Pneumococcal VaccinesPhase 3NCT00574548

Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

A Phase 3 study testing 13 valent Pneumococcal Conjugate Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine in people with Pneumococcal Vaccines, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS. Read more about this study

Who is it for?: Ages 60 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: 13 valent Pneumococcal Conjugate Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 720 participants
Where: 6 sitesUnited States
Study dates: Nov 2007to Feb 2010
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 60 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or Female, aged 60 to 64 years.
Healthy.

Who cannot join

Previous vaccination with any licensed or experimental pneumococcal vaccine.
History of severe adverse reaction associated with a vaccine.
Immunodeficiency.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Chandler, Arizona, 85224
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Raleigh, North Carolina, 27609

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS

Conditions: Pneumococcal Vaccines
Being tested: 13 valent Pneumococcal Conjugate Vaccine, 23-valent Pneumococcal Polysaccharide Vaccine
Keywords: Vaccines, Pneumococcal Conjugate Vaccine

What participants receive

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

13 valent Pneumococcal Conjugate VaccineBiological
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
13 valent Pneumococcal Conjugate VaccineBiological
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
13 valent Pneumococcal Conjugate VaccineBiological
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
23-valent Pneumococcal Polysaccharide VaccineBiological
0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
23-valent Pneumococcal Polysaccharide VaccineBiological
0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1

Study groups in NCT00574548
Study group	Role	What they receive
Group 1.1	Experimental	Group 1.1 = 13vPnC then 13vPnC Receives: Biological: 13 valent Pneumococcal Conjugate Vaccine
Group 1.2	Experimental	Group 1.2 = 13vPnC then 23vPS Receives: Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 23-valent Pneumococcal Polysaccharide Vaccine
Group 2	Experimental	Group 2 = 23vPS then 13vPnC Receives: Biological: 13 valent Pneumococcal Conjugate Vaccine; Biological: 23-valent Pneumococcal Polysaccharide Vaccine

What is being measured

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

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Secondary outcomes (2)

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for the pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The 6A pneumococcal serotype is specific to 13vPnC. Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Timeline

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

Nov 2007Feb 2010

First posted17 Dec 2007 (estimated)
Study startNov 2007
Primary completionFeb 2010
Study completionFeb 2010

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 VaccinesStudies of the same condition, open and under way.
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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 720 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00574548
Sponsor's protocol ID: 6115A1-3010
Other IDs: B1851027
Status last verified: Jul 2011
First submitted: 13 Dec 2007
Last updated: 22 Jul 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.
PubMed 24606865

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

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All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2011. 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 to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS
ClinicalTrials.gov ID: NCT00574548
Acronym / sponsor ID: 6115A1-3010
Conditions: Pneumococcal Vaccines
Keywords: Vaccines, Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 720 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 17 Dec 2007 (estimated)
Results: Posted 9 May 2011

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: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Group 1.1	Experimental	Biological: 13 valent Pneumococcal Conjugate VaccineGroup 1.1 = 13vPnC then 13vPnC
Group 1.2	Experimental	Biological: 13 valent Pneumococcal Conjugate Vaccine, Biological: 23-valent Pneumococcal Polysaccharide VaccineGroup 1.2 = 13vPnC then 23vPS
Group 2	Experimental	Biological: 13 valent Pneumococcal Conjugate Vaccine, Biological: 23-valent Pneumococcal Polysaccharide VaccineGroup 2 = 23vPS then 13vPnC

Who may qualify

Ages: 60 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male or Female, aged 60 to 64 years.
Healthy.

Key exclusion criteria (3 listed)

Previous vaccination with any licensed or experimental pneumococcal vaccine.
History of severe adverse reaction associated with a vaccine.
Immunodeficiency.

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 Vaccine0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1	Biological	Group 1.1
13 valent Pneumococcal Conjugate Vaccine0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1	Biological	Group 1.2
13 valent Pneumococcal Conjugate Vaccine0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1	Biological	Group 2
23-valent Pneumococcal Polysaccharide Vaccine0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1	Biological	Group 2
23-valent Pneumococcal Polysaccharide Vaccine0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1	Biological	Group 1.2

Primary outcome

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)
Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)
Time frame: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Antibody geometric mean titers as measured by opsonophagocytic assays (OPA) for 12 common pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Confidence intervals (CI) for the GMTs are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

2 secondary outcomes

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 13 Serotypes for 13vPnC / 13vPnC (Year 1) Versus 13vPnC (Year 0)
Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)
Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 13vPnC (Year 0)
Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)

Results and safety

Results posted to the registry on 9 May 2011, 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 - Group 1.1 or 1.2	482	421
23vPS - Group 2	238	222

Primary outcome: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0)

Time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1). Geometric mean (95% Confidence Interval). Unit: geometric mean titer

Measure	13vPnC / 23vPS n = 233	23vPS n = 229
Common Serotype 1	148 (123.7 to 176.5)	148 (117.9 to 185.9)
Common Serotype 3	125 (108.6 to 143.4)	80 (67.5 to 95.7)
Common Serotype 4	1385 (1171.2 to 1638.7)	1357 (1023.0 to 1799.0)
Common Serotype 5	199 (161.4 to 246.2)	140 (107.0 to 183.5)
Common Serotype 6B	1215 (965.4 to 1528.3)	706 (522.1 to 954.0)
Common Serotype 7F	537 (422.4 to 682.6)	331 (233.5 to 469.1)
Common Serotype 9V	373 (268.4 to 517.6)	288 (198.0 to 419.1)
Common Serotype 14	622 (485.7 to 796.4)	734 (543.6 to 990.1)

13vPnC / 23vPS vs 23vPS: ratio of geometric mean titer: 1.0 (95% CI 0.75 to 1.33)
13vPnC / 23vPS vs 23vPS: ratio of geometric mean titer: 1.6 (95% CI 1.24 to 1.94)
13vPnC / 23vPS vs 23vPS: ratio of geometric mean titer: 1.0 (95% CI 0.74 to 1.41)

Population analysed: Evaluable immunogenicity population: participants who were eligible for the study, adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations. GMTs were calculated using all participants with available data for the specified blood draw.

Primary outcome: Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS Versus 23vPS / 13vPnC (Year 1)

Time frame: 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1). Geometric mean (95% Confidence Interval). Unit: geometric mean titer

Measure	13vPnC / 23vPS n = 233	23vPS / 13vPnC n = 196
Common Serotype 1	148 (123.7 to 176.5)	77 (60.7 to 98.1)
Common Serotype 3	125 (108.6 to 143.4)	50 (40.9 to 61.7)
Common Serotype 4	1385 (1171.2 to 1638.7)	935 (739.9 to 1182.4)
Common Serotype 5	199 (161.4 to 246.2)	85 (64.2 to 112.0)
Common Serotype 6B	1215 (965.4 to 1528.3)	710 (529.1 to 953.2)
Common Serotype 7F	537 (422.4 to 682.6)	126 (85.6 to 184.6)
Common Serotype 9V	373 (268.4 to 517.6)	114 (76.5 to 169.3)
Common Serotype 14	622 (485.7 to 796.4)	435 (323.0 to 585.7)

13vPnC / 23vPS vs 23vPS / 13vPnC: ratio of geometric mean titer: 1.9 (95% CI 1.43 to 2.57)
13vPnC / 23vPS vs 23vPS / 13vPnC: ratio of geometric mean titer: 2.5 (95% CI 1.95 to 3.16)
13vPnC / 23vPS vs 23vPS / 13vPnC: ratio of geometric mean titer: 1.5 (95% CI 1.12 to 1.96)

Population analysed: Evaluable immunogenicity population. GMTs were calculated using all participants with available data for the specified blood draw.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Informed consent through 6 Month Follow-up after last vaccination. Local reactions and systemic events assessed within 14 days after vaccination 1 (Vax 1=Day 1/Year 0 [Visit 1]) and 14 days after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC (Year 0)	2 of 478 (0.4%)	256 of 478 (53.6%)	Not reported
23vPS (Year 0)	1 of 237 (0.4%)	102 of 237 (43%)	Not reported
13vPnC: 6 Month Follow-up After Vax 1 (Year 0)	15 of 478 (3.1%)	41 of 478 (8.6%)	Not reported
23vPS: 6 Month Follow-up After Vax 1 (Year 0)	6 of 237 (2.5%)	24 of 237 (10.1%)	Not reported
13vPnC / 13vPnC (Year 1)	0 of 160 (0%)	97 of 160 (60.6%)	Not reported
13vPnC / 23vPS (Year 1)	2 of 267 (0.7%)	198 of 267 (74.2%)	Not reported
23vPS / 13vPnC (Year 1)	1 of 223 (0.4%)	118 of 223 (52.9%)	Not reported
13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)	5 of 160 (3.1%)	16 of 160 (10%)	Not reported
13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)	6 of 267 (2.2%)	23 of 267 (8.6%)	Not reported
23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)	3 of 223 (1.3%)	16 of 223 (7.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24606865Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.
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

6 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 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 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 9 May 2011). 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?

Pneumococcal OPA Geometric Mean Titers (GMTs) for the 12 Common Serotypes for 13vPnC / 23vPS (Year 1) Versus 23vPS (Year 0) (time frame: 1 month after vaccination 1 (Vax 1=Day 1/ Year 0 [Visit 1]) and 1 month after vaccination 2 (Vax 2=Day 351 up to Day 379 after Visit 1)). 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 NCT00574548, 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 22 Jul 2011.