Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00947115
• Date of registration: 16/07/2009
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
• Scientific title: Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects
• Date of first enrolment: September 22, 2009
• Target sample size: 525
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00947115
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany, Poland

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects who the investigator believed that they could and would comply with the
requirements of the protocol.

- A female who had been enrolled in NCT00196937 study and received three doses of
HPV-16/18 vaccine.

- Written informed consent obtained from the subject.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) or planned use
during the study period.

- Chronic administration (defined as more than 14 consecutive days) of
immunosuppressants or other immune-modifying drugs occurring less than three months
prior to blood sampling.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product (pharmaceutical product or device).

- Administration of immunoglobulins and/or any blood products within the three months
preceding blood sampling.

- Administration or planned administration of any HPV vaccine, other than the three
doses of HPV-16/18 vaccine administered in NCT00196937 study.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infections, Papillomavirus

Intervention(s)

Procedure: Blood sampling

Procedure: Cervico-vaginal secretion (CVS) samples

Primary Outcome(s)

Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 [Time Frame: At Years 8, 9 and 10]

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 [Time Frame: At Years 8, 9 and 10]

Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 [Time Frame: At Years 5, 6 and 7]

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 [Time Frame: At Years 5, 6 and 7]

Secondary Outcome(s)

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6 [Time Frame: From Year 5 up to Year 6]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study [Time Frame: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9 [Time Frame: From Year 8 up to Year 9]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10 [Time Frame: From Year 9 up to Year 10]

Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects [Time Frame: At Years 7, 8, 9 and 10]

Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects [Time Frame: At Year 5 and Year 6]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7 [Time Frame: From Year 6 up to Year 7]

Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects [Time Frame: At Years 7, 8, 9 and 10]

Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity [Time Frame: At Years 5, 6 and 7]

Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity [Time Frame: At Years 8, 9 and 10]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10 [Time Frame: From Year 0 up to Year 10]

Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC [Time Frame: At Years 8, 9 and 10]

Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects [Time Frame: At Year 5 and Year 6]

Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8 [Time Frame: From Year 7 up to Year 8]

Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC [Time Frame: At Years 5, 6 and 7]

Secondary ID(s)

2009-011357-41

112772

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/05/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00947115