ID
36104
Beschreibung
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00344318
Stichworte
Versionen (2)
- 09.04.19 09.04.19 -
- 15.04.19 15.04.19 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. April 2019
DOI
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Lizenz
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
Beschreibung
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Beschreibung
day month year. (fill in only if different from visit date).
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Beschreibung
Pre-Vaccination temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0042196
Beschreibung
Route of temperature measurement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Beschreibung
(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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042210
Beschreibung
If you tick "not administered", please complete following Itemgroup.
Datentyp
text
Alias
- UMLS CUI [1]
- C2368628
Beschreibung
Replacement vial Identifier
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Beschreibung
Wrong vial number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C3827420
Beschreibung
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".
Datentyp
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
Beschreibung
Vaccine administration NOT according to the Protocol: Side
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Beschreibung
OPV is excluded.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschreibung
No vaccine administration
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1272696
Beschreibung
Vaccine
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042210
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Beschreibung
SAE Identifier
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschreibung
AE Identifier
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449788
Beschreibung
(e.g.: consent withdrawal, Protocol violation, …)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Beschreibung
Decision taken
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0679006
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Ähnliche Modelle
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])