Pneumococcal VaccinesPhase 3NCT01646398

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in people with Pneumococcal Vaccines and Pneumococcal Conjugate Vaccine, run by Pfizer at 8 sites in Japan.

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

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
What is being tested?: 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 764 participants
Where: 8 sitesJapan
Study dates: Jun 2012to Oct 2012
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Who cannot join

History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
Previous vaccination with any licensed or experimental pneumococcal vaccine.
Documented Streptococcus pneumoniae infection within the past 5 years.
Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Japan8 sites

Medical Co.LTA PS Clinic
Fukuoka, Fukuoka
Seishinkai Inoue Hospital
Itoshima, Fukuoka
Uzumasa Medical Clinic
Kyoto, Kyoto
Senbon Hospital
Osaka, Osaka
Oda Clinic
Shinjuku-ku, Tokyo
Sone Clinic
Shinjuku-ku, Tokyo
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo
Yokohama Minoru Clinic
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine

Conditions: Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
Being tested: 13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine
Keywords: 13VPNC, 23VPS

What participants receive

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

13-valent pneumococcal conjugate vaccineBiological
Also called 13vPnC
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
23-valent pneumococcal polysaccharide vaccineBiological
Also called 23VPS
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.

Study groups in NCT01646398
Study group	Role	What they receive
>= 65-year age group-13vPnC	Experimental	Not described Receives: Biological: 13-valent pneumococcal conjugate vaccine
>= 65-year age group-23vPS	Active comparator	Not described Receives: Biological: 23-valent pneumococcal polysaccharide vaccine

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) for 12 Common Serotypes 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: One month after vaccination
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
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

Secondary outcomes (1)

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Measured: One month after vaccination

Timeline

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

Jun 2012Oct 2012

First posted20 Jul 2012 (estimated)
Study startJun 2012
Primary completionOct 2012
Study completionOct 2012

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 VaccinesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 764 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01646398
Sponsor's protocol ID: B1851088
Status last verified: Jul 2013
First submitted: 10 May 2012
Last updated: 20 Sep 2013
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
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only

All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine
ClinicalTrials.gov ID: NCT01646398
Acronym / sponsor ID: B1851088
Conditions: Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
Keywords: 13VPNC, 23VPS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 764 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 20 Jul 2012 (estimated)
Results: Posted 20 Sep 2013

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
>= 65-year age group-13vPnC	Experimental	Biological: 13-valent pneumococcal conjugate vaccine
>= 65-year age group-23vPS	Active comparator	Biological: 23-valent pneumococcal polysaccharide vaccine

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Key exclusion criteria (4 listed)

History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
Previous vaccination with any licensed or experimental pneumococcal vaccine.
Documented Streptococcus pneumoniae infection within the past 5 years.
Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

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 vaccineAlso: 13vPnCA single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.	Biological	>= 65-year age group-13vPnC
23-valent pneumococcal polysaccharide vaccineAlso: 23VPSA single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.	Biological	>= 65-year age group-23vPS

Primary outcome

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
Time frame: One month after vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
Time frame: One month after vaccination
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.

1 secondary outcome

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
Time frame: One month after vaccination

Results and safety

Results posted to the registry on 20 Sep 2013, 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	382	381
23vPS	382	382

Primary outcome: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination

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

Measure	13vPnC n = 366	23vPS n = 367
1 (n=366, 366)	103 (84.6 to 125.5)	78 (63.6 to 95.8)
3 (n=365, 367)	44 (38.1 to 51.5)	61 (52.8 to 70.1)
4 (n=360, 362)	1016 (850.7 to 1213.2)	392 (314.7 to 487.1)
5 (n=350, 361)	347 (282.3 to 425.6)	118 (98.4 to 142.5)
6B (n=360, 359)	1995 (1689.3 to 2355.9)	1440 (1223.5 to 1694.2)
7F (n=365, 364)	1901 (1642.8 to 2198.7)	1361 (1153.3 to 1605.6)
9V (n=365,358)	858 (675.7 to 1089.5)	379 (290.2 to 493.9)
14 (n=363, 359)	1028 (866.9 to 1217.9)	1059 (896.6 to 1250.6)

13vPnC vs 23vPS: GMT Ratio: 1.3 (95% CI 0.99 to 1.75)
13vPnC vs 23vPS: GMT Ratio: 0.7 (95% CI 0.59 to 0.89)
13vPnC vs 23vPS: GMT Ratio: 2.6 (95% CI 1.96 to 3.44)

Population analysed: Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had 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 Titers for Serotype 6A 1 Month After Vaccination

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

Measure	13vPnC n = 319	23vPS n = 320
Value	74.0 (68.8 to 78.7)	47.2 (41.6 to 52.8)

13vPnC vs 23vPS: Difference in percentage: 26.8 (95% CI 19.3 to 34.0)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 14 days after vaccination).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC	1 of 382 (0.3%)	211 of 382 (55.2%)	Not reported
23vPS	0 of 382 (0%)	166 of 382 (43.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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.

Related trials for Pneumococcal Vaccines

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
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only

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

8 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 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. 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 20 Sep 2013). 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) for 12 Common Serotypes 1 Month After Vaccination (time frame: One month after vaccination). The study lists 2 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 NCT01646398.

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 20 Sep 2013.