Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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  1. 1/16/19
  2. 1/18/19
  3. 1/22/19
  4. 1/22/19
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January 22, 2019

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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

Visit 2 103812 (DTPW-HBV=HIB-MENAC-TT-014 BST:013&004 (15-18/24M) - Study Continuation; Date of Birth; Large swelling reaction; Concomitant vaccination

Check for Study Continuation
Did the subject return for visit 2?
If subject did not return for visit 2, please tick the ONE most appropriate reason and skip the following pages of this visit.
Please tick who took descision
Date of Birth
Large swelling reaction - Report of physical examination
Was the examination performed by a member of study personnel during the large swelling reaction period?
4. Type of swelling
6a. Temperature measurement site
6b. Redness
6c. Induration
6d. Pain at administration site
6d. Intensity of pain at administration site
6e. Functional impairment
6e. Intensity of Functional impairment
Large swelling reaction - Clinical case desciption and outcome of the adverse event
9. Outcome of the large swellling reaction:
10. Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
Concomitant Vaccination
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Concomitant Vaccination specification