Description:

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on the microbiology results of the swab samples taken at Visits 1, 4, 5, 6, 7, 8, 9 and 10 (identical for all cohorts).

Keywords:
Versions (2) ▾
  1. 8/26/19
  2. 9/3/19
Copyright Holder:
GlaxoSmithKline
Uploaded on:

September 3, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed, and HIV-negative infants - NCT00829010

Swab Microbiology

  1. StudyEvent: ODM
    1. Swab Microbiology
Administrative data
Visit Type
Has a swab sample been collected and received?
Date of sample
Streptococcus pneumoniae
Microbiological result of Streptococcus pneumoniae
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 1)
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 2)
Please specify serotyping for each Streptococcus pneumoniae culture (Culture 3)
Has a quantitative count been performed?
Colony count result
Haemophilus influenzae
Microbiological result of Haemophilus influenzae
Please specify serotyping for each Haemophilus influenzae culture (Culture 1)
Please specify serotyping for each Haemophilus influenzae culture (Culture 2)
Please specify serotyping for each Haemophilus influenzae culture (Culture 3)
Has a quantitative count been performed?
Colony count result
Staphylococcus aureus
Microbiological result of Staphylococcus aureus
Other bacteria
Microbiological result of other bacteria
Moraxella catarrhalis detected?
Group A Streptococcus detected?
Normal flora detected?
Other bacteria detected?
Investigator's Signature