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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00373958
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Biological: 13 valent pneumococcal conjugate vaccine Biological: 7vPnc pneumococcal conjugate vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 666 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Study Start Date : September 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 13vPnC vaccine Biological: 13 valent pneumococcal conjugate vaccine
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.

Active Comparator: 7vPnC vaccine Biological: 7vPnc pneumococcal conjugate vaccine
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.




Primary Outcome Measures :
  1. Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [ Time Frame: One month after the 3-dose infant series (7 months of age) ]
    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.

  2. Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose [ Time Frame: 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.

  3. 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 [ Time Frame: One Month After the Infant Series (7 months of age) ]
    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).

  4. Percentage of Participants Reporting Pre-specified Systemic Events [ Time Frame: Within 7 days after each dose ]
    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.

  5. Percentage of Participants Reporting Pre-specified Local Reactions [ Time Frame: Within 7 days after each dose ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: One month after toddler dose (13 to 16 months of age) ]
  2. Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose ]
  3. Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose ]
    Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.

  4. Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose ]
  5. 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 [ Time Frame: One month after infant series and one month after toddler dose ]
    Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.

  6. Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose [ Time Frame: one month after the infant series and the toddler dose ]
    Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.



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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373958


Locations
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United States, Arkansas
Fayetteville, Arkansas, United States, 72703
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Downey, California, United States, 90242
Fontana, California, United States, 92335
Loma Linda, California, United States, 92354
Paramount, California, United States, 90723
Riverside, California, United States, 92505
United States, Colorado
Centennial, Colorado, United States, 80112
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, Florida
Tampa, Florida, United States, 33606
United States, Georgia
Marietta, Georgia, United States, 30062
Woodstock, Georgia, United States, 30189
United States, Illinois
Chicago, Illinois, United States, 60612
Park Ridge, Illinois, United States, 60068
United States, Kansas
Overland Park, Kansas, United States, 66212
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Louisville, Kentucky, United States, 40202
Louisville, Kentucky, United States, 40207
United States, New York
Bronx, New York, United States, 10467
Rochester, New York, United States, 14620
United States, Ohio
Cincinnati, Ohio, United States, 45245
Cleveland, Ohio, United States, 44118
Mason, Ohio, United States, 45040
United States, Pennsylvania
Latrobe, Pennsylvania, United States, 15650
Pittsburgh, Pennsylvania, United States, 15227
Pittsburgh, Pennsylvania, United States, 15236
Pittsburg, Pennsylvania, United States, 15241
Sellersville, Pennsylvania, United States, 18960
Wexford, Pennsylvania, United States, 15090
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Jackson, Tennessee, United States, 38305
United States, Texas
The Woodlands, Texas, United States, 77380
United States, Utah
Murray, Utah, United States, 84107
Provo, Utah, United States, 84604
United States, Virginia
Richmond, Virginia, United States, 23219
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373958    
Other Study ID Numbers: 6096A1-004
First Posted: September 8, 2006    Key Record Dates
Results First Posted: February 21, 2013
Last Update Posted: February 21, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs