Pneumococcal InfectionsPhase 2NCT03313050

A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

A Phase 2 study testing Multivalent, Tdap and polysaccharide in people with Pneumococcal Infections, run by Pfizer at 18 sites in United States.

Completed

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

Official record

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Trial summary

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent… Read more about this study

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: Multivalent, Tdap and polysaccharide
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 511 participants
Where: 18 sitesUnited States
Study dates: 12 Oct 2017to 24 May 2019
Phase: Phase 2
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 50 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Who cannot join

Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Augusta Family Practice
Augusta, Kansas, 67010
Heartland Research Associates, LLC
Augusta, Kansas, 67010
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Achieve Clinical Research LLC
Birmingham, Alabama, 35216
Core Healthcare Group
Cerritos, California, 90703
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28209
Medical Research South, LLC
Goose Creek, South Carolina, 29445
Axtell Clinic, P.A.
Newton, Kansas, 67114
Heartland Research Associates, LLC
Newton, Kansas, 67114
Meridian Clinical Research, LLC
Norfolk, Nebraska, 68701
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
J. Lewis Research Incorporated, Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, 84121
Meridian Clinical Research, LLC
Savannah, Georgia, 31406
Omega Medical Research
Warwick, Rhode Island, 02886
Advanced Clinical Research
West Jordan, Utah, 84088
Heartland Research Associates, LLC
Wichita, Kansas, 67205
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Conditions: Pneumococcal Infections
Being tested: Multivalent, Tdap, polysaccharide
Medical subject headings: Pneumococcal Infections

What participants receive

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

MultivalentBiological
Pneumococcal conjugate vaccine
TdapBiological
Tetanus, diphtheria, acellular pertussis vaccine
polysaccharideBiological
23-valent pneumococcal polysaccharide vaccine

Study groups in NCT03313050
Study group	Role	What they receive
Stage 1 multivalent (ages 50-64 years)	Experimental	multivalent Receives: Biological: Multivalent
Stage 1 Tdap (ages 50-64 years)	Active comparator	Tdap Receives: Biological: Tdap
Stage 2 multivalent (ages 65-85 years)	Experimental	multivalent Receives: Biological: Multivalent
Stage 2 polysaccharide (ages 65-85 years)	Active comparator	polysaccharide Receives: Biological: polysaccharide

What is being measured

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

Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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.
Measured: within 14 days after vaccination
Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >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.
Measured: within 14 days after vaccination
Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Measured: within 14 days after vaccination
Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees C, >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Measured: within 14 days after vaccination
Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Measured: within 1 month after vaccination
Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Measured: within 1 month after vaccination
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: within 6 months after vaccination
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: within 6 months after vaccination
Stage 1: Percentage of Participants With 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 is expected to be persistent or is otherwise long-lasting in its effects.
Measured: within 6 months after vaccination
Stage 2: Percentage of Participants With 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 is expected to be persistent or is otherwise long-lasting in its effects.
Measured: within 6 months after vaccination
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: within 12 months after vaccination
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.
Measured: within 12 months after vaccination

Secondary outcomes (4)

Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Antibody-mediated serum OPA against the 7 pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis. Evaluable immunogenicity population = EIP.
Measured: 1 month after vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Antibody-mediated serum OPA against the 7 common pneumococcal serotypes specific to c7vPnC (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Measured: within 1 month after vaccination
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Measured: before Vaccination to 1 month after Vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
GMFR for the 7 pneumococcal serotypes (serotypes 8, 10A, 11A, 12F, 15B, 22F and 33F) from before Vaccination to one month after Vaccination. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.
Measured: before Vaccination to 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.

12 Oct 201724 May 2019

First posted18 Oct 2017
Study start12 Oct 2017
Primary completion24 May 2019
Study completion24 May 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 (1)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionsStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 511 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03313050
Sponsor's protocol ID: C3571001
Status last verified: May 2020
First submitted: 10 Oct 2017
Last updated: 4 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. 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. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.
PubMed 33661716

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?

See locations

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
RecruitingPhase 3
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1/2, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY ADULTS 50 THROUGH 85 YEARS OF AGE
ClinicalTrials.gov ID: NCT03313050
Acronym / sponsor ID: C3571001
Conditions: Pneumococcal Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 12 Oct 2017 (actual)
Primary completion: 24 May 2019 (actual)
Study completion: 24 May 2019 (actual)
First posted: 18 Oct 2017 (actual)
Results: Posted 4 Jun 2020

Clinical summary

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

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

Study design

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

Arm	Type	Receives
Stage 1 multivalent (ages 50-64 years)	Experimental	Biological: Multivalentmultivalent
Stage 1 Tdap (ages 50-64 years)	Active comparator	Biological: TdapTdap
Stage 2 multivalent (ages 65-85 years)	Experimental	Biological: Multivalentmultivalent
Stage 2 polysaccharide (ages 65-85 years)	Active comparator	Biological: polysaccharidepolysaccharide

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Key exclusion criteria (2 listed)

Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13

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
MultivalentPneumococcal conjugate vaccine	Biological	Stage 1 multivalent (ages 50-64 years), Stage 2 multivalent (ages 65-85 years)
TdapTetanus, diphtheria, acellular pertussis vaccine	Biological	Stage 1 Tdap (ages 50-64 years)
polysaccharide23-valent pneumococcal polysaccharide vaccine	Biological	Stage 2 polysaccharide (ages 65-85 years)

Primary outcome

Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Time frame: within 14 days after vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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.
Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
Time frame: within 14 days after vaccination
Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >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.
Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Time frame: within 14 days after vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
Time frame: within 14 days after vaccination
Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees C, >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.
Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: within 1 month after vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: within 1 month after vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.
Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Time frame: within 6 months after vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Time frame: within 6 months after vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Stage 1: Percentage of Participants With 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 is expected to be persistent or is otherwise long-lasting in its effects.
Stage 2: Percentage of Participants With 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 is expected to be persistent or is otherwise long-lasting in its effects.
Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
Time frame: within 12 months after vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
Time frame: within 12 months after vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

4 secondary outcomes

Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Time frame: 1 month after vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After Vaccination
Time frame: within 1 month after vaccination
Stage 1: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-vaccination to 1 Month After Vaccination
Time frame: before Vaccination to 1 month after Vaccination
Stage 2: Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) From Pre-Vaccination to 1 Month After Vaccination
Time frame: before Vaccination to 1 month after Vaccination

Results and safety

Results posted to the registry on 4 Jun 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
Stage 1: c7vPnC (50 to 64 Years of Age)	34	34
Stage 1: Tdap (50 to 64 Years of Age)	32	32
Stage 2: c7vPnC (65 to 85 Years of Age)	0	0
Stage 2: PPSV23 (65 to 85 Years of Age)	0	0

Primary outcome: Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination

Time frame: within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stage 1: c7vPnC (50 to 64 Years of Age) n = 34	Stage 1: Tdap (50 to 64 Years of Age) n = 32
Redness: Any	2.9 (0.1 to 15.3)	12.5 (3.5 to 29.0)
Redness: Mild	2.9 (0.1 to 15.3)	6.3 (0.8 to 20.8)
Redness: Moderate	0 (0.0 to 10.3)	6.3 (0.8 to 20.8)
Redness: Severe	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Swelling: Any	8.8 (1.9 to 23.7)	18.8 (7.2 to 36.4)
Swelling: Mild	5.9 (0.7 to 19.7)	6.3 (0.8 to 20.8)
Swelling: Moderate	2.9 (0.1 to 15.3)	12.5 (3.5 to 29.0)
Swelling: Severe	0 (0.0 to 10.3)	0 (0.0 to 10.9)

Population analysed: The safety population of Stage 1 included all participants who received at least 1 dose of c7vPnC or Tdap and had post-vaccination follow-up in Stage 1 and participants who lacked any safety data were excluded from the analysis.

Primary outcome: Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination

Time frame: within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stage 2: c7vPnC (65 to 85 Years of Age) n = 221	Stage 2: PPSV23 (65 to 85 Years of Age) n = 223
Redness: Any	8.1 (4.9 to 12.6)	17.9 (13.1 to 23.6)
Redness: Mild	5.9 (3.2 to 9.8)	8.1 (4.9 to 12.5)
Redness: Moderate	2.3 (0.7 to 5.2)	4.5 (2.2 to 8.1)
Redness: Severe	0 (0.0 to 1.7)	5.4 (2.8 to 9.2)
Swelling: Any	6.8 (3.8 to 10.9)	16.6 (12.0 to 22.1)
Swelling: Mild	5.9 (3.2 to 9.8)	5.4 (2.8 to 9.2)
Swelling: Moderate	0.9 (0.1 to 3.2)	7.6 (4.5 to 11.9)
Swelling: Severe	0 (0.0 to 1.7)	3.6 (1.6 to 6.9)

Population analysed: The safety population of Stage 2 included all participants who received at least 1 dose of c7vPnC or PPSV23 and had post-vaccination follow-up in Stage 2 and participants who lacked any safety data were excluded from the analysis.

Primary outcome: Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination

Time frame: within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stage 1: c7vPnC (50 to 64 Years of Age) n = 34	Stage 1: Tdap (50 to 64 Years of Age) n = 32
Fever: >=38.0 degree C	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Fever: >=38.0 to 38.4 degree C	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Fever: >38.4 to 38.9 degree C	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Fever: >38.9 to 40.0 degree C	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Fever: >40.0 degree C	0 (0.0 to 10.3)	0 (0.0 to 10.9)
Fatigue: Any	29.4 (15.1 to 47.5)	28.1 (13.7 to 46.7)
Fatigue: Mild	29.4 (15.1 to 47.5)	9.4 (2.0 to 25.0)
Fatigue: Moderate	0 (0.0 to 10.3)	18.8 (7.2 to 36.4)

Primary outcome: Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination

Time frame: within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Stage 2: c7vPnC (65 to 85 Years of Age) n = 221	Stage 2: PPSV23 (65 to 85 Years of Age) n = 223
Fever: >=38.0 degree C	0.5 (0.0 to 2.5)	0.9 (0.1 to 3.2)
Fever: >=38.0 to 38.4 degree C	0.5 (0.0 to 2.5)	0 (0.0 to 1.6)
Fever: >38.4 to 38.9 degree C	0 (0.0 to 1.7)	0.4 (0.0 to 2.5)
Fever: >38.9 to 40.0 degree C	0 (0.0 to 1.7)	0.4 (0.0 to 2.5)
Fever: >40.0 degree C	0 (0.0 to 1.7)	0 (0.0 to 1.6)
Fatigue: Any	34.4 (28.1 to 41.1)	33.2 (27.0 to 39.8)
Fatigue: Mild	24.9 (19.3 to 31.1)	17.5 (12.7 to 23.1)
Fatigue: Moderate	7.7 (4.5 to 12.0)	13.9 (9.6 to 19.1)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions and systemic events: within 14 days after vaccination; Non serious AEs: Stage 1 and 2- baseline up to 1 month after vaccination (approximately up to 35 days); SAEs: Stage 1- baseline up to 6 months after vaccination (approximately up to 196 days), Stage 2- baseline up to 12 months after vaccination (approximately up to 378 days). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1: c7vPnC (50 to 64 Years of Age)	2 of 34 (5.9%)	27 of 34 (79.4%)	0 of 34
Stage 1: Tdap (50 to 64 Years of Age)	0 of 32 (0%)	28 of 32 (87.5%)	0 of 32
Stage 2: c7vPnC (65 to 85 Years of Age)	9 of 221 (4.1%)	161 of 221 (72.9%)	3 of 221
Stage 2: PPSV23 (65 to 85 Years of Age)	8 of 223 (3.6%)	171 of 223 (76.7%)	0 of 223

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33661716Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. 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. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Multivalent, Tdap and polysaccharide in people with Pneumococcal Infections, run by Pfizer at 18 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 2 inclusion and 2 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jun 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?

Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination (time frame: within 14 days after vaccination). The study lists 12 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 NCT03313050, which also lists 1 linked publication.

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 4 Jun 2020.