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Haemophilus Influenzae Type B clinical trials

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NCT ID: NCT00317174 Completed - Hepatitis B Clinical Trials

A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

Start date: July 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is as follows: - To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects. - To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.

NCT ID: NCT00317161 Completed - Hepatitis B Clinical Trials

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

Start date: August 2004
Phase: Phase 3
Study type: Interventional

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 injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.

NCT ID: NCT00317135 Completed - Hepatitis B Clinical Trials

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

Start date: December 11, 2003
Phase: Phase 3
Study type: Interventional

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™.

NCT ID: NCT00316680 Terminated - Hepatitis B Clinical Trials

Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

Start date: March 2006
Phase: Phase 3
Study type: Interventional

A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

NCT ID: NCT00316147 Completed - Hepatitis B Clinical Trials

Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

Start date: December 2005
Phase: Phase 3
Study type: Interventional

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: - one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age - the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

NCT ID: NCT00313911 Completed - Hepatitis B Clinical Trials

Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

Start date: July 2006
Phase: Phase 3
Study type: Interventional

To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.

NCT ID: NCT00290303 Completed - Hepatitis B Clinical Trials

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

Start date: May 2004
Phase: Phase 3
Study type: Interventional

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 vaccine to Tritanrix™-HepB/Hiberix™ when given to healthy infants (born to mothers who do not carry hepatitis B virus) at 6, 10 & 14 weeks of age. This study will also include a small group of infants born to mothers who do carry hepatitis B virus; these infants will receive a birth dose of hepatitis B vaccine and will be vaccinated with Tritanrix™ HepB/Hib-MenAC at 6, 10 & 14 weeks age.

NCT ID: NCT00289783 Completed - Clinical trials for Haemophilus Influenzae Type b

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Start date: February 22, 2006
Phase: Phase 3
Study type: Interventional

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

NCT ID: NCT00287092 Completed - Tetanus Clinical Trials

Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

Start date: February 2006
Phase: Phase 3
Study type: Interventional

Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.