ID
36104
Beskrivning
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 Vaccine Administration form. It has to be filled in for Visit 1-3.
Länk
https://clinicaltrials.gov/ct2/show/NCT00344318
Nyckelord
Versioner (2)
- 2019-04-09 2019-04-09 -
- 2019-04-15 2019-04-15 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 april 2019
DOI
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Licens
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
Vaccine Administration
- StudyEvent: ODM
Beskrivning
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Beskrivning
day month year. (fill in only if different from visit date).
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Beskrivning
Pre-Vaccination temperature
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0042196
Beskrivning
Route of temperature measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beskrivning
(only one box must be ticked by vaccine). NOTE: "OPV Vaccine" is for workbook 1. "IPV Vaccine" is for wokbook 2. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042210
Beskrivning
If you tick "not administered", please complete following Itemgroup.
Datatyp
text
Alias
- UMLS CUI [1]
- C2368628
Beskrivning
Replacement vial Identifier
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Beskrivning
Wrong vial number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C3827420
Beskrivning
According to the protocol: -For 10Pn-PD-DiT or Prevenar Vaccine take the right thigh I.M. -For DTPw-HBV/Hib Vaccine take the left upper thigh I.M. -For OPV Vaccine administer oral -For IPV Vaccine take the left lower thigh I.M. If you administered differently than protocol intended tick "Not according to the protocol".
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [2,1]
- C0013153
- UMLS CUI [2,2]
- C0441987
- UMLS CUI [2,3]
- C2348563
Beskrivning
Vaccine administration NOT according to the Protocol: Side
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
For 10Pn-PD-DiT or Prevenar Vaccine: Deltoid, Thigh, Buttock For DTPw-HBV/Hib Vaccine: Deltoid, Upper thigh, Lower thigh, Buttock For IPV: Deltoid, Upper thigh, Lower thigh, Buttock
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beskrivning
OPV is excluded.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beskrivning
No vaccine administration
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1272696
Beskrivning
Vaccine
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042210
Beskrivning
If you tick SAE: Please complete and submit SAE report If you tick AEX: Please complete Non-serious Adverse Event section If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event report. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Beskrivning
SAE Identifier
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beskrivning
AE Identifier
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449788
Beskrivning
(e.g.: consent withdrawal, Protocol violation, …)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Beskrivning
Decision taken
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0679006
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Similar models
Vaccine Administration
- StudyEvent: ODM
C2368628 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C1515974 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0013153 (UMLS CUI [2,1])
C0441987 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C1272696 (UMLS CUI-2)
C1272696 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])