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

NCT01250756 | Completed Phase 4 Results

• 2 other identifiers: B1841007B1841007, 6107A1-4000
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Healthy Subjects

Keywords

vaccine; pneumococcal conjugate

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (8)

• Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria Toxoid, Tetanus Toxoid, and Pertussis Antigens 1 Month After the Toddler Dose

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) for Antigen-specific Diphtheria and Tetanus Antibody 1 Month After the Toddler Dose

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) for Antigen-specific Acellular Pertussis Antibody 1 Month After the 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 the Toddler Dose

  1 month after the toddler dose

• Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

  1 month after the toddler dose

Other Outcomes (14)

• Percentage of Participants Reporting Pre-Specified Local Reactions: Infant Series Dose 1 (3 to 6 Months of Age)

  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)

  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)

  Within 7 days after Dose 3 of the infant series

Study Arms (2)

1

EXPERIMENTAL

Experimental

Biological: 7-pneumococcal conjugate vaccine (7vPnC); Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

2

EXPERIMENTAL

Active comparator

Biological: DTaP

Interventions

7-pneumococcal conjugate vaccine (7vPnC) BIOLOGICAL

0.5 mL per dose, 4 doses

1

diphtheria, tetanus, and acellular pertussis vaccine (DTaP) BIOLOGICAL

0.5 mL per dose, 4 doses

1

DTaP BIOLOGICAL

0.5 mL per dose, 4 doses

2

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Tsubaki Children's Clinic

Chiba, Chiba, Japan

Location

Sotobo Children's Clinic

Isumi, Chiba, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Location

Kiyomatsu Childrens Clinic

Fukuoka, Fukuoka, Japan

Location

National Hospital Organization Fukuoka National Hospital

Fukuoka, Fukuoka, Japan

Location

Shindo Children's Clinic

Fukuoka, Fukuoka, Japan

Location

Takasaki Clinic Pedatrics and Child Health

Fukuoka, Fukuoka, Japan

Location

Yamashita Pediatrics Clinic

Itoshima, Fukuoka, Japan

Location

Yokoyama Children's Clinic

Kasuga, Fukuoka, Japan

Location

Furuta Children's Clinic

Sapporo, Hokkaido, Japan

Location

Tenshi Hospital

Sapporo, Hokkaido, Japan

Location

Watanabe Pediatric Allergy Clinic

Sapporo, Hokkaido, Japan

Location

Yamanaka Tatsuru Pediatrics

Sapporo, Hokkaido, Japan

Location

Matsuda Pediatrics Clinic

Kuwana, Mie-ken, Japan

Location

Kawasaki Medical School, Department of Pediatrics

Kurashiki, Okayama-ken, Japan

Location

Momotaro Clinic

Okayama, Okayama-ken, Japan

Location

Hug Hug Kids Clinic

Toyonaka, Osaka, Japan

Location

Shibuya Clinic

Kumagaya, Saitama, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: February 26, 2013
• Results First Posted: February 26, 2013

Record last verified: 2013-01

Locations

JP (18)