Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00546078
First received: October 17, 2007
Last updated: June 7, 2012
Last verified: March 2011
Results First Received: November 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Human Papillomavirus (HPV) Infection
Papillomavirus Vaccines
Intervention: Biological: Cervarix™

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One subject that enrolled into the study was not vaccinated and as such not reported as started in the participant flow.

Reporting Groups
  Description
Cervarix™ 4-Dose Group Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Cervarix™ 3-Dose Group Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.

Participant Flow:   Overall Study
    Cervarix™ 4-Dose Group     Cervarix™ 3-Dose Group  
STARTED     65     50  
Month 18     61     45  
COMPLETED     61     43  
NOT COMPLETED     4     7  
Lost to Follow-up                 1                 3  
Withdrawal by Subject                 2                 3  
Other reason                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cervarix™ 4-Dose Group Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
Cervarix™ 3-Dose Group Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
Total Total of all reporting groups

Baseline Measures
    Cervarix™ 4-Dose Group     Cervarix™ 3-Dose Group     Total  
Number of Participants  
[units: participants]
  65     50     115  
Age  
[units: years]
Mean ± Standard Deviation
  27.8  ± 2.82     27.0  ± 2.89     27.5  ± 2.87  
Gender  
[units: subjects]
     
Female     65     50     115  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-human Papilloma Virus-16 (Anti-HPV-16) and Anti-HPV-18 Antibody Titers Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: At Day 7 and Month 1 (Day 30) ]

2.  Primary:   Anti-HPV-16 and Anti-HPV-18 Antibody Titers   [ Time Frame: At Day 7 and at Month 1 (Day 30) ]

3.  Secondary:   Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Greater Than or Equal to Pre-defined Cut-off Values   [ Time Frame: At Month 7 and Month 18 ]

4.  Secondary:   Anti-HPV-16 and Anti-HPV-18 Antibody Titers   [ Time Frame: At Month 7 and Month 18 ]

5.  Secondary:   Number of Subjects With Antibody Titers Against Other Oncogenic HPV Types (HPV-31 & HPV-45) Greater Than or Equal to 59 EL.U/mL   [ Time Frame: Day 0, Month 1 (Day 30), Month 7 and Month 18 ]

6.  Secondary:   Anti-HPV-31 and Anti-HPV-45 Antibody Titers   [ Time Frame: Day 7, Month 1 (Day 30), Month 7 and Month 18 ]

7.  Secondary:   Number of Subjects With Cluster of Differentiation 4 (CD4) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types   [ Time Frame: Day 0, Month 1 [Day 30], Month 7 and Month 18 ]

8.  Secondary:   Number of Subjects With Cluster of Differentiation 8 (CD8) T Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types   [ Time Frame: Day 0, Month 1 [Day 30], Month 7 and Month 18 ]

9.  Secondary:   Number of Subjects With B Cell-mediated Immune Responses Specific to Defined Oncogenic HPV Types   [ Time Frame: Day 0, Month 1 [Day 30], Month 7 and Month 18 ]

10.  Secondary:   Number of Subjects Seropositive for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervico-vaginal Secretion Samples   [ Time Frame: Day 0, Month 1 (Day 30), Month 7 and Month 18 ]

11.  Secondary:   Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervico-vaginal Secretion Samples   [ Time Frame: Day 0, Month 1 (Day 30), Month 7 and Month 18 ]

12.  Secondary:   Number of Subjects Reporting Solicited Local Symptoms   [ Time Frame: Within 7 days after vaccination ]

13.  Secondary:   Number of Subjects Reporting Solicited General Symptoms   [ Time Frame: Within 7 days of vaccination ]

14.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: Within 30 days of vaccination ]

15.  Secondary:   Outcome of Any Reported Pregnancies   [ Time Frame: From Day 0 up to Month 18 ]

16.  Secondary:   Number of Subjects With New Onset of Chronic Diseases (NOCDs), New Onset of Autoimmune Diseases (NOADs) and Medically Significant Conditions (MSCs)   [ Time Frame: From Day 0 up to Month 18 ]

17.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: From Day 0 up to Month 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Moscicki B et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 ASO4-adjuvanted vaccine in young women. Abstract presented at European Research Organization on Genital Infection and Neoplasia 2010 (EUROGIN). Monte Carlo, Monaco, 17-20 February 2010.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00546078     History of Changes
Other Study ID Numbers: 109628
Study First Received: October 17, 2007
Results First Received: November 12, 2009
Last Updated: June 7, 2012
Health Authority: Canada: Biologics and Genetic Therapies Directorate (BGTD)
United States: Food and Drug Administration