A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

January 9, 2017 updated by: GlaxoSmithKline

A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age

Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
689

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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, 12627
        • GSK Investigational Site
      • Berlin, Germany, 13355
        • GSK Investigational Site
      • Hamburg, Germany, 22307
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
        • GSK Investigational Site
      • Bretten, Baden-Wuerttemberg, Germany, 75015
        • GSK Investigational Site
      • Eppelheim, Baden-Wuerttemberg, Germany, 69214
        • GSK Investigational Site
      • Ettenheim, Baden-Wuerttemberg, Germany, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Germany, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Germany, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Germany, 77654
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Germany, 70469
        • GSK Investigational Site
      • Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
        • GSK Investigational Site
    • Bayern
      • Cham, Bayern, Germany, 93413
        • GSK Investigational Site
      • Herzogenaurach, Bayern, Germany, 91074
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81675
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81241
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80939
        • GSK Investigational Site
      • Noerdlingen, Bayern, Germany, 86720
        • GSK Investigational Site
      • Olching, Bayern, Germany, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, Germany, 82362
        • GSK Investigational Site
      • Zwiesel, Bayern, Germany, 94227
        • GSK Investigational Site
    • Hessen
      • Koenigstein, Hessen, Germany, 61462
        • GSK Investigational Site
      • Marburg/Lahn, Hessen, Germany, 35039
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65205
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18059
        • GSK Investigational Site
      • Waren, Mecklenburg-Vorpommern, Germany, 17192
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Germany, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Germany, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44791
        • GSK Investigational Site
      • Detmold, Nordrhein-Westfalen, Germany, 32756
        • GSK Investigational Site
      • Dortmund, Nordrhein-Westfalen, Germany, 44329
        • GSK Investigational Site
      • Erkrath, Nordrhein-Westfalen, Germany, 40699
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Germany, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Germany, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Germany, 48159
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bodenheim, Rheinland-Pfalz, Germany, 55294
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Germany, 67227
        • GSK Investigational Site
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67059
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
      • Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54290
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Germany, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Germany, 67547
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bredstedt, Schleswig-Holstein, Germany, 25821
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24939
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24943
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Germany, 24944
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Germany, 25813
        • GSK Investigational Site
      • Neumuenster, Schleswig-Holstein, Germany, 24534
        • GSK Investigational Site
    • Thueringen
      • Lobenstein, Thueringen, Germany, 07356
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding 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 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
Time Frame: 1 Month after dose 3
1 Month after dose 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.
Time Frame: 1 Month after dose 3
1 Month after dose 3

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 103488

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Study Protocol
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 103488
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: 103488
    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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