A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

• Conditions: Pneumococcal Infection; 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: EUCTR2014-004953-14-Outside-EU/EEA
• Lead Sponsor: Pfizer, 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: 1674

Inclusion Criteria

1. 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.
2. Subject’s caregiver willing and able to comply with scheduled visits, laboratory tests, and other study procedures. The subject’s caregiver must be able to be reached by telephone for the duration of the study.
3. Male or female subject aged 42 to 77 days (approximately 2 months) at the time of enrollment.
4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1674
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 vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccines.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7. Major known congenital malformation or serious chronic disorder.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Resolving syndromes due to birth trauma such as perception before Brachial plexus birth palsy (Erb palsy) not included.
9. Receipt of blood products or gamma globulin. Hepatitis B immunoglobulin might be given.
10. Participation in another investigational trial within 28 days before the current study begins and during study participation. Participation in purely observational studies acceptable
11. Subjects whose parents or legal guardian are investigational site staff members or subjects whose parents or legal guardian are Pfizer employees directly involved in the conduct of the trial.
12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into this study
13. Known or suspected allergy to 13vPnC, 7vPnC, or other compounds related to these classes of medication.

Study & Design

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