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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00896064
First Posted: May 11, 2009
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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)


Condition Intervention Phase
Infections, Streptococcal Biological: Pneumococcal vaccine GSK2189242A (formulation 1) Biological: Pneumococcal vaccine GSK2189242A (formulation 2) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Safety and Immunogenicity of a Booster Dose of Two Formulations of GSK Biologicals' Pneumococcal Candidate Vaccine in Healthy Young Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-booster vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  • Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-booster vaccination period ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.

  • Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Day 30) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities [ Time Frame: At Days 1 and 7 post-booster vaccination ]

    Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters.

    Note: Blood samples were collected at Days 1 and 6.



Secondary Outcome Measures:
  • Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins [ Time Frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) ]
    Anti-dPly and anti-PhtD antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in LU/mL. The reference seropositivity cut-off values were equal to or above (≥) 599 LU/mL for anti-dPly and ≥ 391 LU/mL for anti-PhtD.

  • Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein [ Time Frame: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30) ]
    Antibody titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 6.

  • Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-booster vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-booster vaccination period ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

  • Number of Subjects With Any Unsolicited AEs [ Time Frame: During the 31-day (Days 0-30) post-booster vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of Subjects With Any SAEs [ Time Frame: During the entire study period (from Day 0 to Day 30) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities [ Time Frame: At 1 and 7 days post-booster vaccination ]
    Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Note: Blood samples were collected at Days 1 and 6.


Enrollment: 43
Study Start Date: May 18, 2009
Study Completion Date: August 5, 2009
Primary Completion Date: August 5, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
One dose will be administered intramuscularly at Study Day 0.
Experimental: Formulation 2 Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
One dose will be administered intramuscularly at Study Day 0.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 41 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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896064


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: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112993
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112993
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112993
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: 112993
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112993
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00896064     History of Changes
Other Study ID Numbers: 112993
First Submitted: May 7, 2009
First Posted: May 11, 2009
Results First Submitted: April 21, 2017
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Pneumococcal vaccine
Streptococcus pneumoniae
Young adults

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