Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
2018. november 30. frissítette: Pfizer
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
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.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
551
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Fukuoka, Japán, 811-1394
- National Hospital Organization Fukuoka National Hospital
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Fukuoka, Japán, 816-0094
- Harada Clinic
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Kumamoto, Japán, 860-0812
- Hattori Pediatric Clinic
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Kumamoto, Japán, 860-0834
- Medical Corporation Seiaikai Seguchi Pediatric Clinic
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Kumamoto, Japán, 862-0924
- Medical Corporation Oukakai Sakuranbo Kodomo Clinic
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Okayama, Japán, 701-0205
- Momotaro Clinic
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Chiba
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Funabashi, Chiba, Japán, 273-0035
- Sunrise Children's Clinic
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Isumi-city, Chiba, Japán, 299-4503
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city, Ehime, Japán, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka
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Higashi-ku, Fukuoka-city, Fukuoka, Japán, 813-0036
- Fukazawa Pediatric Clinic
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Hiroshima
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Fukuyama, Hiroshima, Japán, 720-8520
- National Hospital Organization FUKUYAMA MEDICAL CENTER
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Kure, Hiroshima, Japán, 737-0023
- National Hospital Organization Kure Medical Center
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Hokkaido
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Sapporo, Hokkaido, Japán, 003-0023
- Nakata pediatric clinic
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Sapporo, Hokkaido, Japán, 006-0831
- Watanabe Pediatric Allergy Clinic
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Sapporo, Hokkaido, Japán, 063-0831
- Furuta Children's Clinic
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Sapporo, Hokkaido, Japán, 065-0024
- Motomachi pediatric clinic
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Sapporo, Hokkaido, Japán, 065-8611
- Tenshi Hospital
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Kumamoto
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Kikuchi-gun, Kumamoto, Japán, 869-1102
- Yoshimoto Pediatrist Clinic
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MIE
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Suzuka, MIE, Japán, 510-0235
- Shiroko Clinic
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Tsu, MIE, Japán, 514-0125
- National Mie Hospital
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Tsu, MIE, Japán, 514-1101
- National hospital Organization Mie Chuou Medical Center
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Saitama
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Kumagaya, Saitama, Japán, 360-0018
- Children's Enomoto Clinic
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Kumagaya-city, Saitama, Japán, 360-0812
- Shibuya Clinic
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Tokyo
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Fuchu, Tokyo, Japán, 183-0042
- Sakiyama Children's Clinic
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Ota-ku, Tokyo, Japán, 146-0095
- Okawa Children and Family Clinic
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Setagaya-ku, Tokyo, Japán, 157-8535
- National Center for Child Health and Development
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Setagaya-ku, Tokyo, Japán, 157-0066
- Seijo Sasamoto Pediatric And Allergy Clinic
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Tachikawa-shi, Tokyo, Japán, 190-0002
- Miyata Pediatric Clinic
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Tama, Tokyo, Japán, 206-0011
- Maehara Pediatric Clinic
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Yamanashi
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Kofu, Yamanashi, Japán, 400-0853
- Childrens clinic of Kose
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Koushu-shi, Yamanashi, Japán, 404-0046
- Medical Corporation Bunpoukai Amemiya Clinic
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Tsuru-shi, Yamanashi, Japán, 402-0025
- Medical corporation Seijinkai Takei Clinic
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
3 hónap (Gyermek)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Hármas
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 1
Kísérleti
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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Aktív összehasonlító: 2
Aktív összehasonlító
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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Aktív összehasonlító: 3
Active comparator
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0.5 mL per dose, 4 doses
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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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
Időkeret: 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.
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1 month after the infant series
|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Időkeret: 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.
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1 month after the infant series
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Időkeret: 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).
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1 month after the infant series
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Időkeret: 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.
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1 month after the infant series
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 mcg/mL 1 Month After the Toddler Dose
Időkeret: 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.
|
1 month after the toddler dose
|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Időkeret: 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.
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1 month after the toddler dose
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Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Időkeret: 1 month after the toddler dose
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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.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
Időkeret: 1 month after the infant series
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GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
Időkeret: 1 month after the infant series
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GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the infant series
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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Időkeret: 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.
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1 month after the toddler dose
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Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Időkeret: 1 month after the toddler dose
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GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
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1 month after the toddler dose
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Időkeret: Within 7 days after Dose 1 of the infant series
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Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Redness and swelling were scaled as Any (redness or swelling 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.
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Within 7 days after Dose 1 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Időkeret: Within 7 days after Dose 2 of the infant series
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Redness and swelling were scaled as Any (redness or swelling 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.
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Within 7 days after Dose 2 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Időkeret: Within 7 days after Dose 3 of the infant series
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Redness and swelling were scaled as Any (redness or swelling 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.
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Within 7 days after Dose 3 of the infant series
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Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Időkeret: Within 7 days after the toddler dose
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Redness and swelling were scaled as Any (redness or swelling 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.
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Within 7 days after the toddler dose
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)
Időkeret: Within 7 days after Dose 1 of infant series
|
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.
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Within 7 days after Dose 1 of infant series
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)
Időkeret: Within 7 days after Dose 2 of infant series
|
Systemic events (any fever >= 37.5 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 2 of infant series
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Időkeret: Within 7 days after Dose 3 of infant series
|
Systemic events (any fever >= 37.5 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 3 of infant series
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)
Időkeret: Within 7 days after the toddler dose
|
Systemic events (any fever >= 37.5 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 the toddler dose
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2010. szeptember 24.
Elsődleges befejezés (Tényleges)
2011. november 30.
A tanulmány befejezése (Tényleges)
2011. november 30.
Tanulmányi regisztráció dátumai
Először benyújtva
2010. augusztus 31.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2010. szeptember 10.
Első közzététel (Becslés)
2010. szeptember 13.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2018. december 19.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2018. november 30.
Utolsó ellenőrzés
2018. november 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- B1851056
- 6096A1-3024 (Egyéb azonosító: Alias Study Number)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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