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Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

Primary Purpose

Infections, Streptococcal, Streptococcus Pneumoniae Vaccines

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pneumococcal (vaccine)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Streptococcal

Eligibility Criteria

8 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL

Secondary Outcome Measures

1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concns >= 0.05 µg/mL
Ab concns to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Unsolicited adverse events within 31 days, SAEs (whole study period)

Full Information

First Posted
March 7, 2006
Last Updated
December 27, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00307541
Brief Title
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Official Title
Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2005 (Actual)
Primary Completion Date
April 7, 2006 (Actual)
Study Completion Date
April 7, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Detailed Description
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Pneumococcal (vaccine)
Primary Outcome Measure Information:
Title
1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
Secondary Outcome Measure Information:
Title
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Title
Antibody (Ab) concns >= 0.05 µg/mL
Title
Ab concns to protein D and seropositivity (S+) status
Title
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Title
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Title
Unsolicited adverse events within 31 days, SAEs (whole study period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Marbach
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71672
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Tutzing
State/Province
Bayern
ZIP/Postal Code
82327
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65205
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18146
Country
Germany
Facility Name
GSK Investigational Site
City
Waren
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17192
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32549
Country
Germany
Facility Name
GSK Investigational Site
City
Erkrath
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40699
Country
Germany
Facility Name
GSK Investigational Site
City
Goch
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47574
Country
Germany
Facility Name
GSK Investigational Site
City
Heiligenhaus
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42579
Country
Germany
Facility Name
GSK Investigational Site
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32427
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41061
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41236
Country
Germany
Facility Name
GSK Investigational Site
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48159
Country
Germany
Facility Name
GSK Investigational Site
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Facility Name
GSK Investigational Site
City
Willich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47877
Country
Germany
Facility Name
GSK Investigational Site
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
Facility Name
GSK Investigational Site
City
Gerolstein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54568
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54294
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04178
Country
Germany
Facility Name
GSK Investigational Site
City
Stollberg
State/Province
Sachsen
ZIP/Postal Code
09366
Country
Germany
Facility Name
GSK Investigational Site
City
Lobenstein
State/Province
Thueringen
ZIP/Postal Code
07356
Country
Germany
Facility Name
GSK Investigational Site
City
Neuhaus am Rennweg
State/Province
Thueringen
ZIP/Postal Code
98724
Country
Germany
Facility Name
GSK Investigational Site
City
Weimar
State/Province
Thueringen
ZIP/Postal Code
99425
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12679
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13409
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14197
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=465
Citations:
PubMed Identifier
21909049
Citation
Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.
Results Reference
background
Links:
URL
http://www.clinicaltrials.gov/ct/show/NCT00333450
Description
Booster Study
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105554
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

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