Trial Outcomes & Findings for 13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India (NCT NCT02034877)

NCT ID: NCT02034877

Last Updated: 2016-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1200 participants

Primary outcome timeframe

Within 1 month after 13vPnC vaccination

Results posted on

2016-07-01

Participant Flow

A total of 1200 (200 pediatric and 1000 adult) participants were randomized in the study. Out of the 1000 adult participants, 999 participants and all 200 pediatric participants received vaccination.

Participant milestones

Participant milestones
Measure	13vPnC (Pediatric Participants) Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Overall Study STARTED	200	999
Overall Study COMPLETED	200	993
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC (Pediatric Participants) Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Overall Study Lost to Follow-up	0	3
Overall Study No Longer Willing to Participate	0	3

Baseline Characteristics

13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=999 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.	Total n=1199 Participants Total of all reporting groups
Age, Customized 6 to 11 years	157 Participants n=5 Participants	0 Participants n=7 Participants	157 Participants n=5 Participants
Age, Customized 12 to 17 years	43 Participants n=5 Participants	0 Participants n=7 Participants	43 Participants n=5 Participants
Age, Customized 50 to 64 years	0 Participants n=5 Participants	997 Participants n=7 Participants	997 Participants n=5 Participants
Age, Customized 65 to 84 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	414 Participants n=7 Participants	521 Participants n=5 Participants
Sex: Female, Male Male	93 Participants n=5 Participants	585 Participants n=7 Participants	678 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 month after 13vPnC vaccination

Population: Safety population included all participants who received 1 dose of 13vPnC vaccination.

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=999 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination AEs	0 Percentage of participants	7 Percentage of participants
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination SAEs	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Before 13vPnC vaccination

Population: Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, 'n'=number of participants with valid and determinate assay results for specified serotype.

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.

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=388 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 1 (n=194, 385)	11 Titers Interval 9.6 to 11.8	11 Titers Interval 10.4 to 11.7
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 3 (n=197, 384)	18 Titers Interval 15.3 to 22.2	10 Titers Interval 9.1 to 11.1
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 4 (n=176, 358)	230 Titers Interval 155.8 to 339.2	212 Titers Interval 165.7 to 271.3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 5 (n=199, 383)	19 Titers Interval 16.8 to 20.9	17 Titers Interval 16.5 to 18.3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 6A (n=170, 347)	461 Titers Interval 339.6 to 626.8	304 Titers Interval 255.0 to 363.5
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 6B (n=163, 339)	263 Titers Interval 184.2 to 376.3	331 Titers Interval 266.2 to 410.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 7F (n=160, 363)	742 Titers Interval 585.8 to 940.5	324 Titers Interval 289.0 to 363.9
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 9V (n=183, 369)	2097 Titers Interval 1702.4 to 2582.9	826 Titers Interval 730.8 to 933.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 14 (n=182, 380)	1387 Titers Interval 1091.0 to 1763.0	400 Titers Interval 335.9 to 476.3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 18C (n=154, 374)	216 Titers Interval 138.9 to 336.6	213 Titers Interval 170.7 to 265.8
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 19A (n=195, 383)	62 Titers Interval 47.2 to 80.1	66 Titers Interval 56.4 to 76.2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 19F (n=194, 375)	265 Titers Interval 201.9 to 348.5	115 Titers Interval 97.2 to 136.2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination Serotype 23F (n=184, 379)	84 Titers Interval 58.3 to 121.4	57 Titers Interval 45.5 to 71.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=388 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 4 (n=199, 371)	7860 Titers Interval 7074.0 to 8732.4	6029 Titers Interval 5433.0 to 6691.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 5 (n=200, 354)	286 Titers Interval 232.9 to 351.9	639 Titers Interval 540.5 to 755.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 1 (n=191, 376)	176 Titers Interval 146.1 to 212.7	266 Titers Interval 231.4 to 304.6
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 3 (n=200, 378)	118 Titers Interval 103.7 to 133.6	143 Titers Interval 126.4 to 162.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 6A (n=199, 376)	9247 Titers Interval 8197.4 to 10431.8	6653 Titers Interval 5963.1 to 7423.8
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 6B (n=195, 362)	6755 Titers Interval 6018.5 to 7581.7	7690 Titers Interval 6844.8 to 8640.2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 7F (n=199, 378)	5251 Titers Interval 4787.9 to 5758.1	3211 Titers Interval 2939.4 to 3507.2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 9V (n=197, 375)	7028 Titers Interval 6211.9 to 7951.1	5441 Titers Interval 4954.6 to 5974.5
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 14 (n=197, 379)	7484 Titers Interval 6586.1 to 8503.6	3182 Titers Interval 2789.9 to 3628.6
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 18C (n=198, 360)	8641 Titers Interval 7729.0 to 9661.2	7670 Titers Interval 6818.0 to 8627.4
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 19A (n=197, 380)	1928 Titers Interval 1660.6 to 2238.5	2371 Titers Interval 2092.7 to 2686.6
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 19F (n=200, 368)	3551 Titers Interval 3099.1 to 4069.0	3340 Titers Interval 2937.7 to 3797.3
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination Serotype 23F (n=199, 378)	4419 Titers Interval 3945.7 to 4949.2	5766 Titers Interval 5034.4 to 6604.2

PRIMARY outcome

Timeframe: Before 13vPnC vaccination, 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.

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=388 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 3 (n=197, 374)	6.4 Fold rise Interval 5.23 to 7.8	14.4 Fold rise Interval 12.49 to 16.63
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 4 (n=175, 344)	32.6 Fold rise Interval 21.59 to 49.08	27.6 Fold rise Interval 21.15 to 35.89
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 1 (n=185, 373)	16.3 Fold rise Interval 13.26 to 19.92	24.0 Fold rise Interval 20.79 to 27.64
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 5 (n=199, 351)	15.3 Fold rise Interval 12.15 to 19.26	36.9 Fold rise Interval 31.18 to 43.6
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 6A (n=169, 339)	19.1 Fold rise Interval 13.77 to 26.48	23.1 Fold rise Interval 18.93 to 28.12
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 6B (n=160, 316)	24.9 Fold rise Interval 17.19 to 35.94	24.2 Fold rise Interval 19.35 to 30.27
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 7F (n=160, 354)	7.1 Fold rise Interval 5.52 to 9.05	9.5 Fold rise Interval 8.3 to 10.96
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 9V (n=180, 358)	3.3 Fold rise Interval 2.65 to 4.1	6.6 Fold rise Interval 5.75 to 7.48
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 14 (n=179, 372)	5.5 Fold rise Interval 4.16 to 7.19	7.8 Fold rise Interval 6.33 to 9.7
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 18C (n=153, 350)	41.5 Fold rise Interval 26.82 to 64.25	36.6 Fold rise Interval 28.69 to 46.68
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 19A (n=192, 375)	31.2 Fold rise Interval 23.38 to 41.74	36.3 Fold rise Interval 30.21 to 43.6
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 19F (n=194, 358)	13.3 Fold rise Interval 9.87 to 17.99	29.2 Fold rise Interval 23.64 to 35.98
Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination Serotype 23F (n=183, 371)	53.3 Fold rise Interval 36.17 to 78.4	102.7 Fold rise Interval 81.1 to 130.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=388 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 1 (n=194, 385)	6.7 Percentage of participants Interval 3.6 to 11.2	12.7 Percentage of participants Interval 9.6 to 16.5
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 3 (n=197, 384)	50.8 Percentage of participants Interval 43.6 to 57.9	25.8 Percentage of participants Interval 21.5 to 30.5
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 4 (n=176, 358)	60.2 Percentage of participants Interval 52.6 to 67.5	65.6 Percentage of participants Interval 60.5 to 70.6
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 5 (n=199, 383)	12.1 Percentage of participants Interval 7.9 to 17.4	13.1 Percentage of participants Interval 9.8 to 16.8
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 6A (n=170, 347)	73.5 Percentage of participants Interval 66.2 to 80.0	77.8 Percentage of participants Interval 73.1 to 82.1
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 6B (n=163, 339)	55.8 Percentage of participants Interval 47.9 to 63.6	68.7 Percentage of participants Interval 63.5 to 73.6
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 7F (n=160, 363)	78.1 Percentage of participants Interval 70.9 to 84.3	57.9 Percentage of participants Interval 52.6 to 63.0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 9V (n=183, 369)	90.2 Percentage of participants Interval 84.9 to 94.1	74.5 Percentage of participants Interval 69.8 to 78.9
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 14 (n=182, 380)	91.2 Percentage of participants Interval 86.1 to 94.9	82.1 Percentage of participants Interval 77.9 to 85.8
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 18C (n=154, 374)	50.0 Percentage of participants Interval 41.8 to 58.2	67.6 Percentage of participants Interval 62.6 to 72.4
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 19A (n=195, 383)	62.1 Percentage of participants Interval 54.8 to 68.9	74.2 Percentage of participants Interval 69.5 to 78.5
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 19F (n=194, 375)	66.5 Percentage of participants Interval 59.4 to 73.1	54.4 Percentage of participants Interval 49.2 to 59.5
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination Serotype 23F (n=184, 379)	53.3 Percentage of participants Interval 45.8 to 60.6	54.6 Percentage of participants Interval 49.5 to 59.7

PRIMARY outcome

Timeframe: 1 month after 13vPnC vaccination

Outcome measures

Outcome measures
Measure	13vPnC (Pediatric Participants) n=200 Participants Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=388 Participants Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 1 (n=191, 376)	92.7 Percentage of participants Interval 88.0 to 95.9	94.9 Percentage of participants Interval 92.2 to 96.9
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 3 (n=200, 378)	99.5 Percentage of participants Interval 97.2 to 100.0	95.8 Percentage of participants Interval 93.2 to 97.6
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 4 (n=199, 371)	100.0 Percentage of participants Interval 98.2 to 100.0	100.0 Percentage of participants Interval 99.0 to 100.0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 5 (n=200, 354)	91.0 Percentage of participants Interval 86.1 to 94.6	93.8 Percentage of participants Interval 90.7 to 96.1
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 6A (n=199, 376)	100.0 Percentage of participants Interval 98.2 to 100.0	100.0 Percentage of participants Interval 99.0 to 100.0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 6B (n=195, 362)	100.0 Percentage of participants Interval 98.1 to 100.0	99.7 Percentage of participants Interval 98.5 to 100.0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 7F (n=199, 378)	100.0 Percentage of participants Interval 98.2 to 100.0	99.2 Percentage of participants Interval 97.7 to 99.8
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 9V (n=197, 375)	100.0 Percentage of participants Interval 98.1 to 100.0	99.7 Percentage of participants Interval 98.5 to 100.0
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 14 (n=197, 379)	100.0 Percentage of participants Interval 98.1 to 100.0	98.7 Percentage of participants Interval 96.9 to 99.6
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 18C (n=198, 360)	100.0 Percentage of participants Interval 98.2 to 100.0	99.4 Percentage of participants Interval 98.0 to 99.9
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 19A (n=197, 380)	99.0 Percentage of participants Interval 96.4 to 99.9	99.5 Percentage of participants Interval 98.1 to 99.9
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 19F (n=200, 368)	99.0 Percentage of participants Interval 96.4 to 99.9	98.9 Percentage of participants Interval 97.2 to 99.7
Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination Serotype 23F (n=199, 378)	100.0 Percentage of participants Interval 98.2 to 100.0	98.9 Percentage of participants Interval 97.3 to 99.7

Adverse Events

13vPnC (Pediatric Participants)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

13vPnC (Adult Participants)

Serious events: 0 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Restriction Description: 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	13vPnC (Pediatric Participants) n=200 participants at risk Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.	13vPnC (Adult Participants) n=999 participants at risk Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
Gastrointestinal disorders Nausea	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Vaccination site pain	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	4.6% 46/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Pyrexia	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	2.2% 22/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Fatigue	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.40% 4/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Chills	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.20% 2/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Vaccination site erythema	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.20% 2/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Vaccination site nodule	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.20% 2/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Malaise	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
General disorders Vaccination site induration	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Infections and infestations Viral infection	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.90% 9/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.40% 4/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.40% 4/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.20% 2/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Nervous system disorders Headache	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/200 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)	0.10% 1/999 • Baseline to 1 month after 13vPnC vaccination (up to 42 days)