Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
|ClinicalTrials.gov Identifier: NCT00500266|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : September 16, 2011
Last Update Posted : September 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pneumococcal Infections||Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1053 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Primary Completion Date :||April 2009|
|Study Completion Date :||May 2009|
13-valent Pneumococcal Conjugate Vaccine
|Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500266
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|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|