Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in Adult Human Immunodeficiency Virus (HIV) Infected Female Subjects
Brief Summary: Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. The current study is designed to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in the Republic of South Africa. The study is double blinded, randomized for HIV positive subjects and open for HIV negative subjects. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Options:
A: 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))
B: Geometric mean titres of serum HPV-16 and HPV-18 antibody titers on measured by Pseudovirion-Based Neutralization Assay (PBNA) (Day 0, Day 45, Day 180, Day 210 and Day 365)
C: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)); Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen (4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13))
D: 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)

Answer: D