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| Name | Class |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd | INDUSTRY |
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In order to evaluate immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine produced by Beijing Minhai Biotechnology Co., Ltd., a randomized, double-blind, parallel-controlled phase III clinical trial is planned to conduct in healthy infants aged 2 months in China.
There will be two arms. 1200 healthy infants aged 2 months will be randomly assigned (1:1) to receive an experimental vaccine or a comparator vaccine in Month 0,2 and 4 (primary vaccination). All of them will receive a fourth dose as booster vaccination in Month 10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental | Single 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10 |
|
| Prevnar 13 | Active Comparator | Single 0.5 ml dose will be given via intramuscular injection in Month 0,2,4 and 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | 0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after primary vaccination | 30 days after primary vaccination |
| Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination | Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination | 30 days after primary vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after primary vaccination | 30 days after primary vaccination |
| Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination |
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Inclusion Criteria:
Exclusion Criteria for First Vaccination:
Exclusion Criteria for Second/Third and Booster Vaccination:
If one of the following (1) to (3) adverse events (AE) occurs, further vaccination is prohibited, but other study steps can be continued according to the judgment of the investigators; If one of the following (4) to (5) adverse events occurs, the investigator shall determine whether to continue the following vaccination. In the event of one of the following adverse events (6) to (7), vaccination may be postponed within the time window specified in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Provincial Centre for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huaiyin District Center for Diseases Control and Prevention | Huai'an | Jiangsu | 222300 | China | ||
| Hongze District Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34706841 | Derived | Liang Q, Li H, Chang X, Zhang H, Hao H, Ye Q, Li G. A phase 3 clinical trial of MINHAI PCV13 in Chinese children aged from 7 months to 5 years old. Vaccine. 2021 Nov 16;39(47):6947-6955. doi: 10.1016/j.vaccine.2021.09.047. Epub 2021 Oct 24. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| Prevnar 13 | Biological | 0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose |
|
Geometric mean fold increase (GMI) of serotype-specific pneumococcal IgG antibody 30 days after primary vaccination |
| 30 days after primary vaccination |
| Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination | Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after primary vaccination | 30 days after primary vaccination |
| Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination | Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after primary vaccination | 30 days after primary vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 0.35 ug/mL 30 days after booster vaccination | 30 days after booster vaccination |
| Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination | Proportion of subjects with serotype-specific pneumococcal IgG antibody concentration ≥ 1.0 ug/mL 30 days after booster vaccination | 30 days after booster vaccination |
| Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination | Geometric mean concentration (GMC) of serotype-specific pneumococcal IgG antibody 30 days after booster vaccination | 30 days after booster vaccination |
| Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination | Proportion of subjects with serotype-specific geometric mean titer measured by OPA ≥1:8 30 days after booster vaccination | 30 days after booster vaccination |
| Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination | Geometric mean titer (GMT) of serotype-specific pneumococcal IgG antibody measured by OPA 30 days after booster vaccination | 30 days after booster vaccination |
| Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination | Incidence of adverse reactions (including systemic and local adverse reaction) 30 days after each dose of vaccination | 30 days after each dose of vaccination |
| Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination | Incidence of severe adverse event (SAE) within 6 months after the first doseof vaccination | 6 months after the first doseof vaccination |
| Incidence of severe adverse event (SAE) 30 days after booster vaccination | Incidence of severe adverse event (SAE) 30 days after booster vaccination | 30 days after booster vaccination |
| Huai'an |
| Jiangsu |
| China |
| Lianshui County Center for Disease Control and Prevention | Huai'an | Jiangsu | China |
| Guanyun County Center for Disease Control and Prevention | Lianyungang | Jiangsu | China |