Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT02572635
Eligibility Criteria:
Inclusion Criteria:
* healthy male and female subjects between 18 and 40 years of age (inclusive).
* female subjects of child bearing potential with negative pregnancy test at screening and willing to use 2 effective methods of contraception (i.e. established method of contraception plus condom, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
* male subjects willing to use 2 effective methods of contraception unless anatomically sterile, or where abstaining from heterosexual intercourse is in line with the preferred and usual lifestyle of the subject, from Day 1 until 3 months after the last dose of PnuBioVax/Placebo.
* subjects with a Body Mass Index (BMI) of \<30 kg/m2.
* subjects with a negative urinary drugs of abuse screen determined within 28 days of the first dose.
* subjects with negative HIV and Hepatitis B and C results.
* subjects must be willing and able to comply with the requirements of the protocol and must be available to complete the trial, including all follow up visits.
* subject must provide written informed consent to participate in the trial.
Exclusion Criteria:
* any relevant abnormality in medical history examination, vital signs laboratory tests or ECG.
* any reason that would make the assessment of any injection site reaction difficult (e.g. tattoos at injections site, black skin).
* history of migraine or asthma (no inhaler use for 5 years).
* proven diagnosis of pneumonia within last 5 years.
* current smokers.
* history of anaphylaxis or hypersensitivity to previous vaccinations.
* known impairment of the immune system or chronic diseases, e.g. autoimmune diseases, diabetes, cancer.
* anticipation that the subject may require any other vaccination during the trial period.
* subjects who are antinuclear antibody (ANA) positive (above a titre of 1:80).
* subjects with haemoglobin level \< 8.4 mmol/ L (males) and \<7.8 mmol/L (females).
* palpable cervical or axillary lymph nodes.
* receipt of regular prescribed medication within 28 days of the first trial day and / or receipt of vitamins, minerals, herbal remedies and nutritional supplements within 7 days of the first trial day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02572635
Study Brief:
Protocol Section:
NCT02572635