Evaluation of the Immune Responses of GSK Biologicals' HPV Vaccine Following Manufacturing Process Adaptation.

Infections, Papillomavirus Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250276
• Other study ID #: 104772
• Secondary ID: 2005-001667-58
• Status: Completed
• Phase: Phase 3
• Start date: October 28, 2005
• Est. completion date: March 1, 2007

Study information

• Verified date: December 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 798
• Est. completion date: March 1, 2007
• Est. primary completion date: March 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Papillomavirus
• Papillomavirus Vaccines

Intervention

Biological:
• Cervarix™
GSK Biologicals' vaccine against human papillomaviruses 16 and 18.

Locations

Country	Name	City	State
Denmark	GSK Investigational Site	Hvidovre
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Denmark,  Lithuania,  Poland, 

References & Publications (1)

Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. Epub 2009 May 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Seroconverted (SCR) Subjects for Anti-Human Papillomavirus Type 16 (Anti-HPV-16) and Anti-Human Papillomavirus Type 18 (Anti-HPV-18)	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations =8 Enzyme-Linked Immunosorbent Assay [ELISA] units per milliliter [EL.U/mL] and anti-HPV-18 concentrations =7 EL.U/mL) in the serum of subjects seronegative before vaccination.	At Month 7
Primary	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18	Seropositivity defined subjects with anti-HPV-16 antibody concentration = 8 EL.U/mL and/or anti-HPV-18 antibody concentration = 7 EL.U/mL.	At Month 7
Secondary	Number of SCR Subjects for Anti-HPV-16 and Anti-HPV-18	Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 concentrations =8 ELISA units per milliliter [EL.U/mL] and anti-HPV-18 concentrations =7 EL.U/mL) in the serum of subjects seronegative before vaccination.	At Month 2
Secondary	Number of Seropositive Subjects for Anti-HPV-16 and Anti-HPV-18	Seropositivity defined subjects with anti-HPV-16 antibody concentration = 8 EL.U/mL and/or anti-HPV-18 antibody concentration = 7 EL.U/mL .	At Month 2
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) diameter of injection site.	During the 7-days (Day 0-6) post-vaccination
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 1 of vaccination.	During the 7-days (Day 0-6) post-vaccination
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 2 of vaccination.	During the 7-days (Day 0-6) post-vaccination
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents solicited general symptoms post dose 3 of vaccination.	During the 7-days (Day 0-6) post-vaccination
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], gastro-intestinal, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Arthralgia (joint pain) = pain occurring in joints that were distal from the injection site. This outcome presents results across vaccination doses for solicited general symptoms.	During the 7-days (Day 0-6) post-vaccination
Secondary	Number of Subjects With New Onset Chronic Diseases (NOCDs)	NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.	From Month 0 to Month 7
Secondary	Number of Subjects With Medically Significant Adverse Events (MSAEs)	MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.	From Month 0 to Month 7
Secondary	Number of Subjects With (NOCDs)	NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.	From Month 0 to Month 12
Secondary	Number of Subjects With MSAEs	MSAEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.	From Month 0 to Month 12
Secondary	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	Within 30 days (Day 0-29) post vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Month 0 to Month 7
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Month 0 to Month 12

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