Information:
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ID
33949
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
Keywords
Versions (2)
- 1/8/19 1/8/19 -
- 1/9/19 1/9/19 -
Copyright Holder
GSK group of companies
Uploaded on
January 9, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974
Visit 1: Eligibility Criteria, Consent Form
- StudyEvent: ODM
Similar models
Visit 1: Eligibility Criteria, Consent Form
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
CL Item
Visit 1 (1)
CL Item
Day 0 (1)
CL Item
Dose 1 (1)
Subject Number
Item
integer
Item
The following criteria should be checked at each visit subsequent to the first visit
integer
Code List
The following criteria should be checked at each visit subsequent to the first visit
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (1)
CL Item
Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (2)
CL Item
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 (3)
CL Item
Administration of immunoglobulins and/or any blood products during the study period (4)
Item
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
text
Code List
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
text
Code List
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
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
text
Code List
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
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
4. Administration of immunoglobulins and/or any blood products during the study period
text
Code List
4. Administration of immunoglobulins and/or any blood products during the study period
CL Item
Applicable (1)
CL Item
Not applicable (2)
Absolute Contraindications
Item
Absolute Contraindications
text
Item
1. Anaphylactic reaction following the administration of vaccine(s)
text
Code List
1. Anaphylactic reaction following the administration of vaccine(s)
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
text
Code List
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
CL Item
Applicable (1)
CL Item
Not applicable (2)
General Contraindications
Item
General Contraindications
text
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
text
Code List
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item Group
Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
The following adverse experiences associated with InfarixTM-IPV or PediacelTM combined vaccination constitute absolute contraindications to administration of these vaccines.
Item
The following adverse experiences associated with InfarixTM-IPV or PediacelTM combined vaccination constitute absolute contraindications to administration of these vaccines.
text
Item
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
text
Code List
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
CL Item
Applicable (1)
CL Item
Not applicable (2)
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
If any of the following events are known to have occurred, the decision to vaccinate further should be carefully considered:
text
Code List
If any of the following events are known to have occurred, the decision to vaccinate further should be carefully considered:
CL Item
Fever of ≥ 40.0°C (rectal t°) or ≥39.5°C (axillary t°) within 48 hours of vaccination not due to another identifiable cause (1)
CL Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination (2)
CL Item
Persistent inconsolable crying lasting ≥3 hours occurring within 48 hours of vaccination (3)
CL Item
Seizures with or without fever occurring within 3 days of vaccination (4)
CL Item
Hypersensitivity to any component of the vaccine including diphtheria toxoid. As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness (1)
I certify that Informed Consent has been obtained prior to any study procedure
Item
I certify that Informed Consent has been obtained prior to any study procedure
date
Center Number
Item
Center Number
integer
Date of birth
Item
Date of birth
date
CL Item
Male (M)
CL Item
Female (F)
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other (8)
If Other, please specify
Item
If Other, please specify
text
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
1. Parents/guardians of the subject can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) according to the investigator's opinion
Item
1. Parents/guardians of the subject can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) according to the investigator's opinion
boolean
2. A male or female between, and including, 6 to 12 weeks of age at the time of the first vaccination
Item
2. A male or female between, and including, 6 to 12 weeks of age at the time of the first vaccination
boolean
3. Written informed consent obtained from the parent or guardian of the subject
Item
3. Written informed consent obtained from the parent or guardian of the subject
boolean
4. Free of obvious health problems as established by medical history and clinical examination before entering into the study
Item
4. Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
5. Born after a gestation period between 36 and 42 weeks
Item
5. Born after a gestation period between 36 and 42 weeks
boolean
6. Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine) is accepted but not mandatory
Item
6. Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine) is accepted but not mandatory
boolean
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
Item
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period
boolean
2. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
Item
2. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
boolean
3. Planned administration/administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines (as per-country recommendations on immunization)
Item
3. Planned administration/administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines (as per-country recommendations on immunization)
boolean
4. History of Haemophilus influenzae type b and/or meningococcal serogroup C disease
Item
4. History of Haemophilus influenzae type b and/or meningococcal serogroup C disease
boolean
5. Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease
Item
5. Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease
boolean
6. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
Item
6. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
boolean
7. A family history of congenital or hereditary immunodeficiency
Item
7. A family history of congenital or hereditary immunodeficiency
boolean
8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
Item
8. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
boolean
9. Major congenital defects or serious chronic illness
Item
9. Major congenital defects or serious chronic illness
boolean
10. History of any neurologic disorders or seizures
Item
10. History of any neurologic disorders or seizures
boolean
11. Acute disease at the time of enrollment
Item
11. Acute disease at the time of enrollment
boolean
12. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
Item
12. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
boolean
Record Treatment Number
Item
Record Treatment Number
integer
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
Cutaneous
Item
Cutaneous
text
CL Item
Past (1)
CL Item
Current (2)
Eyes
Item
Eyes
text
CL Item
Past (1)
CL Item
Current (2)
Ears-Nose-Throat
Item
Ears-Nose-Throat
text
CL Item
Past (1)
CL Item
Current (2)
Cardiovascular
Item
Cardiovascular
text
CL Item
Past (1)
CL Item
Current (2)
Respiratory
Item
Respiratory
text
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal
text
CL Item
Past (1)
CL Item
Current (2)
Muskuloskeletal
Item
Muskuloskeletal
text
CL Item
Past (1)
CL Item
Current (2)
Neurological
Item
Neurological
text
CL Item
Past (1)
CL Item
Current (2)
Genitourinary
Item
Genitourinary
text
CL Item
Past (1)
CL Item
Current (2)
Haematology
Item
Haematology
text
CL Item
Past (1)
CL Item
Current (2)
Allergies
Item
Allergies
text
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
CL Item
Past (1)
CL Item
Current (2)
Other, specify
Item
Other, specify
text
CL Item
Past (1)
CL Item
Current (2)
Trade / Generic Name
Item
Trade / Generic Name
text
Dose Number
Item
Dose Number
integer
Estimated date of vaccine
Item
Estimated date of vaccine
date
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
Date sample taken
Item
Date sample taken
date
Date
Item
Date
date
Pre-Vaccination Temperature
Item
Pre-Vaccination Temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
CL Item
Hib-MenC Vaccine (1)
CL Item
MeningitecTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If replacement vial, please record the number
Item
If replacement vial, please record the number
integer
If wrong vial, please record the number
Item
If wrong vial, please record the number
text
CL Item
Right (1)
CL Item
Thigh (1)
CL Item
I.M (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
CL Item
InfanrixTM-IPV Vaccine (1)
CL Item
PediacelTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If replacement vial, please record the number
Item
If replacement vial, please record the number
integer
If wrong vial, please record the number
Item
If wrong vial, please record the number
integer
CL Item
Left (1)
CL Item
Thigh (1)
CL Item
I.M. (1)
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments
Item
Comments
text
Item
If vaccine not administered, choose ONE most appropriate reason
text
Code List
If vaccine not administered, choose ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
integer
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - Local Symptoms - Vaccine 2
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
medically attended visit?
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
CL Item
Fever (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Fever, record t°
Item
If Fever, record t°
float
Item
If Irritability / Fussiness, record intensity
text
Code List
If Irritability / Fussiness, record intensity
CL Item
none (1)
CL Item
mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
CL Item
none (1)
CL Item
mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
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