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 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

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  1. 1/10/19
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GSK group of companies
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January 10, 2019

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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 3 - Local Symptoms - Vaccine 1
Redness (Local Symptoms)
Swelling (Local Symptoms)
Pain (Local Symptoms)
Dose 3 - Local Symptoms - Vaccine 2
Redness (Local Symptoms)
Swelling (Local Symptoms)
Pain (Local Symptoms)
Dose 3 - Other Local Symptoms
Dose 3 - General Symptoms
Temperature (General Symptoms)
Irritability / Fussiness (General Symptoms)
Drowsiness (General Symptoms)
Loss of Appetite (General Symptoms)
Dose 3 - Other General Symptoms
Dose 3 - Medication