Last updated: 12/17/2019 15:50:08
Evaluation of pneumococcal vaccine formulations in young adults
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to evaluate GSK Biologicals’ candidate formulations of pneumococcal vaccines (GSK2189242A) in young adults.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
Timeframe: During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
Timeframe: During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
Timeframe: From Visit 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
Timeframe: During a 7-day follow up period after each vaccine dose
Secondary outcomes:
Occurrence of any solicited local and general adverse events
Timeframe: During a 7-day follow up period after each vaccine dose.
Occurrence of any unsolicited adverse events
Timeframe: During a 31-day follow up period after each vaccine dose
Occurrence of any haematological, biochemical, or urinary abnormalities
Timeframe: At 1 and 7 days after each vaccine dose
Anti-pneumococcal and anti-NTHi candidate vaccine antigens
Timeframe: At Days 0, 30 and 90
Interventions:
Enrollment:
157
Primary completion date:
2009-15-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Leroux-Roels G et al. (2014) Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 32(50):6838-6846.
Medical condition
Infections, Streptococcal
Product
GSK2189242A
Collaborators
Not applicable
Study date(s)
June 2008 to January 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- 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.
- Previous vaccination against Streptococcus pneumoniae.
- Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2009-15-01
Actual study completion date
2009-15-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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