Last updated: 07/17/2024 15:08:21
Evaluation of the immune responses of GSK Biologicals' HPV vaccine following manufacturing process adaptation.
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Assess lot-to-lot consistency of GSK Biologicals' HPV-16/18 L1/AS04 vaccine following manufacturing adjustments administered intramuscularly according to a 0,1,6-mth schedule in healthy female subjects (18-25 y)
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of seroconverted (SCR) subjects for anti-Human Papillomavirus type 16 (anti-HPV-16) and anti-Human Papillomavirus type 18 (anti-HPV-18)
Timeframe: At Month 7
Number of seropositive subjects for anti-HPV-16 and anti-HPV-18
Timeframe: At Month 7
Secondary outcomes:
Number of SCR subjects for anti-HPV-16 and anti-HPV-18
Timeframe: At Month 2
Number of seropositive subjects for anti-HPV-16 and anti-HPV-18
Timeframe: At Month 2
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-days (Day 0-6) post-vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-days (Day 0-6) post-vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-days (Day 0-6) post-vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-days (Day 0-6) post-vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 7-days (Day 0-6) post-vaccination
Number of subjects with new onset chronic diseases (NOCDs)
Timeframe: From Month 0 to Month 7
Number of subjects with medically significant adverse events (MSAEs)
Timeframe: From Month 0 to Month 7
Number of subjects with (NOCDs)
Timeframe: From Month 0 to Month 12
Number of subjects with MSAEs
Timeframe: From Month 0 to Month 12
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within 30 days (Day 0-29) post vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 to Month 7
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 to Month 12
Interventions:
Biological/vaccine: Cervarix™
Enrollment:
798
Observational study model:
Not applicable
Primary completion date:
2007-01-03
Time perspective:
Not applicable
Clinical publications:
Descamps D et al. (2009) Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention : A pooled analysis of 11 clinical trials. Hum Vaccin. 5(5):332-340.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
October 2005 to March 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18 - 25 years
Accepts healthy volunteers
Yes
- 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.
- pregnant or breastfeeding subject.
- previous vaccination against human papillomavirus (HPV).
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A female subject between, and including, 18 and 25 years of age at the time of the first vaccination.
Exclusion criteria:
- 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.
pregnant or breastfeeding subject.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-01-03
Actual study completion date
2007-01-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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