Phase 2
Completed N=383
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine
Infections, Papillomavirus · Papillomavirus Vaccines
Source: ClinicalTrials.gov NCT00359619 ↗
Enrolled (actual)
383
Serious AEs
6.0%
Results posted
Feb 2015
Primary outcomePrimary: Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. — 27; 10; 9; 8 subjects
Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted Subjects Against Human Papillomavirus-16 (HPV-16) Antibodies. |
27; 10; 9; 8; 14; 13 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies. |
1933.9; 1868.3; 1902.3; 1996.4; 1437.1; 2200.3 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Human Papillomavirus-16 (HPV-16) Antibodies |
1902.6; 1558.5; 1791.7; 1552.9; 1242.8; 1869.6 | — |
| PRIMARY Number of Seroconverted Subjects Against Human Papillomavirus-18 (HPV-18) Antibodies. |
26; 10; 12; 16; 11; 15 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies. |
1060.9; 469.3; 532.5; 536.7; 563.7; 637.9 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Human Papillomavirus-18 (HPV-18) Antibodies |
994.4; 525.5; 524.1; 536.7; 551.1; 574.9 | — |
| SECONDARY Number of Seroconverted Subjects Against Human Papillomavirus-31 (HPV-31) Antibodies. |
25; 13; 12; 13; 14; 15 | — |
| SECONDARY Geometric Mean Titers (GMTs) for Human Papillomavirus-31 (HPV-31) Antibodies. |
187.7; 1776.8; 2685.9; 2388.8; 2714.9; 1952.4 | — |
| SECONDARY Number of Seroconverted Subjects Against Human Papillomavirus-45 (HPV-45) Antibodies. |
20; 14; 10; 11; 14; 15 | — |
| SECONDARY Geometric Mean Titers (GMTs) for Human Papillomavirus-45 (HPV-45) Antibodies. |
184.8; 919.8; 1731.0; 959.1; 1086.6; 1235.8 | — |
| SECONDARY Number of Subjects With at Least One New Onset of Chronic Disease (NOCDs) |
6; 1; 6; 2; 3; 1 | — |
| SECONDARY Number of Subjects With at Least One Medically Significant Condition (MAEs). |
4; 3; 2; 4; 5; 1 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs). |
2; 3; 1; 3; 2; 0 | — |
| SECONDARY Number of Subjects With Pregnancy Outcomes. |
9; 6; 3; 2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- A female who enrolled in the study 102115 and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment.
Exclusion Criteria
- Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
- Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
Data sourced from ClinicalTrials.gov (NCT00359619). 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. Informational only — not medical advice.