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Poliomyelitis clinical trials

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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: NCT00611559 Completed - Hepatitis B Clinical Trials

Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

Start date: February 14, 2008
Phase: Phase 4
Study type: Interventional

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

NCT ID: NCT00604058 Completed - Poliomyelitis Clinical Trials

Immunogenicity and Safety of Fractional Doses of IPV Intradermally vs Full Doses Intramuscularly

Start date: January 2008
Phase: Phase 2
Study type: Interventional

The present study intends to investigate the use of fractional doses of sanofi pasteur's IMOVAX Polio injected intradermally. The primary objective will be to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly, in terms of seroprotection rates (polio types 1, 2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.

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: NCT00514033 Completed - Poliomyelitis Clinical Trials

A Post-marketing Safety Study of GSK Bio IPV Vaccine (PoliorixTM) in Korean Children

Start date: July 2007
Phase: N/A
Study type: Observational

Following licensing of PoliorixTM in Korea, this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration (KFDA).

NCT ID: NCT00463437 Completed - Hepatitis B Clinical Trials

Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

Start date: April 25, 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. 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 = NCT00334334).

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: 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®