Phase 3
Completed N=798
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Infections, Papillomavirus · Papillomavirus Vaccines
Source: ClinicalTrials.gov NCT00250276 ↗
Enrolled (actual)
798
Serious AEs
1.5%
Results posted
Mar 2017
Primary outcomePrimary: Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) — 118; 127; 126; 371 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will compare the immune response induced by different lots of the HPV-16/18 L1/AS04 vaccine, following adjustments to the manufacturing process.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18) |
118; 127; 126; 371; 102; 129 | — |
| PRIMARY Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 |
54; 38; 43; 56; 43; 22 | — |
| SECONDARY Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18 |
117; 126; 125; 102; 128; 142 | — |
| SECONDARY Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18 |
54; 38; 43; 56; 43; 22 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
188; 190; 178; 556; 185; 20 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
38; 40; 32; 110; 35; 2 | — |
| SECONDARY Number of Subjects With New Onset Chronic Diseases (NOCDs) |
3; 4; 7; 14; 3 | — |
| SECONDARY Number of Subjects With Medically Significant Adverse Events (MSAEs) |
71; 23 | — |
| SECONDARY Number of Subjects With (NOCDs) |
4; 4; 7; 15; 3 | — |
| SECONDARY Number of Subjects With MSAEs |
78; 23 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
58; 56; 76; 190; 67; 5 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 1; 2; 9; 3 | — |
Eligibility Criteria
Inclusion Criteria
- A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment.
- Subject must have a negative urine pregnancy test.
- Healthy subject before entering the study entry as established by medical history and physical examination.
- Subject must be of non-childbearing potential.
Exclusion Criteria
- pregnant or breastfeeding subject.
- previous vaccination against human papillomavirus (HPV).
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality.
- History of chronic condition(s) requiring treatment such as cancer, chronic hepatic or kidney disease(s), diabetes or autoimmune disease.
Data sourced from ClinicalTrials.gov (NCT00250276). 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.