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. 1/11/19
  2. 10/30/19
Copyright Holder:
GSK group of companies
Uploaded on:

October 30, 2019

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056

Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

Administrative data
Temperature Log
Type of measurement
°C
If the event matches the definition of fever, please record whether is was connected to the investigational product
Was the visit medically attended?
If yes, record the type of medical involvement
Reminder
Rash / Exanthem
Has any rash / exanthem event occurred?
Rash Event Log
Did rash occur at administration site of vaccine or non-administration site?
If administration site, please record the vaccine
If non-administration site, please record the site
Rash intensity
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Outcome
Was the visit medically attended?
Please specify the type:
Parotid/Salivary Gland Swelling Events
Intensity
Was saliva sample taken for mumps virus detection, strain identification and for viral culture?
Is there a reasonable possibility that the AE hay have been caused by the investigational product?
Outcome
Was the visit medically attended?
Please specify the type:
Febrile Convulsions - Suspected Signs of Meningitis
Intensity
Was a neurological examination performed?
If Yes, was a lumbar puncture performed?
Is there a reasonable possibility that the AE hay have been caused by the investigational product?
Outcome
Was the visit medically attended?
Please specify the type:
Concomitant Vaccination
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Concomitant Vaccination Details
Route
Concomitant Medications
Have any medications / treatments been administered during the study period?
Concomitant Medications Details
Was the administration prophylactic?
Route
Is the event continuing?
Non-Serious Adverse Events
Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
Non-Serious Adverse Events Log
Was the Adverse Event at the administration site?
Please record the vaccine
Intensity
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Outcome
Medically attended visit
If Yes, please specify type