Pneumococcal InfectionsPhase 3NCT00427895

Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (13vPnC) and 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) in people with Pneumococcal Infections, run by Pfizer at 26 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

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: 13-valent pneumococcal conjugate vaccine (13vPnC) and 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,141 participants
Where: 26 sitesUnited States
Study dates: 27 Feb 2007to 1 Aug 2011
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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Who cannot join

Previous immunization with any licensed or experimental pneumococcal vaccine.
Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
Known or suspected impairment of immunological function.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Kentucky Pediatric /Adult Research
Bardstown, Kentucky, 40004
Internal Medicine and Pediatrics Associates of Bristol, PC
Bristol, Tennessee, 37520
PMG Research of Bristoll, LLC
Bristol, Tennessee, 37620
PMG Research of Raleigh, LLC
Cary, North Carolina, 275188
East Valley Family Physicians, PLC
Chandler, Arizona, 85224
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Accelovance
Huntsville, Alabama, 35802
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
University of Louisville
Louisville, Kentucky, 40202
Advanced Clinical Research
Meridian, Idaho, 83642
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Clinical Research Advantage/Central Phoenix
Phoenix, Arizona, 85020
Primary Physicians Research
Pittsburgh, Pennsylvania, 15205
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
University of Rochester Medical Center
Rochester, New York, 14642
J. Lewis Research Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84109
J. Lewis Research Inc./Foothill Family Clinic South
Salt Lake City, Utah, 84121
Group Health Research Institute
Seattle, Washington, 98101
Accelovance
South Bend, Indiana, 46601
Radiant Research - St. Louis
St Louis, Missouri, 63141
Primary Physicians Research
Upper Saint Clair, Pennsylvania, 15241
Omega Medical Research
Warwick, Rhode Island, 02886
Advanced Clinical Research
West Jordan, Utah, 84088
J. Lewis Research/First Med
West Jordan, Utah, 84088
Heartland Research Associates LLC
Wichita, Kansas, 67205
Heartland Research Associates, LLC
Wichita, Kansas, 67207

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

Conditions: Pneumococcal Infections
Being tested: 13-valent pneumococcal conjugate vaccine (13vPnC), 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
Keywords: Vaccine, Pneumococcal Infections Prevention and Control
Medical subject headings: Pneumococcal Infections

What participants receive

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

13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL dose administered on day 1
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)Biological
0.5 mL dose administered on day 1
13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL dose administered on day 1
13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL dose administered on day 1
13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL dose administered 3-4 years after dose 1
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)Biological
0.5 mL dose administered 3-4 years after dose 1
13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL dose administered 3-4 years after dose 1

Study groups in NCT00427895
Study group	Role	What they receive
13vPnC Cohort 1, Vaccination 1	Experimental	Participants aged 60-64 years were given a 0.5 mL dose administered on day 1. Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
23vPS Cohort 1, Vaccination 1	Active comparator	Participants aged 60-64 years were given a 0.5 mL dose administered on day 1. Receives: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
13vPnC Cohort 2, Vaccination 1	Experimental	Participants aged 50-59 years given a 0.5 mL dose administered on day 1. Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
13vPnC Cohort 3, Vaccination 1	Experimental	Participants aged 18-49 years given a 0.5 mL dose administered on day 1. Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
13vPnC Cohort 1, Vaccination 2	Experimental	Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1. Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
23vPS Cohort 1, Vaccination 2	Active comparator	Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1. Receives: Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)
13vPnC Cohort 2, Vaccination 2	Experimental	Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1. Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)

What is being measured

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

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: One month after vaccination 1
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Measured: One month after vaccination 1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Secondary outcomes (3)

Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.
Measured: One month after vaccination 1
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs are back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
Measured: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Antibody geometric mean concentration (GMC) as measured by microgram/milliliter (mcg/mL) for 12 common pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Timeline

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

27 Feb 20071 Aug 2011

First posted29 Jan 2007 (estimated)
Study start27 Feb 2007
Primary completion1 Aug 2011
Study completion1 Aug 2011

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.
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 3
Primary purpose: Prevention
Allocation: Randomised
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,141 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00427895
Sponsor's protocol ID: 6115A1-004
Other IDs: B1851019
Status last verified: Nov 2021
First submitted: 25 Jan 2007
Last updated: 15 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Active-controlled, Modified Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine (13vpnc) Compared To A 23-valent Pneumococcal Polysaccharide Vaccine (23vps) In Adults 60 To 64 Years Old Who Are Naive To 23vps And The Safety, Tolerability, And Immunogenicity Of 13vpnc In Adults 18-59 Years Old Who Are Naïve To 23vps
ClinicalTrials.gov ID: NCT00427895
Acronym / sponsor ID: 6115A1-004
Conditions: Pneumococcal Infections
Keywords: Vaccine, Pneumococcal Infections Prevention and Control
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,141 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 27 Feb 2007 (actual)
Primary completion: 1 Aug 2011 (actual)
Study completion: 1 Aug 2011 (actual)
First posted: 29 Jan 2007 (estimated)
Results: Posted 5 Sep 2012

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
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
13vPnC Cohort 1, Vaccination 1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
23vPS Cohort 1, Vaccination 1	Active comparator	Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)Participants aged 60-64 years were given a 0.5 mL dose administered on day 1.
13vPnC Cohort 2, Vaccination 1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Participants aged 50-59 years given a 0.5 mL dose administered on day 1.
13vPnC Cohort 3, Vaccination 1	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Participants aged 18-49 years given a 0.5 mL dose administered on day 1.
13vPnC Cohort 1, Vaccination 2	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Participants aged 60-64 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.
23vPS Cohort 1, Vaccination 2	Active comparator	Biological: 23-valent Pneumococcal Polysaccharide Vaccine (23vPS)Participants aged 60-64 years who received 23vPS at vaccination 1 receive a 0.5 mL dose of 23vPS administered 3-4 years after dose 1.
13vPnC Cohort 2, Vaccination 2	Experimental	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Participants aged 50-59 years who received 13vPnC at vaccination 1 receive a 0.5 mL dose of 13vPnC administered 3-4 years after dose 1.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

First Cohort: Healthy Male and female adults 60 to 64 years of age at time of enrollment.
Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of enrollment.
Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of enrollment.

Key exclusion criteria (3 listed)

Previous immunization with any licensed or experimental pneumococcal vaccine.
Serious chronic disorders 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 which in the investigator's opinion precludes the subject from participating in the study.
Known or suspected impairment of immunological function.

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
13-valent pneumococcal conjugate vaccine (13vPnC)0.5 mL dose administered on day 1	Biological	13vPnC Cohort 1, Vaccination 1
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)0.5 mL dose administered on day 1	Biological	23vPS Cohort 1, Vaccination 1
13-valent pneumococcal conjugate vaccine (13vPnC)0.5 mL dose administered on day 1	Biological	13vPnC Cohort 2, Vaccination 1
13-valent pneumococcal conjugate vaccine (13vPnC)0.5 mL dose administered on day 1	Biological	13vPnC Cohort 3, Vaccination 1
13-valent pneumococcal conjugate vaccine (13vPnC)0.5 mL dose administered 3-4 years after dose 1	Biological	13vPnC Cohort 1, Vaccination 2
23-valent Pneumococcal Polysaccharide Vaccine (23vPS)0.5 mL dose administered 3-4 years after dose 1	Biological	23vPS Cohort 1, Vaccination 2
13-valent pneumococcal conjugate vaccine (13vPnC)0.5 mL dose administered 3-4 years after dose 1	Biological	13vPnC Cohort 2, Vaccination 2

Primary outcome

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1
Time frame: One month after vaccination 1
Serotype-specific OPA GMTs for the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1
Time frame: One month after vaccination 1
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group
Time frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4
Serotype-specific OPA GMTs for the 12 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

3 secondary outcomes

Percentage of Participants Achieving OPA Titers With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination 1
Time frame: One month after vaccination 1
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rises (GMFRs) for the 13 Serotypes From Prevaccination 1 to 1 Month After Vaccination 2 in Cohort 1 and Cohort 2
Time frame: Prevaccination 1 to 1 month after vaccination 2/Year 3 to 4
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS and 23vPS/23vPS Groups in Cohort 1; and in 13vPnC/13vPnC Group in Cohort 2, 1 Month After Vaccination
Time frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4

Results and safety

Results posted to the registry on 5 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC, Cohort 1	411	411
23vPS, Cohort 1	411	411
13vPnC, Cohort 2	392	392
13vPnC, Cohort 3	854	502
13vPnC/13vPnC, Cohort 1	0	0
13vPnC/23vPS, Cohort 1	0	0
23vPS/23vPS, Cohort 1	0	0
13vPnC/13vPnC, Cohort 2	0	0

Primary outcome: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1

Time frame: One month after vaccination 1. Geometric mean (95% Confidence Interval). Unit: titer

Measure	13vPnC, Cohort 1 n = 411	23vPS, Cohort 1 n = 407	13vPnC, Cohort 2 n = 388	13vPnC, Cohort 3 n = 874
1	146 (124.0 to 172.9)	104 (87.7 to 124.4)	200 (170.3 to 236.0)	353 (322.8 to 386.9)
3	93 (81.1 to 106.6)	85 (74.2 to 98.3)	91 (79.9 to 104.7)	91 (84.2 to 98.4)
4	2062 (1693.6 to 2510.5)	1295 (1045.9 to 1603.0)	2833 (2412.1 to 3327.4)	4747 (4370.2 to 5155.5)
5	199 (164.0 to 242.3)	162 (133.6 to 197.5)	269 (218.1 to 332.5)	386 (342.6 to 435.8)
6A	2593 (2146.7 to 3131.1)	213 (160.3 to 284.3)	4328 (3658.1 to 5121.5)	5746 (5240.7 to 6300.4)
6B	1984 (1604.0 to 2453.6)	788 (615.9 to 1008.5)	3212 (2728.6 to 3781.4)	9813 (9097.8 to 10583.5)
7F	1120 (907.6 to 1382.9)	405 (311.9 to 524.7)	1520 (1274.5 to 1812.1)	3249 (2994.8 to 3523.9)
9V	1164 (934.8 to 1448.3)	407 (307.2 to 539.8)	1726 (1428.5 to 2086.2)	3339 (3037.4 to 3670.4)

13vPnC, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 1.4 (95% CI 1.10 to 1.78)
13vPnC, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 1.1 (95% CI 0.90 to 1.32)
13vPnC, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 1.6 (95% CI 1.19 to 2.13)

Population analysed: Evaluable immunogenicity population:eligible participants, received vaccination to which randomized, blood drawn within required timeframes, at least 1 valid, determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.

Primary outcome: Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titer for Serotype 6A 1 Month After Vaccination 1 in Cohort 1

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

Measure	13vPnC, Cohort 1 n = 374	23vPS, Cohort 1 n = 377
Value	88.5 (84.8 to 91.6)	49.3 (44.2 to 54.5)

13vPnC, Cohort 1 vs 23vPS, Cohort 1: Difference in Percentage: 39.2 (95% CI 33.0 to 45.1)

Population analysed: Evaluable immunogenicity population; N (number of participants analyzed) signifies participants with determinate OPA antibody titer to serotype 6A.

Primary outcome: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination for 12 Common Serotypes in 13vPnC/23vPS Group Relative to 23vPS Group and 23vPS/23vPS Group

Time frame: One month after vaccination 1 and One month after vaccination 2/Year 3 to 4. Geometric mean (95% Confidence Interval). Unit: titers

Measure	13vPnC/23vPS, Cohort 1 n = 108	23vPS, Cohort 1 n = 407	23vPs/23vPS, Cohort 1 n = 189
1	398 (306.2 to 516.3)	116 (89.4 to 149.6)	95 (74.8 to 121.1)
3	164 (129.0 to 207.5)	105 (85.3 to 128.7)	53 (42.8 to 64.4)
4	1875 (1488.8 to 2360.7)	1420 (1066.2 to 1890.5)	733 (555.1 to 968.2)
5	476 (356.2 to 636.1)	149 (111.1 to 201.2)	74 (54.2 to 100.3)
6B	2670 (2012.9 to 3540.6)	1088 (774.7 to 1528.1)	916 (670.0 to 1252.4)
7F	1895 (1471.0 to 2441.1)	403 (276.3 to 588.9)	497 (361.8 to 682.0)
9V	1089 (699.2 to 1695.0)	654 (452.5 to 944.9)	187 (125.0 to 280.3)
14	1268 (951.8 to 1690.0)	824 (612.9 to 1107.8)	661 (515.6 to 848.6)

13vPnC/23vPS, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 3.4 (95% CI 2.32 to 5.09)
13vPnC/23vPS, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 1.6 (95% CI 1.13 to 2.16)
13vPnC/23vPS, Cohort 1 vs 23vPS, Cohort 1: GMT Ratio: 1.3 (95% CI 0.88 to 1.98)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected after vaccination and at the 6-month follow-up contact. Participants recorded pre-specified AEs in electronic diary: local reactions and systemic events from Day 1-Day 14 post vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC, Cohort 1	1 of 417 (0.2%)	277 of 417 (66.4%)	Not reported
13vPnC: 6 Month Follow-up After Vax 1, Cohort 1	12 of 417 (2.9%)	0 of 417 (0%)	Not reported
23vPS, Cohort 1	2 of 414 (0.5%)	271 of 414 (65.5%)	Not reported
23vPS: 6 Month Follow-up After Vax 1, Cohort 1	10 of 414 (2.4%)	5 of 414 (1.2%)	Not reported
13vPnC, Cohort 2	2 of 403 (0.5%)	293 of 403 (72.7%)	Not reported
13vPnC: 6 Month Follow-up After Vax 1, Cohort 2	5 of 403 (1.2%)	2 of 403 (0.5%)	Not reported
13vPnC/13vPnC, Cohort 1	1 of 108 (0.9%)	66 of 108 (61.1%)	Not reported
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1	2 of 108 (1.9%)	1 of 108 (0.9%)	Not reported
13vPnC/23vPS, Cohort 1	1 of 108 (0.9%)	73 of 108 (67.6%)	Not reported
13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1	1 of 108 (0.9%)	4 of 108 (3.7%)	Not reported
23vPS/23vPS, Cohort 1	0 of 189 (0%)	143 of 189 (75.7%)	Not reported
23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1	3 of 189 (1.6%)	13 of 189 (6.9%)	Not reported
13vPnC/13vPnC, Cohort 2	0 of 214 (0%)	164 of 214 (76.6%)	Not reported
13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2	0 of 214 (0%)	4 of 214 (1.9%)	Not reported
13vPnC, Cohort 3	2 of 899 (0.2%)	779 of 899 (86.7%)	Not reported
13vPnC: 6 Month Follow-up After Vax 1, Cohort 3	2 of 899 (0.2%)	1 of 899 (0.1%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

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 3 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 5 Sep 2012). 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?

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination 1 (time frame: One month after vaccination 1). The study lists 3 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 NCT00427895.

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 15 Nov 2021.