A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250756
• Other study ID #: B1841007
• Secondary ID: B1841007, 6107A1
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: January 22, 2013
• Start date: November 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Months to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• 7-pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
• diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
• DTaP
0.5 mL per dose, 4 doses

Locations

Country	Name	City	State
Japan	Tsubaki Children's Clinic	Chiba
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	Fukuoka
Japan	Sotobo Children's Clinic	Isumi-city	Chiba
Japan	Yamashita Pediatrics Clinic	Itoshima	Fukuoka
Japan	Yokoyama Children's Clinic	Kasuga	Fukuoka
Japan	Shibuya Clinic	Kumagaya-city	Saitama
Japan	Kawasaki Medical School, Department of Pediatrics	Kurashiki	Okayama
Japan	Matsuda Pediatrics Clinic	Kuwana	Mie
Japan	Matsuyama Red Cross Hospital	Matsuyama-city	Ehime
Japan	Momotaro Clinic	Okayama-city	Okayama
Japan	Furuta Children's Clinic	Sapporo	Hokkaido
Japan	Watanabe Pediatric Allergy Clinic	Sapporo	Hokkaido
Japan	Yamanaka Tatsuru Pediatrics	Sapporo	Hokkaido
Japan	Tenshi Hospital	Sapporo-city	Hokkaido
Japan	Hug Hug Kids Clinic	Toyonaka	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 2 (4 to 8 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 3 (5 to 10 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Toddler Dose (12 to 15 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Local Reactions: Post Infant Series Catch-up Dose 3 (13 to16.5 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 1 (3 to 6 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 to 8 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (5 to 10 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 1 (6 to 11.5 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 2 (7 to 13 Months of Age)	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	Yes
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Post Infant Series Catch-up Dose 3 (13 to 16.5 Months of Age)	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	Yes
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 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	No
Primary	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 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	No
Primary	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 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	No
Primary	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	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	No
Primary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 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	No
Secondary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 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	No
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 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	No
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 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	No
Secondary	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 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	No
Secondary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 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	No
Secondary	Geometric Mean Fold Rise (GMFR) of Pneumococcal Antibodies From Pretoddler Dose to 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	No
Secondary	Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level >=0.35 Mcg/mL 1 Month After 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	No
Secondary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 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	No

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