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 (1) ▾
  1. 1/10/19
Copyright Holder:
GSK group of companies
Uploaded on:

January 10, 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

Diary Cards for Dose 3 (Primary)

Administrative data
Dose Number
Dose 3 - Local Symptoms - Vaccine 1
Side of injection
Site of injection
Redness (Local Symptoms)
Day
mm
Is the symptom ongoing after day 3?
Was the visit medically attended?
Swelling (Local Symptoms)
Day
mm
Is the symptom ongoing after day 3?
Was the visit medically attended?
Pain (Local Symptoms)
Day
Intensity
Is the symptom ongoing after day 3?
Was the visit medically attended?
Dose 3 - Local Symptoms - Vaccine 2
Injection Side
Injection Site
Redness (Local Symptoms)
Day
mm
Is the symptom ongoing after day 3?
Was the visit medically attended?
Swelling (Local Symptoms)
Day
mm
Is the symptom ongoing after day 3?
Was the visit medically attended?
Pain (Local Symptoms)
Day
Intensity
Is the symptom ongoing after day 3?
Was the visit medically attended?
Dose 3 - Other Local Symptoms
Please record the intensity of a symptom
Is the symptom/event ongoing after day 3?
Was the visit medically attended?
Dose 3 - General Symptoms
Temperature (General Symptoms)
Day
°C
Type of temperature taking
Is the symptom ongoing after day 3?
Was the visit medically attended?
Irritability / Fussiness (General Symptoms)
Day
Intensity
Is the symptom ongoing after day 3?
Was the visit medically attended?
Drowsiness (General Symptoms)
Day
Intensity
Is the symptom ongoing after day 3?
Was the visit medically attended?
Loss of Appetite (General Symptoms)
Day
Intensity
Is the symptom ongoing after day 3?
Was the visit medically attended?
Dose 3 - Other General Symptoms
Intensity
End date
Is the symptom / event ongoing?
Was the visit medically attended?
Dose 3 - Medication
Is the medication treatment ongoing?
Reminder