Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
30 listopada 2018 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
551
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Fukuoka, Japonia, 811-1394
- National Hospital Organization Fukuoka National Hospital
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Fukuoka, Japonia, 816-0094
- Harada Clinic
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Kumamoto, Japonia, 860-0812
- Hattori Pediatric Clinic
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Kumamoto, Japonia, 860-0834
- Medical Corporation Seiaikai Seguchi Pediatric Clinic
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Kumamoto, Japonia, 862-0924
- Medical Corporation Oukakai Sakuranbo Kodomo Clinic
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Okayama, Japonia, 701-0205
- Momotaro Clinic
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Chiba
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Funabashi, Chiba, Japonia, 273-0035
- Sunrise Children's Clinic
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Isumi-city, Chiba, Japonia, 299-4503
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city, Ehime, Japonia, 790-8524
- Matsuyama Red Cross Hospital
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Fukuoka
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Higashi-ku, Fukuoka-city, Fukuoka, Japonia, 813-0036
- Fukazawa Pediatric Clinic
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Hiroshima
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Fukuyama, Hiroshima, Japonia, 720-8520
- National Hospital Organization Fukuyama Medical Center
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Kure, Hiroshima, Japonia, 737-0023
- National Hospital Organization Kure Medical Center
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Hokkaido
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Sapporo, Hokkaido, Japonia, 003-0023
- Nakata pediatric clinic
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Sapporo, Hokkaido, Japonia, 006-0831
- Watanabe Pediatric Allergy Clinic
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Sapporo, Hokkaido, Japonia, 063-0831
- Furuta Children's Clinic
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Sapporo, Hokkaido, Japonia, 065-0024
- Motomachi pediatric clinic
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Sapporo, Hokkaido, Japonia, 065-8611
- Tenshi Hospital
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Kumamoto
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Kikuchi-gun, Kumamoto, Japonia, 869-1102
- Yoshimoto Pediatrist Clinic
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MIE
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Suzuka, MIE, Japonia, 510-0235
- Shiroko Clinic
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Tsu, MIE, Japonia, 514-0125
- National Mie Hospital
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Tsu, MIE, Japonia, 514-1101
- National hospital Organization Mie Chuou Medical Center
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Saitama
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Kumagaya, Saitama, Japonia, 360-0018
- Children's Enomoto Clinic
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Kumagaya-city, Saitama, Japonia, 360-0812
- Shibuya Clinic
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Tokyo
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Fuchu, Tokyo, Japonia, 183-0042
- Sakiyama Children's Clinic
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Ota-ku, Tokyo, Japonia, 146-0095
- Okawa Children and Family Clinic
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Setagaya-ku, Tokyo, Japonia, 157-8535
- National Center for Child Health and Development
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Setagaya-ku, Tokyo, Japonia, 157-0066
- Seijo Sasamoto Pediatric And Allergy Clinic
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Tachikawa-shi, Tokyo, Japonia, 190-0002
- Miyata Pediatric Clinic
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Tama, Tokyo, Japonia, 206-0011
- Maehara Pediatric Clinic
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Yamanashi
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Kofu, Yamanashi, Japonia, 400-0853
- Childrens Clinic of Kose
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Koushu-shi, Yamanashi, Japonia, 404-0046
- Medical Corporation Bunpoukai Amemiya Clinic
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Tsuru-shi, Yamanashi, Japonia, 402-0025
- Medical corporation Seijinkai Takei Clinic
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
3 miesiące do 6 miesięcy (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 1
Eksperymentalny
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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Aktywny komparator: 2
Aktywny komparator
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0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
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Aktywny komparator: 3
Active comparator
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0.5 mL per dose, 4 doses
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: 1 month after the infant series
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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
Ramy czasowe: 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
Ramy czasowe: 1 month after the infant series
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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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
Ramy czasowe: 1 month after the infant series
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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
Ramy czasowe: 1 month after the toddler dose
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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.
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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
Ramy czasowe: 1 month after the toddler dose
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Ramy czasowe: 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)
Ramy czasowe: Within 7 days after Dose 2 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 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)
Ramy czasowe: Within 7 days after Dose 3 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 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
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Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
24 września 2010
Zakończenie podstawowe (Rzeczywisty)
30 listopada 2011
Ukończenie studiów (Rzeczywisty)
30 listopada 2011
Daty rejestracji na studia
Pierwszy przesłany
31 sierpnia 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
10 września 2010
Pierwszy wysłany (Oszacować)
13 września 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 grudnia 2018
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
30 listopada 2018
Ostatnia weryfikacja
1 listopada 2018
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B1851056
- 6096A1-3024 (Inny identyfikator: Alias Study Number)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na 13-valent pneumococcal conjugate vaccine (13vPnC)
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Vaxcyte, Inc.ZakończonySzczepionki przeciw pneumokokomStany Zjednoczone