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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Infections, Streptococcal

Treatments

Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

Biological: Pneumococcal vaccine GSK2189242A (formulation 1)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00896064

112993

Details and patient eligibility

About

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)

Enrollment

43 patients

Sex

All

Ages

18 to 41 years old

Volunteers

Accepts Healthy Volunteers

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.