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| Name | Class |
|---|---|
| Hunan Provincial Center for Disease Control and Prevention | OTHER |
| Liaoning Chengda Biotechnology CO., LTD | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A | Experimental | Subjects received one dose of PCV13 at 18 years of age and above. |
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| 2A | Experimental | Subjects received one dose of PCV13 at 6~17 years of age. |
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| 3A | Experimental | Subjects received one dose of PCV13 at 2~5 years of age. |
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| 4A | Experimental | Subjects received two doses of PCV13 at 12~23 months of age. |
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| 5A | Experimental | Subjects received three doses of PCV13 at 7~11 months of age. |
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| 6A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine | Biological | 0.5mL, Intramuscular |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Xu, Ph.D. | Contact | +86 27 8798 8585 ext. 8251 | ct@bravovax.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangtan Maternal and Child Health Hospital | Recruiting | Xiangtan | Hunan | China |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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One arm, open label in subjects aged 3 months and above; Randomized, blinded and active comparator in subjects aged 2 months.
Subjects received four doses of PCV13 at 3 months of age. |
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| 6B | Experimental | Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). |
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| 6C | Active Comparator | Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). |
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| 7A | Experimental | Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old). |
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| 7B | Active Comparator | Subjects received four doses of control PCV13 at 2 months of age (At least 6 weeks old). |
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| 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine | Biological | 0.5mL, Intramuscular |
|
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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 |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |