Clinical trial NCT02544698: Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pneumococcal 13-valent Conjugate Vaccine
Keywords: vaccine
safety
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study evaluates the safety of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older.120 Subjects will be equally divided into 4 groups,including 18 years and older,2-5 years old, 2 months old and 3 months old. Subjects aged 18 years and 2-5 years old will receive one dose of PCV13 vaccine,while subjects aged 2 and 3 months will receive 3 doses of PCV13 vaccine,injected at 2, 4, 6 months or 3、4、5 months respectively.


Eligibility criteria: Inclusion Criteria:

1. Healthy babies with health conditions confirmed according to medical history, medical examination and judgment of researchers;
2. Satisfy the age requirements of the clinical trial.(children from 2 months to 5 years old and adults over the age of 18);
3. Parents or guardians of the subjects must provide informed consent forms with personally signature and date;
4. Parents or guardians of the subjects have been informed of all aspects of the research;
5. Subjects or guardians can obey the requirements of the clinical research;
6. No pneumococcal vaccine inoculation history, no other preventive vaccination within 7 days;
7. Axillary temperature below 37℃

Exclusion Criteria:

1. People with pneumococcal vaccine inoculation history, no matter experimentally or already on the market;
2. People has allergic reaction to any drugs, vaccine or vaccine-related components previously;
3. People has allergic reaction to 13vPnC, 7vPnC or other complexes associated with the drug, known or suspected;
4. People has hemorrhagic physical constitution or diseases that prolong bleeding time, intramuscular injection taboo;
5. People has immune deficiency or immune function inhibition, known or suspected;
6. People has irritability, convulsions, epilepsy, brain diseases and mental history or family history;
7. People has culture-confirmed invasive diseases caused by streptococcus pneumoniae history;
8. People has serious congenital malformations or serious chronic diseases that are known, people with congenital deformities, stunted or has a clinical diagnosis of serious chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or nerve disorders, Guillain-Barre syndrome);
9. People suffers from these diseases: respiratory diseases, acute or chronic active stage of infection, severe cardiovascular disease, kidney and liver diseases, malignant tumors, skin diseases, babies with HIV infected mothers(inspection report is available);
10. People with vaccination-related contraindications that other researchers believe;
11. People take part in other clinical trials while taking part in this clinical trial or 28 days before this clinical trial. People who participate in purely observational studies are acceptable;
12. People received blood products or intravenous immunoglobulin. People who was inoculated Hepatitis B immunoglobulin can be acceptable.

Primary outcomes:
measure: Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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