for pediatric use and Td, which contains 5- to 10-fold less diphtheria toxoid, for other use). Diphtheria toxoid is used for the prevention of diphtheria; DIPHTHERIA ANTITOXIN is for treatment.

A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)

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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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...


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