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Diphtheria clinical trials

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NCT ID: NCT00753649 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants

Start date: September 23, 2008
Phase: Phase 4
Study type: Interventional

This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in Canada.

NCT ID: NCT00712959 Completed - Tetanus Clinical Trials

Immune Responses in Adults to Revaccination With ADACEL® 10 Years After a Previous Dose

Start date: June 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to collect additional immunogenicity and safety data on re-dosing with Tdap vaccine (ADACEL®) in a continuing effort to address the public health need to establish broader population immunity against pertussis, as well as diphtheria and tetanus. Primary Objective: - To assess immune response to Tdap vaccine (ADACEL®) one month after booster vaccination.

NCT ID: NCT00707148 Completed - Tetanus Clinical Trials

Pertussis Vaccine in Healthy Pregnant Women

Start date: January 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.

NCT ID: NCT00696423 Completed - Tetanus Clinical Trials

Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

Start date: June 7, 2008
Phase: Phase 3
Study type: Interventional

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.

NCT ID: NCT00674908 Completed - Hepatitis B Clinical Trials

Phase IV Interchangeability Study of a Liquid Pentavalent Combination Vaccine

Start date: March 2008
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.

NCT ID: NCT00662870 Completed - Tetanus Clinical Trials

Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

Start date: May 2001
Phase: Phase 3
Study type: Interventional

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

NCT ID: NCT00654901 Completed - Hepatitis B Clinical Trials

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

Start date: March 2008
Phase: Phase 3
Study type: Interventional

This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity - To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™. - To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects. Safety - To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.

NCT ID: NCT00635128 Completed - Tetanus Clinical Trials

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

Start date: February 1, 2008
Phase: Phase 4
Study type: Interventional

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

NCT ID: NCT00627458 Completed - Hepatitis B Clinical Trials

Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

Start date: February 1, 2008
Phase: Phase 2
Study type: Interventional

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

NCT ID: NCT00619502 Completed - Hepatitis B Clinical Trials

Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

Start date: December 2007
Phase: Phase 3
Study type: Interventional

This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity - To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®. - To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T. Safety - To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.