ID
36101
Description
Study ID: 107007 Clinical Study ID: 107007 Study Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compared to Prevenar™, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00344318 https://clinicaltrials.gov/ct2/show/NCT00344318 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal conjugate vaccine GSK1024850A Trade Name: Prevenar, Tritanrix-HepB, Hiberix, Polio Sabin., Poliorix Study Indication: Infections, Streptococcal This study consists of 2 groups of probands (Children of 6-10-14 weeks or 2-4-6 months of age are included): One group receive a 3-dose primary vaccination with the GSK Biologicals' (10-valent) pneumococcal conjugate vaccine. The other group r eceive a 3-dose primary vaccination with Prevenar™. All probands receive DTPw-HBV/Hib and OPV or IPV vaccines. Ths study consists of 3 workbooks (WB): WB 1: The WB 1 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 1; Age for 10 weeks scheduled Visit 3, Timing: Month 2; Age for 14 weeks scheduled Visit 4, Timing: Month 3; Age for +/- 4 months scheduled Intervals between the visits: Visit 1 to Visit 2: 28-42 days, Visit 2 to Visit 3: 28-42 days, Visit 3 to Visit 4: 30-42 days WB 2: The WB 2 consists 4 visits (all in active phase): Visit 1, Timing: Month 0; Age for 6-12 weeks scheduled Visit 2, Timing: Month 2; Age for +/- 4 months scheduled Visit 3, Timing: Month 4; Age for +/- 6 months scheduled Visit 4, Timing: Month 5; Age for +/- 7 months scheduled Intervals between the visits: Visit 1 to Visit 2: 49-83 days, Visit 2 to Visit 3: 49-83 days, Visit 3 to Visit 4: 30-42 days WB 3: The WB 3 consists the phone contact (6 months safety follow-up), Timing: Month 8 or 10. This document contains the General medical history/ physical examination. Physical examination has to be filled in for WB 1 and WB 2 for each Visit (Visit 1-4). General medical history is mandatory for Visit 1 for both workbooks.
Link
https://clinicaltrials.gov/ct2/show/NCT00344318
Keywords
Versions (2)
- 4/9/19 4/9/19 -
- 4/15/19 4/15/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
April 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety, reactogenicity and immunogenicity 10-valent pneumococcal conjugate vaccine compared to Prevenar™, co-administration of DTPw-HBV/Hib and OPV or IPV vaccines in infants, NCT00344318
General medical history/ physical examination
- StudyEvent: ODM
Description
General Medical History/ Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
If you tick yes, please give diagnosis and tick appropriate Past/Current box(es).
Data type
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0037088
Description
MedDRA SYSTEM ORGAN CLASS
Data type
integer
Alias
- UMLS CUI [1]
- C2347091
Description
Please report medication(s) as specified in the protocol and fill in the Medication section.
Data type
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [2,1]
- C0031809
- UMLS CUI [2,2]
- C0011900
Description
Disease, signs and symptoms
Data type
integer
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C0449438
Similar models
General medical history/ physical examination
- StudyEvent: ODM
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0449438 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
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