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

Conditions: Prevention of disease caused by a type of bacteria called Streptococcus pneumoniae (pneumococcal disease).
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-004177-16-Outside-EU/EEA

Lead Sponsor: Pfizer Japan, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 321

Inclusion Criteria

1.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.
2.Available for entire study period and whose parent/legal guardian can be reached by telephone.
3.Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4.Subject’s parent/legal guardian must be willing and able to comply with scheduled visits, treatment plan and other study procedures.
5.Evidence of a personally signed and dated informed consent document indicating that the subject’s parent/legal guardian has been informed of all pertinent aspects of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 321
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
2.A previous anaphylactic reaction to any vaccine or vaccine-related component.
3.Contraindication to vaccination with a pneumococcal conjugate, diphtheria, tetanus, or pertussis vaccines.
4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
5.Known or suspected immune deficiency or suppression.
6.History of culture-proven invasive disease caused by S pneumoniae (example [e.g.], meningitis, bacteremia, osteomyelitis, arthritis).
7.Major known congenital malformation or serious chronic disorder (eg, Down syndrome, diabetes, sickle cell anemia).
8.Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb’s palsy.
9.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis) within the past 3 months.
10.Participation in other studies before the current study begins and/or during study participation.
11.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.
12.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or test drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.