Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

NCT00444457 | Completed Phase 3 Results

• 1 other identifier: 6096A1-3005
• Study Type: interventional
• Target: 1,712
• Locations: 1 country
• Sites: 78

Brief Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.

Conditions

Vaccines, Pneumococcal

Keywords

Vaccine; Infants; Pneumococcal Conjugate Vaccines; Vaccines, Pneumococcal

Outcome Measures

Primary Outcomes (4)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series

  Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) 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. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

  1 Month after the infant series (7 Months of age)

• Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

  Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

  1 month after the infant series (7 months of age)

• Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

  Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

  1 month after the infant series (7 months of age)

• Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

  Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

  1 month after the infant series (7 months of age)

Secondary Outcomes (5)

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series

  1 month after the infant series (7 months of age)

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose

  1 month after the toddler dose (13 months of age)

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series

  1 month after the infant series (7 months of age)

• Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose

  1 month after the toddler dose (13 months of age)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

  1 month after the toddler dose (13 months of age)

Other Outcomes (8)

• Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

  Within 7 days after dose (2 months of age)

• Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

  Within 7 days after dose (4 months of age)

• Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

  Within 7 days after dose (6 months of age)

Study Arms (4)

1

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

3

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

4

ACTIVE COMPARATOR

Biological: 7vPnC

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.

1; 2; 3

7vPnC BIOLOGICAL

0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.

4

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 duration of the study and reachable by telephone
• Able to complete two blood drawing procedures during the study

You may not qualify if:

• Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
• Bleeding disorder, immune deficiency or significant chronic or congenital disease
• Previous receipt of blood products or immune globulin

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (78)

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Benton, Arkansas, 72019, United States

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Conway, Arkansas, 72033, United States

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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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North Little Rock, Arkansas, 72117, United States

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Downey, California, 90242, United States

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Fontana, California, 92335, United States

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Fountain Valley, California, 92708, United States

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Lakewood, California, 90805, United States

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Loma Linda, California, 92354, United States

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Moreno Valley, California, 92557, United States

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Paramount, California, 90723, United States

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Riverside, California, 92505, United States

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Rolling Hills Estates, California, 90274, United States

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Boulder, Colorado, 80303, United States

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Longmont, Colorado, 80501, United States

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Norwich, Connecticut, 06360, United States

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Palm Beach Gardens, Florida, 33410, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30322, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Nampa, Idaho, 83686, United States

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Chicago, Illinois, 60647, United States

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DeKalb, Illinois, 60115, United States

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Bardstown, Kentucky, 40004, United States

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Crestview Hills, Kentucky, 41017, United States

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Louisville, Kentucky, 40202, United States

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Louisville, Kentucky, 40207, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02116, United States

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Fall River, Massachusetts, 02124, United States

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Jamaica Plain, Massachusetts, 02130, United States

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Jackson, Mississippi, 39216, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68127, United States

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Omaha, Nebraska, 68131, United States

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Lebanon, New Hampshire, 03756, United States

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Whitehouse Station, New Jersey, 08809, United States

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Fishkill, New York, 12524, United States

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Hopewell Jct, New York, 12533, United States

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Ithaca, New York, 14850, United States

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Syracuse, New York, 13202, United States

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The Bronx, New York, 10467, United States

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Cary, North Carolina, 27518, United States

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Durham, North Carolina, 27704, United States

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Durham, North Carolina, 27705, United States

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Sylva, North Carolina, 28779, United States

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Bismarck, North Dakota, 58501, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45245, United States

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Cleveland, Ohio, 44121, United States

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Huber Heights, Ohio, 45424, United States

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Kettering, Ohio, 45429, United States

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Mason, Ohio, 45040, United States

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Tulsa, Oklahoma, 74127, United States

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Kittanning, Pennsylvania, 16201, 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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Clarksville, Tennessee, 37043, United States

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Franklin, Tennessee, 37067, United States

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Jackson, Tennessee, 38305, United States

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Kingsport, Tennessee, 37660, United States

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Galveston, Texas, 77555, United States

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San Antonio, Texas, 78212, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84107, United States

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South Jordan, Utah, 84095, United States

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Vienna, Virginia, 22180, United States

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Vancouver, Washington, 98664, United States

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Vancouver, Washington, 98684, United States

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Vancouver, Washington, 98686, United States

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La Crosse, Wisconsin, 54601, United States

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Marshfield, Wisconsin, 54449, United States

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Monroe, Wisconsin, 53566, United States

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Related Publications (2)

• Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.

  PMID: 23584582 DERIVED

• 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

Limitations and Caveats

Commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella) was not available as planned; the alternate of a commercially available MMR and a commercially available varicella vaccine was administered in separate injections.

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
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2007
• First Posted: March 7, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 15, 2012
• Results First Posted: July 14, 2010

Record last verified: 2012-10

Locations

US (78)