Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

• 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: EUCTR2009-017304-88-Outside-EU/EEA
• Lead Sponsor: Wyeth Research division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

All subjects
1.Male or female subject between the ages of greater than (>)15 months and less than (<)18 years at time of enrollment.
2.Child is available for the entire study period and his/her parent/legal guardian can be reached by telephone.
3.Child is determined to be in good health by medical history, physical examination, and judgment of the investigator.
4.Parent/legal guardian must be able and willing to comply with all study procedures.
Groups 1 (subjects aged less than <15 months to >2 years), Group 2 (subjects aged greater than or equal to [>=] 2 to <5 years) and Group 3 (>=5 to <10 years) only
5.Written documentation endorsed by a health professional showing vaccination with at least 3 doses of Prevnar in children aged <5 years or at least 1 dose of Prevnar in children aged =5 to <10 years. The last dose of Prevnar must have been received at least 56 days before study entry.
Group 4 (subjects aged >=10 to <18 years) only
6.Negative urine pregnancy test for female subjects who are menstruating.
All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception for 3 months after the vaccination. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.

Are the trial subjects under 18? yes
Number of subjects for this age range: 1200
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

All subjects
1.Child had a previous anaphylactic reaction to any vaccine or vaccine-related component.
2.Contraindication to vaccination with pneumococcal conjugate vaccine.
3.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
4.History of culture-proven invasive disease caused by S pneumoniae.
5.Major known congenital malformation or serious chronic disorder.
6.Significant neurological disorder or history of seizure (excluding simple febrile seizure), or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
7.Receipt of blood products or gamma-globulin.
8.Known or suspected immune deficiency or suppression.
9.Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
10.Child is a direct descendant (child or grandchild) of site study personnel.
11.Subject has been previously vaccinated with 23-valent pneumococcal polysaccharide.
Group 4 only
12.Children aged =10 years to <18 years (group 4) who have previously been vaccinated with Prevnar or any other pneumococcal vaccine.
13.Pregnant or breastfeeding adolescent females.

Study & Design

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