Phase 3
N=524
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infections, Papillomavirus
Bottom Line
View on ClinicalTrials.gov: NCT00947115 ↗Enrolled (actual)
524
Serious AEs
0.6%
Results posted
May 2011
Primary outcome: Primary: Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 — 1495.7; 518.7; 282.4; 1344.6 EL.U/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood sampling (Procedure); Cervico-vaginal secretion (CVS) samples (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 |
1495.7; 518.7; 282.4; 1344.6; 526.0; 277.7 | — |
| PRIMARY Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 |
1123.3; 392.1; 189.1; 980.9; 366.5; 180.2 | — |
| PRIMARY Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 |
128; 127; 118; 128; 130; 116 | — |
| PRIMARY Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 |
116; 106; 95; 127; 132; 106 | — |
| SECONDARY Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects |
90.2; 47.2; 56.8; 30.9; 24.6; 33.3 | — |
| SECONDARY Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects |
63.0; 33.3; 42.3; 33.5; 17.5; 49.0 | — |
| SECONDARY Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects |
577.8; 550.5; 990.6; 546.5; 499.8; 1012.9 | — |
| SECONDARY Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects |
517.5; 372.2; 1263.2; 304.8; 457.2; 928.2 | — |
| SECONDARY Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity |
19481.8; 18388.2; 17657.2; 13376.5; 12262.7; 12040.2 | — |
| SECONDARY Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity |
11059.5; 10656.3; 10605.7; 11212.2; 10693.8; 10427.8 | — |
| SECONDARY Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC |
19453.0; 18092.4; 17885.0; 13318.5; 12173.1; 12040.2 | — |
| SECONDARY Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC |
11084.4; 10602.4; 10725.5; 11212.2; 10693.8; 10427.8 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY 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 |
0; 0; 1; 0; 1; 0 | — |
| SECONDARY 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 |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY 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 |
0; 1; 1; 0; 1; 0 | — |
Summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00947115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.