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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Healthy Subjects

Treatments

Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)

Biological: DTaP

Biological: 7-pneumococcal conjugate vaccine (7vPnC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01250756

B1841007, 6107A1-4000

B1841007

Details and patient eligibility

About

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.

Enrollment

321 patients

Sex

All

Ages

3 to 6 months old

Volunteers

Accepts Healthy Volunteers

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.