ID
36104
Descripción
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
Palabras clave
Versiones (2)
- 9/4/19 9/4/19 -
- 15/4/19 15/4/19 - Sarah Riepenhausen
Titular de derechos de autor
GlaxoSmithKline
Subido en
15 de abril de 2019
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Descripción
day month year. (fill in only if different from visit date).
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Descripción
Pre-Vaccination temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0042196
Descripción
Route of temperature measurement
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Descripción
(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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042210
Descripción
If you tick "not administered", please complete following Itemgroup.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2368628
Descripción
Replacement vial Identifier
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Descripción
Wrong vial number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0600091
- UMLS CUI [1,3]
- C3827420
Descripción
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".
Tipo de datos
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
Descripción
Vaccine administration NOT according to the Protocol: Side
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0441987
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Descripción
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
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0042210
Descripción
OPV is excluded.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Descripción
No vaccine administration
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1272696
Descripción
Vaccine
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0042210
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1272696
- UMLS CUI [1,3]
- C0566251
Descripción
SAE Identifier
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Descripción
AE Identifier
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0449788
Descripción
(e.g.: consent withdrawal, Protocol violation, …)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Descripción
Decision taken
Tipo de datos
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])