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Tetanus clinical trials

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NCT ID: NCT00325143 Completed - Tetanus Clinical Trials

Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine

Start date: December 1, 2003
Phase: Phase 3
Study type: Interventional

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

NCT ID: NCT00325130 Completed - Tetanus Clinical Trials

Concomitant Use of Gardasil (V501) (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diphtheria, Tetanus, Pertussis Vaccine and Meningococcal Conjugate Vaccine in Adolescents (V501-025)

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

Data from this study are expected to demonstrate that V501 (Human Papillomavirus (HPV) [Types 6, 11, 16, 18] Recombinant Vaccine) , when administered concomitantly with a combined diphtheria, tetanus, pertussis (Tdap) vaccine and a meningococcal conjugate vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

NCT ID: NCT00320463 Completed - Hepatitis B Clinical Trials

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

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

In this study, infants will be randomly allocated into three groups: - one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) - the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) - the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

NCT ID: NCT00319852 Completed - Tetanus Clinical Trials

Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

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

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus commercially available Biken's DTaP (CJ purified PDT vaccine ™) and Aventis Pasteur's IPV (IMOVAX POLIO) monovalent vaccines, one month after the three-dose primary vaccination. Secondary objectives 1. Immunogenicity: To assess the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion / vaccine response rates to Pertussis antigens (PT, FHA) of Sanofi Pasteur's DTaP-IPV combined vaccine versus historical reference (Study E2I03294 - France). To assess and describe the immunogenicity of the study vaccines in both groups. 2. Safety: To assess and describe the safety of the study vaccines after each dose.

NCT ID: NCT00319553 Completed - Tetanus Clinical Trials

Post-licensure, Modified Double-blind, Multi-center Study Evaluating Safety and Immunogenicity of ADACEL® and BOOSTRIX®

Start date: May 2006
Phase: Phase 4
Study type: Interventional

This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.

NCT ID: NCT00317187 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: June 8, 2004
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: 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.