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Evaluation of Pneumococcal Vaccine Formulations in Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00707798
First received: June 30, 2008
Last updated: May 9, 2017
Last verified: May 2017
  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
Infections, Streptococcal Biological: Pneumococcal vaccine GSK2189242A Biological: Pneumo 23™ Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Prevention
Official Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189242A) in Young Adults.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]
  • Occurrence of any vaccine related and grade 3 unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ]
  • Occurrence of any vaccine related serious adverse events (SAE) [ Time Frame: From Visit 1 to study conclusion ]
  • Occurrence of any grade 3 laboratory abnormalities [ Time Frame: During a 7-day follow up period after each vaccine dose ]

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. ]
  • Occurrence of any unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ]
  • Occurrence of any haematological, biochemical, or urinary abnormalities [ Time Frame: At 1 and 7 days after each vaccine dose ]
  • Anti-pneumococcal and anti-NTHi candidate vaccine antigens [ Time Frame: At Days 0, 30 and 90 ]

Enrollment: 157
Actual Study Start Date: June 30, 2008
Study Completion Date: January 15, 2009
Primary Completion Date: January 15, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 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
Experimental: Formulation 2 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
Experimental: Formulation 3 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
Experimental: Formulation 4 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
Experimental: Formulation 5 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
Experimental: Formulation 6 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
Active Comparator: 23 valent pneumococcal vaccine 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

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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111651
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111651
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111651
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111651
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111651
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00707798     History of Changes
Other Study ID Numbers: 111651
Study First Received: June 30, 2008
Last Updated: May 9, 2017
Individual Participant Data  
Plan to Share IPD: Yes
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.

Keywords provided by GlaxoSmithKline:
Young adults
Pneumococcal vaccine,
Streptococcus pneumoniae,

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 27, 2017