ID
35819
Descrição
Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other
Palavras-chave
Versões (3)
- 25/03/2019 25/03/2019 -
- 31/12/2019 31/12/2019 -
- 15/03/2021 15/03/2021 - Dr. rer. medic Philipp Neuhaus
Titular dos direitos
GSK group of companies
Transferido a
25 de março de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Hib-MenAC vaccine administered intramuscularly in infants at 6, 10 and 14 weeks of age - 104430
Visit 5 ( Month 7.5)
- StudyEvent: ODM
Descrição
ELIMINATION CRITERIA DURING THE STUDY
Descrição
If any become applicable during the study, it will not require withdrawal of the subject from the study but does determine a subject’s evaluability in the according-to-protocol (ATP) analysis
Tipo de dados
text
Descrição
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
Tipo de dados
boolean
Descrição
(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
Tipo de dados
boolean
Descrição
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose of vaccine(s) with the exception of OPV.
Tipo de dados
boolean
Descrição
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
Tipo de dados
boolean
Descrição
Administration of immunoglobulins and/or any blood products during the study period.
Tipo de dados
boolean
Descrição
Contraindications and precautions for further doses
Descrição
if any of these AEs occur during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE
Tipo de dados
text
Descrição
Anaphylactic reaction following the administration of vaccine(s).
Tipo de dados
boolean
Descrição
Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, HB, Hib or meningococcal vaccines.
Tipo de dados
boolean
Descrição
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Tipo de dados
boolean
Descrição
The following AEs constitute contraindications to administration of the study vaccines at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any adverse event
Tipo de dados
boolean
Descrição
The following AEs constitute contraindications to administration of the study vaccines at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any adverse event
Tipo de dados
boolean
Descrição
DEMOGRAPHICS
Descrição
Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
Tipo de dados
integer
Descrição
Birth date
Tipo de dados
date
Descrição
Gender
Tipo de dados
text
Descrição
Race
Tipo de dados
text
Descrição
Specify Other
Tipo de dados
text
Descrição
If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
Tipo de dados
boolean
Descrição
PRE-VACCINATION ASSESSMENT
Descrição
THROAT SWAB (for subject’s parents/guardians)
Descrição
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
Tipo de dados
boolean
Descrição
Informed Consent
Tipo de dados
boolean
Descrição
Informed Consent Date
Tipo de dados
date
Descrição
Has a throat swab been taken ?
Tipo de dados
boolean
Descrição
Date
Tipo de dados
date
Descrição
THROAT SWAB (for subject)
Descrição
VACCINE ADMINISTRATION
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Visit 5 ( Month 7.5)
- StudyEvent: ODM