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

NCT00896064 | Completed Phase 2 Results

• 1 other identifier: 112993
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Keywords

Pneumococcal vaccine; Streptococcus pneumoniae; Young adults

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Grade 3 Solicited Local Symptoms

  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.

  During the 7-day (Days 0-6) post-booster vaccination period

• Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms

  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.

  During the 7-day (Days 0-6) post-booster vaccination period

• Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)

  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.

  During the 31-day (Days 0-30) post-booster vaccination period

• Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)

  SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  During the entire study period (from Day 0 to Day 30)

• Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities

  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. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening

  At Days 1 and 6 post-booster vaccination

Secondary Outcomes (7)

• Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins

  Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

• Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein

  Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

• Number of Subjects With Any Solicited Local Symptoms

  During the 7-day (Days 0-6) post-booster vaccination period

• Number of Subjects With Any Solicited General Symptoms

  During the 7-day (Days 0-6) post-booster vaccination period

• Number of Subjects With Any Unsolicited AEs

  During the 31-day (Days 0-30) post-booster vaccination period

Study Arms (2)

Formulation 1

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A (formulation 1)

Formulation 2

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

Interventions

Pneumococcal vaccine GSK2189242A (formulation 1) BIOLOGICAL

One dose will be administered intramuscularly at Study Day 0.

Formulation 1

Pneumococcal vaccine GSK2189242A (formulation 2) BIOLOGICAL

One dose will be administered intramuscularly at Study Day 0.

Formulation 2

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 11, 2009
• Study Start: May 18, 2009
• Primary Completion: August 5, 2009
• Study Completion: August 5, 2009
• Last Updated: August 17, 2018
• Results First Posted: July 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)