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Also known as GSK580299 (CervarixTM), GSK580299 (Cervarix)
GSK580299 · 5 trials · 1 indication
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
A seroconverted subject was defined as a subject seronegative at baseline whose concentration for anti-HPV-16/18 antibodies, as measured by Enzyme-linked Immunosorbent assay (ELISA) , was higher than or equal to (≥) cut-off value. A seronegative subject was defined as a subject whose antibody concentration was below (\<) cut-off value. Cut-off values were 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as the occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 SAE = SAE which prevented normal, everyday activities (in adults/adolescents, such an SAE, for example, prevented attendance at work/school and necessitated the administration of corrective therapy). Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Medically significant conditions (MSCs) are defined as: AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination; SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Potential immune-mediated diseases (pIMDs) are a subset of medically significant conditions that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as the occurrence of any MSC or pIMD regardless of intensity grade or relation to vaccination. Grade 3 MSC or pIMD = a MSC or pIMD which prevented normal, everyday activities. Related MSC or pIMD = a MSC or pIMD assessed by the investigator as related to the vaccination.
Live infant NO apparent congenital anomaly; Live infant congenital anomaly; Premature live infant NO apparent congenital anomaly; Premature live infant congenital anomaly; Elective termination NO apparent congenital anomaly; Elective termination congenital anomaly; Therapeutic abortion; Ectopic pregnancy; Spontaneous abortion NO apparent congenital anomaly; Spontaneous abortion congenital anomaly; Stillbirth NO apparent congenital anomaly; Stillbirth congenital anomaly; Molar pregnancy; Pregnancy ongoing; Lost to follow up.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Note: Results from one center where compliance issues were discovered are presented also separately.
MSCs include adverse events 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.
The pregnancy outcomes reported included elective termination, live birth and spontaneous abortion, all of which occurred with no apparent congenital (congenit.) anomalies (anom.) Note: Results from one non-compliant center (NCC) are also presented separately.
Solicited local symptoms assessed include pain, redness and swelling.
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
An unsolicited adverse event is defined as any adverse event (AE) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Hematological and biochemical parameters assessed in blood samples include alanine aminotransferase (ALT), basophils, creatinine, eosinophils, hematocrit, lymphocytes, monocytes, neutrophils, platelets, red blood cell, and white blood cells. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as "Above" and values lower than normal as "Below".
Medically significant AEs were defined as AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
| Arm | Type | Description |
|---|---|---|
| Cervarix Group | EXPERIMENTAL | Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule. |
| Engerix Group | ACTIVE_COMPARATOR | Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule. |
| HPV vaccine | EXPERIMENTAL | Healthy female subjects aged 26 years and above, who received control vaccine in the primary study NCT00294047, were administrated 3 intramuscular injections of Cervarix vaccine into the deltoid of the non-dominant arm, according to a 0, 1, 6-month schedule in the current study. |
| Cervarix Compliance Issue Centre Group | EXPERIMENTAL | Subjects from one centre where compliance issues were discovered, who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study |
| Cervarix All Centres Group | EXPERIMENTAL | Subjects from all study centres who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study. |
| Name | Type | Description |
|---|---|---|
| GSK580299 (Cervarix) | BIOLOGICAL | 3-dose schedule intramuscularly vaccination |
| GSK580299 (CervarixTM) | BIOLOGICAL | 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6) |
| Engerix-BTM | BIOLOGICAL | 3-dose schedule intramuscularly vaccination (Months 0, 1 and 6) |
| GSK580299, GSK Biological's HPV vaccine | BIOLOGICAL | All subjects will receive 3 doses administered as an intramuscular injection, according to a 0, 1, 6-month schedule. |
| GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine) | BIOLOGICAL | Intramuscular injection, 3 doses |
Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol * A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which ...
GSK580299 is an investigational vaccine developed by GSK plc for infections and papillomavirus. It is a Phase 3 candidate studied in healthy women aged 26 years and older. The program includes five completed clinical trials with a total enrollment of 2,817 participants, all randomized, double-blind, and active-controlled.
GSK580299 is being studied for the prevention of infections and papillomavirus in women. Its clinical trials enrolled healthy female volunteers aged 26 years and older across China, Brazil, Taiwan, Thailand, the United States, Canada, Australia, Portugal, Russia, and Singapore. The vaccine remains investigational and is not approved for use.
GSK580299 is developed by GSK plc, which trades under the ticker GSK. The vaccine is also referred to as GSK Biological's HPV vaccine and has been studied under the Cervarix name in its clinical program.
GSK580299 is in Phase 3 clinical development. All five of its recorded trials are Phase 3 studies, and all five have been completed. No active trials are currently listed for this vaccine candidate.
GSK580299 has been evaluated in five completed Phase 3 trials, including NCT01277042 in China with 1,212 women, NCT01249365 across Australia, Portugal, Russia, and Singapore with 199 women, NCT01190189 in the United States and Canada with 137 women, and NCT00849381 in Brazil, Taiwan, and Thailand with 1,239 women.
GSK580299 is also known as Cervarix, or the HPV-16/18 L1 VLP AS04 vaccine. These names refer to the same GSK vaccine candidate studied for papillomavirus infections. Searches for GSK580299, Cervarix, or GSK Biological's HPV vaccine all point to this same asset.