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Uterine Cervical Neoplasms

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Immunologic Factors

Healthy female subjects who received three doses of the Cervarix vaccine, administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.

Cervarix

GSK Clinical Trials

The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.

A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

A Post-marketing Surveillance (PMS) Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in 3,000 Healthy Female Filipino Subjects When Administered According to the Prescribing Information From the Age of 10 Years Onwards.

IPD for this study will be made available via the Clinical Study Data Request site.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).

Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0°C.

An unsolicited AE covers any AE 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 study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.

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 occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

GlaxoSmithKline

For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported and one (Uterine leiomyoma) was assessed as severe (Grade 3).

Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

Cervarix Group

Age, Continuous

Sex: Female, Male

South Asian

Chinese

Not specified

Race/Ethnicity, Customized

GSK Response Center

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Redness, Dose 1

Grade 3 Redness, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Redness, Dose 2

Grade 3 Redness, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Dose 3

Grade 3 Pain, Dose 3

Any Redness, Dose 3

Grade 3 Redness, Dose 3

Any Swelling, Dose 3

Grade 3 Swelling, Dose 3

Any Pain, Across doses

Grade 3 Pain, Across doses

Any Redness, Across doses

Grade 3 Redness, Across doses

Any Swelling, Across doses

Grade 3 Swelling, Across doses

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Any Arthralgia, Dose 1

Grade 3 Arthralgia, Dose 1

Related Arthralgia, Dose 1

Any Fatigue, Dose 1

Grade 3 Fatigue, Dose 1

Related Fatigue, Dose 1

Any Fever, Dose 1

Grade 3 Fever, Dose 1

Related Fever, Dose 1

Any Gastrointestinal, Dose 1

Grade 3 Gastrointestinal, Dose 1

Related Gastrointestinal, Dose 1

Any Headache, Dose 1

Grade 3 Headache, Dose 1

Related Headache, Dose 1

Any Myalgia, Dose 1

Grade 3 Myalgia, Dose 1

Related Myalgia, Dose 1

Any Rash, Dose 1

Grade 3 Rash, Dose 1

Related Rash, Dose 1

Any Urticaria, Dose 1

Grade 3 Urticaria, Dose 1

Related Urticaria, Dose 1

Any Arthralgia, Dose 2

Grade 3 Arthralgia, Dose 2

Related Arthralgia, Dose 2

Any Fatigue, Dose 2

Grade 3 Fatigue, Dose 2

Related Fatigue, Dose 2

Any Fever, Dose 2

Grade 3 Fever, Dose 2

Related Fever, Dose 2

Any Gastrointestinal, Dose 2

Grade 3 Gastrointestinal, Dose 2

Related Gastrointestinal, Dose 2

Any Headache, Dose 2

Grade 3 Headache, Dose 2

Related Headache, Dose 2

Any Myalgia, Dose 2

Grade 3 Myalgia, Dose 2

Related Myalgia, Dose 2

Any Rash, Dose 2

Grade 3 Rash, Dose 2

Related Rash, Dose 2

Any Urticaria, Dose 2

Grade 3 Urticaria, Dose 2

Related Urticaria, Dose 2

Any Arthralgia, Dose 3

Grade 3 Arthralgia, Dose 3

Related Arthralgia, Dose 3

Any Fatigue, Dose 3

Grade 3 Fatigue, Dose 3

Related Fatigue, Dose 3

Any Fever, Dose 3

Grade 3 Fever, Dose 3

Related Fever, Dose 3

Any Gastrointestinal, Dose 3

Grade 3 Gastrointestinal, Dose 3

Related Gastrointestinal, Dose 3

Any Headache, Dose 3

Grade 3 Headache, Dose 3

Related Headache, Dose 3

Any Myalgia, Dose 3

Grade 3 Myalgia, Dose 3

Related Myalgia, Dose 3

Any Rash, Dose 3

Grade 3 Rash, Dose 3

Related Rash, Dose 3

Any Urticaria, Dose 3

Grade 3 Urticaria, Dose 3

Related Urticaria, Dose 3

Any Arthralgia, Across doses

Grade 3 Arthralgia, Across doses

Related Arthralgia, Across doses

Any Fatigue, Across doses

Grade 3 Fatigue, Across doses

Related Fatigue, Across doses

Any Fever, Across doses

Grade 3 Fever, Across doses

Related Fever, Across doses

Any Gastrointestinal, Across doses

Grade 3 Gastrointestinal, Across doses

Related Gastrointestinal, Across doses

Any Headache, Across doses

Grade 3 Headache, Across doses

Related Headache, Across doses

Any Myalgia, Across doses

Grade 3 Myalgia, Across doses

Related Myalgia, Across doses

Any Rash, Across doses

Grade 3 Rash, Across doses

Related Rash, Across doses

Any Urticaria, Across doses

Grade 3 Urticaria, Across doses

Related Urticaria, Across doses

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Any AE(s)

Grade 3 AE(s)

Related AE(s)

Grade 3 and Related AE(s)

The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.

Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)

Spots Global Cancer Trial Database for safety and reactogenicity