Active clinical trials for "Poliomyelitis"

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines. Primary Objectives: To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses. To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™. Secondary Objectives: To describe in each group the immunogenicity parameters for all antigens for each vaccine To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of DTPa-HBV-IPV (Infanrix penta™) and Hib (Hiberix™) vaccine administered at 3, 5 and 11 (or 12) months of age.

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine. To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.

This study is an open-label phase III randomized clinical trial that would compare immunogenicity after receiving one of five different combinations of polio vaccines. Infants will be enrolled and randomized at 6 weeks of age to one of five different arms: A) Three doses of trivalent oral poliovirus vaccine (tOPV) at 6, 10 and 14 weeks of age B) Three doses of bivalent OPV (bOPV) at 6, 10 and 14 weeks of age C) Two doses of intramuscular (IM) inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age D) Two doses of intra-dermal (ID) fractional IPV (f-IPV) at 6 and 14 weeks of age E) Sequential administration of ID f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age To assess the immunogenicity of each study vaccine and vaccination schedule, antibody titers against poliovirus types 1, 2 and 3 will be determined in sera extracted from blood collected before (at 6 weeks of age) and after receiving 3 doses of study vaccine (18 weeks of age). Seroconversion will be defined as a titer 4-fold higher than the expected fall in maternally derived antibodies, assuming a half-life of 28 days. The initial antibody titer at 6 weeks of age will be used as the starting point for the expected decline in maternal antibody. This study will compare the immunogenicity of: Sequential dose of intra-dermal f-IPV and bOPV to bOPV alone administered at 6, 10 and 14 weeks of age tOPV to bOPV administered at 6,10 and 14 weeks of age IM IPV to ID f-IPV administered at 6 and 14 weeks of age The answer to these questions will guide the global polio eradication program in designing new routine immunization schedule for children that eliminates the risks of paralysis due to vaccine derived poliovirus (VDPV) from type 2 vaccine poliovirus.

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.

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.

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.

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.