Clinical Study with Prevenar 13 vaccine in Alaskan Native Childre

• Conditions: prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.; MedDRA version: 14.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2008-003648-12-Outside-EU/EEA
• Lead Sponsor: Wyeth Pharmaceuticals Inc. (a Pfizer company)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 373

Inclusion Criteria

All Participants
1. Male or female infants and children between the ages of = 42 days (6 weeks) and <5 years of age at the time of enrollment.
2. Must be available for the entire study period and the parent/legal guardian can be reached by telephone.
3. Must be determined to be in good health by medical history, physical examination, and the judgment of the investigator or a medically qualified designee.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Immunogenicity Study Participants
1. Parent/legal guardian is willing to complete a supplemental informed consent form permitting blood to be taken from the subject.
2. Subject lives in the Bethel, Alaska area.

Are the trial subjects under 18? yes
Number of subjects for this age range: 373
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 Participants
1. A previous anaphylactic reaction to any vaccine or vaccine-related component.
2. Contraindication to vaccination with pneumococcal vaccine.
3. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
4. Major known congenital malformation.
5. Significant neurological disorder or significant evolving disorders such as
encephalopathy, hydrocephalus, a history of seizures including uncontrolled
epilepsy/infantile or other significant disorders. Does not include resolving syndromes
due to birth trauma such as Erb palsy or simple febrile seizures.
6. Participation in another investigational or interventional trial. Participation in purely
observational studies is acceptable.
Immunogenicity Study Participants
1. Receipt of blood products or gamma globulin within the last 3 months.
2. Known or suspected immune deficiency or suppression.

Study & Design

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