Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Study Overview
=================
Brief Summary
-----------------
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.

Official Title
-----------------
Phase I Clinical Trial to Evaluate the Safety and Explore the Immunogenicity of a Candidate PCV13 in Healthy People Aged 2 Months (Minimum 6 Weeks) and Above

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
* Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Satisfy the age requirements of the clinical trial; willing to provide proof of identity; Subjects or guardians must provide informed consent forms with personal signature and date; Male and female of childbearing age should agree to take effective contraception measures; Subjects or guardians can obey the requirements of the clinical study; Axillary temperature below 37.3 °C. Exclusion Criteria: Laboratory indicators (expect those have no clinical significance) out of normal ranges required; Received any pneumococcal vaccine; Allergic history to any drugs, vaccine or vaccine-related component; Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition; Infants diagnosed with pathological jaundice that lasts for 2 4 weeks and occurs repeatedly; Breast-feeding or pregnant women, or positive U-HCG; High blood pressure uncontrolled by medication; Known or suspected immune deficiency or immune suppression; Serious congenital malformation, history of organ resection or serious chronic illness; Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin); History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae; History of convulsions, epilepsy or encephalopathy or a family history of mental illness; A vaccination-related contraindications that other investigator believes; Plans to participate in or is participating in any other clinical study; Any other factors judged by investigator that may interfere subject's compliance with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1A<br>Subjects received one dose of PCV13 at 18 years of age and above. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 2A<br>Subjects received one dose of PCV13 at 6 17 years of age. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 3A<br>Subjects received one dose of PCV13 at 2 5 years of age. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 4A<br>Subjects received two doses of PCV13 at 12 23 months of age. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 5A<br>Subjects received three doses of PCV13 at 7 11 months of age. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 6A<br>Subjects received four doses of PCV13 at 3 months of age. | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Experimental: 6B<br>Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Active Comparator: 6C<br>Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: Prevnar 13;|
| Experimental: 7A<br>Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: PCV13;|
| Active Comparator: 7B<br>Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). | Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine<br>* 0.5mL, Intramuscular<br>* Other names: Prevnar 13;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety in terms of adverse reactions | Occurrence of AEs on vaccination site (local) and non-vaccination site (systemic) of each subject | within 30 minutes post each vaccination | 
| Safety in terms of adverse events | Occurrence of solicited AEs of each subject | within 7 days post each vaccination | 
| Safety in terms of adverse events | Occurrence of non-solicited AEs of each subject | within 30 days post each vaccination | 
| Safety in terms of SAEs | Occurrence of SAEs of each subject | within 6 months post last vaccination | 
| Safety in terms of laboratory-based AEs | Occurrence of laboratory-based AEs in subjects of 2 years old and above(Arm 1A-3A) | within 4 days post each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogencity in terms of seropositivity rates by ELISA | Seropositivity rates of serotype-specific pneumococcal IgG antibody in subjects of each age group | 30 days post basic vaccination | 
| Immunogencity in terms of GMC by ELISA | GMC of serotype-specific pneumococcal IgG antibody in subjects of each age group | 30 days post basic vaccination | 
| Immunogencity in terms of subjects with IgG concentrations ≥1.0 µg/mL | Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL | 30 days post basic vaccination | 
| Immunogencity Comparison with control vaccine group | Comparison of the seropositivity rates, GMC of serotype-specific pneumococcal IgG antibody and the Percentage of subjects with serotype-specific IgG concentrations ≥1.0 µg/mL in subjects aged 2 months of Experimental group and Control group | 30 days post basic vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumonia, Pneumococcal