NCT01249365

The Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Completed Phase 3 Results posted Last updated 13 November 2019

What this trial tests

Phase 3 trial testing GSK580299 (Cervarix) in Infections, Papillomavirus in 199 participants. Completed in 10 January 2017.

Timeline

24 January 2011

Primary endpoint
10 January 2017

10 January 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	199
Start date	24 January 2011
Primary completion	10 January 2017
Estimated completion	10 January 2017
Sites	15 locations across Portugal, Singapore, Russia, Australia

Drugs / interventions tested

• GSK580299 (Cervarix) — full drug profile →

Conditions studied

• Infections, Papillomavirus — all drugs for Infections, Papillomavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

26 and older, female only, with Infections, Papillomavirus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects Reporting Serious Adverse Events Primary · Throughout the study (from Month 0 to Month 12)

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). R

Any SAE(s)

Group	Value	95% CI
HPV Vaccine	6

Grade 3 SAE(s)

Group	Value	95% CI
HPV Vaccine	2

Related SAE(s)

Group	Value	95% CI
HPV Vaccine	0

Number of Subjects Reporting Medically Significant Conditions (MSCs) and Potential Immune-mediated Diseases (pIMDs) Primary · Throughout the study (from Month 0 to Month 12)

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 othe

Any MSCs

Group	Value	95% CI
HPV Vaccine	16

Grade 3 MSCs

Group	Value	95% CI
HPV Vaccine	2

Related MSCs

Group	Value	95% CI
HPV Vaccine	0

Any pIMDs

Group	Value	95% CI
HPV Vaccine	1

Grade 3 pIMDs

Group	Value	95% CI
HPV Vaccine	0

Related pIMDs

Group	Value	95% CI
HPV Vaccine	0

Number of Subjects Reporting Pregnancies and Outcome of Reported Pregnancies Primary · Throughout the study (from Month 0 to Month 12)

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.

Live infant NO apparent congenital anomaly

Group	Value	95% CI
HPV Vaccine	1

Live infant congenital anomaly

Group	Value	95% CI
HPV Vaccine	0

Premature live infant NO apparent congen. anomaly

Group	Value	95% CI
HPV Vaccine	0

Premature live infant congenital anomaly

Group	Value	95% CI
HPV Vaccine	0

Elective termination NO apparent congen. anomaly

Group	Value	95% CI
HPV Vaccine	0

Elective termination congenital anomaly

Group	Value	95% CI
HPV Vaccine	0

Therapeutic abortion

Group	Value	95% CI
HPV Vaccine	0

Ectopic pregnancy

Group	Value	95% CI
HPV Vaccine	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were reported from the first receipt of study vaccine (Month 0) until 6 months following administration of the last dose of study vaccine (i.e. at study conclusion, Month 12).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

HPV Vaccine

Serious: 6/199 (3%)

Deaths: 0/199

Serious adverse events (10 terms)

Reaction	System	HPV Vaccine
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Trigger finger	Musculoskeletal and connective tissue disorders	—
Migraine	Nervous system disorders	—
Nerve root compression	Nervous system disorders	—
Agitated depression	Psychiatric disorders	—
Major depression	Psychiatric disorders	—
Post-traumatic stress disorder	Psychiatric disorders	—
Dysfunctional uterine bleeding	Reproductive system and breast disorders	—
Ovarian cyst	Reproductive system and breast disorders	—

Most-reported serious reactions: Joint range of motion decreased, Osteoarthritis, Trigger finger, Migraine, Nerve root compression, Agitated depression, Major depression, Post-traumatic stress disorder.

Data from ClinicalTrials.gov NCT01249365 adverse events section.

Sponsor's own description

This extension study is designed to assess the safety of GSK Biological's HPV vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cross-sectional and longitudinal analysis of cancer vaccination trials registered on the US Clinical Trials Database demonstrates paucity of immunological trial endpoints and decline in registration since 2008.
   Lu L, Yan H, Shyam-Sundar V, Janowitz T. · · 2014 · cited 17× · PMID 25302014 · DOI 10.2147/dddt.s65963