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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500266
• Other study ID #: 6115A1-3000
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2007
• Last updated: August 11, 2011
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 68 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 1 through 14	Yes
Primary	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.	Days 1 through 14	Yes
Primary	Percentage of Participants Taking Pain or Antipyretic Medication	Use of pain or antipyretic medication was collected by the participants using an electronic diary.	Days 1 through 14	Yes