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Diphtheria clinical trials

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NCT ID: NCT00453570 Completed - Tetanus Clinical Trials

Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

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

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

NCT ID: NCT00452686 Completed - Tetanus Clinical Trials

Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

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

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.

NCT ID: NCT00447525 Completed - Tetanus Clinical Trials

REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

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

Primary objective: To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children . Secondary objectives: - Additional immunogenicity assessments. - To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

NCT ID: NCT00432042 Completed - Hepatitis B Clinical Trials

Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Start date: January 12, 2007
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination. Secondary Objectives: - To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled. - To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.

NCT ID: NCT00412854 Completed - Tetanus Clinical Trials

Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

Start date: January 3, 2007
Phase: Phase 3
Study type: Interventional

This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.

NCT ID: NCT00406562 Completed - Tetanus Clinical Trials

Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.

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

This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.

NCT ID: NCT00404651 Completed - Hepatitis B Clinical Trials

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

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

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: - To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series - To assess the overall safety in each group one month after the third dose of the primary series.

NCT ID: NCT00401531 Completed - Hepatitis B Clinical Trials

Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

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

The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, according to the 2-4-6 month immunization schedule, following one dose of HB vaccine at birth. Primary Objective: To demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix™-Hexa in terms of seroprotection rates to HB and PRP, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with Prevnar® Secondary Objectives: Immunogenicity: To describe in each group the immunogenicity parameters to each vaccine component (for DTaP-IPV-HB-PRP~T and Infanrix™-Hexa) one month after the third dose of the primary series. Safety: To describe the overall safety after each injection.

NCT ID: NCT00385255 Completed - Tetanus Clinical Trials

Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

Start date: October 23, 2006
Phase: Phase 3
Study type: Interventional

The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.

NCT ID: NCT00379977 Completed - Tetanus Clinical Trials

Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

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

This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.