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Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

Primary Purpose

Acellular Pertussis, Tetanus, Hepatitis B

Status
Completed
Phase
Phase 2
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 Acellular Pertussis

Eligibility Criteria

11 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, 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 vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study

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
  • 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 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,

Secondary Outcome Measures

Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Ab concentrations to protein D & seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Occurrence of: solicited local*,general *symptoms within 4 d
Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster

Full Information

First Posted
March 7, 2006
Last Updated
September 22, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00307567
Brief Title
Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488
Official Title
A Phase II, Multicentre Booster Study to Evaluate Booster Vaccination With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or to Evaluate the Immune Memory Following the Administration of a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children, Previously Vaccinated in Infancy in the Primary Study 11PN-PD-DIT-002 (103488)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Booster and immune memory study
Detailed Description
Total: All 689 subjects enrolled in study 103488. 23PS group: Aventis Pasteurs' 23-valent polysaccharide pneumococcal vaccine (Pneumovax 23) + DTPa-HBV-IPV/Hib; 10V group: GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
689 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Pneumococcal (vaccine)
Primary Outcome Measure Information:
Title
1 mth after admin. of booster dose with either GSK Biologicals' 10Pn-PD-DiT vaccine or 1 mth after admin. of single dose of unconjugated 23- valent pneumococcal polysaccharide vaccine (Pneumovax™ 23), anti-pneumococcal serotypes 1,4,5,6B,7F,9V,14,18C,
Secondary Outcome Measure Information:
Title
Pre&post booster: All vaccine pneumococcal serotypes: Opsono titres*
Title
Antibody (Ab) concentrations >= 0.05, 0.20 µg/mL
Title
Ab concentrations to protein D & seropositivity (S+) status
Title
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
Title
Occurrence of: solicited local*,general *symptoms within 4 d
Title
Unsolicited adverse events* within 31 d, SAEs (whole study period) *only post booster

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, 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 vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
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
Bad Saulgau
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88348
Country
Germany
Facility Name
GSK Investigational Site
City
Bretten
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75015
Country
Germany
Facility Name
GSK Investigational Site
City
Eppelheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69214
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Oberkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77704
Country
Germany
Facility Name
GSK Investigational Site
City
Offenburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77654
Country
Germany
Facility Name
GSK Investigational Site
City
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70469
Country
Germany
Facility Name
GSK Investigational Site
City
Tauberbischofsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
97941
Country
Germany
Facility Name
GSK Investigational Site
City
Cham
State/Province
Bayern
ZIP/Postal Code
93413
Country
Germany
Facility Name
GSK Investigational Site
City
Herzogenaurach
State/Province
Bayern
ZIP/Postal Code
91074
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80939
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Weilheim
State/Province
Bayern
ZIP/Postal Code
82362
Country
Germany
Facility Name
GSK Investigational Site
City
Koenigstein
State/Province
Hessen
ZIP/Postal Code
61462
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
18059
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
Salzgitter
State/Province
Niedersachsen
ZIP/Postal Code
38226
Country
Germany
Facility Name
GSK Investigational Site
City
Wolfenbuettel
State/Province
Niedersachsen
ZIP/Postal Code
38302
Country
Germany
Facility Name
GSK Investigational Site
City
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44329
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
Heiligenhaus
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42579
Country
Germany
Facility Name
GSK Investigational Site
City
Kleve-Materborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47533
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47798
Country
Germany
Facility Name
GSK Investigational Site
City
Loehne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
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
Bodenheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55294
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
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
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
Schoeneberg - Kuebelberg
State/Province
Rheinland-Pfalz
ZIP/Postal Code
66901
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
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
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Bredstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
25821
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24939
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24943
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24944
Country
Germany
Facility Name
GSK Investigational Site
City
Husum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25813
Country
Germany
Facility Name
GSK Investigational Site
City
Neumuenster
State/Province
Schleswig-Holstein
ZIP/Postal Code
24534
Country
Germany
Facility Name
GSK Investigational Site
City
Lobenstein
State/Province
Thueringen
ZIP/Postal Code
07356
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
13355
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105555
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
105555
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
105555
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
105555
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105555
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
105555
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Multicentre Booster & Immune Memory Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine or a Single Dose of 23-valent Plain Polysaccharide Vaccine in Healthy Children Aged 11-18 Mths, Previously Vaccinated in Study 103488

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