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

Phase 3

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

• Registration Number: NCT00500266
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-09
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Study Start: 2008-05
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Disposition First Submitted: 2010-03-02
• Disposition First Submitted QC: 2010-03-02
• Disposition First Posted: 2010-03-03
• Status Verified: 2011-08
• Results First Submitted: 2011-08-11
• Results First Submitted QC: 2011-08-11
• Last Update Submitted: 2011-08-11
• Results First Posted: 2011-09-16
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1053

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	13-valent Pneumococcal Conjugate Vaccine (13vPnC)	13-valent Pneumococcal Conjugate Vaccine

Primary Outcome Measures

Name	Time	Method
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.
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.
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.