Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
30 november 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
551
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Fukuoka, Japan, 811-1394
- National Hospital Organization Fukuoka National Hospital
-
Fukuoka, Japan, 816-0094
- Harada Clinic
-
Kumamoto, Japan, 860-0812
- Hattori Pediatric Clinic
-
Kumamoto, Japan, 860-0834
- Medical Corporation Seiaikai Seguchi Pediatric Clinic
-
Kumamoto, Japan, 862-0924
- Medical Corporation Oukakai Sakuranbo Kodomo Clinic
-
Okayama, Japan, 701-0205
- Momotaro Clinic
-
-
Chiba
-
Funabashi, Chiba, Japan, 273-0035
- Sunrise Children's Clinic
-
Isumi-city, Chiba, Japan, 299-4503
- Sotobo Children's Clinic
-
-
Ehime
-
Matsuyama-city, Ehime, Japan, 790-8524
- Matsuyama Red Cross Hospital
-
-
Fukuoka
-
Higashi-ku, Fukuoka-city, Fukuoka, Japan, 813-0036
- Fukazawa Pediatric Clinic
-
-
Hiroshima
-
Fukuyama, Hiroshima, Japan, 720-8520
- National Hospital Organization Fukuyama Medical Center
-
Kure, Hiroshima, Japan, 737-0023
- National Hospital Organization Kure Medical Center
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 003-0023
- Nakata pediatric clinic
-
Sapporo, Hokkaido, Japan, 006-0831
- Watanabe Pediatric Allergy Clinic
-
Sapporo, Hokkaido, Japan, 063-0831
- Furuta Children's Clinic
-
Sapporo, Hokkaido, Japan, 065-0024
- Motomachi pediatric clinic
-
Sapporo, Hokkaido, Japan, 065-8611
- Tenshi Hospital
-
-
Kumamoto
-
Kikuchi-gun, Kumamoto, Japan, 869-1102
- Yoshimoto Pediatrist Clinic
-
-
MIE
-
Suzuka, MIE, Japan, 510-0235
- Shiroko Clinic
-
Tsu, MIE, Japan, 514-0125
- National Mie Hospital
-
Tsu, MIE, Japan, 514-1101
- National hospital Organization Mie Chuou Medical Center
-
-
Saitama
-
Kumagaya, Saitama, Japan, 360-0018
- Children's Enomoto Clinic
-
Kumagaya-city, Saitama, Japan, 360-0812
- Shibuya Clinic
-
-
Tokyo
-
Fuchu, Tokyo, Japan, 183-0042
- Sakiyama Children's Clinic
-
Ota-ku, Tokyo, Japan, 146-0095
- Okawa Children and Family Clinic
-
Setagaya-ku, Tokyo, Japan, 157-8535
- National Center for Child Health and Development
-
Setagaya-ku, Tokyo, Japan, 157-0066
- Seijo Sasamoto Pediatric And Allergy Clinic
-
Tachikawa-shi, Tokyo, Japan, 190-0002
- Miyata Pediatric Clinic
-
Tama, Tokyo, Japan, 206-0011
- Maehara Pediatric Clinic
-
-
Yamanashi
-
Kofu, Yamanashi, Japan, 400-0853
- Childrens Clinic of Kose
-
Koushu-shi, Yamanashi, Japan, 404-0046
- Medical Corporation Bunpoukai Amemiya Clinic
-
Tsuru-shi, Yamanashi, Japan, 402-0025
- Medical corporation Seijinkai Takei 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
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
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: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 1
Experimentell
|
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
|
|
Aktiv komparator: 2
Aktiv komparator
|
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
|
|
Aktiv komparator: 3
Active comparator
|
0.5 mL per dose, 4 doses
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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% 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.
|
1 month after the infant series
|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 1 Month After the Infant Series
Tidsram: 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.
|
1 month after the infant series
|
|
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
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 1 Month After the Infant Series
Tidsram: 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.
|
1 month after the infant series
|
|
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 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
|
|
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 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.
|
1 month after the toddler dose
|
|
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
|
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.
|
1 month after the toddler dose
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 1 Month After the Infant Series
Tidsram: 1 month after the infant series
|
GMC was measured in IU/mL and corresponding 2-sided 95% CI were evaluated for diphtheria and tetanus antibodies.
|
1 month after the infant series
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 1 Month After the Infant Series
Tidsram: 1 month after the infant series
|
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
|
1 month after the infant series
|
|
Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose
Tidsram: 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.
|
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
|
GMC was measured in EU/mL and corresponding 2-sided 95% CI were evaluated for PT and FHA antibodies.
|
1 month after the toddler dose
|
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).
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.
|
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).
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.
|
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).
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.
|
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).
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.
|
Within 7 days after the toddler dose
|
|
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 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 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 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)
Tidsram: 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)
Tidsram: 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
|
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.
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 (Faktisk)
24 september 2010
Primärt slutförande (Faktisk)
30 november 2011
Avslutad studie (Faktisk)
30 november 2011
Studieregistreringsdatum
Först inskickad
31 augusti 2010
Först inskickad som uppfyllde QC-kriterierna
10 september 2010
Första postat (Uppskatta)
13 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 november 2018
Senast verifierad
1 november 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B1851056
- 6096A1-3024 (Annan identifierare: Alias Study Number)
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 .