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

NCT ID: NCT01250756

Last Updated: 2013-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Experimental

Group Type: EXPERIMENTAL

7-pneumococcal conjugate vaccine (7vPnC)

Intervention Type: BIOLOGICAL

0.5 mL per dose, 4 doses

diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

Intervention Type: BIOLOGICAL

0.5 mL per dose, 4 doses

2

Active comparator

Group Type: EXPERIMENTAL

DTaP

Intervention Type: BIOLOGICAL

0.5 mL per dose, 4 doses

Interventions

7-pneumococcal conjugate vaccine (7vPnC)

0.5 mL per dose, 4 doses

Intervention Type: BIOLOGICAL

diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

0.5 mL per dose, 4 doses

Intervention Type: BIOLOGICAL

DTaP

0.5 mL per dose, 4 doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Tsubaki Children's Clinic

Chiba, Chiba, Japan

Sotobo Children's Clinic

Isumi, Chiba, Japan

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan

Kiyomatsu Childrens Clinic

Fukuoka, Fukuoka, Japan

National Hospital Organization Fukuoka National Hospital

Fukuoka, Fukuoka, Japan

Shindo Children's Clinic

Fukuoka, Fukuoka, Japan

Takasaki Clinic Pedatrics and Child Health

Fukuoka, Fukuoka, Japan

Yamashita Pediatrics Clinic

Itoshima, Fukuoka, Japan

Yokoyama Children's Clinic

Kasuga, Fukuoka, Japan

Furuta Children's Clinic

Sapporo, Hokkaido, Japan

Tenshi Hospital

Sapporo, Hokkaido, Japan

Watanabe Pediatric Allergy Clinic

Sapporo, Hokkaido, Japan

Yamanaka Tatsuru Pediatrics

Sapporo, Hokkaido, Japan

Matsuda Pediatrics Clinic

Kuwana, Mie-ken, Japan

Kawasaki Medical School, Department of Pediatrics

Kurashiki, Okayama-ken, Japan

Momotaro Clinic

Okayama, Okayama-ken, Japan

Hug Hug Kids Clinic

Toyonaka, Osaka, Japan

Shibuya Clinic

Kumagaya, Saitama, Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1841007&StudyName=A%20Trial%20Evaluating%20a%207-valent%20Pneumococcal%20Conjugate%20Vaccine%20Given%20with%20Diphtheria%2C%20Tetanus%2C%20and%20Acellular%20Pertussis%20Vaccine%20%28DTaP%29%20

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Other Identifiers

B1841007, 6107A1-4000

Identifier Type: -

Identifier Source: secondary_id

B1841007

Identifier Type: -

Identifier Source: org_study_id