Pneumococcal InfectionsPhase 3NCT00500266

Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in people with Pneumococcal Infections, run by Pfizer at 59 sites in 3 countries.

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

To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment. Read more about this study

Who is it for?: Ages 68 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,053 participants
Where: 59 sitesin 3 countries
Study dates: May 2008to May 2009
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 68 years and older
All sexes
Healthy volunteers accepted
Older adult

MAIN INCLUSION CRITERIA:

Male or female aged 68 years or older
Determined by medical history, physical examination, and clinical judgment to be eligible for the study
Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment

MAIN EXCLUSION CRITERIA:

Known history of severe reaction to a vaccine
Documented S pneumoniae infection within the past 5 years.
Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.

Trial locations and contacts

59 sites in 3 countries.

Country

City, postcode or hospital

59 sites in 3 countries

United States40 sites

Study site
Akron, Ohio, 44304
Study site
Apopka, Florida, 32703
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Arkansas City, Kansas, 67005
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30342
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Bellingham, Virginia, 98226
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Boynton Beach, Florida, 33472
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Camillus, New York, 13031
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Canal Fulton, Ohio, 44614
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Chandler, Arizona, 85224
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Chiefland, Florida, 32626
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Columbus, Ohio, 43235
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Crescent Springs, Kentucky, 41017
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Franklin, Ohio, 45005
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Gainesville, Florida, 32607
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Glendale, Arizona, 85308
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Goose Creek, South Carolina, 29445
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Houston, Texas, 77074
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Largo, Florida, 33770
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Melbourne, Florida, 32935
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Mt. Pleasant, South Carolina, 29464
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New Orleans, Louisiana, 70112
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Newton, Kansas, 67114
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Nitchitoches, Louisiana, 71547
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Phoenix, Arizona, 85028
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Phoenix, Arizona, 85104
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Pittsburgh, Pennsylvania, 15216
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Portland, Oregon, 97205
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Raleigh, North Carolina, 27609
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Rochester, New York, 14609
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Rolling Hills Estates, California, 90274
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Salt Lake City, Utah, 84109
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Salt Lake City, Utah, 84121
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San Antonio, Texas, 78229
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Walla Walla, Washington, 99362
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Wenatchee, Washington, 98801
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West Jordan, Utah, 84088
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West Palm Beach, Florida, 33409
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Wichita, Kansas, 67205
Study site
Wichita, Kansas, 67207

Other trials in United States

Germany12 sites

Study site
Berlin, 10717
Study site
Berlin, 10969
Study site
Berlin-Wilmersdorf, 10717
Study site
Charlottenburg, 14059
Study site
Deggingen, 73326
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Frankfurt am Main, 60322
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Hanover, 30625
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Kassel, 34121
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Leipzig, 04357
Study site
Offenbach, 63071
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Wangen, 88239
Study site
Würzburg, 97070

Other trials in Germany

Sweden7 sites

Study site
Arlöv, 23234
Study site
Gothenburg, 41136
Study site
Skene, 51162
Study site
Skivarp, 27402
Study site
Stockholm, 11136
Study site
Umeå, 90736
Study site
Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment

Conditions: Pneumococcal Infections
Being tested: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Keywords: pneumococcal conjugate vaccine, 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.

13-valent Pneumococcal Conjugate Vaccine (13vPnC)Biological

Study groups in NCT00500266
Study group	Role	What they receive
1	Experimental	13-valent Pneumococcal Conjugate Vaccine 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.

Percentage of Participants With Pre-specified Local Reactions
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Measured: Days 1 through 14
Percentage of Participants With Pre-specified Systemic Events
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite \& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Measured: Days 1 through 14
Percentage of Participants Taking Pain or Antipyretic Medication
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Measured: Days 1 through 14

Timeline

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

May 2008May 2009

First posted11 Jul 2007 (estimated)
Study startMay 2008
Primary completionApr 2009
Study completionMay 2009

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,053 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00500266
Sponsor's protocol ID: 6115A1-3000
Status last verified: Aug 2011
First submitted: 9 Jul 2007
Last updated: 16 Sep 2011
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

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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment
ClinicalTrials.gov ID: NCT00500266
Acronym / sponsor ID: 6115A1-3000
Conditions: Pneumococcal Infections
Keywords: pneumococcal conjugate vaccine, vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,053 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 11 Jul 2007 (estimated)
Results: Posted 16 Sep 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)13-valent Pneumococcal Conjugate Vaccine

Who may qualify

Ages: 68 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

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)	Biological	1

Primary outcome

Percentage of Participants With Pre-specified Local Reactions
Time frame: Days 1 through 14
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Percentage of Participants With Pre-specified Systemic Events
Time frame: Days 1 through 14
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite \& diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Percentage of Participants Taking Pain or Antipyretic Medication
Time frame: Days 1 through 14
Use of pain or antipyretic medication was collected by the participants using an electronic diary.

Results and safety

Results posted to the registry on 16 Sep 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	1,053	1,040

Primary outcome: Percentage of Participants With Pre-specified Local Reactions

Time frame: Days 1 through 14. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC n = 1049
Redness: Any (n=666)	14.3 (11.7 to 17.2)
Redness: Mild (n=660)	12.6 (10.1 to 15.3)
Redness: Moderate (n=649)	6.5 (4.7 to 8.6)
Redness: Severe (n=638)	1.1 (0.4 to 2.2)
Swelling: Any (n=664)	12.8 (10.4 to 15.6)
Swelling: Mild (n=658)	10.9 (8.7 to 13.6)
Swelling: Moderate (n=651)	5.5 (3.9 to 7.6)
Swelling: Severe (n=636)	0.6 (0.2 to 1.6)

Population analysed: Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting "yes" for at least 1 day or "no" for all days.

Primary outcome: Percentage of Participants With Pre-specified Systemic Events

Time frame: Days 1 through 14. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC n = 1049
Fever (any): >=38 degrees C (n=641)	2.0 (1.1 to 3.4)
Fever: >=38 degrees C but <38.5 degrees C (n=636)	0.8 (0.3 to 1.8)
Fever: >=38.5 degrees C but <39 degrees C (n=634)	0.0 (0.0 to 0.6)
Fever: >=39 degrees C but <=40 degrees C (n=635)	0.3 (0.0 to 1.1)
Fever: >40 degrees C (n=638)	0.9 (0.3 to 2.0)
Fatigue: Any (n=733)	34.4 (30.9 to 37.9)
Fatigue: Mild (n=710)	28.7 (25.4 to 32.2)
Fatigue: Moderate (n=683)	15.2 (12.6 to 18.1)

Population analysed: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.

Primary outcome: Percentage of Participants Taking Pain or Antipyretic Medication

Time frame: Days 1 through 14. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	13vPnC n = 1049
Use of medication to treat pain (n=677)	17.0 (14.2 to 20.0)
Use of medication to treat fever (n=655)	6.4 (4.7 to 8.6)

Population analysed: Safety population: all participants who received 1 dose of 13vPnC. n = number of participants with the event as "yes" for at least 1 day or as "no" for all days.

Adverse events

Time frame: Local reactions, systemic events recorded within 14 days post vaccination. AEs recorded from Visit(V) 1 to 2(29-43 days after V1). At V3(166-194 days after V1), only newly diagnosed chronic medical conditions recorded as AEs. SAEs recorded from V1 to V3.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC: Visit 1 to Visit 2	10 of 1,049 (1%)	486 of 1,049 (46.3%)	Not reported
13vPnC: 6-month Follow-up	41 of 1,049 (3.9%)	77 of 1,049 (7.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumococcal Infections

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Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

59 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in people with Pneumococcal Infections, run by Pfizer at 59 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 16 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Germany, Sweden. 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 16 Sep 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?

Percentage of Participants With Pre-specified Local Reactions (time frame: Days 1 through 14). 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 NCT00500266.

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 16 Sep 2011.