Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
- Conditions
- Healthy Subjects
- Interventions
- Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)Biological: DTaP
- Registration Number
- NCT01200368
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 diphtheria, tetanus, and acellular pertussis vaccine (DTaP) Experimental 1 13-valent pneumococcal conjugate vaccine (13vPnC) Experimental 2 7-valent pneumococcal conjugate vaccine (7vPnC) Active comparator 2 DTaP Active comparator 3 DTaP Active comparator
- Primary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series 1 month after the infant series Antibody geometric mean concentration (GMC) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) 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.
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series 1 month after the infant series 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).
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 1 month after the infant series Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (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. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
- Secondary Outcome Measures
Name Time Method Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series 1 month after the infant series Antibody GMC for 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMs were calculated using all participants with available data for the specified blood draw. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose 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. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest response observed among the 7 common serotypes in the group was taken as reference.
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series 1 month after the infant series GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose 1 month after the toddler dose GMC was 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 1 month after the toddler dose GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose 1 month after the toddler dose Antibody 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. To demonstrate non-inferiority, for 6 additional serotypes in 7vPnC + DTaP group, the lowest GMC observed among the 7 common serotypes in the group was taken as reference.
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose 1 month after the toddler dose Predefined antibody level was 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 Acellular Pertussis Antibodies 1 Month After the Infant Series 1 month after the infant series GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
Trial Locations
- Locations (32)
National Hospital Organization Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Harada Clinic
🇯🇵Fukuoka, Japan
Childrens Clinic of Kose
🇯🇵Kofu, Yamanashi, Japan
Hattori Pediatric Clinic
🇯🇵Kumamoto, Japan
Momotaro Clinic
🇯🇵Okayama, Japan
Miyata Pediatric Clinic
🇯🇵Tachikawa-shi, Tokyo, Japan
National Hospital Organization Fukuyama Medical Center
🇯🇵Fukuyama, Hiroshima, Japan
Shiroko Clinic
🇯🇵Suzuka, MIE, Japan
Maehara Pediatric Clinic
🇯🇵Tama, Tokyo, Japan
National Hospital Organization Fukuoka National Hospital
🇯🇵Fukuoka, Japan
Medical Corporation Oukakai Sakuranbo Kodomo Clinic
🇯🇵Kumamoto, Japan
Medical Corporation Seijinkai Takei Clinic
🇯🇵Tsuru-shi, Yamanashi, Japan
Seijo Sasamoto Pediatric And Allergy Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Sunrise Children's Clinic
🇯🇵Funabashi, Chiba, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyama-city, Ehime, Japan
Fukazawa Pediatric Clinic
🇯🇵Higashi-ku, Fukuoka-city, Fukuoka, Japan
Sotobo Children's Clinic
🇯🇵Isumi-city, Chiba, Japan
Nakata pediatric clinic
🇯🇵Sapporo, Hokkaido, Japan
Watanabe Pediatric Allergy Clinic
🇯🇵Sapporo, Hokkaido, Japan
Furuta Children's Clinic
🇯🇵Sapporo, Hokkaido, Japan
Motomachi pediatric clinic
🇯🇵Sapporo, Hokkaido, Japan
Tenshi Hospital
🇯🇵Sapporo, Hokkaido, Japan
Yoshimoto Pediatrist Clinic
🇯🇵Kikuchi-gun, Kumamoto, Japan
National Mie Hospital
🇯🇵Tsu, MIE, Japan
National hospital Organization Mie Chuou Medical Center
🇯🇵Tsu, MIE, Japan
Children's Enomoto Clinic
🇯🇵Kumagaya, Saitama, Japan
National Center for Child Health and Development
🇯🇵Setagaya-ku, Tokyo, Japan
Shibuya Clinic
🇯🇵Kumagaya-city, Saitama, Japan
Sakiyama Children's Clinic
🇯🇵Fuchu, Tokyo, Japan
Okawa Children and Family Clinic
🇯🇵Ota-ku, Tokyo, Japan
Medical Corporation Bunpoukai Amemiya Clinic
🇯🇵Koushu-shi, Yamanashi, Japan
Medical Corporation Seiaikai Seguchi Pediatric Clinic
🇯🇵Kumamoto, Japan