Description:

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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Versions (1) ▾
  1. 6/21/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

June 21, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Booster Dose

  1. StudyEvent: ODM
    1. Booster Dose
Administrative Data
Unsolicited Adverse Events
Has the subject experienced any non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination or any serious/specific adverse events at any time post vaccination ?
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Hib-MenCY-TT vaccine
Hib-MenCY-TT vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - M-M-R® II Vaccine
M-M-R® II Vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Solicited Adverse Events - Local Symptoms - Hib-MenCY-TT group/Lic MenC group - Varivax® vaccine
Varivax® vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Adverse Events - Local Symptoms - ActHIB group - PedvaxHIB® vaccine
PedvaxHIB® vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Solicited Adverse Events - Local Symptoms - ActHIB group - M-M-R® II Vaccine
M-M-R® II Vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Solicited Adverse Events - Local Symptoms - ActHIB group - Varivax® vaccine
Varivax® vaccine
Local Symptoms
Day 0
Ongoing after day 3?
Medically attended visit
Solicited Adverse Events - General Symptoms
Has the subject experienced any of the following signs/symptoms during the solicited period ?
General Symptoms
Ongoing after day 3?
Causality
Medically attended visit
Fever
General rash/ exanthema
Parotid / salivary gland swelling
Febrile convulsions –suspected signs of meningism