ID
34015
Descripción
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis
Palabras clave
Versiones (1)
- 11/1/19 11/1/19 -
Titular de derechos de autor
GSK group of companies
Subido en
11 de enero de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056
Visit 5
- StudyEvent: ODM
Descripción
Elimination Criteria During The Study
Descripción
If any of the criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.
Tipo de datos
integer
Descripción
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Tipo de datos
text
Descripción
(For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed)
Tipo de datos
text
Descripción
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
Tipo de datos
text
Descripción
4. Administration of immunoglobulins and/or any blood products during the study period
Tipo de datos
text
Descripción
Contraindications To Subsequent Vaccination
Descripción
The following adverse events (AEs) constitute ABSOLUTE contraindications to further administration of study vaccines; if any of these 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 datos
text
Descripción
1. Anaphylactic reaction following the administration of vaccine(s)
Tipo de datos
text
Descripción
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Tipo de datos
text
Descripción
The following AEs constitute contraindications to further administration of study vaccines; if any of these occur during the study, the subject may be vaccinated at a later date within the time window specified in the protocol, or withdrawn at the dscretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
Tipo de datos
text
Descripción
Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e Rectal temperature <38.0°C/Axillary temperature <37.5°C
Tipo de datos
text
Descripción
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
Tipo de datos
text
Descripción
Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
Descripción
If any of these adverse experiences occurred following previous vaccinations during the study, the subject should be withdrawn from the study
Tipo de datos
text
Descripción
1. Known hypersensitivity to any component of the vaccines. It should be noted that in the IPV component, trace levels of neomycin sulfate, streptomycin and polymyxin B may be present
Tipo de datos
text
Descripción
not due to another identifiable cause. This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination,, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given. The vaccination course can be continued with diphtheria-tetanus, hepatitis B, inactivated polio and Hi vaccines (the subject will be eliminated from the study)
Tipo de datos
text
Descripción
Precautions for Vaccination
Descripción
Administration of InfarixTM-IPV or PediacelTM should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is NOT a contraindication. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccines.
Tipo de datos
text
Descripción
As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness
Tipo de datos
text
Descripción
Informed Consent
Descripción
Demographics
Descripción
Center Number
Tipo de datos
integer
Descripción
Date of birth
Tipo de datos
date
Descripción
Gender
Tipo de datos
text
Descripción
Race
Tipo de datos
text
Descripción
If Other, please specify
Tipo de datos
text
Descripción
Eligibility Check
Descripción
Inclusion Criteria
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Tick "Yes" if the subject fulfilled the criterion
Tipo de datos
boolean
Descripción
Exclusion Criteria
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
(one episode of febrile convulsion does not constitute an exclusion criterion). Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
(Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Rectal t° <38°C/Axillary t° < 37.5°C) Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Tipo de datos
boolean
Descripción
Randomisation / Treatment Allocation
Descripción
Physical Examination
Descripción
If Yes, please tick appropriate box(es) and give diagnosis below
Tipo de datos
boolean
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
integer
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Diagnosis
Tipo de datos
text
Descripción
Status
Tipo de datos
text
Descripción
Vaccine History
Descripción
Laboratory Tests - Blood
Descripción
Vaccine Administration
Descripción
Vaccine
Descripción
Tick ONLY one box by vaccine
Tipo de datos
text
Descripción
If replacement vial, please record the number
Tipo de datos
integer
Descripción
If wrong vial, please record the number
Tipo de datos
text
Descripción
according to Protocol
Tipo de datos
text
Descripción
according to Protocol
Tipo de datos
text
Descripción
according to Protocol
Tipo de datos
text
Descripción
If No, please tick below all items that apply
Tipo de datos
boolean
Descripción
Side
Tipo de datos
text
Descripción
Site
Tipo de datos
text
Descripción
Route
Tipo de datos
text
Descripción
Vaccine 2
Descripción
Tick ONLY one box by vaccine
Tipo de datos
text
Descripción
If replacement vial, please record the number
Tipo de datos
integer
Descripción
If wrong vial, please record the number
Tipo de datos
integer
Descripción
According to protocol
Tipo de datos
text
Descripción
According to protocol
Tipo de datos
text
Descripción
According to protocol
Tipo de datos
text
Descripción
If No, please tick below all items that apply
Tipo de datos
boolean
Descripción
Side
Tipo de datos
text
Descripción
Site
Tipo de datos
text
Descripción
Route
Tipo de datos
text
Descripción
Comments
Tipo de datos
text
Descripción
Non-administration
Descripción
If any AE occurred during the immediate post-vaccination time (30 min) please fill in the Solicited AE section, the Non-SAE section or a SAE form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
Tipo de datos
text
Descripción
If Other, please specify
Tipo de datos
text
Descripción
If SAE, record the SAE number
Tipo de datos
integer
Descripción
If non-SAE, please record the AE number
Tipo de datos
integer
Descripción
Unsolicited Adverse Events
Descripción
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Tipo de datos
integer
Descripción
Solicited Adverse Events - Local Symptoms
Descripción
Hib-MenC vaccine or MeningitecTM vaccine
Tipo de datos
integer
Descripción
Day
Tipo de datos
integer
Descripción
If Redness, record size
Tipo de datos
float
Unidades de medida
- mm
Descripción
If Swelling, record size
Tipo de datos
float
Unidades de medida
- mm
Descripción
If Pain, record Intensity
Tipo de datos
text
Descripción
Ongoing after day 3?
Tipo de datos
boolean
Descripción
Date of last day of symptoms
Tipo de datos
date
Descripción
Medically attended visit?
Tipo de datos
boolean
Descripción
If Yes, please record type
Tipo de datos
text
Descripción
Solicited Adverse Events - Local Symptoms - Vaccine 2
Descripción
InfanrixTM-IPV vaccine or PediacelTM vaccine
Tipo de datos
integer
Descripción
Day
Tipo de datos
integer
Descripción
If Redness, record size
Tipo de datos
float
Unidades de medida
- mm
Descripción
If Swelling, record size
Tipo de datos
float
Unidades de medida
- mm
Descripción
If Pain, record Intensity
Tipo de datos
integer
Descripción
Ongoing after day 3?
Tipo de datos
boolean
Descripción
Date of last day of symptoms
Tipo de datos
date
Descripción
medically attended visit?
Tipo de datos
boolean
Descripción
If Yes, please record type
Tipo de datos
text
Descripción
Solicited Adverse Events
Descripción
General Symptoms
Descripción
Symptom
Tipo de datos
integer
Descripción
Day
Tipo de datos
integer
Descripción
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
Tipo de datos
float
Unidades de medida
- °C
Descripción
If Irritability / Fussiness , record intensity
Tipo de datos
text
Descripción
If Drowsiness, record intensity
Tipo de datos
integer
Descripción
If Loss of appetite, record intensity
Tipo de datos
text
Descripción
Ongoing after day 3?
Tipo de datos
boolean
Descripción
Date of last day of symptoms
Tipo de datos
date
Descripción
Causality
Tipo de datos
boolean
Descripción
Medically attended visit?
Tipo de datos
boolean
Descripción
If Yes, record the type
Tipo de datos
integer
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Visit 5
- StudyEvent: ODM