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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

In the News

New Funding for JVC Members

Dr. McGettigan, was awarded a four-year $1.5 million R01 grant from the NIH to extend his exciting work on the development of a novel, safe, and effective rabies virus vaccine.


A Team of Researchers from Fox Chase, Jefferson and Penn State Receive NIAID Grant for Viral Control. Both Dr. Luis Sigal and Dr. Eisenlohr are members of the JVC. The team to receive a total of approximately $2 million each year for the next five years. For more information ...


Dr. David Abraham received a five year R01 grant to study the development of a recombinant vaccine against human onchocerciasis.

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