An interventional study of PCV13 PAC study in Immunogenicity, Vaccine, sponsored by Pfizer. Completed at 1 site in China. Open to participants aged 5 Months to 60 Months. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Pfizer · Not applicable, Interventional, and Prevention
This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 300 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Infant or child who is a family member of:
This study plan to recruit those young patients who have or not have got PCV13 vaccine before study start
Biological: PCV13 PAC study
To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample.
Time frame: Day 1
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution.
Time frame: Day 1
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier).
Time frame: Day 1
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution.
Time frame: Day 1
Children hospitalized with a diagnosis of clinical pneumonia were considered for the study. Participants participated in the study for 1 day. Participants were followed for 12 hours after blood draw and deep respiratory aspirate if collected as a study procedure. A total of 300 participants were enrolled in this study.
| Milestone | 13vPnC Cohort | Non-13vPnC Cohort |
|---|---|---|
| Started | 101 | 199 |
| Completed | 94 | 183 |
| Not completed | 7 | 16 |
| Withdrew: Protocol violation | 7 | 16 |
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample.
| microgram per milliliter (µg/mL) | 13vPnC Cohort | Non-13vPnC Cohort |
|---|---|---|
| Serotype: 1 | 1.55 (1.17 to 2.06) | 0.12 (0.09 to 0.15) |
| Serotype: 3 | 0.42 (0.32 to 0.54) | 0.07 (0.06 to 0.08) |
| Serotype: 4 | 1.36 (1.00 to 1.84) | 0.08 (0.06 to 0.10) |
| Serotype: 5 | 1.74 (1.41 to 2.15) | 0.72 (0.63 to 0.82) |
| Serotype: 6A | 2.42 (1.85 to 3.15) | 0.38 (0.33 to 0.44) |
| Serotype: 6B | 2.47 (1.90 to 3.22) | 0.37 (0.32 to 0.43) |
| Serotype: 7F | 1.81 (1.41 to 2.32) | 0.19 (0.16 to 0.23) |
| Serotype: 9V | 1.18 (0.96 to 1.46) | 0.30 (0.26 to 0.36) |
| Serotype: 14 | 4.67 (3.40 to 6.42) | 0.08 (0.06 to 0.10) |
| Serotype: 18C | 1.03 (0.79 to 1.34) | 0.06 (0.05 to 0.08) |
| Serotype: 19A | 3.19 (2.50 to 4.07) | 0.75 (0.65 to 0.86) |
| Serotype: 19F | 3.31 (2.53 to 4.31) | 0.38 (0.31 to 0.46) |
| Serotype: 23F | 2.04 (1.56 to 2.68) | 0.25 (0.21 to 0.28) |
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution.
| Titers | 13vPnC Cohort | Non-13vPnC Cohort |
|---|---|---|
| Serotype: 1 | 70.9 (40.8 to 123.3) | 14.8 (9.2 to 24.0) |
| Serotype: 3 | 272.8 (173.9 to 428.0) | 30.1 (18.7 to 48.4) |
| Serotype: 4 | 1148.4 (755.0 to 1746.6) | 79.9 (38.6 to 165.3) |
| Serotype: 5 | 326.5 (197.8 to 538.8) | 18.1 (10.8 to 30.2) |
| Serotype: 6A | 1825.9 (1077.4 to 3094.4) | 53.9 (27.0 to 107.4) |
| Serotype: 6B | 844.8 (489.7 to 1457.4) | 60.1 (31.9 to 113.4) |
| Serotype: 7F | 3791.4 (2495.7 to 5759.6) | 223.2 (115.8 to 430.2) |
| Serotype: 9V | 919.7 (559.9 to 1510.6) | 47.6 (27.2 to 83.3) |
| Serotype: 14 | 1387.9 (921.8 to 2089.8) | 132.7 (66.9 to 263.1) |
| Serotype: 18C | 404.2 (255.9 to 638.5) | 33.3 (19.6 to 56.7) |
| Serotype: 19A | 1046.6 (620.0 to 1766.6) | 44.3 (25.1 to 77.9) |
| Serotype: 19F | 554.2 (344.6 to 891.3) | 31.4 (18.5 to 53.4) |
| Serotype: 23F | 3634.9 (2281.4 to 5791.3) | 81.8 (40.1 to 166.7) |
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier).
| microgram per milliliter (µg/mL) | 13vPnC Cohort: VT+ Subgroup | 13vPnC Cohort: VT- or Sp- Subgroup | Non-13vPnC Cohort: VT+ Subgroup | Non-13vPnC Cohort: VT- or Sp- Subgroup |
|---|---|---|---|---|
| Serotype: 1 | 0.81 (0.28 to 2.33) | 1.69 (1.23 to 2.31) | 0.08 (0.04 to 0.18) | 0.12 (0.09 to 0.16) |
| Serotype: 3 | 0.32 (0.10 to 1.04) | 0.44 (0.33 to 0.58) | 0.05 (0.03 to 0.09) | 0.07 (0.06 to 0.09) |
| Serotype: 4 | 0.97 (0.26 to 3.64) | 1.43 (1.02 to 2.00) | 0.05 (0.02 to 0.11) | 0.07 (0.05 to 0.09) |
| Serotype: 5 | 1.45 (0.51 to 4.15) | 1.77 (1.41 to 2.24) | 0.58 (0.40 to 0.83) | 0.72 (0.61 to 0.85) |
| Serotype: 6A | 1.78 (0.73 to 4.32) | 2.59 (1.93 to 3.48) | 0.34 (0.22 to 0.51) | 0.36 (0.31 to 0.43) |
| Serotype: 6B | 1.94 (0.78 to 4.81) | 2.60 (1.93 to 3.50) | 0.51 (0.31 to 0.84) | 0.33 (0.28 to 0.40) |
| Serotype: 7F | 0.83 (0.36 to 1.92) | 1.97 (1.50 to 2.59) | 0.14 (0.07 to 0.29) | 0.19 (0.15 to 0.23) |
| Serotype: 9V | 0.97 (0.37 to 2.53) | 1.21 (0.96 to 1.54) | 0.22 (0.10 to 0.46) | 0.30 (0.25 to 0.36) |
| Serotype: 14 | 3.29 (0.49 to 21.91) | 4.96 (3.54 to 6.94) | 0.04 (0.02 to 0.09) | 0.08 (0.06 to 0.12) |
| Serotype: 18C | 0.65 (0.30 to 1.44) | 1.08 (0.81 to 1.45) | 0.04 (0.02 to 0.09) | 0.06 (0.05 to 0.08) |
| Serotype: 19A | 4.69 (2.35 to 9.38) | 3.02 (2.30 to 3.97) | 0.58 (0.37 to 0.90) | 0.74 (0.63 to 0.86) |
| Serotype: 19F | 5.80 (1.41 to 23.82) | 3.22 (2.41 to 4.28) | 0.38 (0.21 to 0.68) | 0.33 (0.26 to 0.42) |
| Serotype: 23F | 1.04 (0.47 to 2.32) | 2.23 (1.65 to 3.02) | 0.25 (0.15 to 0.40) | 0.23 (0.20 to 0.27) |
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution.
| Titers | 13vPnC Cohort: VT+ Subgroup | 13vPnC Cohort: VT- or Sp- Subgroup | Non-13vPnC Cohort: VT+ Subgroup | Non-13vPnC Cohort: VT- or Sp- Subgroup |
|---|---|---|---|---|
| Serotype: 1 | 35.0 (2.2 to 547.7) | 71.1 (38.4 to 131.4) | 11.1 (4.1 to 30.5) | 14.6 (8.4 to 25.4) |
| Serotype: 3 | 146.6 (35.6 to 602.7) | 273.7 (163.5 to 458.2) | 29.2 (14.0 to 61.0) | 28.6 (16.3 to 50.1) |
| Serotype: 4 | 522.0 (165.0 to 1651.2) | 1154.4 (726.1 to 1835.4) | 38.1 (6.7 to 216.9) | 86.1 (37.4 to 198.3) |
| Serotype: 5 | 539.5 (41.4 to 7035.5) | 302.7 (173.2 to 529.0) | 11.1 (3.6 to 34.7) | 17.6 (9.9 to 31.4) |
| Serotype: 6A | 482.4 (31.8 to 7306.4) | 2110.3 (1176.4 to 3785.6) | 46.1 (5.8 to 366.1) | 52.5 (23.7 to 116.2) |
| Serotype: 6B | 69.4 (1.4 to 3480.8) | 1099.1 (639.5 to 1889.0) | 102.7 (14.2 to 742.0) | 53.9 (26.4 to 110.3) |
| Serotype: 7F | 4661.3 (2222.1 to 9777.9) | 3837.7 (2367.8 to 6220.2) | 442.5 (87.9 to 2228.3) | 180.8 (84.0 to 389.4) |
| Serotype: 9V | 215.9 (6.7 to 6985.7) | 1074.9 (637.7 to 1811.9) | 65.0 (13.3 to 318.0) | 45.3 (23.7 to 86.6) |
| Serotype: 14 | 578.9 (89.2 to 3755.8) | 1617.3 (1046.6 to 2499.2) | 289.1 (22.7 to 3682.3) | 125.9 (59.7 to 265.4) |
| Serotype: 18C | 364.1 (83.5 to 1587.8) | 443.2 (265.2 to 740.7) | 22.3 (5.3 to 93.2) | 34.4 (19.2 to 61.8) |
| Serotype: 19A | 1515.6 (296.4 to 7750.1) | 1122.7 (622.0 to 2026.5) | 62.7 (8.6 to 456.6) | 41.6 (22.1 to 78.3) |
| Serotype: 19F | 1830.0 (240.5 to 13924.9) | 472.7 (279.4 to 799.7) | 19.3 (5.5 to 67.5) | 30.4 (16.6 to 55.7) |
| Serotype: 23F | 1092.5 (140.0 to 8523.4) | 4111.0 (2442.0 to 6920.7) | 104.1 (14.5 to 746.9) | 84.4 (37.3 to 190.9) |
Collected over From the time of the blood draw or aspirate collection through and including 12 hours on Day 1. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13vPnC Cohort | 0/101 (0%) | 0/101 (0%) | 0/101 (0%) |
| Non-13vPnC Cohort | 0/199 (0%) | 0/199 (0%) | 0/199 (0%) |
Analysis population for baseline characteristics included all participants who signed the informed consent document.
| Age, Customized(Participants) | 13vPnC Cohort | Non-13vPnC Cohort | Total |
|---|---|---|---|
| <=4 months | 1 | 0 | 1 |
| 5-12 months | 27 | 50 | 77 |
| 13-24 months | 39 | 49 | 88 |
| 25-60 months | 34 | 100 | 134 |
| Sex: Female, Male(Participants) | 13vPnC Cohort | Non-13vPnC Cohort | Total |
|---|---|---|---|
| Female | 48 | 94 | 142 |
| Male | 53 | 105 | 158 |
| Race/Ethnicity, Customized(Participants) | 13vPnC Cohort | Non-13vPnC Cohort | Total |
|---|---|---|---|
| Race — Asian | 101 | 199 | 300 |
| Race/Ethnicity, Customized(Participants) | 13vPnC Cohort | Non-13vPnC Cohort | Total |
|---|---|---|---|
| Ethnicity — Non-Hispanic/non-Latino | 101 | 199 | 300 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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