Trial · NCT00500266
Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
NCT00500266, Phase 3, Completed, Pfizer; results first posted 2011-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects. Trials, record NCT00500266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500266
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
- NCT number
- NCT00500266
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,053 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Infections
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
- First posted
- 2007-07-11
- Last updated
- 2011-09-16
- Results first posted
- 2011-09-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Pre-specified Local Reactions | 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. |
| Primary | Percentage of Participants With Pre-specified Systemic Events | 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. |
| Primary | Percentage of Participants Taking Pain or Antipyretic Medication | Days 1 through 14 | Use of pain or antipyretic medication was collected by the participants using an electronic diary. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Pre-specified Local Reactions | Days 1 through 14 | Safety population: all participants who received 1 dose of 13vPnC. n = participants reporting yes for at least 1 day or no for all days. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Pre-specified Systemic Events | Days 1 through 14 | 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. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Taking Pain or Antipyretic Medication | Days 1 through 14 | 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. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Redness: Any (n=666) | 14.3 | 95% Confidence Interval 11.7 to 17.2 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Redness: Mild (n=660) | 12.6 | 95% Confidence Interval 10.1 to 15.3 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Redness: Moderate (n=649) | 6.5 | 95% Confidence Interval 4.7 to 8.6 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Redness: Severe (n=638) | 1.1 | 95% Confidence Interval 0.4 to 2.2 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Swelling: Any (n=664) | 12.8 | 95% Confidence Interval 10.4 to 15.6 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Swelling: Mild (n=658) | 10.9 | 95% Confidence Interval 8.7 to 13.6 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Swelling: Moderate (n=651) | 5.5 | 95% Confidence Interval 3.9 to 7.6 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Swelling: Severe (n=636) | 0.6 | 95% Confidence Interval 0.2 to 1.6 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Pain: Any (n=777) | 51.0 | 95% Confidence Interval 47.4 to 54.5 | Percentage of Participants |
| Percentage of Participants With Pre-specified Local Reactions | 13vPnC | Pain: Mild (n=770) | 49.4 | 95% Confidence Interval 45.8 to 52.9 | Percentage of Participants |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 13vPnC | 1,053 | |
| Overall Study | Treated | 13vPnC | 1,049 | |
| Overall Study | COMPLETED | 13vPnC | 1,040 | |
| Overall Study | NOT COMPLETED | 13vPnC | 13 |
Source ClinicalTrials.gov
Adverse events544
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Redness (any) | Skin and subcutaneous tissue disorders | 13vPnC: Visit 1 to Visit 2 | 95 | 666 | |
| other | Redness (any) | Skin and subcutaneous tissue disorders | 13vPnC: 6-month Follow-up | 0 | 0 | |
| other | Redness (mild) | Skin and subcutaneous tissue disorders | 13vPnC: Visit 1 to Visit 2 | 83 | 660 | |
| other | Redness (mild) | Skin and subcutaneous tissue disorders | 13vPnC: 6-month Follow-up | 0 | 0 | |
| other | Redness (moderate) | Skin and subcutaneous tissue disorders | 13vPnC: Visit 1 to Visit 2 | 42 | 649 | |
| other | Redness (moderate) | Skin and subcutaneous tissue disorders | 13vPnC: 6-month Follow-up | 0 | 0 | |
| other | Redness (severe) | Skin and subcutaneous tissue disorders | 13vPnC: Visit 1 to Visit 2 | 7 | 638 | |
| other | Redness (severe) | Skin and subcutaneous tissue disorders | 13vPnC: 6-month Follow-up | 0 | 0 | |
| other | Swelling (any) | Skin and subcutaneous tissue disorders | 13vPnC: Visit 1 to Visit 2 | 85 | 664 | |
| other | Swelling (any) | Skin and subcutaneous tissue disorders | 13vPnC: 6-month Follow-up | 0 | 0 |
1 to 10 of 544Source ClinicalTrials.gov
See all 544 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 13vPnC: Visit 1 to Visit 2 | ||
| Total, all-cause mortality | 13vPnC: 6-month Follow-up | ||
| Total, other adverse events | 13vPnC: Visit 1 to Visit 2 | 486 | 1,049 |
| Total, other adverse events | 13vPnC: 6-month Follow-up | 77 | 1,049 |
| Total, serious adverse events | 13vPnC: Visit 1 to Visit 2 | 10 | 1,049 |
| Total, serious adverse events | 13vPnC: 6-month Follow-up | 41 | 1,049 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 13vPnC: Visit 1 to Visit 2 vs 13vPnC: 6-month Follow-up: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00500266
GET https://conductscience.org/api/trials/v1/NCT00500266/results?page=2