Phase 2
Completed N=43
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
| Outcome | Result | p-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.
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.