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

NCT ID: NCT02544698

Last Updated: 2016-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Pneumococcal 13-valent Conjugate Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

One dose of PCV13a vaccine in aged 18 years and older

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

Group Type: EXPERIMENTAL

One dose of PCV13a vaccine

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

One dose of PCV13a vaccine

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

three doses of PCV13a vaccine

Intervention Type: BIOLOGICAL

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

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

Group Type: EXPERIMENTAL

three doses of PCV13a vaccine

Intervention Type: BIOLOGICAL

Interventions

One dose of PCV13a vaccine

Intervention Type: BIOLOGICAL

One dose of PCV13a vaccine

Intervention Type: BIOLOGICAL

three doses of PCV13a vaccine

Intervention Type: BIOLOGICAL

three doses of PCV13a vaccine

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Chaoyang District Centre for Disease Control and Prevention

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

cycdc2015-2

Identifier Type: -

Identifier Source: org_study_id