Trial Evaluating a 13-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 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01200368
• Other study ID #: B1851056
• Secondary ID: B18510566096A1-3
• Status: Completed
• Phase: Phase 3
• Start date: September 24, 2010
• Est. completion date: November 30, 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: November 30, 2011
• Est. primary completion date: November 30, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL per dose, 4 doses
• diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
0.5 mL per dose, 4 doses
• 7-valent pneumococcal conjugate vaccine (7vPnC)
0.5 mL per dose, 4 doses
• DTaP
0.5 mL per dose, 4 doses
• DTaP
0.5 mL per dose, 4 doses

Locations

Country	Name	City	State
Japan	Sakiyama Children's Clinic	Fuchu	Tokyo
Japan	Harada Clinic	Fukuoka
Japan	National Hospital Organization Fukuoka National Hospital	Fukuoka
Japan	National Hospital Organization Fukuyama Medical Center	Fukuyama	Hiroshima
Japan	Sunrise Children's Clinic	Funabashi	Chiba
Japan	Fukazawa Pediatric Clinic	Higashi-ku, Fukuoka-city	Fukuoka
Japan	Sotobo Children's Clinic	Isumi-city	Chiba
Japan	Yoshimoto Pediatrist Clinic	Kikuchi-gun	Kumamoto
Japan	Childrens Clinic of Kose	Kofu	Yamanashi
Japan	Medical Corporation Bunpoukai Amemiya Clinic	Koushu-shi	Yamanashi
Japan	Children's Enomoto Clinic	Kumagaya	Saitama
Japan	Shibuya Clinic	Kumagaya-city	Saitama
Japan	Hattori Pediatric Clinic	Kumamoto
Japan	Medical Corporation Oukakai Sakuranbo Kodomo Clinic	Kumamoto
Japan	Medical Corporation Seiaikai Seguchi Pediatric Clinic	Kumamoto
Japan	National Hospital Organization Kure Medical Center	Kure	Hiroshima
Japan	Matsuyama Red Cross Hospital	Matsuyama-city	Ehime
Japan	Momotaro Clinic	Okayama
Japan	Okawa Children and Family Clinic	Ota-ku	Tokyo
Japan	Furuta Children's Clinic	Sapporo	Hokkaido
Japan	Motomachi pediatric clinic	Sapporo	Hokkaido
Japan	Nakata pediatric clinic	Sapporo	Hokkaido
Japan	Tenshi Hospital	Sapporo	Hokkaido
Japan	Watanabe Pediatric Allergy Clinic	Sapporo	Hokkaido
Japan	National Center for Child Health and Development	Setagaya-ku	Tokyo
Japan	Seijo Sasamoto Pediatric And Allergy Clinic	Setagaya-ku	Tokyo
Japan	Shiroko Clinic	Suzuka	MIE
Japan	Miyata Pediatric Clinic	Tachikawa-shi	Tokyo
Japan	Maehara Pediatric Clinic	Tama	Tokyo
Japan	National hospital Organization Mie Chuou Medical Center	Tsu	MIE
Japan	National Mie Hospital	Tsu	MIE
Japan	Medical Corporation Seijinkai Takei Clinic	Tsuru-shi	Yamanashi

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). 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
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). 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
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). 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
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). 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
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 infant series
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 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
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 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
Other	Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 to 15 Months of Age)	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
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% 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
Primary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 7 Common Serotypes 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
Primary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 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
Secondary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody for 6 Additional Serotypes 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
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 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
Secondary	Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 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
Secondary	Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 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
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibodies 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
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibodies 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
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 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
Secondary	Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 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