Study Evaluating Antibody Response of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children Previously Given PnC
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumococcal Vaccines
Intervention: 13-valent pneumococcal conjugate vaccine (Biological)
Phase: Phase 3
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Wyeth
Overall contact:
Pfizer CT.gov Call Center 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
Summary
This is an open-label study (a study in which the doctors and participants know which drug
or vaccine is being administered) in children who previously received a 4-dose series of a
pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678).
In this study, participants will receive an additional dose of 13-valent pneumococcal
conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the
antibody response by measuring any remaining pneumococcal antibodies since the previous
study. This study will also evaluate the safety and immunogenicity of 13-valent
pneumococcal conjugate vaccine when administered at least 24 months after the last dose of
pneumococcal conjugate vaccine.
Clinical Details
Official title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Antibody levels to the 13 pneumococcal vaccine serotypes, as measured by serotype-specific (immunoglobulin G) IgG concentrations
Secondary outcome: Antibody levels to the 13 pneumococcal vaccine serotypes, as measured by serotype-specific opsonophagocytic activity (OPA).
Eligibility
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion criteria
- Subjects who received all 4 assigned doses of pneumococcal conjugate vaccine (either
7-valent or 13-valent) as randomized and completed Study 6096A1-008-EU (NCT00366678).
- Subjects are at least 24 months posttoddler dose and at least 3 years of age at visit
1.
- Healthy as determined by medical history, physical examination, and judgment of the
investigator.
- Available for the entire study period and his or her parent/legal guardian must be
able to complete all relevant study procedures during study participation and can be
reached by telephone.
Exclusion criteria
- Vaccination with any licensed or investigational pneumococcal vaccine since
completion of Study 6096A1-008-EU(NCT00366678).
- History of culture-proven invasive disease caused by S pneumoniae since the
completion of Study 6096A1-008-EU (NCT00366678).
- Previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with pneumococcal conjugate vaccine.
- Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression since participation in Study
6096A1-008-EU (NCT00366678).
- Major known congenital malformation or serious chronic disorder.
- 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.
- Receipt of any blood products, including immunoglobulin, within 90 days before the
study.
- Current participation in another investigational or interventional trial. (Note:
participation in purely observational studies is acceptable).
- Received any live vaccine within 28 days before administration of the first study
vaccine.
Locations and Contacts
Pfizer CT.gov Call Center 1-800-718-1021, Email: ClinicalTrials.gov_Inquiries@pfizer.com
Ancenis 44150, France; Recruiting
Bondues 59910, France; Recruiting
Brest 29200, France; Recruiting
Chalons en Champagne 51100, France; Recruiting
Creteil 94000, France; Recruiting
Draguignan 83300, France; Recruiting
Ecully 69130, France; Recruiting
Essey Les Nancy 54270, France; Recruiting
Floirac 33270, France; Recruiting
Garges Les Gonesses 95140, France; Recruiting
Illkirch 67400, France; Recruiting
Joue les Tours 37300, France; Recruiting
Le Havre 76600, France; Recruiting
Lingolsheim 67380, France; Recruiting
Lyon 69007, France; Recruiting
Maromme 76150, France; Recruiting
Moutiers 73600, France; Recruiting
Nancy 54000, France; Recruiting
Olonne Sur Mer 85340, France; Recruiting
Strasbourg 67100, France; Recruiting
Strasbourg 67000, France; Recruiting
Thionville 57100, France; Recruiting
Tours 37000, France; Recruiting
Vandeuvre les Nancy 54500, France; Recruiting
Villers les Nancy 54600, France; Recruiting
Vitry 94400, France; Recruiting
Additional Information
Starting date: February 2010
Last updated: June 11, 2010
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