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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: 13 valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • 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
      • Pfizer Investigational Site
  • California
    • Fountain Valley, California, United States, 92708
      • Pfizer Investigational Site
    • Loma Linda, California, United States, 92354
      • Pfizer Investigational Site
    • Torrance, California, United States, 90502
      • Pfizer Investigational Site
  • Florida
    • Tampa, Florida, United States, 33606
      • Pfizer Investigational Site
  • Georgia
    • Marietta, Georgia, United States, 30062
      • Pfizer Investigational Site
  • Illinois
    • Dekalb, Illinois, United States, 60115
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202-3830
      • Pfizer Investigational Site
  • Minnesota
    • St.Paul, Minnesota, United States, 55108
      • Pfizer Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Pfizer Investigational Site
  • New Jersey
    • Whitehouse Station, New Jersey, United States, 08809
      • Pfizer Investigational Site
  • New York
    • Rochester, New York, United States, 14618
      • Pfizer Investigational Site
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Pfizer Investigational Site
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Pfizer Investigational Site
    • Fargo, North Dakota, United States, 58103
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Pfizer Investigational Site
    • Cleveland, Ohio, United States, 44121
      • Pfizer Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pfizer Investigational Site
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • Pfizer Investigational Site
  • Texas
    • Galveston, Texas, United States, 77555-0351
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Utah
    • Murray, Utah, United States, 84107
      • Pfizer Investigational Site
    • Salt Lake City, Utah, United States, 84132
      • Pfizer Investigational Site
    • South Jordan, Utah, United States, 84095
      • Pfizer Investigational Site
  • Virginia
    • Vienna, Virginia, United States, 22180
      • Pfizer Investigational Site
  • Washington
    • Vancouver, Washington, United States, 98664
      • Pfizer Investigational Site
  • Wisconsin
    • Monroe, Wisconsin, United States, 53566
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Frenck R Jr, Thompson A, Senders S, Harris-Ford L, Sperling M, Patterson S, Devlin C, Jansen KU, Gruber WC, Emini EA, Scott DA, Gurtman A. 13-Valent pneumococcal conjugate vaccine in older children and adolescents either previously immunized with or naive to 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Feb;33(2):183-9. doi: 10.1097/INF.0000000000000056.
• Frenck R Jr, Thompson A, Yeh SH, London A, Sidhu MS, Patterson S, Gruber WC, Emini EA, Scott DA, Gurtman A; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2011 Dec;30(12):1086-91. doi: 10.1097/INF.0b013e3182372c6a.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: September 25, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (ESTIMATE): September 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2013
• Last Update Submitted That Met QC Criteria: May 30, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-3011