Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy, Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects
Brief Summary: This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits.

Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48).

The protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.


Options:
A: Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 (At Month 24); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 (At Month 48); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 (At Month 57); Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 (At Month 72)
B: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms (Within 7 days after each dose and across doses); Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms (Within 7 days after each dose and across doses); Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms (Within 30 days after any vaccination); Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7 (From Day 0 up to Month 7); Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7 (From Day 0 up to Month 7); Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7 (From Day 0 up to Month 7); Number of Subjects Reporting SAEs From Day 0 up to Month 12 (From Day 0 up to Month 12); Number of Subjects With MSCs From Day 0 up to Month 12 (From Day 0 up to Month 12); Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12 (From Day 0 up to Month 12); Number of Subjects Reporting Clinically Relevant Abnormalities in Red Blood Cells and Platelets Parameters at Day 7 and at Months 1, 2, 4, 6 and 7 (At Day 7 and at Months 1, 2, 4, 6 and 7); Number of Subjects Reporting Clinically Relevant Abnormalities in White Blood Cells and Neutrophils Parameters at Day 7 and Months 1, 2, 4, 6 and 7 (At Day 7 and Months 1, 2, 4, 6 and 7); Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7 (At Day 7 and at Months 1, 2, 4, 6 and 7); Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7 (At Day 7 and Months 1, 2, 4, 6 and 7); Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7 (At Day 7 and at Months 1, 2, 4, 6 and 7); Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7 (At Day 7 and Months 1, 2, 4, 6 and 7); Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12 (At Month 10 and Month 12); Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase, Basophils, Creatinine, Eosinophils, Haematocrit, Haemoglobin, Lymphocytes and Monocytes Parameters at Month 10 and Month 12 (At Month 10 and Month 12); Number of Cluster of Differention 4 (CD4+) Cells Per Cubic Millimeter in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 (At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7); Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12 (At Month 10 and Month 12); HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 (At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7); HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12 (At Month 10 and Month 12); Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Months 1, 2, 4, 6 and 7 (At Months 1, 2, 4, 6 and 7); Number of Subjects in Each World Health Organisation (WHO) HIV Clinical Stage by CD4+ Cell Count Category at Baseline in All HIV+ Subjects at Month 10 and Month 12 (At Month 10 and Month 12); Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7 (At pre-vaccination (Day 0) and Months 2 and 7); Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12 (At Month 12); Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7 (At pre-vaccination (Day 0) and Months 2 and 7); Concentrations for HPV-16 and HPV-18 Antibodies at Month 12 (At Month 12); Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0 (At pre-vaccination (Day 0)); CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2 (At Month 2); CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7 (At Month 7); CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12 (At Month 12); CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS) (At pre-vaccination (Day 0) and at Months 2, 7 and 12)
C: Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms (Within 7 days after each vaccine dose)
D: Immunogenicity After Dose 3 (1 month after dose 3 (e.g., month 7 if third dose at 6months or month 13 if third dose at 12 months))

Answer: A