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A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01250756
First received: November 29, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.


Condition Intervention Phase
Healthy Subjects
Biological: 7-pneumococcal conjugate vaccine (7vPnC)
Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
Biological: DTaP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 International Units/mL (IU/mL) for diphtheria, 0.01 IU/mL for tetanus, 5 Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) for pertussis toxoid (PT), and 5 EU/mL for filamentous hemagglutinin (FHA).

  • Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ] [ Designated as safety issue: No ]
    Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.

  • Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ] [ Designated as safety issue: No ]
    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=) 0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

  • Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series [ Time Frame: 1 month after the infant series ] [ Designated as safety issue: No ]
    Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.


Secondary Outcome Measures:
  • Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented. Exact 2-sided CI based on the observed proportion of participants. Predefined antibody levels were 0.1 IU/mL for diphtheria, 0.01 IU/mL for tetanus, 5 EU/mL for PT, and 5 EU/mL for FHA.

  • Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose ] [ Designated as safety issue: No ]
    GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.

  • Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose ] [ Designated as safety issue: No ]
    GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

  • Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose [ Time Frame: 1 month after the toddler dose ] [ Designated as safety issue: No ]
    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

  • Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose [ Time Frame: Pre-toddler dose, 1 month after the toddler dose ] [ Designated as safety issue: No ]
    Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results. CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

  • Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3 [ Time Frame: 1 month after the catch-up dose 3 ] [ Designated as safety issue: No ]
    Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented. Exact 2-sided CI based on the observed proportion of participants.

  • Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3 [ Time Frame: 1 month after the catch-up dose 3 ] [ Designated as safety issue: No ]
    Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.


Other Outcome Measures:
  • Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age) [ Time Frame: Within 7 days after Dose 1 of the infant series ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age) [ Time Frame: Within 7 days after Dose 2 of the infant series ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age) [ Time Frame: Within 7 days after Dose 3 of the infant series ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age) [ Time Frame: Within 7 days after the toddler dose ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 1 ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 2 ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 3 ] [ Designated as safety issue: Yes ]
    Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age) [ Time Frame: Within 7 days after Dose 1 of the infant series ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age) [ Time Frame: Within 7 days after Dose 2 of the infant series ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age) [ Time Frame: Within 7 days after Dose 3 of the infant series ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age) [ Time Frame: Within 7 days after the toddler dose ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 1 ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 2 ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.

  • Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age) [ Time Frame: Within 7 days after Catch-up Dose 3 ] [ Designated as safety issue: Yes ]
    Systemic events (any fever >= 37.5 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.


Enrollment: 321
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Experimental
Biological: 7-pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
Experimental: 2
Active comparator
Biological: DTaP
0.5 mL per dose, 4 doses

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
  • Available for entire study period and whose parent/legal guardian can be reached by telephone.
  • Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
  • Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250756

Locations
Japan
Sotobo Children's Clinic
Isumi-city, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama-city, Ehime, Japan
Yamashita Pediatrics Clinic
Itoshima, Fukuoka, Japan
Yokoyama Children's Clinic
Kasuga, Fukuoka, Japan
Watanabe Pediatric Allergy Clinic
Sapporo, Hokkaido, Japan
Yamanaka Tatsuru Pediatrics
Sapporo, Hokkaido, Japan
Furuta Children's Clinic
Sapporo, Hokkaido, Japan
Tenshi Hospital
Sapporo-city, Hokkaido, Japan
Matsuda Pediatrics Clinic
Kuwana, Mie, Japan
Kawasaki Medical School, Department of Pediatrics
Kurashiki, Okayama, Japan
Momotaro Clinic
Okayama-city, Okayama, Japan
Hug Hug Kids Clinic
Toyonaka, Osaka, Japan
Shibuya Clinic
Kumagaya-city, Saitama, Japan
Tsubaki Children's Clinic
Chiba, Japan
Kiyomatsu Childrens Clinic
Fukuoka, Japan
National Hospital Organization Fukuoka National Hospital
Fukuoka, Japan
Shindo Children's Clinic
Fukuoka, Japan
Takasaki Clinic Pedatrics and Child Health
Fukuoka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01250756     History of Changes
Other Study ID Numbers: B1841007, B1841007, 6107A1-4000
Study First Received: November 29, 2010
Results First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
vaccine
pneumococcal conjugate

ClinicalTrials.gov processed this record on November 20, 2014