Clinical Trials About "A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine" RSS

04:42 EDT 19th September 2018 | BioPortfolio

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Showing "Study Evaluate Safety Immunogenicity Novel Oral Polio Vaccine" Clinical Trials 1–25 of 38,000+

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Immunogenicity of Co-administered Oral Polio Vaccine and Oral Cholera Vaccine

Concomitant administration of multiple vaccines, including live attenuated immunizations, is safe and effective. Some restrictions apply for live vaccines; administering a live-virus vaccine within 4 weeks after administration of another live-virus vaccine can decrease immunogenicity to the second administered vaccine. Thus, it is recommended that live-virus vaccines should be administered the same day or ≥4 weeks apart. Data on co-administration of the currently available wh...

A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine

This will be a single center, age de-escalation, partly-blinded, randomized study. The trial will be performed with the participation of 100 healthy children age 1-5 years who have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old infants to groups will be perform...

A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children

Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-contain...

Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine

Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.

Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants

In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the inves...

Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants

The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.

Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa

The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.

Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of African Sub-Saharan infants with pneumococcal conjugate vaccine GSK 1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and oral polio vaccine in children during the first 4 months of life.

Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

This phase 3b study will compare the immunogenicity and reactogenicity of the dTpa-IPV vaccine to that of a DTPa-IPV vaccine when administered as a booster dose in healthy children 5-6 years of age who have received three primary vaccination doses of DTPa-based vaccine according to the "3-5-11" month schedule recommended in Italy. In this study, MMRV vaccine will also be co-administered to all children.

Immunogenicity and Safety of Adacel Polio Vaccine

The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan. Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.

A Clinical Study Comparing Safety and Immunogenicity of Bivalent Oral Polio Vaccine (bOPV) of Bilthoven Biologicals (BBio) With a Licensed bOPV

Bilthoven Biologicals has developed a new bivalent oral polio vaccine (bOPV) containing World Health Organization (WHO) approved Sabin strains of poliovirus type 1 and type 3. This study will assess non-inferiority of bOPV manufactured by BBio to that of licensed bOPV. This study will also assess lot-to-lot consistency among three lots of BBio bOPV.

A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).

Immunogenicity and Safety of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given as a Booster at Age 15-18 Months

This is a phase III assessing the safety and immunogenicity of adjuvanted the reduced dose inactivated polio vaccine, IPV-Al SSI given as a booster vaccination to infants who were previously immunised with primary vaccination of IPV-Al SSI or IPV SSI in the VIPV-07 trial at age 2, 4, and 6 months. The IPV-Al SSI vaccine will be given at the age of 15-18 months.

Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh

Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breastmilk antibodies, changes in gut microbiota, and gene...

A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania

A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.

Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly

The purpose of this study is to investigate the use of a fourth fractional booster dose of sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster dose between 15 to 18 months of age, in terms of immunogenicity and safety. Objectives: - To describe in each group the immunogenicity of IMOVAX Polio administered intradermally or intramuscularly, one month after the booster dose given at 15-18 months of age in toddlers prev...

A Study Comparing LBVD to Eupenta and Imovax Polio in Healthy Adults

This is a single-center, randomized, active-controlled, parallel-group, open-label, phase I study to evaluate safety and immunogenicity of single injection of LBVD or Eupenta co-administered with Imovax Polio in healthy adults.

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

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...

A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.

Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

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.

Immunogenicity and Safety of Tetraxim Versus Local DTP + IPV

The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTaP-IPV combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in South Korea. Primary objective To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response...

Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase IIIb study is designed to evaluate the safety and immunogenicity of co-administering Bo...

Phase 3 Study of BK1310 in Healthy Infants

The purpose of this study is to: - (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. - (cohort 2) evaluate efficacy of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as safety, in healthy infants.

Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen

This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals

The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

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