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A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05875727
Enrollment
405
Registered
2023-05-25
Start date
2023-08-16
Completion date
2023-10-02
Last updated
2024-10-24

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

Conditions

Pneumococcal Disease

Brief summary

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: * are generally healthy adults of 18 years or older. * have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Interventions

One dose of 20vPnC will be administered intramuscularly.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.

Eligibility

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

Inclusion criteria

\- Generally healthy participants ≥18 years of age at the time of consent.

Exclusion criteria

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine. * Known or suspected immune deficiency or suppression. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Local Reactions Within 7 Days After VaccinationDay 1 to Day 7 after vaccinationLocal reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After VaccinationDay 1 to Day 7 after vaccinationSystemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After VaccinationFrom vaccination on Day 1 up to 1 Month after vaccinationAn AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After VaccinationFrom vaccination on Day 1 up to 1 Month after vaccinationAn SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.

Secondary

MeasureTime frameDescription
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationFrom before vaccination to 1 Month after vaccinationGMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician.

Countries

India

Participant flow

Recruitment details

A total of 405 participants signed the informed consent form. Two participants were screen failures and 3 were not assigned to receive study treatment and 400 participants received study treatment.

Participants by arm

ArmCount
Cohort 1: 18 to 49 Years
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
200
Cohort 2: >= 50 Years
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
200
Total400

Baseline characteristics

CharacteristicCohort 2: >= 50 YearsTotalCohort 1: 18 to 49 Years
Age, Continuous58.8 Years
STANDARD_DEVIATION 7.22
46.7 Years
STANDARD_DEVIATION 14.31
34.7 Years
STANDARD_DEVIATION 8.18
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
200 Participants400 Participants200 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
200 Participants400 Participants200 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
52 Participants116 Participants64 Participants
Sex: Female, Male
Male
148 Participants284 Participants136 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 400
other
Total, other adverse events
171 / 400
serious
Total, serious adverse events
0 / 400

Outcome results

Primary

Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: From vaccination on Day 1 up to 1 Month after vaccination

Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

ArmMeasureValue (NUMBER)
Cohort 1: 18 to 49 YearsPercentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination1.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination3.0 Percentage of participants
Primary

Percentage of Participants With Local Reactions Within 7 Days After Vaccination

Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: Day 1 to Day 7 after vaccination

Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

ArmMeasureGroupValue (NUMBER)
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Mild33.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Severe0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Any1.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Moderate9.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Mild0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Severe0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Moderate0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Moderate0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Severe0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Any1.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Any43.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Mild0.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Moderate4.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Mild0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Any32.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Mild27.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationPain at the injection site: Severe0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Moderate0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Severe0.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Any1.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Mild0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Moderate1.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationSwelling: Severe0.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Local Reactions Within 7 Days After VaccinationRedness: Any1.0 Percentage of participants
Primary

Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination

An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.

Time frame: From vaccination on Day 1 up to 1 Month after vaccination

Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

ArmMeasureValue (NUMBER)
Cohort 1: 18 to 49 YearsPercentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination0 Percentage of participants
Primary

Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: Day 1 to Day 7 after vaccination

Population: Safety population included all participants who received any study intervention and had safety data assessed after vaccination.

ArmMeasureGroupValue (NUMBER)
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Severe0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >=38.0 to 38.4 degree C1.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >38.4 to 38.9 degree C0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >38.9 to 40.0 degree C1.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >40.0 degree C0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Any12.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Mild7.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Moderate4.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Severe0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Mild9.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Moderate2.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Severe0.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Any5.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Mild3.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Moderate2.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >= 38.0 degree C3.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Any14.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Mild10.0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Moderate4.5 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Severe0 Percentage of participants
Cohort 1: 18 to 49 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Any12.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Mild7.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >= 38.0 degree C1.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Moderate1.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >=38.0 to 38.4 degree C0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Severe0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >38.4 to 38.9 degree C1.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Severe0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >38.9 to 40.0 degree C0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Severe0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFever: >40.0 degree C0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Any4.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Any12.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Any9.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Mild8.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Mild2.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Moderate3.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationMuscle pain: Moderate1.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationFatigue: Severe0.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Any11.5 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationJoint pain: Moderate1.0 Percentage of participants
Cohort 2: >= 50 YearsPercentage of Participants With Systemic Events Within 7 Days After VaccinationHeadache: Mild9.5 Percentage of participants
Secondary

Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination

GMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician.

Time frame: From before vaccination to 1 Month after vaccination

Population: Evaluable immunogenicity population evaluated. Number of participants analyzed= Number of participants in evaluable immunogenicity population. Number Analyzed = Number of evaluable participants with valid OPA titers for the specified serotype both before and after vaccination.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 124.3 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 38.9 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 415.2 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 514.9 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 6A29.8 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 6B8.6 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 7F16.0 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 9V4.8 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 145.8 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 18C21.4 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 19A15.0 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 19F13.1 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 23F46.2 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 818.4 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 10A8.4 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 11A3.3 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 12F76.1 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 15B48.8 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 22F12.6 Fold rise
Cohort 1: 18 to 49 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 33F8.4 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 15B86.2 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 117.1 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 19A30.9 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 11A9.5 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 442.6 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 19F19.1 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 524.3 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 33F11.7 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 38.8 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 6A30.9 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 23F53.6 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 6B11.6 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 12F75.2 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 7F24.1 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 838.2 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 9V9.5 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 22F30.8 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 146.0 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 10A31.1 Fold rise
Cohort 2: >= 50 YearsGeometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After VaccinationSerotype 18C42.0 Fold rise

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026