Pneumococcal DiseasePhase 3NCT03828617

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

A Phase 3 study testing 20vPnC and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: 20vPnC and 13vPnC
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,710 participants
Where: 21 sitesUnited States
Study dates: 14 Feb 2019to 9 Oct 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female adults ≥18 and <50 years of age.
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.

Who cannot join

Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
History of microbiologically proven invasive disease caused by S pneumoniae.
Pregnant female subjects or breastfeeding female subjects (known or suspected).

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Benchmark Research
Austin, Texas, 78705
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049
Accel Research Sites - Clinical Research Unit
DeLand, Florida, 32720
Research Centers of America, LLC
Hollywood, Florida, 33024
East West Medical Research Institute
Honolulu, Hawaii, 96814
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Kaiser Permanente Sacramento
Sacramento, California, 95815
Kaiser Permanente South Sacramento
Sacramento, California, 95823
J. Lewis Research, Inc. /Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. /Foothill Family Clinic South
Salt Lake City, Utah, 84121
Kaiser Permanente San Jose
San Jose, California, 95119
Kaiser Permanente Santa Clara
Santa Clara, California, 95051
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Omega Medical Research
Warwick, Rhode Island, 02886
Heartland Research Associates, LLC
Wichita, Kansas, 67207
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE

Conditions: Pneumococcal Disease
Being tested: 20vPnC, 13vPnC
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

20vPnCBiological
20vPnC
20vPnCBiological
20vPnC
20vPnCBiological
20vPnC
13vPnCBiological
Pneumococcal conjugate vaccine

Study groups in NCT03828617
Study group	Role	What they receive
20vPnC Lot 1	Experimental	20vPnC Lot 1 Receives: Biological: 20vPnC
20vPnC Lot 2	Experimental	20vPnC Lot 2 Receives: Biological: 20vPnC
20vPnC Lot 3	Experimental	20vPnC Lot 3 Receives: Biological: 20vPnC
13vPnC	Active comparator	13vPnC Receives: Biological: 13vPnC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local Reactions 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 pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Measured: Within 10 days after vaccination
Percentage of Participants With Systemic Events 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, 2 and 3) and 13vPnC group.
Measured: Within 7 days after vaccination
Percentage of Participants With Any Adverse Events (AEs) 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.
Measured: Within 1 month after vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months 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.
Measured: Within 6 month after vaccination
Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) 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.
Measured: Within 6 months after vaccination
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 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.
Measured: 1 month after vaccination

Secondary outcomes (3)

Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 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.
Measured: Before vaccination to 1 month after vaccination
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
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.
Measured: Before vaccination to 1 month after vaccination
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
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.
Measured: 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20199 Oct 2019

First posted4 Feb 2019
Study start14 Feb 2019
Primary completion9 Oct 2019
Study completion9 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,710 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03828617
Sponsor's protocol ID: B7471008
Status last verified: Nov 2020
First submitted: 1 Feb 2019
Last updated: 23 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. 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. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
PubMed 36368038
Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. 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):5428-5435. doi: 10.1016/j.vaccine.2021.07.004. Epub 2021 Jul 24.
PubMed 34315611

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE
ClinicalTrials.gov ID: NCT03828617
Acronym / sponsor ID: B7471008
Conditions: Pneumococcal Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,710 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 14 Feb 2019 (actual)
Primary completion: 9 Oct 2019 (actual)
Study completion: 9 Oct 2019 (actual)
First posted: 4 Feb 2019 (actual)
Results: Posted 4 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
20vPnC Lot 1	Experimental	Biological: 20vPnC20vPnC Lot 1
20vPnC Lot 2	Experimental	Biological: 20vPnC20vPnC Lot 2
20vPnC Lot 3	Experimental	Biological: 20vPnC20vPnC Lot 3
13vPnC	Active comparator	Biological: 13vPnC13vPnC

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Male or female adults ≥18 and <50 years of age.
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.

Key exclusion criteria (4 listed)

Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
History of microbiologically proven invasive disease caused by S pneumoniae.
Pregnant female subjects or breastfeeding female subjects (known or suspected).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
20vPnC20vPnC	Biological	20vPnC Lot 1
20vPnC20vPnC	Biological	20vPnC Lot 2
20vPnC20vPnC	Biological	20vPnC Lot 3
13vPnCPneumococcal conjugate vaccine	Biological	13vPnC

Primary outcome

Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Time frame: 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 pooled 20vPnC vaccine groups (20vPnC Lots 1, 2 and 3) and 13vPnC group.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Time frame: 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, 2 and 3) and 13vPnC group.
Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: 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.
Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Time frame: 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.
Percentage of Participants With Any Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Time frame: 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.
Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Time frame: 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.

3 secondary outcomes

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

Results and safety

Results posted to the registry on 4 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20vPnC Lot 1	489	465
20vPnC Lot 2	490	475
20vPnC Lot 3	486	460
13vPnC	245	235

Primary outcome: Percentage of Participants With Local Reactions Within 10 Days After Vaccination

Time frame: Within 10 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pooled 20vPnC n = 1456	13vPnC n = 243
Redness: Any	7.0 (5.7 to 8.4)	6.2 (3.5 to 10.0)
Redness: Mild	3.9 (3.0 to 5.0)	3.3 (1.4 to 6.4)
Redness: Moderate	2.6 (1.9 to 3.6)	2.9 (1.2 to 5.8)
Redness: Severe	0.5 (0.2 to 1.0)	0 (0.0 to 1.5)
Swelling: Any	8.5 (7.1 to 10.1)	8.6 (5.4 to 12.9)
Swelling: Mild	5.4 (4.3 to 6.7)	5.3 (2.9 to 9.0)
Swelling: Moderate	2.9 (2.1 to 3.9)	3.3 (1.4 to 6.4)
Swelling: Severe	0.2 (0.0 to 0.6)	0 (0.0 to 1.5)

Population analysed: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination. Here, "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Time frame: Within 7 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pooled 20vPnC n = 1456	13vPnC n = 243
Fever: >=38.0 degree C (Any)	1.2 (0.7 to 1.9)	0.8 (0.1 to 2.9)
Fever: >=38.0 degree C to 38.4 degree C	0.8 (0.4 to 1.3)	0.4 (0.0 to 2.3)
Fever: >38.4 degree C to 38.9 degree C	0.3 (0.1 to 0.7)	0.4 (0.0 to 2.3)
Fever: >38.9 degree C to 40.0 degree C	0.2 (0.0 to 0.6)	0 (0.0 to 1.5)
Fever: >40.0 degree C	0 (0.0 to 0.3)	0 (0.0 to 1.5)
Fatigue: Any	47.6 (45.0 to 50.2)	43.6 (37.3 to 50.1)
Fatigue: Mild	24.7 (22.5 to 27.0)	24.3 (19.0 to 30.2)
Fatigue: Moderate	21.2 (19.1 to 23.4)	17.7 (13.1 to 23.1)

Primary outcome: Percentage of Participants With Any Adverse Events (AEs) Within 1 Month After Vaccination

Time frame: Within 1 month after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pooled 20vPnC n = 1463	13vPnC n = 245
Value	6.8 (5.6 to 8.3)	5.3 (2.9 to 8.9)

Population analysed: Safety population included all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.

Primary outcome: Percentage of Participants With Any Serious Adverse Events (SAEs) Within 6 Months After Vaccination

Time frame: Within 6 month after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pooled 20vPnC n = 1463	13vPnC n = 245
Value	0.7 (0.3 to 1.3)	0 (0.0 to 1.5)

Population analysed: Safety population includes all participants who received 1 dose of any 20vPnC lot or 13vPnC and had safety follow-up after the vaccination.

3 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled 20vPnC	10 of 1,463 (0.7%)	1,275 of 1,463 (87.1%)	0 of 1,463
13vPnC	0 of 245 (0%)	206 of 245 (84.1%)	0 of 245

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36368038Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. 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. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
Derived from this study: PubMed 34315611Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. 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):5428-5435. doi: 10.1016/j.vaccine.2021.07.004. Epub 2021 Jul 24.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 20vPnC and 13vPnC in people with Pneumococcal Disease, run by Pfizer at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Local Reactions Within 10 Days After Vaccination (time frame: Within 10 days after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03828617, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.