Pneumococcal InfectionPhase 2NCT01654263

A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

A Phase 2 study testing Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] in people with Pneumococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 55 to 74 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infection
What is being tested?: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 884 participants
Where: 7 sitesUnited States
Study dates: 10 Oct 2012to 21 Aug 2015
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 55 to 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Male or female adults 55 through 74 years of age at the time of enrollment who are able to provide informed consent. 2. For the pneumococcal vaccine-naïve group (Group I), no pneumococcal vaccine received prior to enrollment, as documented by participant report and review of available vaccine records. For the previously vaccinated group (Group II), documented vaccination with exactly one dose of PPSV23 administered >/=3 and </=7 years prior to enrollment and no other lifetime doses of PPSV23. (History of receipt or non-receipt of a pneumococcal vaccine may be presumptively ascertained by participant report but must be confirmed by review of primary source information, including but not limited to medical records, primary care or other provider report, and health department records. Medical records should be reviewed and/or primary care or other providers queried to identify pneumococcal vaccinations administered for a period of not less than 10 years prior to enrollment.) 3. Determined by medical history, targeted physical examination (if indicated), and clinical judgment to be eligible for the study. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy (A change in dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g. surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease.) or hospitalization for worsening disease 12 weeks prior to enrollment, are eligible. 4. Agree not to receive a live virus vaccine (for example, zoster vaccine) before the Day 28 (Visit 03) blood specimen collection and not to receive an inactivated vaccine (for example, inactivated influenza vaccine) within 14 days after enrollment. 5. The subject is able to understand and comply with the planned study procedures including being available for all study visits. 6. The subject has provided informed consent prior to any study procedures.

Who cannot join

1. Receipt of any PCV or investigational pneumococcal vaccine prior to enrollment. 2. Receipt of any inactivated vaccine within 14 days prior to enrollment or receipt of any live vaccine within 30 days prior to enrollment. 3. Receipt of an allergy desensitization injection within 14 days prior to enrollment or planned receipt of an allergy desensitization injection within 7 days following enrollment. 4. Receipt of a diphtheria toxoid containing vaccine (for example, tetanus and diphtheria toxoid [Td] or tetanus and diphtheria toxoid and acellular pertussis [TdaP] vaccine) within six months prior to enrollment. 5. Known or suspected immunodeficiency, receipt of cancer chemotherapy or radiation therapy within the preceding 36 months, or receiving treatment with immunosuppressive therapy, including systemic corticosteroids, e.g., for cancer, HIV or autoimmune disease. If any systemic (oral, parenteral) corticosteroids have been administered for treatment of acute illness within 30 days of vaccination, and any long term use (>2 weeks) in the 30 through 59 days before vaccination should be excluded. (Topical, intranasal, and inhaled corticosteroids are allowed.) 6. Serious chronic disorders including active or metastatic malignancy, hematologic malignancy, severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the opinion of the investigator precludes the subject's participation. 7. Known HIV, hepatitis B or hepatitis C infection. 8. Residence in a nursing home or other skilled nursing facility or requirement for skilled nursing care. An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for the trial. 9. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment. 10. Poor or missing eyesight, requiring third party support to read. 11. Receipt of any blood products, including immunoglobulin, within three months prior to enrollment. 12. Heart rate less than 40 bpm or greater than 120 bpm as measured at the enrollment visit and prior to vaccination. 13. Systolic blood pressure less than 90 mm Hg or greater than 170 mm Hg as measured at the enrollment visit and prior to vaccination. 14. Diastolic blood pressure greater than 110 mm Hg as measured at the enrollment visit and prior to vaccination. 15. For Group I, unable to receive a vaccination in the deltoid muscle of the right arm and unable to receive a vaccination in the deltoid muscle of the left arm because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. For Group II, unable to receive a vaccination in the deltoid muscle of one or both arms because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. 16. Currently on anticoagulant therapy (for example, warfarin, heparin [IV or SQ], or dabigatran) or a history of bleeding diathesis that would contraindicate intramuscular injection. (Aspirin, clopidogrel, dipyridamole, and nonsteroidal anti-inflammatory agents are allowed). 17. Known clinically significant allergic reaction to prior pneumococcal vaccination (for Group II participants) or to a component of PCV13 vaccine (PCV13 is latex free). 18. Current known abuse of alcohol or drug addiction that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures. 19. Rec eipt of any other investigational vaccine or agent within one month before enrollment or intent to receive any other investigational vaccine or agent prior to the conclusion of the study. 20. Any medical condition that would, in the opinion of the investigator, place the participant at an unacceptable risk of an adverse event or interfere with the evaluation of the study objectives.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45229-3039
Emory Vaccine Center - The Hope Clinic
Decatur, Georgia, 30030-1705
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
Group Health Research Institute - Seattle - Vaccines and Infectious Diseases
Seattle, Washington, 98101-1466
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015

Other trials in United States

About this study

Official title: A Phase IIb, Open-Label, Dose-Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study

Read the detailed description

This is a phase IIb open-label immunogenicity and safety study to evaluate dosages of 0.5 mL and 1.0 mL (given as two 0.5 mL injections in separate arms) of PCV13 in adults 55 through 74 years of age previously vaccinated with PPSV23. The study will enroll two groups of participants. Group I participants will all receive an open-label dose of 0.5 mL PCV13 and will include 294 adults 55-74 years of age who have not previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23). Group II will be randomized 1:1 to receive 0.5 mL PCV13 (Group IIA) or 0.5 mL PCV13 in the right arm and 0.5 mL PCV 13 in the left arm (Group IIB). Group II will include 588 adults 55 through 74 years of age who previously received a single dose of PPSV23 > /=3 years and < /=7 years prior to enrollment. Enrollment in both groups will be stratified by age group (55 through 64 years and 65 through 74 years).The study duration is approximately 18 months. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study vaccination, and is non-inferior to 12 vaccine serotypes; and determine if two 0.5 mL doses of PCV13 administered to participants previously vaccinated with PPSV23 are non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for the 12 vaccine serotypes, as measured by serotype-specific OPA titers 28 days after study vaccination. The secondary objectives of this study are to: determine if two x 0.5mL doses of PCV13 is statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 180 days after study vaccination, and is non-inferior to 12 vaccine serotypes; to determine if two x 0.5mL doses of PCV13 administered to participants previously vaccinated with PPSV23 is non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for 12 vaccine serotypes, as measured by serotype-specific OPA titers 180 days after study vaccination. Parent protocol to sub-study 12-0031.

Conditions: Pneumococcal Infection
Being tested: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Keywords: 13-valent, 23-valent, elderly, parent protocol, Pneumococcal infections, vaccine
Medical subject headings: Pneumococcal Infections

What participants receive

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

Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Biological
Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.

Study groups in NCT01654263
Study group	Role	What they receive
Group IA: Pneumococcal vaccine-naive, age 55 - 64	Experimental	Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to 147 subjects vaccine-naive adults Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Group IB: Pneumococcal vaccine-naive, age 65 - 74	Experimental	Open- label, PCV13 given as 0.5 mL IM injection to 147 subjects vaccine-naive adults Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Group IIA: age 55 - 64, previous PPSV23	Experimental	Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Group IIAA: age 55 - 64, previous PPSV23	Experimental	Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Group IIB: age 65 - 74, previous PPSV23	Experimental	Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Group IIBB: age 65 - 74, previous PPSV23	Experimental	Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment Receives: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]

What is being measured

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

Number of Participants Reporting Solicited Local and Systemic Adverse Events
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.
Measured: Days 0 to Day 7 post vaccination
Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.
Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Measured: Up to Day 28 post vaccination
Number of Participants Reporting Vaccine-related Serious Adverse Events.
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Measured: Up to Day 180 post vaccination
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Measured: Day 0 and Day 28 post vaccination

Secondary outcomes (1)

Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
Measured: Day 0 and Day 180 post vaccination

Timeline

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

10 Oct 201221 Aug 2015

First posted31 Jul 2012 (estimated)
Study start10 Oct 2012
Primary completion21 Aug 2015
Study completion21 Aug 2015

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 InfectionStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
Enrolment: 884 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01654263
Sponsor's protocol ID: 11-0034
Other IDs: HHSN272201300018I
Status last verified: 15 Apr 2016
First submitted: 19 Jul 2012
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Jackson LA, El Sahly HM, George S, Winokur P, Edwards K, Brady RC, Rouphael N, Keitel WA, Mulligan MJ, Burton RL, Nakamura A, Ferreria J, Nahm MH. Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2018 Jan 29;36(5):606-614. doi: 10.1016/j.vaccine.2017.12.061. Epub 2017 Dec 24.
PubMed 29279281

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 Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Open-Label, Dose-Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
ClinicalTrials.gov ID: NCT01654263
Acronym / sponsor ID: 11-0034
Conditions: Pneumococcal Infection
Keywords: 13-valent, 23-valent, elderly, parent protocol, Pneumococcal infections, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 884 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 10 Oct 2012 (actual)
Primary completion: 21 Aug 2015 (actual)
Study completion: 21 Aug 2015 (actual)
First posted: 31 Jul 2012 (estimated)
Results: Posted 23 Jan 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 6

Arm	Type	Receives
Group IA: Pneumococcal vaccine-naive, age 55 - 64	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to 147 subjects vaccine-naive adults
Group IB: Pneumococcal vaccine-naive, age 65 - 74	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open- label, PCV13 given as 0.5 mL IM injection to 147 subjects vaccine-naive adults
Group IIA: age 55 - 64, previous PPSV23	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
Group IIAA: age 55 - 64, previous PPSV23	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
Group IIB: age 65 - 74, previous PPSV23	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
Group IIBB: age 65 - 74, previous PPSV23	Experimental	Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment

Who may qualify

Ages: 55 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Male or female adults 55 through 74 years of age at the time of enrollment who are able to provide informed consent. 2. For the pneumococcal vaccine-naïve group (Group I), no pneumococcal vaccine received prior to enrollment, as documented by participant report and review of available vaccine records. For the previously vaccinated group (Group II), documented vaccination with exactly one dose of PPSV23 administered >/=3 and </=7 years prior to enrollment and no other lifetime doses of PPSV23. (History of receipt or non-receipt of a pneumococcal vaccine may be presumptively ascertained by participant report but must be confirmed by review of primary source information, including but not limited to medical records, primary care or other provider report, and health department records. Medical records should be reviewed and/or primary care or other providers queried to identify pneumococcal vaccinations administered for a period of not less than 10 years prior to enrollment.) 3. Determined by medical history, targeted physical examination (if indicated), and clinical judgment to be eligible for the study. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy (A change in dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g. surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease.) or hospitalization for worsening disease 12 weeks prior to enrollment, are eligible. 4. Agree not to receive a live virus vaccine (for example, zoster vaccine) before the Day 28 (Visit 03) blood specimen collection and not to receive an inactivated vaccine (for example, inactivated influenza vaccine) within 14 days after enrollment. 5. The subject is able to understand and comply with the planned study procedures including being available for all study visits. 6. The subject has provided informed consent prior to any study procedures.

Key exclusion criteria (1 listed)

1. Receipt of any PCV or investigational pneumococcal vaccine prior to enrollment. 2. Receipt of any inactivated vaccine within 14 days prior to enrollment or receipt of any live vaccine within 30 days prior to enrollment. 3. Receipt of an allergy desensitization injection within 14 days prior to enrollment or planned receipt of an allergy desensitization injection within 7 days following enrollment. 4. Receipt of a diphtheria toxoid containing vaccine (for example, tetanus and diphtheria toxoid [Td] or tetanus and diphtheria toxoid and acellular pertussis [TdaP] vaccine) within six months prior to enrollment. 5. Known or suspected immunodeficiency, receipt of cancer chemotherapy or radiation therapy within the preceding 36 months, or receiving treatment with immunosuppressive therapy, including systemic corticosteroids, e.g., for cancer, HIV or autoimmune disease. If any systemic (oral, parenteral) corticosteroids have been administered for treatment of acute illness within 30 days of vaccination, and any long term use (>2 weeks) in the 30 through 59 days before vaccination should be excluded. (Topical, intranasal, and inhaled corticosteroids are allowed.) 6. Serious chronic disorders including active or metastatic malignancy, hematologic malignancy, severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the opinion of the investigator precludes the subject's participation. 7. Known HIV, hepatitis B or hepatitis C infection. 8. Residence in a nursing home or other skilled nursing facility or requirement for skilled nursing care. An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for the trial. 9. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment. 10. Poor or missing eyesight, requiring third party support to read. 11. Receipt of any blood products, including immunoglobulin, within three months prior to enrollment. 12. Heart rate less than 40 bpm or greater than 120 bpm as measured at the enrollment visit and prior to vaccination. 13. Systolic blood pressure less than 90 mm Hg or greater than 170 mm Hg as measured at the enrollment visit and prior to vaccination. 14. Diastolic blood pressure greater than 110 mm Hg as measured at the enrollment visit and prior to vaccination. 15. For Group I, unable to receive a vaccination in the deltoid muscle of the right arm and unable to receive a vaccination in the deltoid muscle of the left arm because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. For Group II, unable to receive a vaccination in the deltoid muscle of one or both arms because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. 16. Currently on anticoagulant therapy (for example, warfarin, heparin [IV or SQ], or dabigatran) or a history of bleeding diathesis that would contraindicate intramuscular injection. (Aspirin, clopidogrel, dipyridamole, and nonsteroidal anti-inflammatory agents are allowed). 17. Known clinically significant allergic reaction to prior pneumococcal vaccination (for Group II participants) or to a component of PCV13 vaccine (PCV13 is latex free). 18. Current known abuse of alcohol or drug addiction that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures. 19. Rec eipt of any other investigational vaccine or agent within one month before enrollment or intent to receive any other investigational vaccine or agent prior to the conclusion of the study. 20. Any medical condition that would, in the opinion of the investigator, place the participant at an unacceptable risk of an adverse event or interfere with the evaluation of the study objectives.

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
Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.	Biological	Group IA: Pneumococcal vaccine-naive, age 55 - 64, Group IB: Pneumococcal vaccine-naive, age 65 - 74, Group IIA: age 55 - 64, previous PPSV23, Group IIAA: age 55 - 64, previous PPSV23, Group IIB: age 65 - 74, previous PPSV23, Group IIBB: age 65 - 74, previous PPSV23

Primary outcome

Number of Participants Reporting Solicited Local and Systemic Adverse Events
Time frame: Days 0 to Day 7 post vaccination
Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.
Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.
Time frame: Up to Day 28 post vaccination
Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Number of Participants Reporting Vaccine-related Serious Adverse Events.
Time frame: Up to Day 180 post vaccination
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.
Time frame: Day 0 and Day 28 post vaccination
Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).

1 secondary outcome

Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.
Time frame: Day 0 and Day 180 post vaccination

Results and safety

Results posted to the registry on 23 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection	164	164
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection	147	147
IIA: Age 55-64, Previous PPSV23, Single Injection	139	137
IIB: Age 65-74, Previous PPSV23, Single Injection	145	144
IIAA: Age 55-64, Previous PPSV23, Two Injections	140	139
IIBB: Age 65 - 74, Previous PPSV23, Two Injections	149	148

Primary outcome: Number of Participants Reporting Solicited Local and Systemic Adverse Events

Time frame: Days 0 to Day 7 post vaccination. Number. Unit: participants

Measure	Group IA/B: Pneumococcal Vaccine-naive, Single Injection n = 311	Group IIA/B: Previous PPSV23, Single Injection n = 284	Group IIAA/BB: Previous PPSV23, Two Injections n = 288
Pain	148	153	187
Tenderness	213	180	214
Redness (measurement)	40	47	53
Swelling	39	49	45
Swelling (measurement)	39	48	45
Elevated oral temperature	5	3	7
Feverishness	18	25	29
Malaise	53	56	86

Population analysed: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.

Primary outcome: Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.

Time frame: Up to Day 28 post vaccination. Number. Unit: participants

Measure	Group IA/B: Pneumococcal Vaccine-naive, Single Injection n = 311	Group IIA/B: Previous PPSV23, Single Injection n = 284	Group IIAA/BB: Previous PPSV23, Two Injections n = 288
Value	19	14	22

Population analysed: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.

Primary outcome: Number of Participants Reporting Vaccine-related Serious Adverse Events.

Time frame: Up to Day 180 post vaccination. Number. Unit: participants

Measure	Group IA/B: Pneumococcal Vaccine-naive, Single Injection n = 311	Group IIA/B: Previous PPSV23, Single Injection n = 284	Group IIAA/BB: Previous PPSV23, Two Injections n = 288
Value	0	0	0

Population analysed: All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.

Primary outcome: Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.

Time frame: Day 0 and Day 28 post vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Group IA/B: Pneumococcal Vaccine-naive, Single Injection n = 307	Group IIA/B: Previous PPSV23, Single Injection n = 277	Group IIAA/BB: Previous PPSV23, Two Injections n = 283
Serotype 1, Day 0	6.8 (6.0 to 7.7)	20.9 (16.9 to 25.7)	20.4 (16.9 to 24.6)
Serotype 1, Day 28	216.0 (177.5 to 262.7)	75.2 (61.4 to 92.1)	95.1 (78.6 to 115.0)
Serotype 4, Day 0	20.6 (16.6 to 25.5)	92.3 (72.2 to 117.9)	81.3 (63.7 to 103.7)
Serotype 4, Day 28	1808.9 (1570.4 to 2083.5)	926.6 (787.5 to 1090.3)	1451.3 (1277.3 to 1649.0)
Serotype 5, Day 0	8.8 (7.6 to 10.2)	53.0 (41.7 to 67.4)	36.8 (29.3 to 46.1)
Serotype 5, Day 28	509.8 (416.4 to 624.2)	287.8 (237.1 to 349.4)	302.8 (249.5 to 367.5)
Serotype 6A, Day 0	24.1 (19.0 to 30.5)	47.5 (35.9 to 62.8)	53.8 (41.1 to 70.5)
Serotype 6A, Day 28	3222.1 (2697.1 to 3849.5)	2256.7 (1867.1 to 2727.6)	2903.1 (2364.5 to 3564.5)

Population analysed: All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Solicited events were collected for 8 days after vaccination, unsolicited AEs through 28 days after vaccination, and SAEs through 180 days after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection	7 of 164 (4.3%)	146 of 164 (89%)	Not reported
IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection	4 of 147 (2.7%)	113 of 147 (76.9%)	Not reported
IIA: Previous PPSV23, Age 55-64, Single Injection	2 of 139 (1.4%)	124 of 139 (89.2%)	Not reported
IIB: Previous PPSV23, Age 65-74, Single Injection	3 of 145 (2.1%)	115 of 145 (79.3%)	Not reported
IIAA: Previous PPSV23, Age 55-64, Two Injections	4 of 140 (2.9%)	126 of 140 (90%)	Not reported
IIBB: Previous PPSV23, Age 65-74, Two Injections	5 of 149 (3.4%)	131 of 149 (87.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29279281Jackson LA, El Sahly HM, George S, Winokur P, Edwards K, Brady RC, Rouphael N, Keitel WA, Mulligan MJ, Burton RL, Nakamura A, Ferreria J, Nahm MH. Randomized clinical trial of a single versus a double dose of 13-valent pneumococcal conjugate vaccine in adults 55 through 74 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2018 Jan 29;36(5):606-614. doi: 10.1016/j.vaccine.2017.12.061. Epub 2017 Dec 24.

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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.

The record lists no contact. Use the official record to reach the sponsor.

7 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 1 inclusion and 1 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 23 Jan 2017). 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?

Number of Participants Reporting Solicited Local and Systemic Adverse Events (time frame: Days 0 to Day 7 post vaccination). The study lists 4 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 NCT01654263, 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 27 Mar 2017.