Clinical trial NCT01250756: A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Subjects
Keywords: vaccine
pneumococcal conjugate
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-01
Enrollment: 321
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: 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
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
Secondary outcomes:
measure: Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
timeFrame: Pre-toddler dose, 1 month after the toddler dose
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
timeFrame: 1 month after the catch-up dose 3
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
timeFrame: 1 month after the catch-up dose 3
Other outcomes:
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
timeFrame: Within 7 days after Dose 1 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
timeFrame: Within 7 days after Dose 2 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
timeFrame: Within 7 days after Dose 3 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
timeFrame: Within 7 days after the toddler dose
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 1
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 2
measure: Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 3
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
timeFrame: Within 7 days after Dose 1 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
timeFrame: Within 7 days after Dose 2 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
timeFrame: Within 7 days after Dose 3 of the infant series
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
timeFrame: Within 7 days after the toddler dose
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 1
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 2
measure: Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
timeFrame: Within 7 days after Catch-up Dose 3
Locations:
city: Isumi-city
country: Japan
facility: Sotobo Children's Clinic
state: Chiba
city: Matsuyama-city
country: Japan
facility: Matsuyama Red Cross Hospital
state: Ehime
city: Itoshima
country: Japan
facility: Yamashita Pediatrics Clinic
state: Fukuoka
city: Kasuga
country: Japan
facility: Yokoyama Children's Clinic
state: Fukuoka
city: Sapporo-city
country: Japan
facility: Tenshi Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Furuta Children's Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Watanabe Pediatric Allergy Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Yamanaka Tatsuru Pediatrics
state: Hokkaido
city: Kuwana
country: Japan
facility: Matsuda Pediatrics Clinic
state: Mie
city: Kurashiki
country: Japan
facility: Kawasaki Medical School, Department of Pediatrics
state: Okayama
city: Okayama-city
country: Japan
facility: Momotaro Clinic
state: Okayama
city: Toyonaka
country: Japan
facility: Hug Hug Kids Clinic
state: Osaka
city: Kumagaya-city
country: Japan
facility: Shibuya Clinic
state: Saitama
city: Chiba
country: Japan
facility: Tsubaki Children's Clinic
city: Fukuoka
country: Japan
facility: Kiyomatsu Childrens Clinic
city: Fukuoka
country: Japan
facility: National Hospital Organization Fukuoka National Hospital
city: Fukuoka
country: Japan
facility: Shindo Children's Clinic
city: Fukuoka
country: Japan
facility: Takasaki Clinic Pedatrics and Child Health
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: