Trial Outcomes & Findings for A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India. (NCT NCT05875727)
NCT ID: NCT05875727
Last Updated: 2024-10-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
Day 1 to Day 7 after vaccination
Results posted on
2024-10-24
Participant Flow
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.
Participant milestones
| Measure |
Cohort 1: 18 to 49 Years
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 milliliter (mL) of 20-valent pneumococcal conjugate vaccine (20vPnC) vaccine, intramuscularly (IM) on Day 1 (Visit 1).
|
Cohort 2: >=50 Years
Pneumococcal vaccine naive participants aged more than or equal to (\>=)50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
200
|
200
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.
Baseline characteristics by cohort
| Measure |
Cohort 1: 18 to 49 Years
n=200 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=200 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.7 Years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
58.8 Years
STANDARD_DEVIATION 7.22 • n=7 Participants
|
46.7 Years
STANDARD_DEVIATION 14.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
200 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
200 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
400 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after vaccinationPopulation: Safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
Cohort 1: 18 to 49 Years
n=200 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=200 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Any
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Mild
|
0.0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Moderate
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Redness: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Any
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Mild
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Moderate
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Swelling: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Any
|
43.5 Percentage of participants
Interval 36.5 to 50.7
|
32.0 Percentage of participants
Interval 25.6 to 38.9
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Mild
|
33.5 Percentage of participants
Interval 27.0 to 40.5
|
27.5 Percentage of participants
Interval 21.4 to 34.2
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Moderate
|
9.5 Percentage of participants
Interval 5.8 to 14.4
|
4.0 Percentage of participants
Interval 1.7 to 7.7
|
|
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Pain at the injection site: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 after vaccinationPopulation: Safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
Cohort 1: 18 to 49 Years
n=200 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=200 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >= 38.0 degree C
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >=38.0 to 38.4 degree C
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.4 to 38.9 degree C
|
0 Percentage of participants
Interval 0.0 to 1.8
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >38.9 to 40.0 degree C
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fever: >40.0 degree C
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Any
|
12.0 Percentage of participants
Interval 7.8 to 17.3
|
12.0 Percentage of participants
Interval 7.8 to 17.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Mild
|
7.5 Percentage of participants
Interval 4.3 to 12.1
|
8.5 Percentage of participants
Interval 5.0 to 13.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Moderate
|
4.0 Percentage of participants
Interval 1.7 to 7.7
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Fatigue: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Any
|
12.0 Percentage of participants
Interval 7.8 to 17.3
|
11.5 Percentage of participants
Interval 7.4 to 16.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Mild
|
9.5 Percentage of participants
Interval 5.8 to 14.4
|
9.5 Percentage of participants
Interval 5.8 to 14.4
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Moderate
|
2.0 Percentage of participants
Interval 0.5 to 5.0
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Headache: Severe
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Any
|
5.0 Percentage of participants
Interval 2.4 to 9.0
|
4.0 Percentage of participants
Interval 1.7 to 7.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Mild
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
2.5 Percentage of participants
Interval 0.8 to 5.7
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Moderate
|
2.0 Percentage of participants
Interval 0.5 to 5.0
|
1.0 Percentage of participants
Interval 0.1 to 3.6
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Any
|
14.5 Percentage of participants
Interval 9.9 to 20.2
|
9.0 Percentage of participants
Interval 5.4 to 13.9
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Mild
|
10.0 Percentage of participants
Interval 6.2 to 15.0
|
7.0 Percentage of participants
Interval 3.9 to 11.5
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Moderate
|
4.5 Percentage of participants
Interval 2.1 to 8.4
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
|
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 1.8
|
0.5 Percentage of participants
Interval 0.0 to 2.8
|
PRIMARY outcome
Timeframe: From vaccination on Day 1 up to 1 Month after vaccinationPopulation: Safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
Cohort 1: 18 to 49 Years
n=200 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=200 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
|
1.5 Percentage of participants
Interval 0.3 to 4.3
|
3.0 Percentage of participants
Interval 1.1 to 6.4
|
PRIMARY outcome
Timeframe: From vaccination on Day 1 up to 1 Month after vaccinationPopulation: Safety population included all participants who received any study intervention and had safety data assessed 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.
Outcome measures
| Measure |
Cohort 1: 18 to 49 Years
n=200 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=200 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From before vaccination to 1 Month after vaccinationPopulation: 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.
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.
Outcome measures
| Measure |
Cohort 1: 18 to 49 Years
n=50 Participants
Pneumococcal vaccine naive participants aged 18 to 49 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
Cohort 2: >= 50 Years
n=49 Participants
Pneumococcal vaccine naive participants aged \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 22F
|
12.6 Fold rise
Interval 7.8 to 20.4
|
30.8 Fold rise
Interval 14.2 to 67.0
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 33F
|
8.4 Fold rise
Interval 5.0 to 14.0
|
11.7 Fold rise
Interval 7.3 to 18.6
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 1
|
24.3 Fold rise
Interval 17.2 to 34.3
|
17.1 Fold rise
Interval 10.9 to 26.9
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 3
|
8.9 Fold rise
Interval 5.7 to 13.8
|
8.8 Fold rise
Interval 5.6 to 13.8
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 4
|
15.2 Fold rise
Interval 7.7 to 29.8
|
42.6 Fold rise
Interval 22.0 to 82.6
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 5
|
14.9 Fold rise
Interval 8.6 to 25.8
|
24.3 Fold rise
Interval 13.5 to 43.7
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6A
|
29.8 Fold rise
Interval 16.3 to 54.5
|
30.9 Fold rise
Interval 17.5 to 54.7
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 6B
|
8.6 Fold rise
Interval 5.0 to 15.0
|
11.6 Fold rise
Interval 6.6 to 20.5
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 7F
|
16.0 Fold rise
Interval 9.2 to 27.9
|
24.1 Fold rise
Interval 15.6 to 37.4
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 9V
|
4.8 Fold rise
Interval 3.2 to 7.1
|
9.5 Fold rise
Interval 5.7 to 15.8
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 14
|
5.8 Fold rise
Interval 3.5 to 9.9
|
6.0 Fold rise
Interval 3.3 to 10.9
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 18C
|
21.4 Fold rise
Interval 11.4 to 40.1
|
42.0 Fold rise
Interval 22.4 to 78.6
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19A
|
15.0 Fold rise
Interval 9.1 to 24.7
|
30.9 Fold rise
Interval 18.1 to 52.6
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 19F
|
13.1 Fold rise
Interval 7.3 to 23.5
|
19.1 Fold rise
Interval 10.5 to 35.0
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 23F
|
46.2 Fold rise
Interval 21.8 to 98.2
|
53.6 Fold rise
Interval 28.3 to 101.4
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 8
|
18.4 Fold rise
Interval 10.5 to 32.4
|
38.2 Fold rise
Interval 22.8 to 64.2
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 10A
|
8.4 Fold rise
Interval 5.0 to 14.0
|
31.1 Fold rise
Interval 16.1 to 59.9
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 11A
|
3.3 Fold rise
Interval 2.3 to 4.7
|
9.5 Fold rise
Interval 5.2 to 17.3
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 12F
|
76.1 Fold rise
Interval 33.4 to 173.7
|
75.2 Fold rise
Interval 36.7 to 154.0
|
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
Serotype 15B
|
48.8 Fold rise
Interval 22.2 to 107.0
|
86.2 Fold rise
Interval 40.8 to 182.1
|
Adverse Events
20vPnC
Serious events: 0 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
20vPnC
n=400 participants at risk
Pneumococcal vaccine naive participants aged 18 to 49 years and \>=50 years were administered 0.5 mL of 20vPnC vaccine, IM on Day 1 (Visit 1).
|
|---|---|
|
General disorders
Fatigue (FATIGUE)
|
12.0%
48/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
General disorders
Injection site pain (PAIN)
|
37.8%
151/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
General disorders
Injection site swelling (SWELLING)
|
1.5%
6/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
General disorders
Pyrexia (FEVER)
|
2.2%
9/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
4.5%
18/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
11.8%
47/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
|
Nervous system disorders
Headache (HEADACHE)
|
11.8%
47/400 • Systematic assessment: local reactions and systemic events recorded from Day 1 to Day 7 after vaccination; Non-systematic assessment: All-cause mortality, SAEs and other AEs recorded from day of vaccination (Day 1) up to 1 month after vaccination
As all participants received 20vPnC the AEs section was reported together.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER