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| ID | Type | Description | Link |
|---|---|---|---|
| 6096A1-3019 | Other Identifier | Alias Study Number | |
| 2009-017123-26 | EudraCT Number | ||
| 2014-004953-14 | EudraCT Number |
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This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7vPnC (3-, 4-, 5-, 12-Month) | Active Comparator |
| |
| 13vPnC (3-, 4-, 5-, 12-Month) | Experimental |
| |
| 13vPnC (2-, 4-, 6-, 12-Month) | Experimental |
| |
| 13vPnC (3-, 5-, 12-Month) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7-valent Pneumococcal Conjugate Vaccine | Biological | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2. | 1 month after the infant series (6 Months of age) | |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3. | 1 month after the infant series (7 Months of age) | |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2. | 1 month after the infant series (6 Months of age) | |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3. | 1 month after the infant series (7 Months of age) | |
| Percentage of Participants Reporting Adverse Events in Group 1 and Group 2. | Approximately 16 months from the participation into the study to the end of study | |
| Percentage of Participants Reporting Adverse Events in Group 3 and Group 4. | Approximately 16 months from the participation into study to the end of study | |
| Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. | Seven days after each pneumococcal vaccination dose within the period up to 12 months | |
| Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2. | 1 month after the infant series (6 Months of age) | |
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Guanyun County Center for Disease prevention and Control | Guanyun County, | Jiangsu | 222200 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31626050 | Derived | Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine Administered in a 3 + 1 versus 2 + 1 Dose Schedule Among Infants in China. Pediatr Infect Dis J. 2019 Nov;38(11):1150-1158. doi: 10.1097/INF.0000000000002458. | |
| 27254028 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| 13-valent Pnumococcal Conjugate vaccine | Biological | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively |
|
|
| 13-valent Pnumococcal Conjugate vaccine | Biological | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively |
|
|
| 13-valent Pnumococcal Conjugate vaccine | Biological | suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively |
|
|
| Seven days after each pneumococcal vaccination dose within the period up to 12 months |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2. | Seven days after each pneumococcal vaccination dose within the period up to 12 months |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4. | Seven days after each pneumococcal vaccination dose within the period up to 12 months |
| 1 month after the infant series (7 Months of age) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2. | 1 month after the infant series (6 Months of age) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3. | 1 month after the infant series (7 Months of age) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3. | 1 month after the toddler dose (13 Months of age) |
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3. | 1 month after the toddler dose (13 Months of age) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3. | 1 month after the toddler dose (13 Months of age) |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4. | 1 month after the infant series (6 Months of age) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4. | 1 month after the infant series (6 Months of age) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4. | 1 month after the toddler dose (13 Months of age) |
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4. | 1 month after the infant series (6 Months of age) |
| Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4. | 1 month after the toddler dose (13 Months of age) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4. | 1 month after the infant series (6 Months of age) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4. | 1 month after the toddler dose (13 Months of age) |
| Jiangsu Province Huaiyin District Center for Disease prevention and Control |
| Huaian City, |
| Jiangsu |
| 223300 |
| China |
| Jiangsu Province Hongze County Center for Disease prevention and Control | Huaian City | Jiangsu | 223100 | China |
| Jiangsu Province Lianshui County Center for Disease prevention and Control | Lianshui County | Jiangsu | 223400 | China |
| Zhu F, Hu Y, Li J, Ye Q, Young MM Jr, Zhou X, Chen Z, Yan B, Liang JZ, Gruber WC, Giardina PC, Scott DA. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine Compared With 7-valent Pneumococcal Conjugate Vaccine Among Healthy Infants in China. Pediatr Infect Dis J. 2016 Sep;35(9):999-1010. doi: 10.1097/INF.0000000000001248. |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
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