Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
Brief Summary: This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.


Options:
A: Titers of Anti-Papillomavirus 16 (Anti-HPV-16) and Anti-human Papillomavirus 18 (Anti-HPV-18) Antibodies (One month after vaccination with the last dose of the Cervarix vaccine (Cervarix 1/Placebo Group: Month 3; Other groups: Month 7).); Number of Subjects With Report of Any, and Grade 3 Solicited Local Symptoms (Within 7 days (Day 0-6) after vaccination.); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (Within 7 days (Day 0-6) after vaccination.)
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: Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 (At Month 7 (i.e. one month after the last dose of study vaccine)); Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 (At Month 7 (i.e. one month after the last dose of study vaccine))
D: number of HR-HPV infections and number of infections due to HPV vaccine types in cervical sample in the Experimental arm and in No intervention arm (30 months); number of cytological abnormalities in the Experimental arm and in No intervention arm (30 months)

Answer: C