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Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00963235
Enrollment
331
Registered
2009-08-21
Start date
2009-11-30
Completion date
2012-05-31
Last updated
2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Pneumococcal Infections

Keywords

vaccine, 13-valent pneumococcal conjugate vaccine, human immunodeficiency virus

Brief summary

The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.

Interventions

BIOLOGICAL13-valent pneumococcal conjugate vaccine

Three doses of 13vPnC given 6 months apart.

PROCEDUREBlood draw

Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male or female subjects aged 18 years or older at the time of enrollment. * All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product. * Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment. * CD4+ T-cell count \>= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination. * HIV-infected subjects with viral load \<50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination. * Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy. * Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone. * Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation. * Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)

Exclusion criteria

* Subjects with active AIDS related illness, including opportunistic infections or malignancy. * Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives.. * Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment. * Contraindication to vaccination with pneumococcal conjugate vaccine. * Previous anaphylactic reaction to any vaccine or vaccine-related component. * History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year. * Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.) * Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test. * History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \>5 times the upper limit of normal within the last 6 months. * Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease). * Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response. * History of splenectomy. * Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination). * Evidence of dementia or other severe cognitive impairment. * Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass. * Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.) * Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial. * Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel. Temporary Delay Criteria: * Current febrile illness (oral temperature of =38.0°C \[100.4°F\]) or other acute illness within 48 hours before study vaccine administration. * Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration. * Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator).

Design outcomes

Primary

MeasureTime frameDescription
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC1 month post-dose 2, 1 month post-dose 3Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Secondary

MeasureTime frameDescription
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC1 month post-dose 2, 1 month post-dose 3Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC1 month post-dose 1, 1 month post-dose 2Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC1 month post-dose 2, 1 month post-dose 3Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC1 month post-dose 1, 1 month post-dose 2Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC1 month post-dose 2, 1 month post-dose 3GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC1 month post-dose 1, 1 month post-dose 2GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Other

MeasureTime frameDescription
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Within 14 days post-dose 2Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Within 14 days post-dose 3Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Within 14 days post-dose 1Specific systemic events (fever greater than or equal to \[\>=\]38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours \[hrs\]); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs). Report of fever \>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Within 14 days post-dose 2Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).
Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Within 14 days post-dose 3Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).
Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Within 14 days post-dose 1Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.5 to 10.0 cm); Severe (greater than \[\>\] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

Countries

United States

Participant flow

Participants by arm

ArmCount
13vPnC
Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
329
Total329

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event5
Overall StudyFailed to return9
Overall StudyLost to Follow-up14
Overall StudyOther1
Overall StudyPhysician Decision2
Overall StudyProtocol Violation7
Overall StudyWithdrawal by Subject22

Baseline characteristics

Characteristic13vPnC
Age Continuous47.3 years
STANDARD_DEVIATION 9.1
Sex: Female, Male
Female
66 Participants
Sex: Female, Male
Male
263 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
244 / 329196 / 300169 / 27830 / 329
serious
Total, serious adverse events
24 / 32914 / 3004 / 27810 / 329

Outcome results

Primary

Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC

Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Time frame: 1 month post-dose 2, 1 month post-dose 3

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 31.01 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 41.01 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 23F1.25 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 10.94 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 50.99 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 6A1.19 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 6B1.21 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 7F1.07 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 9V1.08 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 141.08 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 18C1.09 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 19A1.03 fold rise
13vPnCGeometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 19F1.17 fold rise
Secondary

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 1 and post-dose 2 blood draws.

Time frame: 1 month post-dose 1, 1 month post-dose 2

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 3: Dose 20.57 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 4: Dose 11.37 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 4: Dose 21.64 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 5: Dose 12.90 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6B: Dose 24.47 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 7F: Dose 23.41 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 9V: Dose 12.63 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 9V: Dose 22.99 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 18C: Dose 22.68 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19A: Dose 27.63 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 1: Dose 12.15 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 1: Dose 22.36 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 3: Dose 10.48 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 5: Dose 23.29 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6A: Dose 12.80 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6A: Dose 23.86 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6B: Dose 12.90 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 7F: Dose 13.45 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 14: Dose 16.18 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 14: Dose 27.60 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 18C: Dose 12.87 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19A: Dose 16.53 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19F: Dose 12.75 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19F: Dose 25.70 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 23F: Dose 12.62 mcg/mL
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 23F: Dose 23.82 mcg/mL
Secondary

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC

Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means (GMs) were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.

Time frame: 1 month post-dose 2, 1 month post-dose 3

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 7F: Dose 23.40 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 7F: Dose 33.62 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 1: Dose 22.31 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 1: Dose 32.18 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 3: Dose 20.54 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 3: Dose 30.55 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 4: Dose 21.62 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 4: Dose 31.63 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 5: Dose 23.26 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 5: Dose 33.23 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6A: Dose 23.86 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6A: Dose 34.60 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6B: Dose 24.49 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6B: Dose 35.45 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 9V: Dose 22.95 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 9V: Dose 33.20 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 14: Dose 27.57 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 14: Dose 38.16 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 18C: Dose 22.75 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 18C: Dose 32.99 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19A: Dose 27.57 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19A: Dose 37.80 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19F: Dose 25.73 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19F: Dose 36.70 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 23F: Dose 23.80 microgram per milliliter (mcg/mL)
13vPnCGeometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 23F: Dose 34.77 microgram per milliliter (mcg/mL)
Secondary

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnC

GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 1 to 1 month post-dose 2 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Time frame: 1 month post-dose 1, 1 month post-dose 2

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 11.0 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 31.5 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 41.1 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 51.0 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 6A1.7 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 6B1.6 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 7F1.2 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 9V1.6 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 141.1 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 18C1.2 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 19A1.3 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 19F1.9 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 1 of 13vPnC to 1 Month After Dose 2 of 13vPnCSerotype 23F2.9 fold rise
Secondary

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC

GMFRs for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

Time frame: 1 month post-dose 2, 1 month post-dose 3

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 11.2 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 31.3 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 41.0 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 51.1 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 6A1.2 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 6B1.3 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 7F1.1 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 9V1.4 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 141.1 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 18C1.3 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 19A1.0 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 19F0.9 fold rise
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnCSerotype 23F1.3 fold rise
Secondary

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.

Time frame: 1 month post-dose 1, 1 month post-dose 2

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 23F: Dose 2269 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 1: Dose 140 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 1: Dose 240 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 3: Dose 129 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 3: Dose 243 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 4: Dose 1622 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 4: Dose 2695 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 5: Dose 166 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 5: Dose 265 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6A: Dose 1976 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6A: Dose 21687 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6B: Dose 11088 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 6B: Dose 21789 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 7F: Dose 1786 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 7F: Dose 2927 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 9V: Dose 1423 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 9V: Dose 2695 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 14: Dose 1640 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 14: Dose 2723 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 18C: Dose 1475 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 18C: Dose 2562 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19A: Dose 1299 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19A: Dose 2391 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19F: Dose 1132 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 19F: Dose 2247 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnCSerotype 23F: Dose 192 titers
Secondary

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC

Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for both post-dose 2 and post-dose 3 blood draws.

Time frame: 1 month post-dose 2, 1 month post-dose 3

Population: Evaluable immunogenicity population: eligible participants who were \>=18 years of age on the day of first vaccination, received at least 2 doses of 13vPnC in the sequence assigned, had valid and determinate assay results, and had no major protocol violations. N (number of participants analyzed)=participants who were evaluable for this measure.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 5: Dose 267 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 14: Dose 2746 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19F: Dose 2269 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 1: Dose 241 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 1: Dose 349 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 3: Dose 244 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 3: Dose 356 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 4: Dose 2703 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 4: Dose 3724 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 5: Dose 374 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6A: Dose 21780 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6A: Dose 32139 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6B: Dose 21857 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 6B: Dose 32447 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 7F: Dose 2942 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 7F: Dose 31041 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 9V: Dose 2657 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 9V: Dose 3922 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 14: Dose 3819 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 18C: Dose 2521 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 18C: Dose 3692 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19A: Dose 2401 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19A: Dose 3419 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 19F: Dose 3245 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 23F: Dose 2293 titers
13vPnCSerotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnCSerotype 23F: Dose 3393 titers
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]); Moderate (5.5 to 10.0 cm); Severe (greater than \[\>\] 10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

Time frame: Within 14 days post-dose 1

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified local reaction. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Pain: mild (n = 258)76.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Pain: moderate (n = 173)18.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Pain: severe (n = 158)1.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Redness: any (n = 162)5.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Redness: mild (n = 161)4.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Redness: moderate (n = 158)1.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Redness: severe (n = 157)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Swelling: any (n = 162)6.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Swelling: mild (n = 161)6.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Swelling: moderate (n = 158)0.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Swelling: severe (n = 158)0.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1Pain: any (n = 260)78.8 percentage of participants
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

Time frame: Within 14 days post-dose 2

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified local reaction. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Redness: any (n = 122)8.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Redness: mild (n = 120)6.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Redness: moderate (n = 117)1.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Swelling: any (n = 126)12.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Redness: severe (n = 117)1.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Swelling: mild (n = 125)12.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Swelling: moderate (n = 116)0.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Swelling: severe (n = 117)1.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Pain: any (n = 237)81.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Pain: mild (n = 230)78.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Pain: moderate (n = 150)33.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2Pain: severe (n = 123)8.1 percentage of participants
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 cm); Moderate (5.5 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating).

Time frame: Within 14 days post-dose 3

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified local reaction. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Redness: any (n = 105)9.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Redness: mild (n = 104)8.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Redness: moderate (n = 102)3.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Redness: severe (n = 101)1.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Swelling: any (n = 107)11.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Swelling: mild (n = 106)8.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Swelling: moderate (n = 102)3.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Swelling: severe (n = 101)1.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Pain: any (n = 204)81.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Pain: mild (n = 197)80.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Pain: moderate (n = 129)30.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3Pain: severe (n = 105)5.7 percentage of participants
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1

Specific systemic events (fever greater than or equal to \[\>=\]38 degrees Celsius\[C\], fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours \[hrs\]); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs). Report of fever \>40 degrees C after 13vPnC Dose 1 was confirmed as data entry error.

Time frame: Within 14 days post-dose 1

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified systemic event. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized joint pain: moderate (n = 172)19.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized joint pain: severe (n = 159)1.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Use of medication to treat pain (n = 185)29.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Use of medication to treat fever (n = 173)17.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fever >=38 degrees C (n = 162)6.2 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fever >=38, <38.5 degrees C (n = 160)3.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fever >=38.5, <39 degrees C (n = 157)1.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fever >=39, =<40 degrees C (n = 159)1.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fever >40 degrees C (n = 158)0.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fatigue: any (n = 235)60.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fatigue: mild (n = 223)54.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fatigue: moderate (n = 200)37.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Fatigue: severe (n = 163)6.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Headache: any (n = 224)61.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Headache: mild (n = 216)57.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Headache: moderate (n = 183)31.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Headache: severe (n = 160)3.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Vomiting: any (n = 164)11.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Vomiting: mild (n = 164)11.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Vomiting: moderate (n = 157)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Vomiting: severe (n = 157)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Diarrhea: any (n = 193)44.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Diarrhea: mild (n = 191)40.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Diarrhea: moderate (n = 166)12.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1Diarrhea: severe (n = 160)1.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized muscle pain: any (n = 234)65.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized muscle pain: mild (n = 230)60.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized muscle pain: moderate (n = 183)29.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized muscle pain: severe (n = 161)3.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized joint pain: any (n = 193)35.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 1New generalized joint pain: mild (n = 185)29.7 percentage of participants
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2

Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).

Time frame: Within 14 days post-dose 2

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified systemic event. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fever >=38 degrees C (n = 117)5.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fever >=38, <38.5 degrees C (n = 116)4.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fever >=38.5, <39 degrees C (n = 116)0.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fever >=39, =<40 degrees C (n = 115)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fever >40 degrees C (n = 115)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fatigue: mild (n = 176)57.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fatigue: moderate (n = 154)38.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fatigue: severe (n = 121)7.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Headache: any (n = 173)56.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Headache: mild (n = 165)48.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Headache: moderate (n = 142)31.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Headache: severe (n = 117)3.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Vomiting: any (n = 120)7.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Vomiting: mild (n = 119)6.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Vomiting: moderate (n = 116)0.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Vomiting: severe (n = 115)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Diarrhea: any (n = 155)44.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Diarrhea: mild (n = 147)39.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Diarrhea: moderate (n = 130)15.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Diarrhea: severe (n = 119)5.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized muscle pain: any (n = 199)71.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized muscle pain: mild (n = 188)66.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized muscle pain: moderate (n = 153)38.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized muscle pain: severe (n = 125)10.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized joint pain: mild (n = 144)34.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized joint pain: moderate (n = 135)21.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized joint pain: severe (n = 119)3.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Use of medication to treat pain (n = 141)35.5 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Use of medication to treat fever (n = 127)18.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2Fatigue: any (n = 188)63.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 2New generalized joint pain: any (n = 150)40.0 percentage of participants
Other Pre-specified

Percentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3

Specific systemic events (fever \>=38 degrees C, fatigue, headache, vomiting, diarrhea, new generalized muscle/joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, new generalized muscle and joint pain were scaled as: Any (symptom present); Mild (no interference with activity); Moderate (some interference); Severe (prevents routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hrs); Moderate (\>2 times in 24 hrs); Severe (requires intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hrs); Moderate (4-5 loose stools 24 hrs); Severe (\>=6 loose stools in 24 hrs).

Time frame: Within 14 days post-dose 3

Population: Safety population:participants who received at least 1 dose of study vaccine. 'N'(number of participants analyzed)=participants whose response was Yes for any day or No for all days. 'n' = participants whose response was Yes for any day or No for all days for specified systemic event. Participants may be represented in more than 1 category.

ArmMeasureGroupValue (NUMBER)
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fever >=38 degrees C (n = 104)7.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fever >=38, <38.5 degrees C (n = 104)4.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fever >=38.5, <39 degrees C (n = 101)1.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fever >=39, =<40 degrees C (n = 101)2.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fever >40 degrees C (n = 101)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fatigue: any (n = 160)56.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fatigue: mild (n = 149)48.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fatigue: moderate (n = 132)36.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Fatigue: severe (n = 105)5.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Headache: any (n = 137)46.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Headache: mild (n = 130)40.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Headache: moderate (n = 118)24.6 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Headache: severe (n = 103)4.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Vomiting: any (n = 109)11.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Vomiting: mild (n = 107)8.4 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Vomiting: moderate (n = 104)4.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Vomiting: severe (n = 101)0.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Diarrhea: moderate (n = 109)11.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Diarrhea: severe (n = 103)1.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized muscle pain: any (n = 170)65.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized muscle pain: mild (n = 155)61.3 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized muscle pain: moderate (n = 132)31.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized muscle pain: severe (n = 110)10.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized joint pain: any (n = 129)31.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized joint pain: mild (n = 119)26.1 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized joint pain: moderate (n = 120)20.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3New generalized joint pain: severe (n = 106)5.7 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Use of medication to treat pain (n = 122)32.0 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Diarrhea: any (n = 134)38.8 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Diarrhea: mild (n = 131)35.9 percentage of participants
13vPnCPercentage of Participants Reporting Pre-Specified Systemic Events: 13vPnC Dose 3Use of medication to treat fever (n = 118)25.4 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026