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Pertussis clinical trials

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NCT ID: NCT00467519 Completed - Tetanus Clinical Trials

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

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

Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Primary Objective: - To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. Secondary/Observational Objectives: - To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years. - To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up. - To describe the safety profile following vaccine administration.

NCT ID: NCT00457249 Completed - Tetanus Clinical Trials

A Trial to Evaluate the Safety and Immunogenicity of ADACEL® Vaccine in Persons 65 Years of Age and Older

Start date: March 2007
Phase: Phase 4
Study type: Interventional

It is well recognized that older adults can contract pertussis, suffer its complications, and unwittingly transmit it to close contacts, which may well include infants too young to have received their primary series of DTaP vaccinations. ADACEL® vaccine is currently licensed in the US for persons 11 - 64 years of age, but no pertussis vaccine is yet approved for administration to older adults. The most widely used Td vaccine in the US, DECAVAC®, has no upper limit on its age indication. The purpose of this trial is to describe the safety and immunogenicity of ADACEL® vaccine among individuals ≥ 65 years of age.

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: 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: 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: NCT00362427 Completed - Hepatitis B Clinical Trials

Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

Start date: August 2006
Phase: Phase 2
Study type: Interventional

PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3. Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar® Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

NCT ID: NCT00362336 Completed - Hepatitis B Clinical Trials

Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV

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

The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth. The secondary Objectives are: To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. To describe Immunogenicity after the primary series and prior to and after a booster vaccination.

NCT ID: NCT00355121 Completed - Tetanus Clinical Trials

Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

Start date: October 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

NCT ID: NCT00348881 Completed - Influenza Clinical Trials

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

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

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.