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

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ClinicalTrials.gov Identifier: NCT00761631
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : August 10, 2011
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Biological: 13 valent pneumococcal conjugate vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single
Open label
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 28 to 42 days after dose 2 for Group 1 and 28 to 42 days after dose 1 for Group 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.

  2. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Measured 1 Month After Vaccination in Group 3 [ Time Frame: 28 to 42 days after dose 1 for 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.

  3. 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) [ Time Frame: 28 to 42 days after dose 1 ]
    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.

  4. Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination in Group 3 and 4 [ Time Frame: 28 to 42 days after dose 1 for 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.


Other Outcome Measures:
  1. Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1 [ Time Frame: From the day of dose 1 (Day 1) to Day 7 after 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).

  2. Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 [ Time Frame: From the day of dose 2 (Day 1) to Day 7 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).

  3. Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 [ Time Frame: From the day of dose 1 (Day 1) to Day 7 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.

  4. Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 2 [ Time Frame: From the day of dose 2 (Day 1) to Day 7 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.



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Ages Eligible for Study:   15 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT00761631


Locations
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United States, Arkansas
Pfizer Investigational Site
Benton, Arkansas, United States, 72019
Pfizer Investigational Site
Fayetteville, Arkansas, United States, 72703
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Loma Linda, California, United States, 92354
Pfizer Investigational Site
Torrance, California, United States, 90502
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33606
United States, Georgia
Pfizer Investigational Site
Marietta, Georgia, United States, 30062
United States, Illinois
Pfizer Investigational Site
Dekalb, Illinois, United States, 60115
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202-3830
United States, Minnesota
Pfizer Investigational Site
St.Paul, Minnesota, United States, 55108
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Pfizer Investigational Site
Whitehouse Station, New Jersey, United States, 08809
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27518
United States, North Dakota
Pfizer Investigational Site
Bismarck, North Dakota, United States, 58501
Pfizer Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45229
Pfizer Investigational Site
Cleveland, Ohio, United States, 44121
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Pfizer Investigational Site
Clarksville, Tennessee, United States, 37043
United States, Texas
Pfizer Investigational Site
Galveston, Texas, United States, 77555-0351
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Murray, Utah, United States, 84107
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
Pfizer Investigational Site
South Jordan, Utah, United States, 84095
United States, Virginia
Pfizer Investigational Site
Vienna, Virginia, United States, 22180
United States, Washington
Pfizer Investigational Site
Vancouver, Washington, United States, 98664
United States, Wisconsin
Pfizer Investigational Site
Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00761631    
Other Study ID Numbers: 6096A1-3011
First Posted: September 29, 2008    Key Record Dates
Results First Posted: August 10, 2011
Last Update Posted: July 31, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs