Clinical Trials About "Human Medicines European Public Assessment Report EPAR Prevenar" RSS

12:38 EST 20th November 2019 | BioPortfolio

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Showing "Human Medicines European Public Assessment Report EPAR Prevenar" Clinical Trials 1–25 of 21,000+

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Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time

The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants


Study Evaluating Prevenar Vaccine in Healthy Infants

To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.

This Study Will Evaluate the Immunogenicity, Reactogenicity and Safety of the Routine Infant Vaccines Pediarix®, Hiberix® and Prevenar 13® When Co-administered With GlaxoSmithKline (GSK) Biologicals' Liquid Human Rotavirus Vaccine (HRV) as Compared to

The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

Safety and Local Tolerability of Prevenar in Indian Children

This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children. Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. Prevenar has been marketed in India since June 2006. The Board of Health in India has gi...

Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. Primary Objectives: - To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. - To describe the post-dose 3 pertussis antibody responses. Secondary Objectives: - To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-...

Knowledge Assessment of Women About Pictograms Associated With the Danger of Medicines Taken During Pregnancy

Women's awareness about the danger of certain medicines taken during pregnancy presents a real public health issue. To enhance awareness and information for women and healthcare professionals, new pictograms " pregnant women " appeared on medication boxes, on October 16, 2017. These new pictograms can change women's perception of self-medication during pregnancy and of the danger of taking certain medicines for the unborn development. Furthermore, the investigators can wonder i...

Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

PENTA Fosamprenavir Study

Twice daily fosamprenavir, in combination with low dose ritonavir (FPV/RTV BID), is indicated for the treatment of HIV-infected adults, adolescents and children of 6 years of age and above for use in combination with other anti-HIV medicines. Safety data from two GlaxoSmithKline (GSK) clinical trials (APV29005 - involving twice-daily doses of FPV with or without RTV and APV20003 - with once daily dosing of FPV/RTV among 2-18 year olds) indicated that gastrointestinal events we...

Study Evaluating Prevenar in High-Risk Children

The purpose of this study is to estimate the local and systemic tolerability of Prevenar in children ages 2 to 5 years old in usual care settings.

Development of the Medicines Optimisation Assessment Tool

The purpose of this study is to develop a prediction-tool, the Medicines Optimisation Assessment Tool (MOAT), to assist hospital pharmacists identify patients at highest risk of preventable medication related problems (MRPs). This has the potential to permit pharmacists to identify and focus on the small number of patients (approximately 6%) who are likely to experience a significant MRP while in hospital.

Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media

The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.

Tuberculosis Treatment Shortening Trial

Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this study is to see if taking 4 months of TB medicines is as effective in curing some TB patients as taking 6 months of TB medicines. Study participants will include 758 human immunodeficiency virus (HIV)-non-i...

A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice

This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice. The results will be used for the "Periodic Safety Update Report", which is to be regularly sent to the European Medicines Agency (EMEA) and the responsible German Higher Federal Authority (BfArM).

Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®. Primary Objective: To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age. Secondary Objectives: - To describe the incidence rate of severe fever within four days post-vaccination - To describ...

Post-Marketing Study of the Safety of Prevenar (Pneumococcal Conjugate Vaccine, 7-valent)

To collect post-marketing information on the safety of Prevenar in Filipino patients

Enhanced Safety Surveillance of GlaxoSmithKline's (GSK's) Quadrivalent Seasonal Influenza Vaccines During the 2018/19 Influenza Season

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain). This study may help to inform decisions regarding future influenza vacci...

Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

European Multicentre Study of Human Spinal Cord Injury

Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures fo...

Study Evaluating Prevenar Immunogenicity in High Risk Children

To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.

Computerized Assessment for Patients With Cancer

This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.

Primary Vaccination Course in Children Receiving Pneumococcal Conjugate Vaccine GSK 1024850A or Prevenar™ and Hiberix™

The purposes of this study are: To demonstrate the immunogenicity in terms of antibody response following primary vaccination of Korean infants with the pneumococcal conjugate vaccine GSK 1024850A compared to Prevenar™ when co-administered with a Haemophilus influenzae type b (Hib) vaccine in children during the first 6 months of life. To evaluate the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vacc...

Evaluation of Novartis Access; a Non-communicable Disease (NCD) Access Initiative

Countries throughout the world are facing a growing non-communicable disease (NCD) burden. In developing countries, medicines to treat NCDs are often difficult to access or too expensive for many households. Novartis/Sandoz has recently launched Novartis Access, an initiative to subsidize a basket of NCD medicines sold to purchasers in program countries and delivered through the public and non-profit health sectors. This study will evaluate the impact of Novartis Access on the ...

Effectiveness of Pharmaceutical Care on Primary Care Patients With Uncontrolled Hypertension

This randomized clinical trial is a multicentre study conducted at 4 community-based pharmacies within the Brazilian public health service, which freely distributes standardized medicines. The group coordinator is located at the Universidade Federal do Rio Grande do Sul, a public university at Porto Alegre.

Effects of Infra- and Ultrasound on the Brain

Findings in neuroscientific research show that the environment one lives in has measurable effects on brain morphology and functioning. Human exposure to airborne infra- and ultrasound has been constantly increasing during the last decades. For instance, the European Renewable Energy Directive, established in 2009, lead to an increased use of wind turbines, generating infrasound. The EU Directive states that until 2020 a 20% of the EUs' total energy needs is to be generated wit...

European Compliance Study in Parkinson's Disease

In both symptomatic and asymptomatic disease, only about half of medicines are taken as prescribed1. Relatively little is known about how patients with Parkinson's disease take their medication. One of the challenges in the management of Parkinson's disease is the prevention and treatment of involuntary movements2,3 and wild fluctuations between being mobile and able to function against being slow, stiff and unable to move which recurs as a delayed (several years) effect of t...

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