Clinical trial NCT01200368: Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Official title: A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-valent Pneumococcal Conjugate Vaccine Given With Dtap Compared To Open-label Dtap In Healthy Japanese Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Keywords: vaccine
pneumococcal conjugate
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 551
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between 3 to 6 months of age at the enrollment.
* Available for the entire study period and whose parent/legal guardian can be reached by telephone.
* Healthy infant as determined by medical history, physical examination, and judgement 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).
* Infant who is a direct descendant (child, grandchild) of the study site personnel.

Primary outcomes:
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 for 7 Common Serotypes 1 Month After the Infant Series
timeFrame: 1 month after the infant series
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
Secondary outcomes:
measure: Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 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 >=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: 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 Antibodies 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 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 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
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 Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
timeFrame: Within 7 days after Dose 1 of 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 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 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
Locations:
city: Funabashi
country: Japan
facility: Sunrise Children's Clinic
state: Chiba
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: Higashi-ku, Fukuoka-city
country: Japan
facility: Fukazawa Pediatric Clinic
state: Fukuoka
city: Fukuyama
country: Japan
facility: National Hospital Organization Fukuyama Medical Center
state: Hiroshima
city: Kure
country: Japan
facility: National Hospital Organization Kure Medical Center
state: Hiroshima
city: Sapporo
country: Japan
facility: Nakata pediatric clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Watanabe Pediatric Allergy Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Furuta Children's Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Motomachi pediatric clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Tenshi Hospital
state: Hokkaido
city: Kikuchi-gun
country: Japan
facility: Yoshimoto Pediatrist Clinic
state: Kumamoto
city: Suzuka
country: Japan
facility: Shiroko Clinic
state: MIE
city: Tsu
country: Japan
facility: National Mie Hospital
state: MIE
city: Tsu
country: Japan
facility: National hospital Organization Mie Chuou Medical Center
state: MIE
city: Kumagaya-city
country: Japan
facility: Shibuya Clinic
state: Saitama
city: Kumagaya
country: Japan
facility: Children's Enomoto Clinic
state: Saitama
city: Fuchu
country: Japan
facility: Sakiyama Children's Clinic
state: Tokyo
city: Ota-ku
country: Japan
facility: Okawa Children and Family Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Seijo Sasamoto Pediatric And Allergy Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Miyata Pediatric Clinic
state: Tokyo
city: Tama
country: Japan
facility: Maehara Pediatric Clinic
state: Tokyo
city: Kofu
country: Japan
facility: Childrens Clinic of Kose
state: Yamanashi
city: Koushu-shi
country: Japan
facility: Medical Corporation Bunpoukai Amemiya Clinic
state: Yamanashi
city: Tsuru-shi
country: Japan
facility: Medical Corporation Seijinkai Takei Clinic
state: Yamanashi
city: Fukuoka
country: Japan
facility: National Hospital Organization Fukuoka National Hospital
city: Fukuoka
country: Japan
facility: Harada Clinic
city: Kumamoto
country: Japan
facility: Hattori Pediatric Clinic
city: Kumamoto
country: Japan
facility: Medical Corporation Seiaikai Seguchi Pediatric Clinic
city: Kumamoto
country: Japan
facility: Medical Corporation Oukakai Sakuranbo Kodomo Clinic
city: Okayama
country: Japan
facility: Momotaro Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Togashi T, Okada K, Yamaji M, Thompson A, Gurtman A, Cutler M, Aizawa M, Gruber WC, Scott DA. Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Pediatr Infect Dis J. 2015 Oct;34(10):1096-104. doi: 10.1097/INF.0000000000000819.