A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
22 stycznia 2013 zaktualizowane przez: Pfizer
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.
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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
321
Faza
- Faza 4
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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Chiba, Japonia
- Tsubaki Children's Clinic
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Fukuoka, Japonia
- Kiyomatsu Childrens Clinic
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Fukuoka, Japonia
- National Hospital Organization Fukuoka National Hospital
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Fukuoka, Japonia
- Shindo children's clinic
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Fukuoka, Japonia
- Takasaki Clinic Pedatrics and Child Health
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Chiba
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Isumi-city, Chiba, Japonia
- Sotobo Children's Clinic
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Ehime
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Matsuyama-city, Ehime, Japonia
- Matsuyama Red Cross Hospital
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Fukuoka
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Itoshima, Fukuoka, Japonia
- Yamashita Pediatrics Clinic
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Kasuga, Fukuoka, Japonia
- Yokoyama Children'S Clinic
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Hokkaido
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Sapporo, Hokkaido, Japonia
- Furuta Children's Clinic
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Sapporo, Hokkaido, Japonia
- Watanabe Pediatric Allergy Clinic
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Sapporo, Hokkaido, Japonia
- Yamanaka Tatsuru Pediatrics
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Sapporo-city, Hokkaido, Japonia
- Tenshi Hospital
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Mie
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Kuwana, Mie, Japonia
- Matsuda Pediatrics Clinic
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Okayama
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Kurashiki, Okayama, Japonia
- Kawasaki Medical School, Department of Pediatrics
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Okayama-city, Okayama, Japonia
- Momotaro Clinic
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Osaka
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Toyonaka, Osaka, Japonia
- Hug Hug Kids Clinic
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Saitama
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Kumagaya-city, Saitama, Japonia
- Shibuya 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
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
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: Brak (otwarta etykieta)
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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Eksperymentalny: 2
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 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
|
Percentage of participants achieving predefined antibody level along with the corresponding 95% confidence interval (CI) were presented.
Exact 2-sided CI based on the observed proportion of participants.
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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Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Ramy czasowe: 1 month after the infant series
|
Geometric mean concentrations (GMCs) were measured in IU/mL and corresponding 2-sided 95% confidence interval (CI) were evaluated for diphtheria and tetanus antibodies.
|
1 month after the infant series
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Infant Series
Ramy czasowe: 1 month after the infant series
|
GMCs were 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
|
|
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
|
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
|
1 month after the infant series
|
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Ramy czasowe: 1 month after the infant series
|
Antibody geometric mean concentrations (GMCs) for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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
|
Percentage of participants achieving predefined antibody level along with the corresponding 95% CI were presented.
Exact 2-sided CI based on the observed proportion of participants.
Predefined antibody levels were 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
|
|
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
|
GMCs were measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
|
1 month after the toddler dose
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the Toddler Dose
Ramy czasowe: 1 month after the toddler dose
|
GMCs were measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
|
1 month after the toddler dose
|
|
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
|
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
|
1 month after the toddler dose
|
|
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
|
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% CIs were evaluated.
GMs were calculated using all participants with available data for the specified blood draw.
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1 month after the toddler dose
|
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Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Ramy czasowe: Pre-toddler dose, 1 month after the toddler dose
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Geometric mean fold rises (GMFRs) for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from prevaccination to 1 month postvaccination were computed using the logarithmically transformed assay results.
CI for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.
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Pre-toddler dose, 1 month after the toddler dose
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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After Catch-up Dose 3
Ramy czasowe: 1 month after the catch-up dose 3
|
Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% CI for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) were presented.
Exact 2-sided CI based on the observed proportion of participants.
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1 month after the catch-up dose 3
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Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Ramy czasowe: 1 month after the catch-up dose 3
|
Antibody GMCs for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were presented.
GMC and corresponding 2-sided 95% CI were evaluated.
GMs were calculated using all participants with available data for the specified blood draw.
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1 month after the catch-up dose 3
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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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
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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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
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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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).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was 7vPnC injection site in the 7vPnC+DTaP group, and DTaP injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after the toddler dose
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 1
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Catch-up Dose 1
|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 2
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
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Within 7 days after Catch-up Dose 2
|
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Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 3
|
Local reactions were reported using an electronic diary.
Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement).
Erythema and induration were scaled as Any (erythema and induration present); Mild (0.5 to 2.0 centimeters [cm]); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm).
Participants may be represented in more than 1 category.
Injection site being evaluated for local reactions was catch-up 7vPnC injection site in the DTaP (Catch-up 7vPnC) group.
|
Within 7 days after Catch-up Dose 3
|
|
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 the 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.
|
Within 7 days after Dose 1 of the infant series
|
|
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 the 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.
|
Within 7 days after Dose 2 of the infant series
|
|
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 the 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.
|
Within 7 days after Dose 3 of the 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 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.
|
Within 7 days after the toddler dose
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 1
|
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.
|
Within 7 days after Catch-up Dose 1
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 2
|
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.
|
Within 7 days after Catch-up Dose 2
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)
Ramy czasowe: Within 7 days after Catch-up Dose 3
|
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.
|
Within 7 days after Catch-up Dose 3
|
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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
1 listopada 2010
Zakończenie podstawowe (Rzeczywisty)
1 marca 2012
Ukończenie studiów (Rzeczywisty)
1 marca 2012
Daty rejestracji na studia
Pierwszy przesłany
29 listopada 2010
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 listopada 2010
Pierwszy wysłany (Oszacować)
1 grudnia 2010
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
26 lutego 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 stycznia 2013
Ostatnia weryfikacja
1 stycznia 2013
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- B1841007
- B1841007, 6107A1-4000
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 .