A Phase 4 interventional study of 13-valent Pneumococcal conjugate vaccine and Blood sample collection in Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC, sponsored by Pfizer. Completed at 16 sites in India. Open to participants aged 6 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-01.
Sponsored by Pfizer · Phase 4, Interventional, and Prevention
This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.
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Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.
Exclusion Criteria:
Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year
Biological: 13-valent Pneumococcal conjugate vaccine · Procedure: Blood sample collection
1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
10 mL of blood will be collected just before and approximately 1 month after vaccination.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Time frame: Within 1 month after 13vPnC vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: 1 month after 13vPnC vaccination
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination
GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: Before 13vPnC vaccination
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
Time frame: 1 month after 13vPnC vaccination
| Milestone | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Started | 200 | 999 |
| Completed | 200 | 993 |
| Not completed | 0 | 6 |
| Withdrew: Lost to follow-up | 0 | 3 |
| Withdrew: No longer willing to participate | 0 | 3 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.
| Percentage of participants | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| AEs | 0 | 7 |
| SAEs | 0 | 0 |
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
| Titers | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Serotype 1 (n=194, 385) | 11 (9.6 to 11.8) | 11 (10.4 to 11.7) |
| Serotype 3 (n=197, 384) | 18 (15.3 to 22.2) | 10 (9.1 to 11.1) |
| Serotype 4 (n=176, 358) | 230 (155.8 to 339.2) | 212 (165.7 to 271.3) |
| Serotype 5 (n=199, 383) | 19 (16.8 to 20.9) | 17 (16.5 to 18.3) |
| Serotype 6A (n=170, 347) | 461 (339.6 to 626.8) | 304 (255.0 to 363.5) |
| Serotype 6B (n=163, 339) | 263 (184.2 to 376.3) | 331 (266.2 to 410.4) |
| Serotype 7F (n=160, 363) | 742 (585.8 to 940.5) | 324 (289.0 to 363.9) |
| Serotype 9V (n=183, 369) | 2097 (1702.4 to 2582.9) | 826 (730.8 to 933.4) |
| Serotype 14 (n=182, 380) | 1387 (1091.0 to 1763.0) | 400 (335.9 to 476.3) |
| Serotype 18C (n=154, 374) | 216 (138.9 to 336.6) | 213 (170.7 to 265.8) |
| Serotype 19A (n=195, 383) | 62 (47.2 to 80.1) | 66 (56.4 to 76.2) |
| Serotype 19F (n=194, 375) | 265 (201.9 to 348.5) | 115 (97.2 to 136.2) |
| Serotype 23F (n=184, 379) | 84 (58.3 to 121.4) | 57 (45.5 to 71.3) |
Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
| Titers | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Serotype 1 (n=191, 376) | 176 (146.1 to 212.7) | 266 (231.4 to 304.6) |
| Serotype 3 (n=200, 378) | 118 (103.7 to 133.6) | 143 (126.4 to 162.4) |
| Serotype 4 (n=199, 371) | 7860 (7074.0 to 8732.4) | 6029 (5433.0 to 6691.4) |
| Serotype 5 (n=200, 354) | 286 (232.9 to 351.9) | 639 (540.5 to 755.4) |
| Serotype 6A (n=199, 376) | 9247 (8197.4 to 10431.8) | 6653 (5963.1 to 7423.8) |
| Serotype 6B (n=195, 362) | 6755 (6018.5 to 7581.7) | 7690 (6844.8 to 8640.2) |
| Serotype 7F (n=199, 378) | 5251 (4787.9 to 5758.1) | 3211 (2939.4 to 3507.2) |
| Serotype 9V (n=197, 375) | 7028 (6211.9 to 7951.1) | 5441 (4954.6 to 5974.5) |
| Serotype 14 (n=197, 379) | 7484 (6586.1 to 8503.6) | 3182 (2789.9 to 3628.6) |
| Serotype 18C (n=198, 360) | 8641 (7729.0 to 9661.2) | 7670 (6818.0 to 8627.4) |
| Serotype 19A (n=197, 380) | 1928 (1660.6 to 2238.5) | 2371 (2092.7 to 2686.6) |
| Serotype 19F (n=200, 368) | 3551 (3099.1 to 4069.0) | 3340 (2937.7 to 3797.3) |
| Serotype 23F (n=199, 378) | 4419 (3945.7 to 4949.2) | 5766 (5034.4 to 6604.2) |
GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
| Fold rise | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Serotype 1 (n=185, 373) | 16.3 (13.26 to 19.92) | 24.0 (20.79 to 27.64) |
| Serotype 3 (n=197, 374) | 6.4 (5.23 to 7.80) | 14.4 (12.49 to 16.63) |
| Serotype 4 (n=175, 344) | 32.6 (21.59 to 49.08) | 27.6 (21.15 to 35.89) |
| Serotype 5 (n=199, 351) | 15.3 (12.15 to 19.26) | 36.9 (31.18 to 43.60) |
| Serotype 6A (n=169, 339) | 19.1 (13.77 to 26.48) | 23.1 (18.93 to 28.12) |
| Serotype 6B (n=160, 316) | 24.9 (17.19 to 35.94) | 24.2 (19.35 to 30.27) |
| Serotype 7F (n=160, 354) | 7.1 (5.52 to 9.05) | 9.5 (8.30 to 10.96) |
| Serotype 9V (n=180, 358) | 3.3 (2.65 to 4.10) | 6.6 (5.75 to 7.48) |
| Serotype 14 (n=179, 372) | 5.5 (4.16 to 7.19) | 7.8 (6.33 to 9.70) |
| Serotype 18C (n=153, 350) | 41.5 (26.82 to 64.25) | 36.6 (28.69 to 46.68) |
| Serotype 19A (n=192, 375) | 31.2 (23.38 to 41.74) | 36.3 (30.21 to 43.60) |
| Serotype 19F (n=194, 358) | 13.3 (9.87 to 17.99) | 29.2 (23.64 to 35.98) |
| Serotype 23F (n=183, 371) | 53.3 (36.17 to 78.40) | 102.7 (81.10 to 130.10) |
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
| Percentage of participants | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Serotype 1 (n=194, 385) | 6.7 (3.6 to 11.2) | 12.7 (9.6 to 16.5) |
| Serotype 3 (n=197, 384) | 50.8 (43.6 to 57.9) | 25.8 (21.5 to 30.5) |
| Serotype 4 (n=176, 358) | 60.2 (52.6 to 67.5) | 65.6 (60.5 to 70.6) |
| Serotype 5 (n=199, 383) | 12.1 (7.9 to 17.4) | 13.1 (9.8 to 16.8) |
| Serotype 6A (n=170, 347) | 73.5 (66.2 to 80.0) | 77.8 (73.1 to 82.1) |
| Serotype 6B (n=163, 339) | 55.8 (47.9 to 63.6) | 68.7 (63.5 to 73.6) |
| Serotype 7F (n=160, 363) | 78.1 (70.9 to 84.3) | 57.9 (52.6 to 63.0) |
| Serotype 9V (n=183, 369) | 90.2 (84.9 to 94.1) | 74.5 (69.8 to 78.9) |
| Serotype 14 (n=182, 380) | 91.2 (86.1 to 94.9) | 82.1 (77.9 to 85.8) |
| Serotype 18C (n=154, 374) | 50.0 (41.8 to 58.2) | 67.6 (62.6 to 72.4) |
| Serotype 19A (n=195, 383) | 62.1 (54.8 to 68.9) | 74.2 (69.5 to 78.5) |
| Serotype 19F (n=194, 375) | 66.5 (59.4 to 73.1) | 54.4 (49.2 to 59.5) |
| Serotype 23F (n=184, 379) | 53.3 (45.8 to 60.6) | 54.6 (49.5 to 59.7) |
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.
| Percentage of participants | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Serotype 1 (n=191, 376) | 92.7 (88.0 to 95.9) | 94.9 (92.2 to 96.9) |
| Serotype 3 (n=200, 378) | 99.5 (97.2 to 100.0) | 95.8 (93.2 to 97.6) |
| Serotype 4 (n=199, 371) | 100.0 (98.2 to 100.0) | 100.0 (99.0 to 100.0) |
| Serotype 5 (n=200, 354) | 91.0 (86.1 to 94.6) | 93.8 (90.7 to 96.1) |
| Serotype 6A (n=199, 376) | 100.0 (98.2 to 100.0) | 100.0 (99.0 to 100.0) |
| Serotype 6B (n=195, 362) | 100.0 (98.1 to 100.0) | 99.7 (98.5 to 100.0) |
| Serotype 7F (n=199, 378) | 100.0 (98.2 to 100.0) | 99.2 (97.7 to 99.8) |
| Serotype 9V (n=197, 375) | 100.0 (98.1 to 100.0) | 99.7 (98.5 to 100.0) |
| Serotype 14 (n=197, 379) | 100.0 (98.1 to 100.0) | 98.7 (96.9 to 99.6) |
| Serotype 18C (n=198, 360) | 100.0 (98.2 to 100.0) | 99.4 (98.0 to 99.9) |
| Serotype 19A (n=197, 380) | 99.0 (96.4 to 99.9) | 99.5 (98.1 to 99.9) |
| Serotype 19F (n=200, 368) | 99.0 (96.4 to 99.9) | 98.9 (97.2 to 99.7) |
| Serotype 23F (n=199, 378) | 100.0 (98.2 to 100.0) | 98.9 (97.3 to 99.7) |
Collected over Baseline to 1 month after 13vPnC vaccination (up to 42 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13vPnC (Pediatric Participants) | — | 0/200 (0%) | 0/200 (0%) |
| 13vPnC (Adult Participants) | — | 0/999 (0%) | 70/999 (7%) |
| Event | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) |
|---|---|---|
| Vaccination site painGeneral disorders | 0/200 | 46/999 |
| PyrexiaGeneral disorders | 0/200 | 22/999 |
| Joint range of motion decreasedMusculoskeletal and connective tissue disorders | 0/200 | 9/999 |
| FatigueGeneral disorders | 0/200 | 4/999 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/200 | 4/999 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/200 | 4/999 |
| ChillsGeneral disorders | 0/200 | 2/999 |
| Vaccination site erythemaGeneral disorders | 0/200 | 2/999 |
| Vaccination site noduleGeneral disorders | 0/200 | 2/999 |
| Limb discomfortMusculoskeletal and connective tissue disorders | 0/200 | 2/999 |
Safety population included all participants who received 1 dose of 13vPnC vaccination.
| Age, Customized(Participants) | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) | Total |
|---|---|---|---|
| 6 to 11 years | 157 | 0 | 157 |
| 12 to 17 years | 43 | 0 | 43 |
| 50 to 64 years | 0 | 997 | 997 |
| 65 to 84 years | 0 | 2 | 2 |
| Sex: Female, Male(Participants) | 13vPnC (Pediatric Participants) | 13vPnC (Adult Participants) | Total |
|---|---|---|---|
| Female | 107 | 414 | 521 |
| Male | 93 | 585 | 678 |
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