Safety Study of Pneumococcal 13-valent Conjugate Vaccine in Healthy People Aged 2 Months and Older

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase: Unknown; Phase 1

Conditions: Pneumococcal 13-valent Conjugate Vaccine

Treatments: Biological: three doses of PCV13a vaccine; Biological: One dose of PCV13a vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02544698

cycdc2015-2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 2+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

One dose of PCV13a vaccine in aged 18 years and older

Experimental group

Description:

One dose of PCV13a vaccine will be given in aged 18 years and older

Treatment:

Biological: One dose of PCV13a vaccine

Biological: One dose of PCV13a vaccine

One dose of PCV13a vaccine in aged 2-5 years old

Experimental group

Description:

One dose of PCV13a vaccine will be given in aged 2-5 years old

Treatment:

Biological: One dose of PCV13a vaccine

Biological: One dose of PCV13a vaccine

One dose of PCV13 vaccine will be given at 2, 4, 6 months

Experimental group

Description:

One dose of PCV13 vaccine will be given at 2, 4, 6 months respectively in aged 2 months old

Treatment:

Biological: three doses of PCV13a vaccine

Biological: three doses of PCV13a vaccine

One dose of PCV13 vaccine will be given at 3、4、5 months

Experimental group

Description:

One dose of PCV13 vaccine will be given at 3、4、5 months respectively in aged 3 months old

Treatment:

Biological: three doses of PCV13a vaccine

Biological: three doses of PCV13a vaccine