Phase 3
N=798
Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.
Infections, Papillomavirus · Papillomavirus Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00250276 ↗Enrolled (actual)
798
Serious AEs
1.5%
Results posted
Mar 2017
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cervarix™ (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2007
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 Any, Grade 3 and Related Solicited General Symptoms |
38; 40; 32; 110; 35; 2 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
38; 40; 32; 110; 35; 2 | — |
| 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 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 1; 2; 9; 3 | — |
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.
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.