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

December 27, 2019 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10315
        • GSK Investigational Site
      • Berlin, Germany, 13055
        • GSK Investigational Site
      • Berlin, Germany, 12627
        • GSK Investigational Site
      • Berlin, Germany, 12679
        • GSK Investigational Site
      • Berlin, Germany, 14197
        • GSK Investigational Site
      • Berlin, Germany, 13409
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
      • Marbach, Baden-Wuerttemberg, Germany, 71672
        • GSK Investigational Site
    • Bayern
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Tutzing, Bayern, Germany, 82327
        • GSK Investigational Site
    • Hessen
      • Wiesbaden, Hessen, Germany, 65205
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18146
        • GSK Investigational Site
      • Waren, Mecklenburg-Vorpommern, Germany, 17192
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
        • GSK Investigational Site
      • Erkrath, Nordrhein-Westfalen, Germany, 40699
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
        • GSK Investigational Site
      • Minden, Nordrhein-Westfalen, Germany, 32427
        • GSK Investigational Site
      • Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
        • GSK Investigational Site
      • Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48159
        • GSK Investigational Site
      • Oberhausen, Nordrhein-Westfalen, Germany, 46145
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Germany, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Gerolstein, Rheinland-Pfalz, Germany, 54568
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54294
        • GSK Investigational Site
    • Sachsen
      • Leipzig, Sachsen, Germany, 04178
        • GSK Investigational Site
      • Stollberg, Sachsen, Germany, 09366
        • GSK Investigational Site
    • Thueringen
      • Lobenstein, Thueringen, Germany, 07356
        • GSK Investigational Site
      • Neuhaus am Rennweg, Thueringen, Germany, 98724
        • GSK Investigational Site
      • Weimar, Thueringen, Germany, 99425
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2005

Primary Completion (Actual)

April 7, 2006

Study Completion (Actual)

April 7, 2006

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105554
  • 2005-003299-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Study Protocol
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistical Analysis Plan
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 105554
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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