Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6114A1-4001 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw | Procedure | One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | Day 1 (36 months after toddler dose) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants. | Day 1 (36 months after toddler dose) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengxiang Town Hospital | Longan County | Guangxi | 532700 | China | ||
| Longan County CDC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27616471 | Derived | Li R, Fang KX, Young M Jr, Zhou X, Chen Z, Liang JZ, Giardina PC, Scott DA. Long-term antibody persistence study (3 years after last dose) of the 7-valent pneumococcal conjugate vaccine in young children in China. Vaccine. 2016 Oct 17;34(44):5359-5365. doi: 10.1016/j.vaccine.2016.08.070. Epub 2016 Sep 8. |
Not provided
Not provided
No vaccines administered during study. However, participants assessed according to the vaccine group they were assigned to in study 0887X-101518: 7-valent pneumococcal conjugate vaccine (7vPnC) alone (Group 1), 7vPnC given concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) (Group 2), or DTaP alone (Group 3).
All eligible participants who completed a previous study, 0887X-101518 (NCT00488826), were invited to participate in this study, at a timepoint at least 3 years after their last vaccination in study 0887X-101518.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Entire Study Population | All randomized participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Longan County |
| Guangxi |
| 532700 |
| China |
| Nanyu Town Hospital | Longan County | Guangxi | 532701 | China |
| Yanjiang Town Hospital | Longan County | Guangxi | 532702 | China |
| Natong Town Hospital | Longan County | Guangxi | 532703 | China |
| Qiaojian Town Hospital | Longan County | Guangxi | 532707 | China |
| Gutan Village Hospital | Longan County | Guangxi | 532708 | China |
| Dingdang Town Hospital | Longan County | Guangxi | 532709 | China |
| Yangwan Hospital | Longan County | Guangxi | 532715 | China |
| GuangXi Center for Disease Prevention and Control | Nanning | Guangxi | 530028 | China |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All randomized participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. | Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (mcg/mL) | Day 1 (36 months after toddler dose) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL, 36 Months After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). Exact 2-sided CI based on the observed proportion of participants. | Evaluable Immunogenicity population | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (36 months after toddler dose) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entire Study Population | All randomized participants | 0 | 335 | 0 | 335 |
Not provided
Not provided
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
| Serotype 9V |
|
| Serotype 14 |
|
| Serotype 18C |
|
| Serotype 19F |
|
| Serotype 23F |
|
Serotype 6B |
| Ratio of GMCs |
| 0.81 |
| 2-Sided |
| 95 |
| 0.64 |
| 1.04 |
Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). |
| Superiority or Other |
| Serotype 9V | Ratio of GMCs | 0.95 | 2-Sided | 95 | 0.74 | 1.23 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | Superiority or Other |
| Serotype 14 | Ratio of GMCs | 0.67 | 2-Sided | 95 | 0.45 | 1.01 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | Superiority or Other |
| Serotype 18C | Ratio of GMCs | 0.96 | 2-Sided | 95 | 0.70 | 1.31 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | Superiority or Other |
| Serotype 19F | Ratio of GMCs | 0.56 | 2-Sided | 95 | 0.40 | 0.77 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | Superiority or Other |
| Serotype 23F | Ratio of GMCs | 0.82 | 2-Sided | 95 | 0.64 | 1.05 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Group 2-Group 1). | Superiority or Other |
| Serotype 4 | Ratio of GMCs | 1.97 | 2-Sided | 95 | 1.39 | 2.80 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 6B | Ratio of GMCs | 3.04 | 2-Sided | 95 | 2.41 | 3.84 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 9V | Ratio of GMCs | 1.26 | 2-Sided | 95 | 0.98 | 1.62 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 14 | Ratio of GMCs | 6.66 | 2-Sided | 95 | 4.53 | 9.79 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 18C | Ratio of GMCs | 2.34 | 2-Sided | 95 | 1.68 | 3.24 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 19F | Ratio of GMCs | 4.47 | 2-Sided | 95 | 3.29 | 6.07 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
| Serotype 23F | Ratio of GMCs | 2.08 | 2-Sided | 95 | 1.65 | 2.63 | Calculated by back transforming the ratio difference between vaccine groups on logarithmic scale. Back transformations of CIs based on Student t distribution for ratio difference of the logarithms of the measures (Groups 1 and 2 combined-Group 3). | Superiority or Other |
No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3). |
|
|
|