Topics

Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine

2014-07-24 14:18:08 | BioPortfolio

Summary

The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:

A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.

Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Active Immunization

Intervention

DTaP-IPV vero vaccine, DTaP-IPV mkc vaccine

Location

Centre Bydgoszcz
Bydgoszcz
Poland

Status

Completed

Source

Statens Serum Institut

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:18:08-0400

Clinical Trials [4019 Associated Clinical Trials listed on BioPortfolio]

Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

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 ob...

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP HB PRP~T Combined Vaccine in Filipino Infants

DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and ...

Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants

Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced incidence ...

Immune Response & Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccine

"The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate non-inferio...

Evaluation of the Safety and Immunogenicity of Simultaneously Administration of sIPV and DTaP

Subjects will be recruited and divided into 3 groups:(1)combined immunization of Sabin-IPV and DTaP, (2) Sabin-IPV only and (3) DTaP only. After finishing the two basic vaccine EPI proced...

PubMed Articles [6415 Associated PubMed Articles listed on BioPortfolio]

A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration.

In many countries, a second dose of a combined measles, mumps, and rubella (MMR) vaccine is recommended at 4-6 years of age - similarly to the booster of diphtheria, tetanus, acellular pertussis, and...

Duration of Immunity and Effectiveness of Diphtheria-Tetanus-Acellular Pertussis Vaccines in Children.

The United States has experienced a nationwide resurgence of pertussis since the mid-1970s, despite high estimated vaccine coverage. Short-lived immunity induced by diphtheria-tetanus-acellular pertus...

Quantitative determination of bioactive proteins in diphtheria tetanus acellular pertussis (DTaP) vaccine by liquid chromatography tandem mass spectrometry.

A liquid chromatography tandem mass spectrometry method (LC-MS/MS) was developed to determine simultaneously the bioactive proteins including pertussis toxin (PT) subunits, filamentous hemagglutinin (...

Vaccine non-receipt and refusal in Ethiopia: The expanded program on immunization coverage survey, 2012.

Rates of full childhood immunization in Ethiopia are well below the WHO global goal of 90% coverage by 2020. This study explores associations between sociodemographic characteristics and healthcare se...

Forecasting Demand for the Typhoid Conjugate Vaccine in Low- and Middle-income Countries.

The World Health Organization (WHO) released a position paper in March 2018 calling for integration of a novel typhoid conjugate vaccine (TCV) into routine immunization along with catch-up campaigns f...

Medical and Biotech [MESH] Definitions

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had mumps or been immunized with live mumps vaccine. Children are usually immunized with measles-mumps-rubella combination vaccine.

A live attenuated virus vaccine of chick embryo origin, used for routine immunization of children and for immunization of adolescents and adults who have not had measles or been immunized with live measles vaccine and have no serum antibodies against measles. Children are usually immunized with measles-mumps-rubella combination vaccine. (From Dorland, 28th ed)

A bacterial vaccine for the prevention of brucellosis in man and animal. Brucella abortus vaccine is used for the immunization of cattle, sheep, and goats.

Active immunization where vaccine is administered for therapeutic or preventive purposes. This can include administration of immunopotentiating agents such as BCG vaccine and Corynebacterium parvum as well as biological response modifiers such as interferons, interleukins, and colony-stimulating factors in order to directly stimulate the immune system.

A live attenuated virus vaccine of duck embryo or human diploid cell tissue culture origin, used for routine immunization of children and for immunization of nonpregnant adolescent and adult females of childbearing age who are unimmunized and do not have serum antibodies to rubella. Children are usually immunized with measles-mumps-rubella combination vaccine. (Dorland, 28th ed)

More From BioPortfolio on "Safety and Immunogenicity of a New Serum-Free DTaP-IPVvero Combination Vaccine"

Quick Search

Relevant Topic

Vaccines
A vaccine is any preparation intended to produce immunity to a disease by stimulating the production of antibodies. It creates immunity but does not cause the disease. There are several differnt types of vaccine avalable; Killed microorganisms; which s...


Searches Linking to this Trial