- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01250756
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
22 januari 2013 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
321
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Chiba, Japan
- Tsubaki Children's Clinic
-
Fukuoka, Japan
- Kiyomatsu Childrens Clinic
-
Fukuoka, Japan
- National Hospital Organization Fukuoka National Hospital
-
Fukuoka, Japan
- Shindo children's clinic
-
Fukuoka, Japan
- Takasaki Clinic Pedatrics and Child Health
-
-
Chiba
-
Isumi-city, Chiba, Japan
- Sotobo Children's Clinic
-
-
Ehime
-
Matsuyama-city, Ehime, Japan
- Matsuyama Red Cross Hospital
-
-
Fukuoka
-
Itoshima, Fukuoka, Japan
- Yamashita Pediatrics Clinic
-
Kasuga, Fukuoka, Japan
- Yokoyama Children'S Clinic
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan
- Furuta Children's Clinic
-
Sapporo, Hokkaido, Japan
- Watanabe Pediatric Allergy Clinic
-
Sapporo, Hokkaido, Japan
- Yamanaka Tatsuru Pediatrics
-
Sapporo-city, Hokkaido, Japan
- Tenshi Hospital
-
-
Mie
-
Kuwana, Mie, Japan
- Matsuda Pediatrics Clinic
-
-
Okayama
-
Kurashiki, Okayama, Japan
- Kawasaki Medical School, Department of Pediatrics
-
Okayama-city, Okayama, Japan
- Momotaro Clinic
-
-
Osaka
-
Toyonaka, Osaka, Japan
- Hug Hug Kids Clinic
-
-
Saitama
-
Kumagaya-city, Saitama, Japan
- Shibuya Clinic
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 månader till 6 månader (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Experimentell
|
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
|
Experimentell: 2
Active comparator
|
0.5 mL per dose, 4 doses
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Infant Series
Tidsram: 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).
|
1 month after the infant series
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Infant Series
Tidsram: 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
Tidsram: 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.
|
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
Tidsram: 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
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Tidsram: 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.
|
1 month after the infant series
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose
Tidsram: 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.
|
1 month after the toddler dose
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
1 month after the toddler dose
|
Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 1 Month After the Toddler Dose
Tidsram: Pre-toddler dose, 1 month after the toddler dose
|
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.
|
Pre-toddler dose, 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 Catch-up Dose 3
Tidsram: 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.
|
1 month after the catch-up dose 3
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Catch-up Dose 3
Tidsram: 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.
|
1 month after the catch-up dose 3
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)
Tidsram: 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.
|
Within 7 days after Dose 1 of the infant series
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)
Tidsram: 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.
|
Within 7 days after Dose 2 of the infant series
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)
Tidsram: 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.
|
Within 7 days after Dose 3 of the infant series
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)
Tidsram: 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.
|
Within 7 days after the toddler dose
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)
Tidsram: 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.
|
Within 7 days after Catch-up Dose 1
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)
Tidsram: 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.
|
Within 7 days after Catch-up Dose 2
|
Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2010
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
29 november 2010
Först inskickad som uppfyllde QC-kriterierna
29 november 2010
Första postat (Uppskatta)
1 december 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 februari 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 januari 2013
Senast verifierad
1 januari 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B1841007
- B1841007, 6107A1-4000
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Friska ämnen
-
University of MiamiJames and Esther King Biomedical Research ProgramAvslutadHealthy Lifetime Icke-rökareFörenta staterna
-
University of LeicesterNational Institute for Health Research, United KingdomAvslutadPatienter med hjärtsvikt och konserverad ejektionsfraktion - HFpEF | Patienter med hjärtsvikt med reducerad ejektionsfraktion - HFrEF | Healthy Controls Group - ålders- och könsmatchad
-
University Hospital, GrenobleUniversity Hospital, Clermont-Ferrand; Grenoble Institut des NeurosciencesAvslutadParkinsons sjukdom | Healthy Controls Group - ålders- och könsmatchadFrankrike
Kliniska prövningar på diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
-
Sanofi Pasteur, a Sanofi CompanyAvslutadKikhosta | Stelkramp | DifteriFörenta staterna, Kanada
-
Sanofi Pasteur, a Sanofi CompanyAvslutadKikhosta | Stelkramp | DifteriFörenta staterna, Kanada
-
SanofiAvslutadKikhosta | Stelkramp | Difteri | PolioKorea, Republiken av
-
Tan Tock Seng HospitalNational Healthcare Group, SingaporeAvslutad
-
CanSino Biologics Inc.Aktiv, inte rekryterandeDifteri, stelkramp och acellulär pertussisKina
-
SanofiAvslutadKikhosta | Stelkramp | Difteri | Polio | Haemophilus Influenzae Typ bFörenta staterna
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.Aktiv, inte rekryterandeKikhosta | Stelkramp | DifteriKina
-
Duke UniversityCenters for Disease Control and Prevention; Children's Hospital Medical... och andra samarbetspartnersAvslutadApné | Prematuritet | Apné NeonatalFörenta staterna
-
PfizerAktiv, inte rekryterandeAlopecia AreataFörenta staterna, Spanien, Kina, Korea, Republiken av, Taiwan, Australien, Kanada, Tyskland, Tjeckien, Polen, Japan, Storbritannien, Mexiko, Argentina, Chile, Colombia, Ryska Federationen
-
Duke UniversityCenters for Disease Control and Prevention; Kaiser PermanenteAvslutadFeber | Feberkramper | Feber efter vaccinationFörenta staterna