Mode
Text Size
Log in / Sign up
Phase 2 Completed N=43 Randomized Double-blind Prevention

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

Infections, Streptococcal
Source: ClinicalTrials.gov NCT00896064 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Number of Subjects With Grade 3 Solicited Local Symptoms — 0; 1; 0; 1 Participants

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)

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Grade 3 Solicited Local Symptoms
0; 1; 0; 1; 1; 0
PRIMARY
Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms
1; 0; 3; 13; 0; 0
PRIMARY
Number of Subjects With Grade 3 and Vaccine-related Unsolicited Adverse Events (AEs)
1; 1; 1; 1
PRIMARY
Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)
0; 0
PRIMARY
Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities
0; 0; 0; 0; 0; 1
SECONDARY
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Histidine Triad Protein D (PhtD) Proteins
41823.0; 89612.2; 92943.4; 144767.0; 26672.0; 42111.0
SECONDARY
Titers for Antibodies Against Pneumolysin Haemolysis (Hem-dPly) Protein
2161.5; 3028.1; 2383.6; 3573.7
SECONDARY
Number of Subjects With Any Solicited Local Symptoms
19; 21; 4; 9; 2; 8
SECONDARY
Number of Subjects With Any Solicited General Symptoms
4; 13; 3; 1; 5; 8
SECONDARY
Number of Subjects With Any Unsolicited AEs
6; 5
SECONDARY
Number of Subjects With Any SAEs
0; 0
SECONDARY
Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities
0; 1; 1; 0; 3; 4

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00896064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search