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NCT00761631 Clinical Trial

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

Healthy Subjects Clinical Trial

Official title:
A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00761631
Other study ID # 6096A1-3011
Secondary ID
Status Completed
Phase Phase 3
First received September 25, 2008
Last updated May 30, 2013
Start date December 2008
Est. completion date July 2010

Study information
Verified date May 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Months to 17 Years
Eligibility Inclusion Criteria:

- Male or female subjects >15months to <18years in good health, available for entire study period and reachable by phone, parents/legal guardian able and willing to complete all study procedures, written documentation from health professional showing prior vaccination with Prevnar (except for group 4).

Group 4 only:

- Negative urine pregnancy test for female subjects who are menstruating.

Exclusion Criteria:

- Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component , bleeding diathesis, received blood transfusion or blood related products, immune deficiency,congenital malformation.

Group 4 only:

- Previous vaccination with Prevnar or any other pneumococcal vaccine.

- Pregnant or breastfeeding adolescent females.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• 13 valent pneumococcal conjugate vaccine
Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.

Locations
Country Name City State
United States Pfizer Investigational Site Benton Arkansas
United States Pfizer Investigational Site Bismarck North Dakota
United States Pfizer Investigational Site Cary North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Clarksville Tennessee
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Dekalb Illinois
United States Pfizer Investigational Site Fargo North Dakota
United States Pfizer Investigational Site Fayetteville Arkansas
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Galveston Texas
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Lebanon New Hampshire
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Loma Linda California
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Marietta Georgia
United States Pfizer Investigational Site Monroe Wisconsin
United States Pfizer Investigational Site Murray Utah
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site South Jordan Utah
United States Pfizer Investigational Site St.Paul Minnesota
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Torrance California
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site Vancouver Washington
United States Pfizer Investigational Site Vienna Virginia
United States Pfizer Investigational Site Whitehouse Station New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). From the day of dose 1 (Day 1) to Day 7 after dose 1 Yes
Other Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). From the day of dose 2 (Day 1) to Day 7 of dose 2 Yes
Other Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 Systemic events (any fever >=38 degrees [deg] Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. From the day of dose 1 (Day 1) to Day 7 of dose 1 Yes
Other Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 Systemic events (any fever >=38 deg C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may have been represented in more than 1 category. Percentage of participants = number of participants reporting specified systemic event divided by number of participants reporting yes for at least 1 day or no for all days. From the day of dose 2 (Day 1) to Day 7 of dose 2 Yes
Primary Percentage of Participants Achieving Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to (=) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination in Group 1 and 2 Percentage of participants achieving world health organization (WHO) predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. Exact 2-sided CI based on observed proportion of participants. 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 2 No
Primary Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 Antibody GMC for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for after dose 1 blood draw. 28 to 42 days after dose 1 for Group 3 No
Primary Comparison of Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After 13vPnC Vaccination in Group 3 Relative to Posttoddler Responses in Study 6096A1-3005 (NCT00444457) Comparison of IgG concentrations 1 month after 13vPnC vaccination in group 3 of study 6096A1-3011 (NCT00761631) to posttoddler responses in 7-valent pneumococcal conjugate vaccine (7vPnC) group for 7 common serotypes and in combined 13vPnC groups for 6 additional serotypes of study 6096A1-3005 (NCT00444457) is not reported here because analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in study and described in Participant Flow and Baseline Characteristics modules. 28 to 42 days after dose 1 No
Primary Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 Serotype-specific OPA GMTs for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. GMT (13vPnC) and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for after dose 1 blood draw. 28 to 42 days after dose 1 for Group 3 and 4 No
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