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Safety, reactogenicity and immunogenicity Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines on children, NCT00344318 - Elimination criteria during the study, Contraindications

- 02-05-19 - 1 Formulier, 9 Itemgroepen, 33 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Elimination criteria, Contraindications to subsequent vaccination, Contraindications for DTPw-HBV/Hib vaccine, Precautions for DTPw-HBV/Hib vaccine, Contraindications for Polio Sabin (TM), Special warnings and special precautions for Polio sabin (TM), Contraindication and Precaution of Prevenar (TM), Contraindications and precautions to Poliorix (TM)
Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the Elimination criteria during the study and Contraindications form. It has to be filled in for WB 1 and WB 2 for each Visit. Note for Contraindications to subsequent vaccination: POLIO SABIN (Trademark): -POLIO SABIN (Trademark) is contra-indicated in subjects with known systemic hypersensitivity to neomycin or to any other component of the vaccine, but a history of contact dermatitis to neomycin is not a contra-indication. In general, POLIO SABIN (Trademark)(oral) should not be administered to subjects suffering from primary and secondary immunodeficiencies. For those persons it is recommended to use the enhanced inactivated polio vaccine (eIPV). However, according to the Expanded Programme on Immunization (EPI) recommendations symptomatic and asymptomatic infection with human immunodeficiency virus does not contra-indicate immunization with POLIO SABIN (Trademark) (oral). -Special warnings and special precautions for use: As with other vaccines, the administration of POLIO SABIN (Trademark)(oral) should be postponed in subjects suffering from acute severe febrile illness, or persistent diarrhea or vomiting. The presence of a minor infection, however, is not a contra-indication for immunization. Whenever POLIO SABIN (Trademark) (oral) is administered to an individual, it is good clinical practice to offer immunization to presumably susceptible close contacts (such as unvaccinated parents) at the same time because of the risk (although very small) of vaccine-contact paralytic poliomyelitis disease. Contacts of recent vaccinees should be advised to observe personal hygiene. In some populations and groups of vaccinees lower seroconversion rates have been observed. Due to various non-specific factors all three vaccines, viruses may not replicate optimally in the gut of susceptible subjects, even after three doses of the POLIO SABIN (Trademark) (oral). POLIO SABIN (Trademark) (oral) is recommended for epidemic control. It should be realized that the vaccine might not prevent or modify disease in those already infected with a wild type poliovirus. Diarrhea or vomiting (including gastrointestinal infections) may interfere with the replication ("take" rate) of the POLIO SABIN (Trademark) (oral). Care should be taken not to contaminate a multidose dropper with saliva of a vaccinee. Poliorix (Tradename): Poliorix (Tradename) should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration of inactivated polio vaccines. As with other vaccines, the administration of Poliorix (Tradename) should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, however, is not a contraindication. Precautions: • Poliorix (Tradename) contains traces of neomycin and polymyxin. The vaccine should be used with caution in patients with known hypersensitivity to one of these antibiotics. • Poliorix (Tradename) should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Prevenar (Trademark): Hypersensitivity to any component of the vaccine, including diphtheria toxoid. Precautions include moderate to severe illness, with or without fever is a reason to defer routine immunization with most vaccines’. The decision to delay vaccination depends on the severity and etiology of the underlying disease.

Vaccination against pneumonia and otitis media, NCT00466947 - Elimination criteria, warnings and precautions, contraindication

- 05-12-18 - 1 Formulier, 7 Itemgroepen, 21 Data-elementen, 1 Taal
Itemgroepen: Administrative data, ELIMINATION CRITERIA DURING THE STUDY, WARNINGS AND PRECAUTIONS, Precautions specific to Diphteria, Tetanus and Pertussis (DTPa) vaccine administration, CONTRAINDICATIONS TO SUBSEQUENT VACCINATION, Absolute contraindication to administration of DTPa-HBV-IPV/Hib or DTPa-IPV/Hib, EXCLUSION CRITERIA FOR FURTHER STUDY PARTICIPATION
Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains information about general study notes which includes Elimination criteria, warnings and precautions and contraindications. It's for all workbooks.

Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020 - Contraindications to Subsequent Vaccination

- 22-11-18 - 1 Formulier, 3 Itemgroepen, 3 Data-elementen, 1 Taal
Itemgroepen: Note, Contraindications to Subsequent Vaccination, Precautions for Vaccination
Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

Precaution (EHR Archetype) - openEHR-EHR-EVALUATION.precaution.v1

- 08-07-17 - 1 Formulier, 1 Itemgroep, 13 Data-elementen, 2 Talen
Itemgroep: openEHR-EHR-EVALUATION.precaution.v1.xml
Use to record a condition or state of the individual that is clinically significant and unique or idiosyncratic for this individual, and which are considered vital information when making treatment decisions. This archetype should be regarded as a critical archetype by any clinical decision support system testing for any relevant therapeutic precautions as a clinician commences a new clinical intervention for an individual. Examples of conditions that warrant creation of a precaution include, but are not limited to: - Immunosuppressed/on immunosuppressive therapy – linked to medication order for chemo or steroids; or diagnosis of leukaemia; - Renal failure – linked to renal function tests and/or a formal diagnosis of renal failure; - Waiting for organ transplant; - Undergoing a regular treatment such as radiation therapy or dialysis; - Transplanted organ or metal implant in situ; - Ongoing investigation or follow up of suspected or verified malignant disease; - Participation in a pharmacological trial; or - Using anticoagulant treatment.

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