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GRADE: 20-valent pneumococcal conjugate vaccine (PCV20) for adults aged 19–64 years with underlying medical conditions or other risk factorsGrading of Recommendations, Assessment, Development, and Evaluation										Related Pages
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			IntroductionMethodsSummaryReference
		
Introduction
On October 21, 2021, the ACIP recommended use of 20-valent pneumococcal conjugate vaccine (PCV20 [Prevnar 20, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.]) alone or 15-valent pneumococcal conjugate vaccine (PCV15 [Vaxneuvance, Merck Sharp & Dohme Corp.]) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) [Pneumovax23, Merck Sharp & Dohme Corp Inc.]) for all adults aged ≥65 years, and for adults aged 19–64 years with certain underlying medical conditions or other risk factors*, who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown. A systematic review and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach was employed to guide ACIP’s deliberations regarding use of these vaccines.
**Introduction Footnote**
*Alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathies.
Methods
A systematic literature search was completed to review all available evidence on the immunogenicity and safety of PCV15 and PCV20 among age groups for which the vaccines were approved.  Since only immunogenicity and safety data were available for PCV15 or PCV20, the search included PCV13 and PPSV23 efficacy or effectiveness studies to help interpret PCV15 and PCV20 immunogenicity study findings. Literature search for evidence on both PCV15 and PCV20 was done simultaneously given the similarities in the policy questions and given that use of both PCV15 and PCV20 were considered by the ACIP simultaneously. GRADE assessment was performed for PCV15 and PCV20 studies only. As a basis for the GRADE analysis, the policy question consisting of the population, intervention, comparison, and outcomes of interest was defined (Table 1).Table 1: Policy question and definition of the Population, Intervention, Comparison, and Outcome for GRADE analysis
Table 1: Policy question and definition of the Population, Intervention, Comparison, and Outcome for GRADE analysis
Policy question:
**Should PCV20 be recommended to US adults aged 19-64 years with immunocompromising or chronic medical conditions?**Population
US adults aged 19-64 years with immunocompromising or chronic medical conditionsIntervention
One dose of PCV20Comparison
1. PCV13 followed by PPSV23 (immunocompromised adults aged **19-64 years**)*
2. PPSV23 (immunocompetent adults with chronic medical conditions aged **19-64 years**)†Outcomes
Vaccine-type invasive pneumococcal disease, vaccine-type non-bacteremic pneumococcal pneumonia, and vaccine-type pneumococcal mortality)
Serious adverse events following immunization**Table 1 Footnote**
*Immunocompromised adults include adults with immunocompromising condition (chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, human immunodeficiency virus, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease, or other hemoglobinopathies), CSF leak, or cochlear implant; immunocompetent adults are those without these conditions.
†Chronic medical conditions include chronic heart/lung/liver disease, diabetes mellitus, alcoholism, and cigarette smoking.
Table 2: Outcomes and Rankings
Table 2: Outcomes and Rankings
Outcome
Importance*
Included in evidence profileVaccine-type invasive pneumococcal disease
Critical
YesVaccine-type non-bacteremic pneumococcal pneumonia
Critical
YesVaccine-type pneumococcal mortality
Critical
YesSerious adverse events following immunization
Critical
Yes
**Table 2. Footnote**
*Three options: 1. Critical; 2.  Important but not critical; 3. Not important for decision making
We leveraged a systematic review presented to the World Health Organization Strategic Advisory Group of Experts (SAGE) meeting in October 2020, which included literature up to March 2019 (1). To identify literature published during April 2019 to February 2021, we searched Pubmed, Medline, Embase, CINAHL, Scopus, Epistemonikos and Cochrane library databases. The search terms are included in **appendix I**. Search results were supplemented by an updated Pubmed search using “V114*”, “PCV15”, “PCV20”. Unpublished data were provided by the vaccine manufacturers.
Studies were included if they presented primary data on PCV20 in adults with underlying medical conditions or other risk factors†. Of the 2,499 titles screened for WHO SAGE and 923 titles screened for the updated review in 2021, 1 unpublished and 2 published PCV20 studies were included in the GRADE analysis (2-4). Characteristics of these studies are presented in **appendix II**. Beneficial and harmful outcomes for the GRADE assessment were selected by the ACIP Pneumococcal Vaccines Work Group calls and via an email survey in which Work Group members were asked to rank the relative importance of each outcome. Vaccine-type invasive pneumococcal disease, vaccine-type non-bacteremic pneumococcal pneumonia, vaccine-type pneumococcal mortality, and serious adverse events (SAEs) following immunization were deemed to be critical outcomes (Table 2).
**Methods Footnote**
*V114 is the name used for Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate
†Alcoholism, chronic heart/liver/lung disease, chronic renal failure, cigarette smoking, cochlear implant, congenital or acquired asplenia, CSF leak, diabetes mellitus, generalized malignancy, HIV, Hodgkin disease, immunodeficiency, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplants, or sickle cell disease or other hemoglobinopathies
Table 3a. Summary of Studies Reporting Immunogenicity
Table 3a. Summary of Studies Reporting Immunogenicity
Study
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
GMR range* (**serotype)**
GMT/GMR interpretation*,†,§
Absolute difference in % seroresponders¶
(**serotype**)
Interpretation of % serorespondners¶,**
Study limitations (Risk of Bias)B7471007
Adults ≥60 years
1435
1420
PCV13
0.76 (6A) to 1.0 (14)
PCV20<PCV13 in 12/13 serotypes (= for serotype 14)
PCV20 GMTs significantly lower in 5/13
Noninferiority criteria met for all 13/13 serotypes
-5.6 (3) to -0.5 (7F)
PCV20<PCV13 in 12/13 PCV13 serotypes
PCV20 significantly lower in 1/13 serotype (Serotype 3)
Not serious1433
1383
PCV13+PPSV23 (28-42 day interval between vaccines; 1-month post-PPSV23; only compared the 7 shared non-PCV13 PPSV23/PCV20 serotypes)
0.55 (8) to 3.1 (15B)
PCV20>PCV13+PPSV23 in 6/7 non-PCV13 serotypes
PCV20 significantly higher in 5/7 serotypes
Significantly lower for 1/7 (serotype 8)
Noninferiority criteria met for 6/7 serotypes (not met for serotype 8)
-9 (8) to 14 (15B)
PCV20>PCV13+PPSV23 in 6/7 non-PCV13 serotypes
PCV20 significantly higher in 6/7
PCV20 significantly lower in 1/7 (Serotype 8)Adults 18-49 years
336
993
PCV20 (in 60-64 year or ≥60 year-olds)
1.00 (3) to 4.8 (23F) (18-49 year-olds compared to ≥60 year-olds)
GMTs among 18-49 year-olds>GMTs among 60-64 year-olds in 20/20 serotypes
18-49 year-olds GMTs significantly higher in 14/20
Noninferiority criteria met for all 20 serotypes
-11.9 (11A) to 16.3 (9V) (in ≥60 year-olds)
PCV20 in 18-49 year-olds>PCV20 in ≥60 year-oldsin 18/20 serotypes
Significantly higher in 11/20
Significantly lower in 1/20 (Serotype 11A)Hurley 2020
Adults 60-64 years
195-210
194-208
PCV13
0.62 (19F) to 0.90 (6B)
PCV20<PCV13 in 13/13 serotypes
Significantly lower in 4/13
-9.8 (19F) to 1.3 (6A)
PCV20<PCV13 in 12/13 serotypes (all non-significant)
Not serious185-207
181-204
PCV13+PPSV23 (1-month interval between vaccines; 1-month post-PPSV23; only compared 7 shared non-PCV13 serotypes)
0.64 (8) to 2.64 (10A)
PCV20>PCV13+PPPSV23 in 6/7 non-PCV13 serotypes
Significantly higher in 3/7
PCV20<PCV13+PPSV23, PCV20 significantly lower in 1/7 (8)
-4.9 (8) to 14.7 (10A)
PCV20>PCV13+PPPSV23 in 6/7 non-PCV13 serotypes
Significantly higher in 2/7
PCV20<PCV13+PPSV23 lower in 1/7 (Serotype 8, non- significant)201-208
196-203
PCV13+PPSV23 (1-month interval between vaccines; 1-month post-PPSV23; only compared 13 shared PCV13 serotypes)
0.50(3) to 0.79(6B)
PCV13+PPSV23>PCV20 in 13/13 serotypes
PCV20 significantly lower in 9/13
Not Reported
Not ReportedKlein 2021
Adults 18-49 years
1463
245
PCV13
0.67 (19F) to 1.00 (14)
PCV20<PCV13 in 12/13 serotypes
PCV20 significantly lower in 3/13 (1,5,19F)
Noninferiority criteria met for all 13/13 serotypes
-7.5 (1) to 1 (14)
PCV20<PCV13 in 12/13 serotypes
PCV20 significantly lower in 3/13 (Serotypes 1, 5,19F)
Not Serious
**Table 3a. Footnotes**
GMR=geometric mean ratio, GMT=geometric mean titers, OPA=opsonophagocytic activity, PCV13=13-valent pneumococcal conjugate vaccine, PCV20=20-valent pneumococcal conjugate vaccine, PPSV23=23-valent pneumococcal polysaccharide vaccine
*GMR (geometric mean ratio) is the ratio of pneumococcal OPA GMTs.Ratio calculated as [GMT (PCV20)] / [GMT (comparator vaccine)].
†GMR noninferiority for a serotype was declared if the lower bound of the 2-sided 95% CI for the GMR for that serotype was greater than 0.5 (2-fold criterion).
§If GMR non-inferiority was not assessed, “statistical significance” of GMTs (geometric mean titers) defined as: 95% CI of GMT point estimates did not overlap.
¶Seroresponse: subjects with ≥4-fold rise in OPA GMT titer 30 days post-vaccination compared to pre-vaccination.
**If seroresponsenon-inferiority was not assessed, “statistical significance” defined as: 95% CI of %serorespondersdid not overlap.
Table 3b. Summary of Studies Reporting Safety
Table 3b. Summary of Studies Reporting Safety
Study
Age or other characteristic of importance
N intervention
N comparison
Comparator vaccine
Absolute % difference (% SAE PCV20 – % SAE comparator)
N related to vaccine
Study limitations (Risk of Bias)B7471007
Adults 60 years and older
1461
1445
PCV13+PPSV23 (6-month observation period)
0.5
(CI overlaps)
0
Not seriousAdults 50-59
334
111
PCV13 (6-month observation period)
-0.6
(CI overlaps)
0Adults 18-49
335
112
PCV13 (6-month observation period)
-0.3
(CI overlaps)
0Hurley, 2020
Adults 60 – 64 years
221
222
PCV13 (1-month observation period)
-0.5
(CI overlaps)
0
Not serious213
214
PCV13+PPSV23 (12-month observation period)
-0.9
(CI overlaps)
0Klein, 2021
Adults 18-49
1463
245
PCV13 (6-month observation period)
0.7
0
Not serious
**Table 3b. Footnote**
CI= confidence interval, PCV13=13-valent pneumococcal conjugate vaccine, PCV20=20-valent pneumococcal conjugate vaccine, PPSV23=23-valent pneumococcal polysaccharide vaccine, SAE=serious adverse events
Table 4. Grade Summary of Findings Table
Table 4. Grade Summary of Findings Table
Certainty assessment
Number of patients
Results
Certainty
ImportanceNo of studies (reference)
Study design
Risk of bias
Inconsistency
Indirectness
Imprecision
Other considerations
Intervention
Comparison**
Relative effect
Absolute effectVaccine effectiveness (Vaccine-type invasive pneumococcal disease, Vaccine-type non-bacteremic pneumococcal pneumonia, Vaccine-type pneumococcal mortality)**2 (2-4)**
Randomized studies
Not serious
Not serious
Very serious*,†,§,¶
Not serious
Not serious
3417
2802
PCV20 vs. PCV13: non-inferiority met for all 13 shared serotypes
PCV20 had slightly lower immune responses vs. PCV13 in 13 shared serotypes across studies.
PCV20 vs. PPSV23 (non-PCV13 serotypes): noninferiority met for 6 of 7 serotypes (not met for serotype 8).
PCV20 had greater immune responses vs. PPSV23 for 6 of 7 PCV20 non-PCV13 shared serotypes.
3, Low
CriticalSerious adverse events**2 (2-4)**
Randomized studies
Not serious
Not serious
Not serious
**Serious††**
None
0/3852
0/2172
Non estimable
—
2, Moderate
Critical
**Table 4. Footnote**
*These are all immunogenicity studies and there are no correlates of protection.
†B7471007, Klein et al., and Hurley et al. enrolled healthy adults (some with chronic stable conditions, but focus is not those with immunocompromising or chronic medical conditions).
§B7471007 provided primary PCV20 vs PCV13 immunogenicity outcomes for adults ≥60 and then showed non-inferiority for PCV20 in 18-49 year-olds compared to PCV20 in 60-64 year-olds. Did not directly compare immunogenicity of PCV20 vs PCV13 in 18-49 year-olds.
¶Hurley et al. only enrolled 60-64 year-olds.
**Number of patients based on minimum number included in immunogenicity comparisons presented; some comparisons may have had more patients than this minimum.
††No vaccine-related serious adverse events reported; sample size relatively small.
Table 5. Summary of Evidence for Outcomes of Interest
Table 5. Summary of Evidence for Outcomes of Interest
Outcome
Importance
Included in evidence profile
CertaintyVaccine-type invasive pneumococcal disease
Critical
Yes
3, lowVaccine-type non-bacteremic pneumococcal pneumonia
Critical
Yes
3, lowVaccine-type pneumococcal mortality
Critical
Yes
3, lowSerious adverse events following immunization
Critical
Yes
2, moderate
Summary
The evidence type for use of PCV20 for adults aged 19–64 years with certain underlying medical conditions or other risk factors was determined to be 3 (low certainty of evidence). The ACIP reviewed the results of both GRADE analysis and the Evidence to Recommendations (EtR) framework in September 2021. In October 2021, the ACIP recommended use of PCV20 for adults aged 19–64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown.
Reference
World Health Organization. Strategic Advisory Group of Experts on Immunization 5-7 October 2020. 2020 [cited 2021 July 28]; Available from: https://terrance.who.int/mediacentre/data/sage/SAGE_eYB_October_2020.pdf?ua=1.
Essink B, Sabharwal C, Xu X, Sundaraiyer V, Peng Y, Moyer L, et al. 3. Phase 3 Pivotal Evaluation of 20-valent Pneumococcal Conjugate Vaccine (PCV20) Safety, Tolerability, and Immunologic Noninferiority in Participants 18 Years and Older. Open Forum Infect Dis. 2020;7(Suppl 1):S2-S.
Hurley D, Griffin C, Young M, Scott DA, Pride MW, Scully IL, et al. Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America. 2020 Jul 27.
Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, et al. A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Vaccine. 2021 Sep 7;39(38):5428-35.Appendix I. Search Strategies
Appendix I. Search Strategies
Database
Strategy
Run Date
Records**Medline
(OVID)**
1. streptococcus pneumoniae/
2. (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”).tw,kf.
3. 1 or 2
4. vaccination/ or immunization/ or Vaccines, Conjugate/
5. (vaccine? or vaccination? or immunisation or immunization).tw,kf.
6. 4 or 5
7. Pneumococcal Vaccines/
8. (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”).tw,kf.
9. 7 or 8
10. (3 and 6)
11. 10 or 9
12. comparative effectiveness research/ or treatment outcome/ or Vaccine Potency/
13. (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”).tw,kf.
14. 12 or 13
15. adult/ or aged/ or “aged, 80 and over”/ or frail elderly/
16. (adult? or elderly or elderlies).tw,kf.
17. 15 or 16
18. 11 and 14 and 17
19. (201904* OR 201905* OR 201906* OR 201907* OR 201908* OR 201909* OR 201910* OR 201911* OR 201912* OR 2020* OR 2021*).ed,ep,yr,dp,dt.
20. 17 and 18
02/18/2021
351**Embase
(OVID)
1988-**
1. Streptococcus pneumoniae/
2. (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”).tw,kw.
3. 1 or 2
4. vaccination/ or immunization/ or vaccine/
5. (vaccine? or vaccination? or immunisation or immunization).tw,kw.
6. 4 or 5
7. Pneumococcus vaccine/
8. (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”).tw,kw.
9. 7 or 8
10. 3 and 6
11. 9 OR 10
12. comparative effectiveness/ or treatment outcome/
13. (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”).tw,kw.
14. 12 or 13
15. aged/ or adult/ or aged hospital patient/ or frail elderly/ or institutionalized elderly/ or very elderly/
16. (adult? or elderly or elderlies).tw,kw.
17. 15 or 16
18. 11 and 14 and 17
19. (201904* OR 201905* OR 201906* OR 201907* OR 201908* OR 201909* OR 201910* OR 201911* OR 201912* OR 2020* OR 2021*).dc
20. limit 19 to (conference abstracts or embase)
02/18/2021
521
–
duplicates
=
unique items**Cochrane Library**
(
(
(pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”):ti,ab
AND
([mh Vaccines] OR [mh Immunization] OR (vaccine# or vaccination# or immunisation or immunization):ti,ab)
)
OR
(MH “Pneumococcal Vaccine”) OR TI (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”) OR AB (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”)
)
AND[mh “Treatment Outcomes”] OR (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”):ti,abAND[mh Adult] OR [mh Aged+] OR (adult# or elderly or elderlies):ti,ab
02/18/2021
56
–
duplicates
=
unique items**CINAHL
(EbscoHost)**
(
(TI (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”) OR AB (pneumococcal or pneumococci or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”)) AND ((MH “Vaccines”) OR (MH “Immunization”) OR TI (vaccine# or vaccination# or immunisation or immunization) OR AB (vaccine# or vaccination# or immunisation or immunization))
OR
(MH “Pneumococcal Vaccine”) OR TI (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”) OR AB (heptavalent or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or pcv10 or “pcv 10” or “13valent” or “13 valent” or pcv13 or “pcv 13” or ppv23 or “ppv 23” or “23 valent” or “23valent”)
)
AND
(MH “Treatment Outcomes”) OR TI (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”) OR AB (efficacy or effectiveness or effects or “immune response” or impact or “treatment outcome”)
AND
((MH “Adult”) OR (MH “Aged+”) OR TI (adult# or elderly or elderlies) OR AB (adult# or elderly or elderlies))Limiters – Published Date: 20190401-20210218; Exclude MEDLINE records
02/18/2021
43
–
duplicates
=
unique items**Scopus
(for WOS)**
**(TITLE-ABS-KEY**(“heptavalent” or “7 valent” or “7valent” or “pcv 7” or pcv7* or “10 valent” or “10valent” or “pcv10” or “pcv 10” or “13valent” or “13 valent” or “pcv13” or “pcv 13” or “ppv23” or “ppv 23” or “23 valent” or “23valent”) OR (**TITLE-ABS-KEY**(“vaccine$” or “vaccination$” or “immunisation” or “immunization”) AND **TITLE-ABS-KEY**(“pneumococcal” or “pneumococci” or “streptococcus pneumonie” or “streptococcus pneumoniae” or “s pneumoniae”))) AND**TITLE-ABS-KEY**(“adult$” or “elderly” or “elderlies”) **AND TITLE-ABS-KEY**(“efficacy” or “effectiveness” or “effects” or “immune response” or “impact” or “treatment outcome”)
Limit April 2019 –
02/18/2021
458
–
duplicates
=
unique items**Epistemonikos**
Search 1:
(pneumococcal OR pneumococci OR “streptococcus pneumonie” OR “streptococcus pneumoniae” OR “s pneumoniae”) AND (vaccine* OR vaccination* OR immunisation OR immunization) AND (efficacy OR effectiveness OR effects OR “immune response” OR impact OR “treatment outcome”) AND (adult* OR elderly OR elderlies)
– limited to 2019-2021Search 2:
(heptavalent OR “7 valent” OR “7valent” OR “pcv 7” OR pcv7* OR “10 valent” OR “10valent” OR pcv10 OR “pcv 10” OR “13valent” OR “13 valent” OR pcv13 OR “pcv 13” OR ppv23 OR “ppv 23” OR “23 valent” OR “23valent”) AND (efficacy OR effectiveness OR effects OR “immune response” OR impact OR “treatment outcome”) AND (adult* OR elderly OR elderlies)
– limited to 2019-2021
02/18/2021
19 + 10
–
duplicates
=
unique itemsAppendix II. Studies Included in the Review of Evidence
Appendix II. Studies Included in the Review of Evidence
Study
Study design
Country (or more detail, if needed)
Age (measure central tendency – mean/SD)
Total population
N Intervention
N comparison
Outcomes
Funding sourceB7471007
Phase III randomized controlled trial
US and Sweden
Adults ≥ 18-49 years (34.0, SD 8.8)
448
336 (PCV20)
112 (PCV13)
Immunogenicity,
Safety
PfizerAdults ≥ 50-59 years (54.9, SD 2.8)
445
334 (PCV20)
111 (PCV13)Adults ≥ 60 years (64.6, SD 4.8)
2997
1507 (PCV20)
1490 (PCV13+PPSV23)Hurley, 2020
Phase II randomized controlled trial
US
Adults 60 – 64 years (62.0, SD 1.4)
444
222
222
Immunogenicity, Safety
PfizerKlein, 2021
Phase III randomized controlled trial
US
Adults 18-49 years
1708
1463
245
Immunogenicity,
Safety
Pfizer
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