Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States

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.

Study Overview

• Status: Completed
• Conditions: Vaccines, Pneumococcal
• Intervention / Treatment: Biological: 13-valent Pneumococcal Conjugate Vaccine; Biological: 7vPnC

• Study Type: Interventional
• Enrollment (Actual): 1712
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Benton, Arkansas, United States, 72019
    • Conway, Arkansas, United States, 72033
    • Fayetteville, Arkansas, United States, 72703
    • Jonesboro, Arkansas, United States, 72401
    • Little Rock, Arkansas, United States, 72205
    • North Little Rock, Arkansas, United States, 72117
  • California
    • Downey, California, United States, 90242
    • Fontana, California, United States, 92335
    • Fountain Valley, California, United States, 92708
    • Lakewood, California, United States, 90805
    • Loma Linda, California, United States, 92354
    • Moreno Valley, California, United States, 92557
    • Paramount, California, United States, 90723
    • Riverside, California, United States, 92505
    • Rolling Hills Estates, California, United States, 90274
  • Colorado
    • Boulder, Colorado, United States, 80303
    • Longmont, Colorado, United States, 80501
  • Connecticut
    • Norwich, Connecticut, United States, 06360
  • Florida
    • Palm Beach Gardens, Florida, United States, 33410
    • Tampa, Florida, United States, 33606
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Marietta, Georgia, United States, 30062
    • Woodstock, Georgia, United States, 30189
  • Idaho
    • Nampa, Idaho, United States, 83686
  • Illinois
    • Chicago, Illinois, United States, 60647
    • Dekalb, Illinois, United States, 60115
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
    • Crestview Hills, Kentucky, United States, 41017
    • Louisville, Kentucky, United States, 40202
    • Louisville, Kentucky, United States, 40207
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
    • Boston, Massachusetts, United States, 02116
    • Fall River, Massachusetts, United States, 02124
    • Jamaica Plain, Massachusetts, United States, 02130
  • Mississippi
    • Jackson, Mississippi, United States, 39216
  • Missouri
    • St. Louis, Missouri, United States, 63110
  • Nebraska
    • Omaha, Nebraska, United States, 68131
    • Omaha, Nebraska, United States, 68127
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
  • New Jersey
    • Whitehouse Station, New Jersey, United States, 08809
  • New York
    • Bronx, New York, United States, 10467
    • Fishkill, New York, United States, 12524
    • Hopewell Jct, New York, United States, 12533
    • Ithaca, New York, United States, 14850
    • Syracuse, New York, United States, 13202
  • North Carolina
    • Cary, North Carolina, United States, 27518
    • Durham, North Carolina, United States, 27705
    • Durham, North Carolina, United States, 27704
    • Sylva, North Carolina, United States, 28779
  • North Dakota
    • Bismark, North Dakota, United States, 58501
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cincinnati, Ohio, United States, 45245
    • Cleveland, Ohio, United States, 44121
    • Huber Heights, Ohio, United States, 45424
    • Kettering, Ohio, United States, 45429
    • Mason, Ohio, United States, 45040
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74127
  • Pennsylvania
    • Kittanning, Pennsylvania, United States, 16201
    • Latrobe, Pennsylvania, United States, 15650
    • Pittsburgh, Pennsylvania, United States, 15236
    • Pittsburgh, Pennsylvania, United States, 15241
    • Pittsburgh, Pennsylvania, United States, 15227
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
    • Franklin, Tennessee, United States, 37067
    • Jackson, Tennessee, United States, 38305
    • Kingsport, Tennessee, United States, 37660
  • Texas
    • Galveston, Texas, United States, 77555
    • San Antonio, Texas, United States, 78212
  • Utah
    • Layton, Utah, United States, 84041
    • Murray, Utah, United States, 84107
    • South Jordan, Utah, United States, 84095
  • Virginia
    • Vienna, Virginia, United States, 22180
  • Washington
    • Vancouver, Washington, United States, 98684
    • Vancouver, Washington, United States, 98686
    • Vancouver, Washington, United States, 98664
  • Wisconsin
    • LaCrosse, Wisconsin, United States, 54601
    • Marshfield, Wisconsin, United States, 54449
    • Monroe, Wisconsin, United States, 53566

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: 13-valent Pneumococcal Conjugate Vaccine; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Experimental: 2	Biological: 13-valent Pneumococcal Conjugate Vaccine; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Experimental: 3	Biological: 13-valent Pneumococcal Conjugate Vaccine; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.
Active Comparator: 4	Biological: 7vPnC; 0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.

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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. Exact 2-sided CI based on the observed proportion of participants.	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	Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/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. Exact 2-sided CI based on the observed proportion of participants.	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	Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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. Exact 2-sided CI based on the observed proportion of participants.	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	Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/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. Exact 2-sided CI based on the observed proportion of participants.	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	Antibody geometric mean concentration (GMC) as measured by 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 toddler dose (13 months of age)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.	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)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.	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)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.	Within 7 days after dose (6 months of age)
Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.	Within 7 days after dose (12 months of age)
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)	Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after dose (2 months of age)
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)	Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after dose (4 months of age)
Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)	Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after dose (6 months of age)
Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)	Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 7 days after dose (12 months of age)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: March 5, 2007
• First Submitted That Met QC Criteria: March 6, 2007
• First Posted (Estimate): March 7, 2007

Study Record Updates

• Last Update Posted (Estimate): October 15, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Vaccine; Infants; Vaccines, Pneumococcal; Pneumococcal Conjugate Vaccines
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-3005