ID
34015
Description
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
Mots-clés
Versions (1)
- 11/01/2019 11/01/2019 -
Détendeur de droits
GSK group of companies
Téléchargé le
11 janvier 2019
DOI
Pour une demande vous connecter.
Licence
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
Description
Elimination Criteria During The Study
Description
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.
Type de données
integer
Description
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Type de données
text
Description
(For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed)
Type de données
text
Description
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
Type de données
text
Description
4. Administration of immunoglobulins and/or any blood products during the study period
Type de données
text
Description
Contraindications To Subsequent Vaccination
Description
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.
Type de données
text
Description
1. Anaphylactic reaction following the administration of vaccine(s)
Type de données
text
Description
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
Type de données
text
Description
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.
Type de données
text
Description
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
Type de données
text
Description
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
Type de données
text
Description
Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
Description
If any of these adverse experiences occurred following previous vaccinations during the study, the subject should be withdrawn from the study
Type de données
text
Description
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
Type de données
text
Description
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)
Type de données
text
Description
Precautions for Vaccination
Description
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.
Type de données
text
Description
As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness
Type de données
text
Description
Informed Consent
Description
Demographics
Description
Center Number
Type de données
integer
Description
Date of birth
Type de données
date
Description
Gender
Type de données
text
Description
Race
Type de données
text
Description
If Other, please specify
Type de données
text
Description
Eligibility Check
Description
Inclusion Criteria
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Tick "Yes" if the subject fulfilled the criterion
Type de données
boolean
Description
Exclusion Criteria
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
(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
Type de données
boolean
Description
(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
Type de données
boolean
Description
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Type de données
boolean
Description
Randomisation / Treatment Allocation
Description
Physical Examination
Description
If Yes, please tick appropriate box(es) and give diagnosis below
Type de données
boolean
Description
Diagnosis
Type de données
text
Description
Status
Type de données
integer
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Diagnosis
Type de données
text
Description
Status
Type de données
text
Description
Vaccine History
Description
Please record any vaccine that has been administered since birth
Type de données
text
Description
Dose Number
Type de données
integer
Description
Please enter approximate date in case the exact date is unknown
Type de données
date
Description
Laboratory Tests - Blood
Description
Vaccine Administration
Description
Vaccine
Description
Tick ONLY one box by vaccine
Type de données
text
Description
If replacement vial, please record the number
Type de données
integer
Description
If wrong vial, please record the number
Type de données
text
Description
according to Protocol
Type de données
text
Description
according to Protocol
Type de données
text
Description
according to Protocol
Type de données
text
Description
If No, please tick below all items that apply
Type de données
boolean
Description
Side
Type de données
text
Description
Site
Type de données
text
Description
Route
Type de données
text
Description
Vaccine 2
Description
Tick ONLY one box by vaccine
Type de données
text
Description
If replacement vial, please record the number
Type de données
integer
Description
If wrong vial, please record the number
Type de données
integer
Description
According to protocol
Type de données
text
Description
According to protocol
Type de données
text
Description
According to protocol
Type de données
text
Description
If No, please tick below all items that apply
Type de données
boolean
Description
Side
Type de données
text
Description
Site
Type de données
text
Description
Route
Type de données
text
Description
Comments
Type de données
text
Description
Non-administration
Description
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.
Type de données
text
Description
If Other, please specify
Type de données
text
Description
If SAE, record the SAE number
Type de données
integer
Description
If non-SAE, please record the AE number
Type de données
integer
Description
Unsolicited Adverse Events
Description
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
Type de données
integer
Description
Solicited Adverse Events - Local Symptoms
Description
Hib-MenC vaccine or MeningitecTM vaccine
Type de données
integer
Description
Day
Type de données
integer
Description
If Redness, record size
Type de données
float
Unités de mesure
- mm
Description
If Swelling, record size
Type de données
float
Unités de mesure
- mm
Description
If Pain, record Intensity
Type de données
text
Description
Ongoing after day 3?
Type de données
boolean
Description
Date of last day of symptoms
Type de données
date
Description
Medically attended visit?
Type de données
boolean
Description
If Yes, please record type
Type de données
text
Description
Solicited Adverse Events - Local Symptoms - Vaccine 2
Description
InfanrixTM-IPV vaccine or PediacelTM vaccine
Type de données
integer
Description
Day
Type de données
integer
Description
If Redness, record size
Type de données
float
Unités de mesure
- mm
Description
If Swelling, record size
Type de données
float
Unités de mesure
- mm
Description
If Pain, record Intensity
Type de données
integer
Description
Ongoing after day 3?
Type de données
boolean
Description
Date of last day of symptoms
Type de données
date
Description
medically attended visit?
Type de données
boolean
Description
If Yes, please record type
Type de données
text
Description
Solicited Adverse Events
Description
General Symptoms
Description
Symptom
Type de données
integer
Description
Day
Type de données
integer
Description
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
Type de données
float
Unités de mesure
- °C
Description
If Irritability / Fussiness , record intensity
Type de données
text
Description
If Drowsiness, record intensity
Type de données
integer
Description
If Loss of appetite, record intensity
Type de données
text
Description
Ongoing after day 3?
Type de données
boolean
Description
Date of last day of symptoms
Type de données
date
Description
Causality
Type de données
boolean
Description
Medically attended visit?
Type de données
boolean
Description
If Yes, record the type
Type de données
integer
Similar models
Visit 5
- StudyEvent: ODM