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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumococcal 13-valent Conjugate Vaccine
• Intervention / Treatment: Biological: One dose of PCV13a vaccine; Biological: three doses of PCV13a vaccine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: One dose of PCV13a vaccine
Experimental: 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	Biological: One dose of PCV13a vaccine
Experimental: 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	Biological: three doses of PCV13a vaccine
Experimental: 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	Biological: three doses of PCV13a vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the rate of adverse reactions of pneumococcal 13-valent conjugate vaccine	Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy	3 months

Collaborators and Investigators

• Sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: September 6, 2015
• First Submitted That Met QC Criteria: September 6, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: safety; vaccine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: cycdc2015-2