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

Pfizer321 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

321

Conditions

Healthy Subjects

Interventions

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (18)

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

...and 8 more locations

Outcomes

Primary Outcomes

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).