Elimination Criteria During The Study
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.
integer
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
text
(For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed)
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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
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4. Administration of immunoglobulins and/or any blood products during the study period
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Contraindications To Subsequent Vaccination
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.
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1. Anaphylactic reaction following the administration of vaccine(s)
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2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
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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during the study, the subject may be vaccinated at a later date within the time window specified in the protocol, or withdrawn at the dscretion of the investigator.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.
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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
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2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
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Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
If any of these adverse experiences occurred following previous vaccinations during the study, the subject should be withdrawn from the study
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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
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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)
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Precautions for Vaccination
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.
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As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness
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Informed Consent
Demographics
Center Number
integer
Date of birth
date
Gender
text
Race
text
If Other, please specify
text
Eligibility Check
Inclusion Criteria
Tick "Yes" if the subject fulfilled the criterion
boolean
Tick "Yes" if the subject fulfilled the criterion
boolean
Tick "Yes" if the subject fulfilled the criterion
boolean
Tick "Yes" if the subject fulfilled the criterion
boolean
Tick "Yes" if the subject fulfilled the criterion
boolean
Tick "Yes" if the subject fulfilled the criterion
boolean
Exclusion Criteria
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
(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
boolean
(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
boolean
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
boolean
Randomisation / Treatment Allocation
Physical Examination
If Yes, please tick appropriate box(es) and give diagnosis below
boolean
Diagnosis
text
Status
integer
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Diagnosis
text
Status
text
Vaccine History
Laboratory Tests - Blood
Vaccine Administration
Vaccine
Tick ONLY one box by vaccine
text
If replacement vial, please record the number
integer
If wrong vial, please record the number
text
according to Protocol
text
according to Protocol
text
according to Protocol
text
If No, please tick below all items that apply
boolean
Side
text
Site
text
Route
text
Vaccine 2
Tick ONLY one box by vaccine
text
If replacement vial, please record the number
integer
If wrong vial, please record the number
integer
According to protocol
text
According to protocol
text
According to protocol
text
If No, please tick below all items that apply
boolean
Side
text
Site
text
Route
text
Comments
text
Non-administration
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.
text
If Other, please specify
text
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
integer
Unsolicited Adverse Events
Solicited Adverse Events - Local Symptoms
Hib-MenC vaccine or MeningitecTM vaccine
integer
Day
integer
If Redness, record size
float
If Swelling, record size
float
If Pain, record Intensity
text
Ongoing after day 3?
boolean
Date of last day of symptoms
date
Medically attended visit?
boolean
If Yes, please record type
text
Solicited Adverse Events - Local Symptoms - Vaccine 2
InfanrixTM-IPV vaccine or PediacelTM vaccine
integer
Day
integer
If Redness, record size
float
If Swelling, record size
float
If Pain, record Intensity
integer
Ongoing after day 3?
boolean
Date of last day of symptoms
date
medically attended visit?
boolean
If Yes, please record type
text
Solicited Adverse Events
General Symptoms
Symptom
integer
Day
integer
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
float
If Irritability / Fussiness , record intensity
text
If Drowsiness, record intensity
integer
If Loss of appetite, record intensity
text
Ongoing after day 3?
boolean
Date of last day of symptoms
date
Causality
boolean
Medically attended visit?
boolean
If Yes, record the type
integer