A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

Active, not recruiting

Conditions: 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: EUCTR2014-004179-22-Outside-EU/EEA

Lead Sponsor: Wyeth, A Pfizer Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 335

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document indicating that the parent/legally acceptable representative has been informed of all pertinent aspects of the study.
2. Male or female subjects who participated in and completed Wyeth study 0887X-101518.
3. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legally acceptable representative is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 335
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. Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X-101518.
2. History of culture-proven invasive disease caused by Streptococcus pneumoniae since the
completion of Wyeth study 0887X-101518.
3. Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X-101518.
4. Receipt of any blood products, including immunoglobulin within 12 weeks before the study.
5. Subjects related to investigational site staff members or subjects related to Pfizer employees directly involved in the conduct of the trial.
6. Participation in other studies at the time of enrollment.
7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or interfered with the interpretation of study results and, in the judgment of the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the antibody levels to the 7 pneumococcal vaccine serotypes at least 36 months after administration of the toddler dose in Groups 1 and 2 in Wyeth study 0887X-101518, as measured by serotype-specific immunoglobulin G (IgG) concentrations.;Secondary Objective: To compare the antibody levels to the 7 pneumococcal vaccine serotypes in subjects who received Prevenar (Groups 1 and 2) with those who did not receive Prevenar (Group 3) in Wyeth study 0887X-101518.;Primary end point(s): Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose;Timepoint(s) of evaluation of this end point: Day 1 (36 months after toddler dose)

Secondary Outcome Measures