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 Us.

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
      • Central Arkansas Pediatric Clinic
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatric Clinic
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, PA
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Pediatric Clinic
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Children's Clinic, PA
  • California
    • Fountain Valley, California, United States, 92708
      • Edinger Medical Group
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Loma Linda, California, United States, 92350
      • Loma Linda University
    • Torrance, California, United States, 90509
      • UCLA School of Medicine - Center for Vaccine Research
  • Florida
    • Tampa, Florida, United States, 33606
      • USF College of Medicine
  • Georgia
    • Marietta, Georgia, United States, 30062
      • Pediatric and Adolescent Medicine, PA
    • Woodstock, Georgia, United States, 30189
      • Pediatric and Adolescent Medicine, PA
  • Illinois
    • DeKalb, Illinois, United States, 60115
      • Northern Illinois Research Associates
  • Kentucky
    • Louisville, Kentucky, United States, 40202-3830
      • Pediatric Infectious Diseases
    • Louisville, Kentucky, United States, 40202
      • Pediatric Infectious Diseases
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • Aspen Medical Group
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Primary Care Pediatric Clinic
  • New Jersey
    • Whitehouse Station, New Jersey, United States, 08889
      • Hunterdon Pediatrics Associates
  • New York
    • Rochester, New York, United States, 14618
      • Elmwood Pediatric Group
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Pediatric Center
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • MedCenter One/ Q&R Clinic
    • Fargo, North Dakota, United States, 58103
      • Dakota Clinicl / Innovis Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45206
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44121
      • Shelly Senders & Associates
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University Center for Health
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • Premier Medical Group
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch at Galveston
    • San Antonio, Texas, United States, 78229
      • Southwest Children's Research Associates
  • Utah
    • Murray, Utah, United States, 84107
      • Cottonwood Pediatrics
    • Salt Lake City, Utah, United States, 84132
      • University of Utah, Department of Pediatrics
    • South Jordan, Utah, United States, 84095
      • Families First Pediatrics
  • Virginia
    • Vienna, Virginia, United States, 22180
      • Advanced Pediatrics
  • Washington
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic 700 N.E. 87th Avenue
    • Vancouver, Washington, United States, 98686
      • The Vancouver Clinic 700 N.E. 87th Avenue
  • Wisconsin
    • Monroe, Wisconsin, United States, 53566
      • The Monroe Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No

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
• Masking: None (Open Label)

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
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
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
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

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
• Investigators: Study Director: Pfizer CT.gov Call Center, 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 (Actual): November 18, 2008
• Primary Completion (Actual): August 10, 2010
• Study Completion (Actual): August 10, 2010

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: March 1, 2019

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; 2009-017304-88 (EudraCT Number); B1851010 (Other Identifier: Alias Study Number)