Trial Outcomes & Findings for A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS (NCT NCT05372575)

NCT ID: NCT05372575

Last Updated: 2023-10-03

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

Day 1

Results posted on

2023-10-03

Participant Flow

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.

No vaccines were administered during the study.

Participant milestones

Participant milestones
Measure	13vPnC Cohort The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.
Overall Study STARTED	101	199
Overall Study COMPLETED	94	183
Overall Study NOT COMPLETED	7	16

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC Cohort The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.
Overall Study Protocol Violation	7	16

Baseline Characteristics

A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC Cohort n=101 Participants The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort n=199 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.	Total n=300 Participants Total of all reporting groups
Age, Customized <=4 months	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 5-12 months	27 Participants n=5 Participants	50 Participants n=7 Participants	77 Participants n=5 Participants
Age, Customized 13-24 months	39 Participants n=5 Participants	49 Participants n=7 Participants	88 Participants n=5 Participants
Age, Customized 25-60 months	34 Participants n=5 Participants	100 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	94 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	105 Participants n=7 Participants	158 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	101 Participants n=5 Participants	199 Participants n=7 Participants	300 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic/non-Latino	101 Participants n=5 Participants	199 Participants n=7 Participants	300 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Analysis population for this outcome measure (OM) included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.

Outcome measures

Outcome measures
Measure	13vPnC Cohort n=92 Participants The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort n=184 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort: VT+ Subgroup The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had a 13vPnC VT strain isolated from the respiratory tract (VT+). No vaccines were administered during the study.	Non-13vPnC Cohort: VT- or Sp- Subgroup The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had no 13vPnC VT strain isolated from the respiratory tract (VT-) or had negative S. pneumoniae (Sp-). No vaccines were administered during the study.
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 7F	1.81 microgram per milliliter (µg/mL) Interval 1.41 to 2.32	0.19 microgram per milliliter (µg/mL) Interval 0.16 to 0.23	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 19A	3.19 microgram per milliliter (µg/mL) Interval 2.5 to 4.07	0.75 microgram per milliliter (µg/mL) Interval 0.65 to 0.86	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 19F	3.31 microgram per milliliter (µg/mL) Interval 2.53 to 4.31	0.38 microgram per milliliter (µg/mL) Interval 0.31 to 0.46	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 1	1.55 microgram per milliliter (µg/mL) Interval 1.17 to 2.06	0.12 microgram per milliliter (µg/mL) Interval 0.09 to 0.15	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 3	0.42 microgram per milliliter (µg/mL) Interval 0.32 to 0.54	0.07 microgram per milliliter (µg/mL) Interval 0.06 to 0.08	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 4	1.36 microgram per milliliter (µg/mL) Interval 1.0 to 1.84	0.08 microgram per milliliter (µg/mL) Interval 0.06 to 0.1	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 5	1.74 microgram per milliliter (µg/mL) Interval 1.41 to 2.15	0.72 microgram per milliliter (µg/mL) Interval 0.63 to 0.82	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 6A	2.42 microgram per milliliter (µg/mL) Interval 1.85 to 3.15	0.38 microgram per milliliter (µg/mL) Interval 0.33 to 0.44	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 6B	2.47 microgram per milliliter (µg/mL) Interval 1.9 to 3.22	0.37 microgram per milliliter (µg/mL) Interval 0.32 to 0.43	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 9V	1.18 microgram per milliliter (µg/mL) Interval 0.96 to 1.46	0.30 microgram per milliliter (µg/mL) Interval 0.26 to 0.36	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 14	4.67 microgram per milliliter (µg/mL) Interval 3.4 to 6.42	0.08 microgram per milliliter (µg/mL) Interval 0.06 to 0.1	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 18C	1.03 microgram per milliliter (µg/mL) Interval 0.79 to 1.34	0.06 microgram per milliliter (µg/mL) Interval 0.05 to 0.08	—	—
Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort Serotype: 23F	2.04 microgram per milliliter (µg/mL) Interval 1.56 to 2.68	0.25 microgram per milliliter (µg/mL) Interval 0.21 to 0.28	—	—

PRIMARY outcome

Timeframe: Day 1

Population: Analysis population for this OM included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.

Outcome measures

Outcome measures
Measure	13vPnC Cohort n=92 Participants The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort n=184 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort: VT+ Subgroup The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had a 13vPnC VT strain isolated from the respiratory tract (VT+). No vaccines were administered during the study.	Non-13vPnC Cohort: VT- or Sp- Subgroup The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had no 13vPnC VT strain isolated from the respiratory tract (VT-) or had negative S. pneumoniae (Sp-). No vaccines were administered during the study.
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 7F	3791.4 Titers Interval 2495.7 to 5759.6	223.2 Titers Interval 115.8 to 430.2	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 1	70.9 Titers Interval 40.8 to 123.3	14.8 Titers Interval 9.2 to 24.0	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 3	272.8 Titers Interval 173.9 to 428.0	30.1 Titers Interval 18.7 to 48.4	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 4	1148.4 Titers Interval 755.0 to 1746.6	79.9 Titers Interval 38.6 to 165.3	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 5	326.5 Titers Interval 197.8 to 538.8	18.1 Titers Interval 10.8 to 30.2	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 6A	1825.9 Titers Interval 1077.4 to 3094.4	53.9 Titers Interval 27.0 to 107.4	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 6B	844.8 Titers Interval 489.7 to 1457.4	60.1 Titers Interval 31.9 to 113.4	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 9V	919.7 Titers Interval 559.9 to 1510.6	47.6 Titers Interval 27.2 to 83.3	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 14	1387.9 Titers Interval 921.8 to 2089.8	132.7 Titers Interval 66.9 to 263.1	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 18C	404.2 Titers Interval 255.9 to 638.5	33.3 Titers Interval 19.6 to 56.7	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 19A	1046.6 Titers Interval 620.0 to 1766.6	44.3 Titers Interval 25.1 to 77.9	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 19F	554.2 Titers Interval 344.6 to 891.3	31.4 Titers Interval 18.5 to 53.4	—	—
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort Serotype: 23F	3634.9 Titers Interval 2281.4 to 5791.3	81.8 Titers Interval 40.1 to 166.7	—	—

PRIMARY outcome

Timeframe: Day 1

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).

Outcome measures

Outcome measures
Measure	13vPnC Cohort n=7 Participants The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort n=79 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort: VT+ Subgroup n=20 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had a 13vPnC VT strain isolated from the respiratory tract (VT+). No vaccines were administered during the study.	Non-13vPnC Cohort: VT- or Sp- Subgroup n=140 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had no 13vPnC VT strain isolated from the respiratory tract (VT-) or had negative S. pneumoniae (Sp-). No vaccines were administered during the study.
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 3	0.32 microgram per milliliter (µg/mL) Interval 0.1 to 1.04	0.44 microgram per milliliter (µg/mL) Interval 0.33 to 0.58	0.05 microgram per milliliter (µg/mL) Interval 0.03 to 0.09	0.07 microgram per milliliter (µg/mL) Interval 0.06 to 0.09
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 4	0.97 microgram per milliliter (µg/mL) Interval 0.26 to 3.64	1.43 microgram per milliliter (µg/mL) Interval 1.02 to 2.0	0.05 microgram per milliliter (µg/mL) Interval 0.02 to 0.11	0.07 microgram per milliliter (µg/mL) Interval 0.05 to 0.09
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 5	1.45 microgram per milliliter (µg/mL) Interval 0.51 to 4.15	1.77 microgram per milliliter (µg/mL) Interval 1.41 to 2.24	0.58 microgram per milliliter (µg/mL) Interval 0.4 to 0.83	0.72 microgram per milliliter (µg/mL) Interval 0.61 to 0.85
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 6A	1.78 microgram per milliliter (µg/mL) Interval 0.73 to 4.32	2.59 microgram per milliliter (µg/mL) Interval 1.93 to 3.48	0.34 microgram per milliliter (µg/mL) Interval 0.22 to 0.51	0.36 microgram per milliliter (µg/mL) Interval 0.31 to 0.43
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 6B	1.94 microgram per milliliter (µg/mL) Interval 0.78 to 4.81	2.60 microgram per milliliter (µg/mL) Interval 1.93 to 3.5	0.51 microgram per milliliter (µg/mL) Interval 0.31 to 0.84	0.33 microgram per milliliter (µg/mL) Interval 0.28 to 0.4
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 7F	0.83 microgram per milliliter (µg/mL) Interval 0.36 to 1.92	1.97 microgram per milliliter (µg/mL) Interval 1.5 to 2.59	0.14 microgram per milliliter (µg/mL) Interval 0.07 to 0.29	0.19 microgram per milliliter (µg/mL) Interval 0.15 to 0.23
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 9V	0.97 microgram per milliliter (µg/mL) Interval 0.37 to 2.53	1.21 microgram per milliliter (µg/mL) Interval 0.96 to 1.54	0.22 microgram per milliliter (µg/mL) Interval 0.1 to 0.46	0.30 microgram per milliliter (µg/mL) Interval 0.25 to 0.36
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 14	3.29 microgram per milliliter (µg/mL) Interval 0.49 to 21.91	4.96 microgram per milliliter (µg/mL) Interval 3.54 to 6.94	0.04 microgram per milliliter (µg/mL) Interval 0.02 to 0.09	0.08 microgram per milliliter (µg/mL) Interval 0.06 to 0.12
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 18C	0.65 microgram per milliliter (µg/mL) Interval 0.3 to 1.44	1.08 microgram per milliliter (µg/mL) Interval 0.81 to 1.45	0.04 microgram per milliliter (µg/mL) Interval 0.02 to 0.09	0.06 microgram per milliliter (µg/mL) Interval 0.05 to 0.08
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 23F	1.04 microgram per milliliter (µg/mL) Interval 0.47 to 2.32	2.23 microgram per milliliter (µg/mL) Interval 1.65 to 3.02	0.25 microgram per milliliter (µg/mL) Interval 0.15 to 0.4	0.23 microgram per milliliter (µg/mL) Interval 0.2 to 0.27
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 1	0.81 microgram per milliliter (µg/mL) Interval 0.28 to 2.33	1.69 microgram per milliliter (µg/mL) Interval 1.23 to 2.31	0.08 microgram per milliliter (µg/mL) Interval 0.04 to 0.18	0.12 microgram per milliliter (µg/mL) Interval 0.09 to 0.16
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 19A	4.69 microgram per milliliter (µg/mL) Interval 2.35 to 9.38	3.02 microgram per milliliter (µg/mL) Interval 2.3 to 3.97	0.58 microgram per milliliter (µg/mL) Interval 0.37 to 0.9	0.74 microgram per milliliter (µg/mL) Interval 0.63 to 0.86
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis Serotype: 19F	5.80 microgram per milliliter (µg/mL) Interval 1.41 to 23.82	3.22 microgram per milliliter (µg/mL) Interval 2.41 to 4.28	0.38 microgram per milliliter (µg/mL) Interval 0.21 to 0.68	0.33 microgram per milliliter (µg/mL) Interval 0.26 to 0.42

PRIMARY outcome

Timeframe: Day 1

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.

Outcome measures

Outcome measures
Measure	13vPnC Cohort n=7 Participants The vaccination history of 13-valent pneumococcal conjugate vaccine (13vPnC) initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this participant was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort n=79 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.	Non-13vPnC Cohort: VT+ Subgroup n=20 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had a 13vPnC VT strain isolated from the respiratory tract (VT+). No vaccines were administered during the study.	Non-13vPnC Cohort: VT- or Sp- Subgroup n=140 Participants The vaccination history of 13vPnC initially was obtained either from the participant's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this participant was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Participants in this subgroup had no 13vPnC VT strain isolated from the respiratory tract (VT-) or had negative S. pneumoniae (Sp-). No vaccines were administered during the study.
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 19A	1515.6 Titers Interval 296.4 to 7750.1	1122.7 Titers Interval 622.0 to 2026.5	62.7 Titers Interval 8.6 to 456.6	41.6 Titers Interval 22.1 to 78.3
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 1	35.0 Titers Interval 2.2 to 547.7	71.1 Titers Interval 38.4 to 131.4	11.1 Titers Interval 4.1 to 30.5	14.6 Titers Interval 8.4 to 25.4
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 3	146.6 Titers Interval 35.6 to 602.7	273.7 Titers Interval 163.5 to 458.2	29.2 Titers Interval 14.0 to 61.0	28.6 Titers Interval 16.3 to 50.1
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 4	522.0 Titers Interval 165.0 to 1651.2	1154.4 Titers Interval 726.1 to 1835.4	38.1 Titers Interval 6.7 to 216.9	86.1 Titers Interval 37.4 to 198.3
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 5	539.5 Titers Interval 41.4 to 7035.5	302.7 Titers Interval 173.2 to 529.0	11.1 Titers Interval 3.6 to 34.7	17.6 Titers Interval 9.9 to 31.4
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 6A	482.4 Titers Interval 31.8 to 7306.4	2110.3 Titers Interval 1176.4 to 3785.6	46.1 Titers Interval 5.8 to 366.1	52.5 Titers Interval 23.7 to 116.2
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 6B	69.4 Titers Interval 1.4 to 3480.8	1099.1 Titers Interval 639.5 to 1889.0	102.7 Titers Interval 14.2 to 742.0	53.9 Titers Interval 26.4 to 110.3
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 7F	4661.3 Titers Interval 2222.1 to 9777.9	3837.7 Titers Interval 2367.8 to 6220.2	442.5 Titers Interval 87.9 to 2228.3	180.8 Titers Interval 84.0 to 389.4
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 9V	215.9 Titers Interval 6.7 to 6985.7	1074.9 Titers Interval 637.7 to 1811.9	65.0 Titers Interval 13.3 to 318.0	45.3 Titers Interval 23.7 to 86.6
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 14	578.9 Titers Interval 89.2 to 3755.8	1617.3 Titers Interval 1046.6 to 2499.2	289.1 Titers Interval 22.7 to 3682.3	125.9 Titers Interval 59.7 to 265.4
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 18C	364.1 Titers Interval 83.5 to 1587.8	443.2 Titers Interval 265.2 to 740.7	22.3 Titers Interval 5.3 to 93.2	34.4 Titers Interval 19.2 to 61.8
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 19F	1830.0 Titers Interval 240.5 to 13924.9	472.7 Titers Interval 279.4 to 799.7	19.3 Titers Interval 5.5 to 67.5	30.4 Titers Interval 16.6 to 55.7
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis Serotype: 23F	1092.5 Titers Interval 140.0 to 8523.4	4111.0 Titers Interval 2442.0 to 6920.7	104.1 Titers Interval 14.5 to 746.9	84.4 Titers Interval 37.3 to 190.9

Adverse Events

13vPnC Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-13vPnC Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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 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