Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults

NCT ID: NCT00896064

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-18
• Study Completion Date: 2009-08-05

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Formulation 1

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A (formulation 1)

Intervention Type: BIOLOGICAL

One dose will be administered intramuscularly at Study Day 0.

Formulation 2

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189242A (formulation 2)

Intervention Type: BIOLOGICAL

One dose will be administered intramuscularly at Study Day 0.

Interventions

Pneumococcal vaccine GSK2189242A (formulation 1)

One dose will be administered intramuscularly at Study Day 0.

Intervention Type: BIOLOGICAL

Pneumococcal vaccine GSK2189242A (formulation 2)

One dose will be administered intramuscularly at Study Day 0.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
• A male or female between, and including, 18 and 41 years old at the time of vaccination.
• Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
• Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
• Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
• Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.
• Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
• History of thrombocytopenia or bleeding disorder.
• Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
• Current serious neurologic or mental disorders.
• Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
• All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
• Acute disease at the time of enrolment/vaccination.
• Fever at the time of vaccination. Fever is defined as temperature >= 37.5°C on oral setting.
• Physical examination positive for acrocyanosis, jaundice, splenomegaly.
• Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator
• Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• History of chronic alcohol consumption and/or drug abuse.
• Other conditions that the principal investigator judges may interfere with study findings.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

Countries

Belgium

Study Documents

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112993

Identifier Type: -

Identifier Source: org_study_id