Trial Evaluating a 13-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).; MedDRA version: 17.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004181-21-Outside-EU/EEA
• Lead Sponsor: Pfizer Japan, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 551

Inclusion Criteria

1. Male or female subjects between 3 months and 6 months of age (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at the time of enrollment.
2. Available for the 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. Parent/legal guardian must be able to complete all relevant study procedures during subject participation. This includes the ability to understand and sign the ICF.

Are the trial subjects under 18? yes
Number of subjects for this age range: 551
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 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 (eg, 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 another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Infant who is a direct descendant (child, grandchild) of the study site personnel.
12. Infant who is judged by the investigator to be ineligible for study enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified