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

NCT00761631 | Completed Phase 3 Results

• 1 other identifier: 6096A1-3011
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 31

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (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

• 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 Outcomes (4)

• Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 1

  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

  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

  From the day of dose 1 (Day 1) to Day 7 of dose 1

Study Arms (1)

Single

EXPERIMENTAL

Open label

Biological: 13 valent pneumococcal conjugate vaccine

Interventions

13 valent pneumococcal conjugate vaccine BIOLOGICAL

Intramuscular injection of 0.5mL at visit 1 and visit 2 for group 1 and and visit 1 for groups 2, 3, and 4.

Single

Eligibility Criteria

• Age: 15 Months - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (31)

Pfizer Investigational Site

Benton, Arkansas, 72019, United States

Location

Pfizer Investigational Site

Fayetteville, Arkansas, 72703, United States

Location

Pfizer Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

Pfizer Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Pfizer Investigational Site

Fountain Valley, California, 92708, United States

Location

Pfizer Investigational Site

Loma Linda, California, 92354, United States

Location

Pfizer Investigational Site

Torrance, California, 90502, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33606, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30062, United States

Location

Pfizer Investigational Site

DeKalb, Illinois, 60115, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202-3830, United States

Location

Pfizer Investigational Site

Saint Paul, Minnesota, 55108, United States

Location

Pfizer Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

Pfizer Investigational Site

Whitehouse Station, New Jersey, 08809, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Cary, North Carolina, 27518, United States

Location

Pfizer Investigational Site

Bismarck, North Dakota, 58501, United States

Location

Pfizer Investigational Site

Fargo, North Dakota, 58103, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45229, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44121, United States

Location

Pfizer Investigational Site

Tulsa, Oklahoma, 74127, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Pfizer Investigational Site

Clarksville, Tennessee, 37043, United States

Location

Pfizer Investigational Site

Galveston, Texas, 77555-0351, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Murray, Utah, 84107, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84132, United States

Location

Pfizer Investigational Site

South Jordan, Utah, 84095, United States

Location

Pfizer Investigational Site

Vienna, Virginia, 22180, United States

Location

Pfizer Investigational Site

Vancouver, Washington, 98664, United States

Location

Pfizer Investigational Site

Monroe, Wisconsin, 53566, United States

Location

Related Publications (2)

• 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.

  PMID: 24136369 DERIVED

• 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.

  PMID: 21983216 DERIVED

Related Links

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 31, 2013
• Results First Posted: August 10, 2011

Record last verified: 2013-05

Locations

US (31)