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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Timings for Efficacy Studies

 Study  Study Title

Final Protocol
Version 

 Submission to IND 

Completion of
subject accrual
Study completion
(last subject, last study visit)
 Projected submission of final clinical study report
HPV-008 A phase III, double-blind, randomized, controlled, multi-center study to evaluate the efficacy of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 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 to a 0, 1, 6 month schedule in healthy females 15-25 years of age.  Amendment 5
Submitted to IND April 18, 2008 (serial no. 0567)
June 27, 2005 October 30, 2009 December 2010
HPV-009 A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia ( CIN2, CIN3, adenocarcinoma in situ [AIS] and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica (study under supervision of National Cancer Institute)  Amendment 5
Submitted to IND October 1, 2009 (serial no. 1149)
 Pending confirmation from NCI  Pending confirmation from NCI  Pending confirmation from NCI
HPV-015 A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ HPV‑16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.  Amendment 3
Submitted to IND December 16, 2008 (serial no. 0787)
August 4, 2006 October 30, 2010 December 2011
HPV-023 A blinded long-term follow-up study of the efficacy of candidate HPV-16/18 L1 VLP AS04 vaccine in young adult women in Brazil vaccinated in the phase IIb, double-blind, multi-center primary study HPV-001 and having participated in the follow-up study HPV-007 Amendment 1
To be submitted to IND by December 1, 2009
July 11, 2008 * September 30, 2010 September 2011
-b(4)- --- ----------b(4)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------  ----b(4)------------------------------------------------------------------------------------------- --b(4)--------- ----b(4)--------------------------------- ----b(4)----------
HPV-040 A phase III /IV, community-randomized, controlled study to evaluate the effectiveness of two vaccination strategies using GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in reducing the prevalence of HPV-16/18 infection when administered intramuscularly according to a 0, 1, 6-month schedule in healthy female and male study participants aged 12 – 15 years. Amendment 3
To be submitted to IND by December 1, 2009 [submitted to BLA March 27, 2009 (sequence no. 0048)]
December 31, 2009 June 30, 2014 December 2015