A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine - Catch-up study

Phase 1

• Conditions: Healthy infants and children

• Registration Number: EUCTR2006-006779-19-PL
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-29
• Study Completion: 2008-03-31
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

1. Aged from 7 months to <72 months, at time of enrollment.
2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
3. Healthy child as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during subject participation.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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 S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. Significant neurological disorder or history of seizure including febrile seizure, or
significant stable or evolving disorders such as cerebral palsy, encephalopathy,
hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.

Study & Design

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