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Clinical Trials/NCT00500266
NCT00500266CompletedPhase 3

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

Pfizer59 sites in 2 countries1,053 target enrollmentStarted: May 2008Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Pfizer
Enrollment
1,053
Locations
59
Primary Endpoint
Percentage of Participants With Pre-specified Local Reactions

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
68 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Pfizer
Sponsor Class
Industry

Study Sites (59)

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