Evaluation of Pneumococcal Vaccine Formulations in Young Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00707798

Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in young adults. Subjects will be vaccinated twice with an interval of two months.

Condition	Intervention	Phase
Diseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae	Biological: Pneumo 23™ Biological: Pneumococcal vaccine GSK2189242A	Phase I

MedlinePlus related topics: Flu Pneumonia

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of any vaccine related and grade 3 unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of any vaccine related serious adverse events (SAE) [ Time Frame: From Visit 1 to study conclusion ] [ Designated as safety issue: Yes ]
Occurrence of any vaccine related and grade 3 solicited local and general adverse events [ Time Frame: During a 7-day follow up period after each vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of any grade 3 laboratory abnormalities [ Time Frame: During a 7-day follow up period after each vaccine dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of any solicited local and general adverse events [ Time Frame: During a 7-day follow up period after each vaccine dose. ] [ Designated as safety issue: Yes ]
Occurrence of any unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ] [ Designated as safety issue: Yes ]
Occurrence of any haematological, biochemical, or urinary abnormalities [ Time Frame: At 1 and 7 days after each vaccine dose ] [ Designated as safety issue: Yes ]
Anti-pneumococcal and anti-NTHi candidate vaccine antigens [ Time Frame: At Days 0, 30 and 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	156
Study Start Date:	June 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Formulation 5: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
Formulation 2: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
Formulation 6: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
Formulation 1: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
23 valent pneumococcal vaccine: Active Comparator	Biological: Pneumo 23™ One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2
Formulation 3: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested
Formulation 4: Experimental	Biological: Pneumococcal vaccine GSK2189242A Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2. Six different formulations of this vaccine will be tested

Detailed Description:

This amendment was due to

The addition of secondary endpoints for safety. The collection of data related to these secondary safety endpoints was already planned and the corresponding statistical analyses were described in the statistical section.
The addition of an exclusion criterion regarding the administration of immunoglobulins and blood products. It is already included in the elimination criteria section. It impacts only immunogenicity.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
A male or female between, and including, 18 and 40 years old at the time of the first vaccination.
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.
If the subject is female, and of child-bearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.

Exclusion Criteria:

Previous vaccination against Streptococcus pneumoniae.
Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered > 7 days preceding or > 7 days following each vaccine dose (after collection of 7-day safety data).
Bacterial pneumonia within 3 years prior to 1st vaccination.
Invasive pneumococcal disease (IPD) within 3 years prior to 1st vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
History of thrombocytopenia or bleeding disorder.
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.
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.
Laboratory evidence of haematological abnormalities.
Laboratory evidence of biochemical abnormalities
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707798

Locations

Belgium
GSK Investigational Site
Gent, Belgium, 9000

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111651
Study First Received:	June 30, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00707798
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

Streptococcus pneumoniae,
Pneumococcal vaccine,
Young adults

Study placed in the following topic categories:

Virus Diseases
Haemophilus influenzae
Respiratory Tract Diseases
Respiratory Tract Infections

Lung Diseases
Influenza, Human
Orthomyxoviridae Infections
Pneumonia

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009