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Polio clinical trials

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NCT ID: NCT01579825 Completed - Polio Clinical Trials

Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh

Start date: April 2012
Phase: N/A
Study type: Interventional

Hypothesis: The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

NCT ID: NCT01559636 Completed - Diarrhea Clinical Trials

Diarrhea and Bivalent Oral Polio Vaccine Immunity

Start date: August 2012
Phase: N/A
Study type: Interventional

Global eradication of poliomyelitis has proven to be elusive. Although 99% of cases have been eliminated since 1988, outbreaks continue to occur, and new tools are needed to accelerate eradication. One concern in this effort is that some populations have decreased immunogenicity to oral poliovirus vaccine (OPV). Past studies have shown decreased seroimmunity to trivalent OPV (tOPV) in children with diarrhea. In 2009, bivalent OPV (bOPV) was recommended for use in immunization campaigns, and will likely replace tOPV in routine immunization in 2016. However, the effect of diarrhea on seroconversion to bOPV has not been studied. This project evaluated the effect of diarrhea on seroconversion to bOPV among infants who reside in Nepal. The investigators conducted a prospective, interventional study that assessed immune response to bOPV among infants with and without diarrhea. Immune responses were compared among infants with and without diarrhea. This study will result in a better understanding of the factors that decrease the ability of some children to seroconvert to OPV and be protected from poliomyelitis infection.

NCT ID: NCT01491087 Completed - Tetanus Clinical Trials

Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China

Start date: December 2011
Phase: Phase 4
Study type: Interventional

The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces. Primary Objective - To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.

NCT ID: NCT01475539 Completed - Poliomyelitis Clinical Trials

Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine

Start date: November 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to generate data to support the registration extension of IMOVAX Polio to be used in a sequential vaccination. Primary objective: - To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2) poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of seroprotection rate 28 to 42 days after the third dose of the primary vaccination series. Secondary objectives: - To evaluate the safety profile of the investigational vaccines after each administration in each group. - To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3) before the first dose and 28 to 42 days after the third primary series dose of vaccine in each group. - To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and 3) after the third primary series dose administration, at 18 months of age in each group.

NCT ID: NCT01389687 Completed - Poliomyelitis Clinical Trials

Study of SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan

Start date: July 2011
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months. Primary objective: - To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV). Secondary objective: - To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination. - To describe the safety after each dose of IPV.

NCT ID: NCT01346293 Completed - Tetanus Clinical Trials

Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

Start date: April 2011
Phase: Phase 3
Study type: Interventional

The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only. Primary Objectives: - To compare the pertussis [Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay [ELISA]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose. - To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose . - To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. Observational Objectives: - To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations. - To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.

NCT ID: NCT01278433 Completed - Poliomyelitis Clinical Trials

A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China. Objective: To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.

NCT ID: NCT01244464 Completed - Poliomyelitis Clinical Trials

A Study of the Safety of IMOVAX Polio™ in China

Start date: November 2010
Phase: Phase 4
Study type: Interventional

This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China. Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.

NCT ID: NCT00932269 Active, not recruiting - Hepatitis B Clinical Trials

Seroimmunity 2007 and Sub Study of the Swedish Population Regarding Vaccine Preventable Disease

Sero 2007
Start date: March 2007
Phase: Phase 0
Study type: Observational

This is a randomized cross-sectional study of the Swedish population. Blood samples will be collected from a subpopulation in order to estimate the age specific sero-prevalence of the Swedish population for diseases included in the National Immunization Program (NIP), and to affirm the population's protection against polio. To be able to recommend complementary immunizations to immigrated children, a sub study focusing on foreign born teenagers will also be done and compared to children of the same age born in Sweden.

NCT ID: NCT00855855 Completed - Tetanus Clinical Trials

Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Start date: February 2009
Phase:
Study type: Observational

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.