ELIMINATION CRITERIA DURING THE STUDY
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
text
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period.
boolean
(For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
boolean
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.
boolean
Administration of a meningococcal vaccine not foreseen by the study protocol during the entire study period.
boolean
Administration of immunoglobulins and/or any blood products during the study period.
boolean
Contraindications and precautions for further doses
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
text
Anaphylactic reaction following the administration of vaccine(s).
boolean
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.
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
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for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator.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
boolean
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for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol or withdrawn at the discretion of the investigator.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
boolean
DEMOGRAPHICS
Previous study : 759346/009 (DTPwHB/HIBMenACTT009)
integer
Birth date
date
Gender
text
Race
text
Specify Other
text
If Yes → Specify number of SAE’s : |__|__| and → Check SAE form(s) have been submitted to GSK Biologicals
boolean
PRE-VACCINATION ASSESSMENT
THROAT SWAB (for subject’s parents/guardians)
Will the throat swab be taken from the same person as at Visit 1, 2 or 4 ?
boolean
Informed Consent
boolean
Informed Consent Date
date
Has a throat swab been taken ?
boolean
Date
date
THROAT SWAB (for subject)
VACCINE ADMINISTRATION