Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine

NCT00373958 | Completed Phase 3 Results

• 1 other identifier: 6096A1-004
• Study Type: interventional
• Target: 666
• Locations: 1 country
• Sites: 37

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal vaccine (13vPnC) compare to the 7-valent pneumococcal vaccine (7vPnC) and to compare the immune response to concomitant vaccines administered with 13vPnC and 7vPnC.

Conditions

Vaccines, Pneumococcal

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series

  Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/mL along with the corresponding 95% 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) are presented.

  One month after the 3-dose infant series (7 months of age)

• Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose

  Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (ELISA) for 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) are presented.

  1 Month After the Toddler Dose

• Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series

  Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).

  One Month After the Infant Series (7 months of age)

• Percentage of Participants Reporting Pre-specified Systemic Events

  Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.

  Within 7 days after each dose

• Percentage of Participants Reporting Pre-specified Local Reactions

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], 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 (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.

  Within 7 days after each dose

Secondary Outcomes (6)

• Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)

  One month after toddler dose (13 to 16 months of age)

• Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  one month after the toddler dose

• Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  one month after the toddler dose

• Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose

  one month after the toddler dose

• Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose

  One month after infant series and one month after toddler dose

Study Arms (2)

13vPnC vaccine

EXPERIMENTAL

Biological: 13 valent pneumococcal conjugate vaccine

7vPnC vaccine

ACTIVE COMPARATOR

Biological: 7vPnc pneumococcal conjugate vaccine

Interventions

13 valent pneumococcal conjugate vaccine BIOLOGICAL

1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

13vPnC vaccine

7vPnc pneumococcal conjugate vaccine BIOLOGICAL

1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.

7vPnC vaccine

Eligibility Criteria

• Age: 42 Days - 98 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy 2-month-old infants.
• Available for the entire study period.

You may not qualify if:

• Previous vaccination with any vaccine before the start of the study.
• Known contraindication to vaccination.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (37)

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Fayetteville, Arkansas, 72703, United States

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Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Downey, California, 90242, United States

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Fontana, California, 92335, United States

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Loma Linda, California, 92354, United States

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Paramount, California, 90723, United States

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Riverside, California, 92505, United States

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Centennial, Colorado, 80112, United States

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Norwich, Connecticut, 06360, United States

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Tampa, Florida, 33606, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Chicago, Illinois, 60612, United States

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Park Ridge, Illinois, 60068, United States

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Overland Park, Kansas, 66212, United States

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Bardstown, Kentucky, 40004, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Rochester, New York, 14620, United States

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The Bronx, New York, 10467, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44118, United States

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Mason, Ohio, 45040, United States

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Latrobe, Pennsylvania, 15650, United States

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Pittsburgh, Pennsylvania, 15227, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Sellersville, Pennsylvania, 18960, United States

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Wexford, Pennsylvania, 15090, United States

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Charleston, South Carolina, 29425, United States

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Jackson, Tennessee, 38305, United States

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The Woodlands, Texas, 77380, United States

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Murray, Utah, 84107, United States

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Provo, Utah, 84604, United States

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Richmond, Virginia, 23219, United States

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Vienna, Virginia, 22180, United States

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Related Publications (2)

• Bryant KA, Gurtman A, Girgenti D, Reisinger K, Johnson A, Pride MW, Patterson S, Devlin C, Gruber WC, Emini EA, Scott DA. Antibody responses to routine pediatric vaccines administered with 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.

  PMID: 23104129 DERIVED

• Yeh SH, Gurtman A, Hurley DC, Block SL, Schwartz RH, Patterson S, Jansen KU, Love J, Gruber WC, Emini EA, Scott DA; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics. 2010 Sep;126(3):e493-505. doi: 10.1542/peds.2009-3027. Epub 2010 Aug 23.

  PMID: 20732948 DERIVED

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of 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: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 21, 2013
• Results First Posted: February 21, 2013

Record last verified: 2013-01

Locations

US (37)