A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

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: EUCTR2014-004180-20-Outside-EU/EEA

Lead Sponsor: Pfizer Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 72

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a parent/legal guardian) has been informed of all pertinent aspects of the study.
2. Chinese male or female subject.
3. Age at the time of enrollment: 18 through 55 years (before the fifty sixth birthday) for Group 1, 3 through 5 years (before the sixth birthday) for Group 2 and 42 to 98 days for Group 3.
4. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
5. Subjects or parent/legal guardian/caregiver willing and able to comply with scheduled visits and study procedures.
6. All male and female subjects (in Group 1) biologically capable of having children agreed and committed to use a reliable method of birth control from the signing of the informed consent form (ICF) until the end of the study.
7. Negative urine pregnancy test for female subjects (in Group 1) who were biologically capable of having children.
Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
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. Previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Woman who were breastfeeding or pregnant (known or suspected).
5. Bleeding diathesis or condition associated with prolonged bleeding time that contraindicated intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. Major known congenital malformation or serious chronic disorder.
8. Significant neurological disorder or history of seizure (including febrile seizure for Group 3), or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
9. 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.
10. Receipt of any investigational products or medical devices within 28 days before investigational product administration and during the study.
11. Subjects related to investigational site staff members or Pfizer employees directly involved in the conduct of the trial. Direct descendent (child or grandchild) of any study personnel or Pfizer employee.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of a single dose of 13vPnC as measured by the incidence of solicited local reactions, systemic events, and unsolicited adverse events (AEs) in healthy Chinese subjects: Group 1: Adults aged 18 through 55 years, Group 2: Children aged 3 through 5 years, Group 3: Infants aged approximately 2 months.;Secondary Objective: Not Applicable;Primary end point(s): - Number of Subjects Reporting Adverse Events<br>- Number of Subjects Reporting Pre-specified Local Reactions<br>- Number of Subjects Reporting Pre-specified Systemic Events;Timepoint(s) of evaluation of this end point: - Baseline up to Month 1<br>- Within 7 days after Vaccination<br>- Within 7 days after Vaccination

Secondary Outcome Measures