NCT03828617 is a Phase 3 clinical trial of 20vPnC in Pneumococcal Disease, sponsored by Pfizer.

Who is sponsoring NCT03828617?

NCT03828617 is sponsored by Pfizer.

What drugs are being tested in NCT03828617?

Interventions in NCT03828617: 20vPnC, 20vPnC, 20vPnC, 13vPnC.

What condition does NCT03828617 study?

NCT03828617 studies Pneumococcal Disease.

Is NCT03828617 still recruiting?

NCT03828617 is currently completed. Last updated 23 November 2020.

Are results published for NCT03828617?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-23 · How we verify

NCT03828617

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults

Completed Phase 3 Results posted Last updated 23 November 2020

What this trial tests

Phase 3 trial testing 20vPnC in Pneumococcal Disease in 1,710 participants. Completed in 9 October 2019.

Timeline

14 February 2019

Primary endpoint
9 October 2019

9 October 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	1,710
Start date	14 February 2019
Primary completion	9 October 2019
Estimated completion	9 October 2019
Sites	21 locations across United States

Drugs / interventions tested

20vPnC (20vpnc) — full drug profile →
20vPnC (20vpnc) — full drug profile →
20vPnC (20vpnc) — full drug profile →
13vPnC (13vpnc) — full drug profile →

Conditions studied

Pneumococcal Disease — all drugs for Pneumococcal Disease →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 49, any sex, with Pneumococcal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Local Reactions Within 10 Days After Vaccination Primary · Within 10 days after vaccination

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Data for this outcome measure was planned to be analyzed for the

Redness: Any

Group	Value	95% CI
Pooled 20vPnC	7.0	5.7 – 8.4
13vPnC	6.2	3.5 – 10.0

Redness: Mild

Group	Value	95% CI
Pooled 20vPnC	3.9	3.0 – 5.0
13vPnC	3.3	1.4 – 6.4

Redness: Moderate

Group	Value	95% CI
Pooled 20vPnC	2.6	1.9 – 3.6
13vPnC	2.9	1.2 – 5.8

Redness: Severe

Group	Value	95% CI
Pooled 20vPnC	0.5	0.2 – 1.0
13vPnC	0	0.0 – 1.5

Swelling: Any

Group	Value	95% CI
Pooled 20vPnC	8.5	7.1 – 10.1
13vPnC	8.6	5.4 – 12.9

Swelling: Mild

Group	Value	95% CI
Pooled 20vPnC	5.4	4.3 – 6.7
13vPnC	5.3	2.9 – 9.0

Swelling: Moderate

Group	Value	95% CI
Pooled 20vPnC	2.9	2.1 – 3.9
13vPnC	3.3	1.4 – 6.4

Swelling: Severe

Group	Value	95% CI
Pooled 20vPnC	0.2	0.0 – 0.6
13vPnC	0	0.0 – 1.5

Percentage of Participants With Systemic Events Within 7 Days After Vaccination Primary · Within 7 days after vaccination

Systemic events fever, fatigue, headache, muscle pain, joint pain were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=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, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1

Fever: >=38.0 degree C (Any)

Group	Value	95% CI
Pooled 20vPnC	1.2	0.7 – 1.9
13vPnC	0.8	0.1 – 2.9

Fever: >=38.0 degree C to 38.4 degree C

Group	Value	95% CI
Pooled 20vPnC	0.8	0.4 – 1.3
13vPnC	0.4	0.0 – 2.3

Fever: >38.4 degree C to 38.9 degree C

Group	Value	95% CI
Pooled 20vPnC	0.3	0.1 – 0.7
13vPnC	0.4	0.0 – 2.3

Fever: >38.9 degree C to 40.0 degree C

Group	Value	95% CI
Pooled 20vPnC	0.2	0.0 – 0.6
13vPnC	0	0.0 – 1.5

Fever: >40.0 degree C

Group	Value	95% CI
Pooled 20vPnC	0	0.0 – 0.3
13vPnC	0	0.0 – 1.5

Fatigue: Any

Group	Value	95% CI
Pooled 20vPnC	47.6	45.0 – 50.2
13vPnC	43.6	37.3 – 50.1

Fatigue: Mild

Group	Value	95% CI
Pooled 20vPnC	24.7	22.5 – 27.0
13vPnC	24.3	19.0 – 30.2

Fatigue: Moderate

Group	Value	95% CI
Pooled 20vPnC	21.2	19.1 – 23.4
13vPnC	17.7	13.1 – 23.1

Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination Primary · Within 1 month after vaccination

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Group	Value	95% CI
Pooled 20vPnC	6.8	5.6 – 8.3
13vPnC	5.3	2.9 – 8.9

Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination Primary · Within 6 month after vaccination

An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Group	Value	95% CI
Pooled 20vPnC	0.7	0.3 – 1.3
13vPnC	0	0.0 – 1.5

Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination Primary · Within 6 months after vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Data for this outcome measure was planned to be analyzed for the pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.

Group	Value	95% CI
Pooled 20vPnC	1.0	0.6 – 1.7
13vPnC	2.0	0.7 – 4.7

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination Primary · 1 month after vaccination

OPA titers were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution. OPA GMTs and 2-sided 95% CIs were calculated. Data for this outcome measure were planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Serotype 1

Group	Value	95% CI
20vPnC Lot 1	199.5	173.5 – 229.6
20vPnC Lot 2	175.1	152.5 – 201.0
20vPnC Lot 3	164.6	143.1 – 189.3

Serotype 3

Group	Value	95% CI
20vPnC Lot 1	47.3	42.7 – 52.4
20vPnC Lot 2	46.8	42.3 – 51.8
20vPnC Lot 3	43.1	38.9 – 47.8

Serotype 4

Group	Value	95% CI
20vPnC Lot 1	1499.7	1288.3 – 1745.6
20vPnC Lot 2	1568.2	1350.2 – 1821.4
20vPnC Lot 3	1505.6	1294.4 – 1751.3

Serotype 5

Group	Value	95% CI
20vPnC Lot 1	125.8	108.6 – 145.7
20vPnC Lot 2	135.6	117.3 – 156.7
20vPnC Lot 3	116.8	100.9 – 135.2

Serotype 6A

Group	Value	95% CI
20vPnC Lot 1	4654.1	4033.0 – 5371.0
20vPnC Lot 2	3748.3	3255.7 – 4315.4
20vPnC Lot 3	3330.4	2885.1 – 3844.6

Serotype 6B

Group	Value	95% CI
20vPnC Lot 1	4403.3	3832.6 – 5059.0
20vPnC Lot 2	4349.9	3796.4 – 4984.1
20vPnC Lot 3	3907.3	3401.4 – 4488.3

Serotype 7F

Group	Value	95% CI
20vPnC Lot 1	1820.6	1588.5 – 2086.5
20vPnC Lot 2	1865.6	1629.7 – 2135.7
20vPnC Lot 3	1875.7	1632.6 – 2154.9

Serotype 9V

Group	Value	95% CI
20vPnC Lot 1	5120.4	4464.6 – 5872.7
20vPnC Lot 2	4604.1	4024.4 – 5267.5
20vPnC Lot 3	4921.7	4292.4 – 5643.2

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination Secondary · Before vaccination to 1 month after vaccination

Fold rises are the ratios of the 1 month after vaccination to before vaccination OPA titers. OPA GMFRs from before to 1 month after vaccination were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Serotype 1

Group	Value	95% CI
20vPnC Lot 1	20.2	17.6 – 23.1
20vPnC Lot 2	17.8	15.6 – 20.3
20vPnC Lot 3	17.3	15.0 – 19.8

Serotype 3

Group	Value	95% CI
20vPnC Lot 1	5.0	4.4 – 5.5
20vPnC Lot 2	5.0	4.5 – 5.5
20vPnC Lot 3	4.6	4.1 – 5.1

Serotype 4

Group	Value	95% CI
20vPnC Lot 1	77.6	63.8 – 94.4
20vPnC Lot 2	94.7	79.4 – 112.9
20vPnC Lot 3	81.0	67.0 – 97.8

Serotype 5

Group	Value	95% CI
20vPnC Lot 1	8.7	7.5 – 10.0
20vPnC Lot 2	9.4	8.2 – 10.7
20vPnC Lot 3	8.0	6.9 – 9.1

Serotype 6A

Group	Value	95% CI
20vPnC Lot 1	157.2	132.6 – 186.3
20vPnC Lot 2	119.6	100.5 – 142.3
20vPnC Lot 3	128.4	107.6 – 153.1

Serotype 6B

Group	Value	95% CI
20vPnC Lot 1	72.5	59.9 – 87.8
20vPnC Lot 2	75.4	62.9 – 90.4
20vPnC Lot 3	70.5	58.1 – 85.6

Serotype 7F

Group	Value	95% CI
20vPnC Lot 1	18.3	15.5 – 21.7
20vPnC Lot 2	19.5	16.5 – 23.0
20vPnC Lot 3	19.0	16.1 – 22.5

Serotype 9V

Group	Value	95% CI
20vPnC Lot 1	25.4	21.1 – 30.7
20vPnC Lot 2	23.3	19.4 – 27.9
20vPnC Lot 3	21.6	17.7 – 26.4

Percentage of Participants With Greater Than or Equal to (>=) 4 -Fold Rise in Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination Secondary · Before vaccination to 1 month after vaccination

Percentage of participants with a \>=4-fold rise in serotype-specific pneumococcal OPA titers from before vaccination to 1 month after vaccination along with corresponding 2-sided 95% CIs were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Serotype 1

Group	Value	95% CI
20vPnC Lot 1	83.7	80.0 – 87.0
20vPnC Lot 2	82.9	79.2 – 86.2
20vPnC Lot 3	82.4	78.6 – 85.8

Serotype 3

Group	Value	95% CI
20vPnC Lot 1	56.1	51.4 – 60.8
20vPnC Lot 2	57.8	53.1 – 62.3
20vPnC Lot 3	53.0	48.3 – 57.7

Serotype 4

Group	Value	95% CI
20vPnC Lot 1	85.0	81.4 – 88.2
20vPnC Lot 2	87.6	84.1 – 90.5
20vPnC Lot 3	86.2	82.6 – 89.3

Serotype 5

Group	Value	95% CI
20vPnC Lot 1	65.7	61.2 – 70.1
20vPnC Lot 2	67.2	62.7 – 71.4
20vPnC Lot 3	65.3	60.7 – 69.7

Serotype 6A

Group	Value	95% CI
20vPnC Lot 1	94.5	91.9 – 96.4
20vPnC Lot 2	93.1	90.4 – 95.3
20vPnC Lot 3	93.0	90.2 – 95.2

Serotype 6B

Group	Value	95% CI
20vPnC Lot 1	90.3	87.1 – 93.0
20vPnC Lot 2	91.4	88.4 – 93.8
20vPnC Lot 3	89.2	85.8 – 91.9

Serotype 7F

Group	Value	95% CI
20vPnC Lot 1	76.8	72.4 – 80.7
20vPnC Lot 2	76.7	72.3 – 80.6
20vPnC Lot 3	80.0	75.8 – 83.9

Serotype 9V

Group	Value	95% CI
20vPnC Lot 1	79.1	74.8 – 83.0
20vPnC Lot 2	79.5	75.2 – 83.3
20vPnC Lot 3	75.7	71.1 – 79.9

Percentage of Participants With Serotype-specific Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to Lower Limit of Quantitation (>= LLOQ) at 1 Month After Vaccination Secondary · 1 month after vaccination

The percentage of participants with OPA titers \>=LLOQ were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Data for this outcome measure was planned to be analyzed for the 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) only.

Serotype 1

Group	Value	95% CI
20vPnC Lot 1	91.8	88.9 – 94.1
20vPnC Lot 2	92.8	90.0 – 94.9
20vPnC Lot 3	91.0	87.9 – 93.4

Serotype 3

Group	Value	95% CI
20vPnC Lot 1	89.7	86.6 – 92.4
20vPnC Lot 2	89.6	86.4 – 92.2
20vPnC Lot 3	88.9	85.6 – 91.7

Serotype 4

Group	Value	95% CI
20vPnC Lot 1	97.6	95.7 – 98.8
20vPnC Lot 2	97.0	95.0 – 98.4
20vPnC Lot 3	97.1	95.1 – 98.5

Serotype 5

Group	Value	95% CI
20vPnC Lot 1	80.3	76.4 – 83.9
20vPnC Lot 2	84.3	80.7 – 87.5
20vPnC Lot 3	81.3	77.4 – 84.8

Serotype 6A

Group	Value	95% CI
20vPnC Lot 1	99.1	97.8 – 99.8
20vPnC Lot 2	98.1	96.4 – 99.1
20vPnC Lot 3	98.2	96.5 – 99.2

Serotype 6B

Group	Value	95% CI
20vPnC Lot 1	97.6	95.7 – 98.8
20vPnC Lot 2	99.6	98.5 – 99.9
20vPnC Lot 3	98.9	97.4 – 99.6

Serotype 7F

Group	Value	95% CI
20vPnC Lot 1	94.7	92.2 – 96.6
20vPnC Lot 2	94.0	91.4 – 96.0
20vPnC Lot 3	96.6	94.5 – 98.1

Serotype 9V

Group	Value	95% CI
20vPnC Lot 1	98.5	96.8 – 99.4
20vPnC Lot 2	98.9	97.5 – 99.7
20vPnC Lot 3	98.2	96.5 – 99.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Local reactions: within 10 days after vaccination (systematic assessment), Systemic events: within 7 days after vaccination (systematic assessment), Non serious AEs: up to 1 month after vaccination, SAEs: up to 6 months after vaccination. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pooled 20vPnC

Serious: 10/1463 (1%)

Deaths: 0/1463

13vPnC

Serious: 0/245 (0%)

Deaths: 0/245

Serious adverse events (14 terms)

Reaction	System	Pooled 20vPnC	13vPnC
Splenic cyst	Blood and lymphatic system disorders	—	—
Gastritis	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Hiatus hernia	Gastrointestinal disorders	—	—
Abdominal abscess	Infections and infestations	—	—
Osteomyelitis	Infections and infestations	—	—
Pneumonia mycoplasmal	Infections and infestations	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—
Procedural pneumothorax	Injury, poisoning and procedural complications	—	—
Subcutaneous haematoma	Injury, poisoning and procedural complications	—	—
Diabetic ketoacidosis	Metabolism and nutrition disorders	—	—
Suicidal ideation	Psychiatric disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Skin necrosis	Skin and subcutaneous tissue disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Pooled 20vPnC	13vPnC
Injection site pain (PAIN)	General disorders	—	—
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	—	—
Fatigue	General disorders	—	—
Headache	Nervous system disorders	—	—
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	—	—
Injection site swelling (SWELLING)	General disorders	—	—
Injection site erythema (REDNESS)	General disorders	—	—
Pyrexia (FEVER)	General disorders	—	—

Most-reported serious reactions: Splenic cyst, Gastritis, Gastrooesophageal reflux disease, Hiatus hernia, Abdominal abscess, Osteomyelitis, Pneumonia mycoplasmal, Staphylococcal bacteraemia.

Data from ClinicalTrials.gov NCT03828617 adverse events section.

Sponsor's own description

This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age.
Hurley D, Griffin C, Young M, Scott DA, et al · · 2021 · cited 117× · PMID 32716500 · DOI 10.1093/cid/ciaa1045
Development of Next Generation <i>Streptococcus pneumoniae</i> Vaccines Conferring Broad Protection.
Masomian M, Ahmad Z, Gew LT, Poh CL. · · 2020 · cited 102× · PMID 32192117 · DOI 10.3390/vaccines8010132
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.
Klein NP, Peyrani P, Yacisin K, Caldwell N, et al · · 2021 · cited 53× · PMID 34315611 · DOI 10.1016/j.vaccine.2021.07.004
Recent advances in the epidemiology and prevention of <i>Streptococcus pneumoniae</i> infections.
Feldman C, Anderson R. · · 2020 · cited 45× · PMID 32411353 · DOI 10.12688/f1000research.22341.1
A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States.
Fitz-Patrick D, Young M, Scott DA, Scully IL, et al · · 2021 · cited 11× · PMID 33545022 · DOI 10.1080/21645515.2020.1863177
Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease.
Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, et al · · 2022 · cited 4× · PMID 36368038 · DOI 10.1080/21645515.2022.2126253
A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age.
Essink B, Peterson J, Yacisin K, Lal H, et al · · 2021 · cited 2× · PMID 33661716 · DOI 10.1080/21645515.2021.1890511

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03828617 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 23 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03828617.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03828617

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (14 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of 20vPnC

Other recruiting trials for Pneumococcal Disease

Other Pfizer trials

Verify against primary sources