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Polio clinical trials

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NCT ID: NCT00802867 Completed - Tetanus Clinical Trials

Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

Start date: February 2004
Phase: Phase 4
Study type: Interventional

Objectives: - To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine. - To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.

NCT ID: NCT00772928 Completed - Tetanus Clinical Trials

Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Start date: October 2003
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

NCT ID: NCT00772369 Completed - Tetanus Clinical Trials

Retrospective Survey of Safety of Fourth Dose Pentacel® in Children

Start date: September 2003
Phase: Phase 4
Study type: Observational

The purpose of this survey is to collect selected safety data. Primary Objective: To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.

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: 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.

NCT ID: NCT00514059 Completed - Tetanus Clinical Trials

Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine

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

An open clinical trial to study the immune response and safety after giving a booster dose (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy adolescents 15-16 Years of age. The first three doses were given during the first year of life, according to the Norwegian child immunization program. The fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old. In 2006 there was a change in the child immunization program in Norway: a fourth dose of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years old. This study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.

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: NCT00348387 Completed - Poliomyelitis Clinical Trials

Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

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

This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.