Thomas Jefferson UniversitySidney Kimmel Medical College

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Primary Care Clinical Trials

Flu Vaccination Trial for men and women aged 18 or over:

Description: A safety and immunogenicity study of two FDA-approved flu vaccines in adults
Title: A phase III, observer-blind, randomized study to evaluate the immunogenicity and safety of Fluarix™ (GlaxoSmithKline Biologicals) compared with Fluzone® (Aventis Pasteur) administered intramuscularly in adults 18 years and older in the U.S.
Sponsor: GSK
Eligibility: Men and women 18 years of age and older
Status: Study is closed (all follow-ups completed in Spring, 2008)
Contact: Lori Conley

Pneumococcal Vaccine Trial for infants, children and adolescents

Description: A safety and immunogenicity study of a 13-valent pneumococcal vaccine in infants, children and adolescents who have been previously immunized with the approved 7-valent pneumococcal vaccine
Title: A Phase 3, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Children, Aged 15 months to 17 Years, in the United States.
Sponsor: Wyeth
Eligibility: Infants, children and adolescents 15 months to 17 years of age who have already received at least 3 of the approved 7-valent pneumococcal vaccinations
Status: Initial enrollment completed as of 3/09; amendment to increase enrollment is pending
Contact: Debbi Moretti

HPV Vaccination Trials:

Description: An efficacy study of an HPV vaccine compared to hepatitis A vaccine in adolescent girls and young women ages 15 to 25
Title: A Phase III, double blind, randomized, controlled, multi-center study to evaluate the efficacy of Glaxo Smith Kline Biologicals HPV-16/18VLP/ASO4 vaccine compared to Hepatitis A vaccine as control, in prevention of persistent HPV-16 or HPV-18 cervical infection and cervical neoplasia, administered intramuscularly according a 0,1,6 month scheduling in healthy females 15 to 25 years of age.
Sponsor: GSK
Eligibility: Healthy girls and young women ages 15-25
Status: Enrollment is closed; subjects are currently in follow-up phase
Contact: Debbi Moretti

Description: A head to head trial of Gardasil® and GSK's HPV vaccine (Cervarix) in adult women
Title: A phase IIIb, observer-blind, randomized, multicenter study with two parallel groups to compare the immunogenicity of GlaxoSmithKline Biological’s HPV-16/18 L1/AS04 vaccine versus Merck’s Gardasil® vaccine when administered intramuscularly according to a 3-dose schedule in healthy adult females 18-45 years of age.
Sponsor: GSK
Eligibility: Healthy women ages 18-45
Status: Enrollment is closed; subjects are currently in follow-up phase
Contact: Debbi Moretti

Description: A phase IIIb, randomized, open, multicenter study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine co-administered intramuscularly with GlaxoSmithKline Biologicals’ Boostrix vaccine and/or Sanofi-Aventis’ Menactra vaccine according to different dose schedule combinations as compared to the administration of HPV vaccine, Boostrix or Menactra alone in healthy female subjects aged 11-18 years.
Title: A safety and immunogenicity study of an HPV vaccine given concomitantly with other routine vaccines in adolescent females
Sponsor: GSK
Eligibility: Healthy females ages 11-18
Status: Enrollment is closed; subjects are currently in follow-up phase
Contact: Debbi Moretti

Description: A safety and immunogenicity study of a booster dose of an HPV vaccine
Title:. An open, phase II, multicenter study to assess the safety and immune response to a HPV-16/18 L1 VLP ASO4 vaccine fourth dose in healthy, young, adult women in North America previously vaccinated with 3 doses of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP ASO4 vaccine.
Sponsor: GSK
Eligibility: Healthy young women who had previously received a 3-shot series of the GSK HPV vaccine
Status: Enrollment is closed; subjects are currently in follow-up phase
Contact: Debbi Moretti

Description: A safety and efficacy extension study for young woman who received the comparator hepatitis A vaccine in a previous HPV-16/18 vaccine trial
Title: A phase IIIb open-label, multi-centre immunization study to evaluate the safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in female American and Canadian subjects who received the active control hepatitis A vaccine in the 580299/008 study.
Sponsor: GSK
Eligibility: Young woman who previously received a hepatitis A vaccine series in a study of the safety and efficacy of the HPV-16/18 vaccine
Status: Subjects who are completing the previous study are currently being enrolled in this extension study
Contact: Debbi Moretti

Description: A study of the HPV vaccine in men who have sex with men
Title: A Study to Evaluate the Efficacy of Gardasil® in Reducing the Incidence of HPV 6-, 11-, 16-, and 18- Related External Genital Warts, PIN, Penile, Perianal, and Perineal Cancer and the Incidence of HPV 6-, 11-, 16-, and 18- Related Genital Infection in Young Men.
Sponsor: Merck
Eligibility: MSMs, 16-23 years of age
Status: Enrollment is closed; subjects are currently in follow-up phase
Contact: Robert Winn, MD; Kelly Litanza