Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

October 6, 2016 updated by: GlaxoSmithKline

Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

Study Overview

Status

Completed

Conditions

Infections, Streptococcal

Intervention / Treatment

Biological: Pneumococcal vaccine

Detailed Description

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

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
- 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
  - 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

11 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion:

healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.

Exclusion:

children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
children having received any additional pneumococcal vaccine than in the primary study;
children with any disease that affect the immune system and history of seizures and/or allergic disease.

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Antibody concentrations against pneumococcal serotypes 1 month post-booster

Secondary Outcome Measures

Outcome Measure
Immunogenicity pre and post-booster and safety (follow up of SAEs)

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

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.

Helpful Links

Primary Study

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

August 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 5, 2006

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

106623

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

Statistical Analysis Plan
Information identifier: 106623

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set
Information identifier: 106623

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report
Information identifier: 106623

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form
Information identifier: 106623

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification
Information identifier: 106623

Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol
Information identifier: 106623

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.