Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00586339
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 42
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infections, Papillomavirus	Biological: Cervarix; Biological: Placebo Control	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Evaluation of the Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in Adult Human Immunodeficiency Virus (HIV) Infected Female Subjects
• Actual Study Start Date: Jan 17, 2008
• Actual Primary Completion Date: Jul 18, 2011
• Actual Study Completion Date: Jul 18, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HIV+/Cervarix Group Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Biological: Cervarix; Intramuscular injection, 3 doses
Active Comparator: HIV+/Aluminium Hydroxide Group Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Biological: Placebo Control; Intramuscular injection, 3 doses
Experimental: HIV-/Cervarix Group Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Biological: Cervarix; Intramuscular injection, 3 doses

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [Within 7 days after each dose and across doses]

   Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Solicited local symptoms were assessed as related to the study vaccination.

2. Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms [Within 7 days after each dose and across doses]

   Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.

3. Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms [Within 30 days after any vaccination]

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

4. Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7 [From Day 0 up to Month 7]

   Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

5. Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7 [From Day 0 up to Month 7]

   SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

6. Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7 [From Day 0 up to Month 7]

   The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

7. Number of Subjects Reporting SAEs From Day 0 up to Month 12 [From Day 0 up to Month 12]

   SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

8. Number of Subjects With MSCs From Day 0 up to Month 12 [From Day 0 up to Month 12]

   MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

9. Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12 [From Day 0 up to Month 12]

   The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

10. 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]

    Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

11. 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]

    Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

12. 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]

    Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

13. 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]

    Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

14. 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]

    Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

15. 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]

    Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

16. 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]

    Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

17. 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]

    Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

18. 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]

    The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.

19. Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12 [At Month 10 and Month 12]

    The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at Month 10 and Month 12 is reported.

20. 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]

    The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) [RNA copies/mL (in log10)].

21. HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12 [At Month 10 and Month 12]

    The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).

22. 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]

    CD4+ cell count categories, at baseline, assessed were (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

23. 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]

    CD4+ cell count categories, at baseline, assessed were: (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above (>) 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

24. 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]

    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.

25. Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12 [At Month 12]

    Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

26. 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 are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

27. Concentrations for HPV-16 and HPV-18 Antibodies at Month 12 [At Month 12]

    Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

28. 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)]

    The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

29. CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2 [At Month 2]

    The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

30. CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7 [At Month 7]

    The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

31. CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12 [At Month 12]

    The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

32. 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]

    The CMI response is the measure of the cytokines production [i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol

• A female between, and including, 18 and 25 years of age at the time of the first vaccination.

• Written, signed or thumb-printed informed consent obtained from the subject prior to enrolment.

• Subjects willing to undergo HIV Voluntary Counseling and Testing (VCT) and willing to be informed of their HIV status.

• Subjects willing to provide place of residence and be visited at home.

• HIV seropositive subjects:

1. Subjects must be HIV seropositive according to WHO case definition

2. Subjects with WHO Clinical Stage 1 HIV-associated disease

3. Subjects currently on antiretroviral therapy (ART) must be compliant to ART and have undetectable viral load

• HIV seronegative subjects: Subjects confirmed as HIV seronegative at the screening visit are eligible to participate in the HIV-/HPV group of the study.

• Non-virgin subjects must have a normal colposcopy at the screening visit.

• Non-virgin subjects must have a normal cervical cytology (Pap smear) or no greater than atypical squamous cells of undetermined significance (ASC-US) at the screening visit.

• All subjects must have a negative urine pregnancy test at the screening visit and at visit 1 (Day 0).

• Subjects must be of non-childbearing potential or, if of childbearing potential, must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

• Subjects must have had no more than 6 life-time sexual partners prior to enrolment.

• Subjects must have one single intact cervix

Exclusion Criteria:

• Active tuberculosis (TB)

• Current TB prophylaxis or therapy.

• Anemia at the screening visit.

• increased creatinine at the screening visit.

• Increased hepatic enzym (ALT) at the screening visit

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine/control, or planned use during the entire study period (up to Month 12).

• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine/control. Enrolment will be postponed until the subject is outside the specified window.

• Planned administration of a vaccine not foreseen by the study protocol within 30 days before or 30 days after (i.e., Days 0-29) any dose of study vaccine.

• Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Month 0 to Month 12).

• previous administration of components of the investigational vaccine

• Cancer or autoimmune disease under treatment.

• Hypersensitivity to latex.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control.

• Acute disease at the time of enrolment.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory testing performed at the screening visit.

• History of any neurological disorders or seizures.

• Pregnant or breastfeeding female.

• A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.

• Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• Any medically diagnosed or suspected immunodeficient condition (other than HIV for HIV seropositive subjects), based on medical history, physical examination and/or laboratory tests results.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine/control or planned administration during the study period. Enrolment will be postponed until the subject is outside the specified window.

• Administration of trimethoprim/sulphamethoxazole within 7 days before the first dose of study vaccine/control, or planned administration of trimethoprim/sulphamethoxazole within 7 days after the first dose of study vaccine/control.

• Current drugs or alcohol abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Khayelitsha		South Africa	7784

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Denny L, Hendricks B, Gordon C, Thomas F, Hezareh M, Dobbelaere K, Durand C, Hervé C, Descamps D. Safety and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine in HIV-positive women in South Africa: a partially-blind randomised placebo-controlled study. Vaccine. 2013 Nov 19;31(48):5745-53. doi: 10.1016/j.vaccine.2013.09.032. Epub 2013 Oct 1.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00586339
• Other Study ID Numbers: 107863
• First Posted: Jan 4, 2008
• Last Update Posted: Jan 3, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: HPV; Human papillomavirus (HPV) vaccine; Human Immunodeficiency Virus (HIV); Cervical cancer; Papillomavirus
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Recruitment Details	HIV+ subjects were randomised to receive either Cervarix or Aluminium Hydroxide vaccines; HIV- subjects were not randomised and all received Cervarix vaccine.
Pre-assignment Detail	Enrollment was staggered as follows: 1) Enrollment of Human immunodeficiency virus positive (HIV+) subjects with cluster of differentiation 4 (CD4+) cell count >200 cells per cubic millimeter (cells/mm^3) and HIV negative (HIV-) subjects (up to 30 subjects) for blinded safety evaluation; 2) Enrollment of remaining HIV+/HIV- subjects.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Period Title: Overall Study
STARTED	61	59	30
COMPLETED	54	52	24
NOT COMPLETED	7	7	6

Baseline Characteristics

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group	Total
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Total of all reporting groups
Overall Participants	61	59	30	150
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	21.6 (2.21)	22.7 (1.70)	21.3 (1.65)	21.9 (1.85)
Sex: Female, Male (Count of Participants)
Female	61 100%	59 100%	30 100%	150 100%
Male	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African heritage/African American	61 100%	59 100%	30 100%	150 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description	Solicited local symptoms assessed were pain and swelling. Any = occurrence of any solicited local regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Solicited local symptoms were assessed as related to the study vaccination.
Time Frame	Within 7 days after each dose and across doses

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Any Pain, Dose 1	46 75.4%	18 30.5%	19 63.3%
Grade 3 Pain, Dose 1	2 3.3%	0 0%	0 0%
Any Swelling, Dose 1	6 9.8%	0 0%	4 13.3%
Grade 3 Swelling, Dose 1	1 1.6%	0 0%	2 6.7%
Any Pain, Dose 2	29 47.5%	12 20.3%	21 70%
Grade 3 Pain, Dose 2	0 0%	0 0%	1 3.3%
Any Swelling, Dose 2	5 8.2%	0 0%	8 26.7%
Grade 3 Swelling, Dose 2	0 0%	0 0%	2 6.7%
Any Pain, Dose 3	27 44.3%	6 10.2%	19 63.3%
Grade 3 Pain, Dose 3	1 1.6%	0 0%	0 0%
Any Swelling, Dose 3	12 19.7%	2 3.4%	3 10%
Grade 3 Swelling, Dose 3	0 0%	0 0%	1 3.3%
Any Pain, Across doses	52 85.2%	27 45.8%	28 93.3%
Grade 3 Pain, Across doses	3 4.9%	0 0%	1 3.3%
Any Swelling, Across doses	19 31.1%	2 3.4%	12 40%
Grade 3 Swelling, Across doses	1 1.6%	0 0%	4 13.3%

2. Primary Outcome

Title	Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms
Description	Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.
Time Frame	Within 7 days after each dose and across doses

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Any Arthralgia, Dose 1	3 4.9%	4 6.8%	2 6.7%
Grade 3 Arthralgia, Dose 1	0 0%	0 0%	0 0%
Related Arthralgia, Dose 1	1 1.6%	1 1.7%	2 6.7%
Any Fatigue, Dose 1	12 19.7%	13 22%	7 23.3%
Grade 3 Fatigue, Dose 1	0 0%	1 1.7%	0 0%
Related Fatigue, Dose 1	9 14.8%	9 15.3%	5 16.7%
Any Fever, Dose 1	1 1.6%	2 3.4%	0 0%
Grade 3 Fever, Dose 1	0 0%	1 1.7%	0 0%
Related Fever, Dose 1	0 0%	0 0%	0 0%
Any Gastrointestinal, Dose 1	5 8.2%	7 11.9%	9 30%
Grade 3 Gastrointestinal, Dose 1	0 0%	0 0%	0 0%
Related Gastrointestinal, Dose 1	2 3.3%	2 3.4%	2 6.7%
Any Headache, Dose 1	13 21.3%	16 27.1%	11 36.7%
Grade 3 Headache, Dose 1	0 0%	0 0%	0 0%
Related Headache, Dose 1	5 8.2%	4 6.8%	1 3.3%
Any Myalgia, Dose 1	2 3.3%	1 1.7%	4 13.3%
Grade 3 Myalgia, Dose 1	0 0%	0 0%	0 0%
Related Myalgia, Dose 1	1 1.6%	1 1.7%	3 10%
Any Rash, Dose 1	0 0%	2 3.4%	0 0%
Grade 3 Rash, Dose 1	0 0%	0 0%	0 0%
Related Rash, Dose 1	0 0%	1 1.7%	0 0%
Any Urticaria, Dose 1	0 0%	0 0%	0 0%
Grade 3 Urticaria, Dose 1	0 0%	0 0%	0 0%
Related Urticaria, Dose 1	0 0%	0 0%	0 0%
Any Arthralgia, Dose 2	0 0%	0 0%	0 0%
Grade 3 Arthralgia, Dose 2	0 0%	0 0%	0 0%
Related Arthralgia, Dose 2	0 0%	0 0%	0 0%
Any Fatigue, Dose 2	4 6.6%	6 10.2%	4 13.3%
Grade 3 Fatigue, Dose 2	0 0%	0 0%	0 0%
Related Fatigue, Dose 2	4 6.6%	4 6.8%	4 13.3%
Any Fever, Dose 2	0 0%	0 0%	0 0%
Grade 3 Fever, Dose 2	0 0%	0 0%	0 0%
Related Fever, Dose 2	0 0%	0 0%	0 0%
Any Gastrointestinal, Dose 2	10 16.4%	2 3.4%	4 13.3%
Grade 3 Gastrointestinal, Dose 2	1 1.6%	0 0%	0 0%
Related Gastrointestinal, Dose 2	3 4.9%	1 1.7%	0 0%
Any Headache, Dose 2	11 18%	9 15.3%	4 13.3%
Grade 3 Headache, Dose 2	0 0%	0 0%	0 0%
Related Headache, Dose 2	5 8.2%	2 3.4%	1 3.3%
Any Myalgia, Dose 2	0 0%	1 1.7%	3 10%
Grade 3 Myalgia, Dose 2	0 0%	0 0%	0 0%
Related Myalgia, Dose 2	0 0%	1 1.7%	3 10%
Any Rash, Dose 2	0 0%	0 0%	1 3.3%
Grade 3 Rash, Dose 2	0 0%	0 0%	0 0%
Related Rash, Dose 2	0 0%	0 0%	0 0%
Any Urticaria, Dose 2	0 0%	0 0%	0 0%
Grade 3 Urticaria, Dose 2	0 0%	0 0%	0 0%
Related Urticaria, Dose 2	0 0%	0 0%	0 0%
Any Arthralgia, Dose 3	1 1.6%	0 0%	0 0%
Grade 3 Arthralgia, Dose 3	0 0%	0 0%	0 0%
Related Arthralgia, Dose 3	1 1.6%	0 0%	0 0%
Any Fatigue, Dose 3	4 6.6%	1 1.7%	4 13.3%
Grade 3 Fatigue, Dose 3	0 0%	0 0%	0 0%
Related Fatigue, Dose 3	4 6.6%	1 1.7%	4 13.3%
Any Fever, Dose 3	1 1.6%	1 1.7%	2 6.7%
Grade 3 Fever, Dose 3	0 0%	0 0%	0 0%
Related Fever, Dose 3	1 1.6%	0 0%	0 0%
Any Gastrointestinal, Dose 3	3 4.9%	2 3.4%	6 20%
Grade 3 Gastrointestinal, Dose 3	0 0%	0 0%	0 0%
Related Gastrointestinal, Dose 3	1 1.6%	0 0%	3 10%
Any Headache, Dose 3	2 3.3%	7 11.9%	6 20%
Grade 3 Headache, Dose 3	0 0%	0 0%	0 0%
Related Headache, Dose 3	1 1.6%	3 5.1%	2 6.7%
Any Myalgia, Dose 3	1 1.6%	1 1.7%	1 3.3%
Grade 3 Myalgia, Dose 3	0 0%	0 0%	0 0%
Related Myalgia, Dose 3	1 1.6%	1 1.7%	1 3.3%
Any Rash, Dose 3	1 1.6%	0 0%	0 0%
Grade 3 Rash, Dose 3	0 0%	0 0%	0 0%
Related Rash, Dose 3	0 0%	0 0%	0 0%
Any Urticaria, Dose 3	0 0%	0 0%	0 0%
Grade 3 Urticaria, Dose 3	0 0%	0 0%	0 0%
Related Urticaria, Dose 3	0 0%	0 0%	0 0%
Any Arthralgia, Across doses	4 6.6%	4 6.8%	2 6.7%
Grade 3 Arthralgia, Across doses	0 0%	0 0%	0 0%
Related Arthralgia, Across doses	2 3.3%	1 1.7%	2 6.7%
Any Fatigue, Across doses	18 29.5%	16 27.1%	8 26.7%
Grade 3 Fatigue, Across doses	0 0%	1 1.7%	0 0%
Related Fatigue, Across doses	15 24.6%	12 20.3%	7 23.3%
Any Fever, Across doses	2 3.3%	3 5.1%	2 6.7%
Grade 3 Fever, Across doses	0 0%	1 1.7%	0 0%
Related Fever, Across doses	1 1.6%	0 0%	0 0%
Any Gastrointestinal, Across doses	15 24.6%	11 18.6%	13 43.3%
Grade 3 Gastrointestinal, Across doses	1 1.6%	0 0%	0 0%
Related Gastrointestinal, Across doses	5 8.2%	3 5.1%	4 13.3%
Any Headache, Across doses	23 37.7%	26 44.1%	16 53.3%
Grade 3 Headache, Across doses	0 0%	0 0%	0 0%
Related Headache, Across doses	10 16.4%	9 15.3%	3 10%
Any Myalgia, Across doses	3 4.9%	3 5.1%	7 23.3%
Grade 3 Myalgia, Across doses	0 0%	0 0%	0 0%
Related Myalgia, Across doses	2 3.3%	3 5.1%	7 23.3%
Any Rash, Across doses	1 1.6%	2 3.4%	1 3.3%
Grade 3 Rash, Across doses	0 0%	0 0%	0 0%
Related Rash, Across doses	0 0%	1 1.7%	0 0%
Any Urticaria, Across doses	0 0%	0 0%	0 0%
Grade 3 Urticaria, Across doses	0 0%	0 0%	0 0%
Related Urticaria, Across doses	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Symptoms
Description	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame	Within 30 days after any vaccination

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Any unsolicited AE(s)	53 86.9%	46 78%	26 86.7%
Grade 3 unsolicited AE(s)	1 1.6%	1 1.7%	0 0%
Related unsolicited AE(s)	16 26.2%	3 5.1%	7 23.3%

4. Primary Outcome

Title	Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7
Description	Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame	From Day 0 up to Month 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Count of Participants [Participants]	18 29.5%	21 35.6%	5 16.7%

5. Primary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs) From Day 0 up to Month 7
Description	SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	From Day 0 up to Month 7

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Count of Participants [Participants]	3 4.9%	2 3.4%	1 3.3%

6. Primary Outcome

Title	Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 7
Description	The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.
Time Frame	From Day 0 up to Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	0	1	0
Count of Participants [Participants]	1 1.6%

7. Primary Outcome

Title	Number of Subjects Reporting SAEs From Day 0 up to Month 12
Description	SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	From Day 0 up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Count of Participants [Participants]	3 4.9%	2 3.4%	1 3.3%

8. Primary Outcome

Title	Number of Subjects With MSCs From Day 0 up to Month 12
Description	MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time Frame	From Day 0 up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	30
Count of Participants [Participants]	19 31.1%	21 35.6%	5 16.7%

9. Primary Outcome

Title	Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies From Day 0 up to Month 12
Description	The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.
Time Frame	From Day 0 up to Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported pregnancies and outcomes of reported pregnancies.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	0	1	0
Count of Participants [Participants]	1 1.6%

10. Primary Outcome

Title	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
Description	Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and at Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	56	55	29
RBC [pre-vacc Normal; post-vacc Normal] Day 7	14 23%	12 20.3%	15 50%
RBC [pre-vacc Normal; post-vacc Below] Day 7	1 1.6%	2 3.4%	0 0%
RBC [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 1	46 75.4%	44 74.6%	25 83.3%
RBC [pre-vacc Normal; post-vacc Below] Month 1	5 8.2%	4 6.8%	4 13.3%
RBC [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 2	44 72.1%	45 76.3%	28 93.3%
RBC [pre-vacc Normal; post-vacc Below] Month 2	5 8.2%	3 5.1%	0 0%
RBC [pre-vacc Normal; post-vacc Above] Month 2	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 4	43 70.5%	40 67.8%	25 83.3%
RBC [pre-vacc Normal; post-vacc Below] Month 4	6 9.8%	6 10.2%	1 3.3%
RBC [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 6	40 65.6%	40 67.8%	25 83.3%
RBC [pre-vacc Normal; post-vacc Below] Month 6	9 14.8%	5 8.5%	1 3.3%
RBC [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 7	43 70.5%	37 62.7%	24 80%
RBC [pre-vacc Normal; post-vacc Below] Month 7	5 8.2%	8 13.6%	1 3.3%
RBC [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Day 7	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Below] Day 7	0 0%	1 1.7%	0 0%
RBC [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 1	4 6.6%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 1	5 8.2%	5 8.5%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 2	3 4.9%	1 1.7%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 2	6 9.8%	8 13.6%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 4	4 6.6%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 4	4 6.6%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 6	3 4.9%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 6	5 8.2%	5 8.5%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 7	2 3.3%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 7	6 9.8%	4 6.8%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Day 7	13 21.3%	14 23.7%	15 50%
PLA [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 1	56 91.8%	54 91.5%	29 96.7%
PLA [pre-vacc Normal; post-vacc Below] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	1 1.7%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 2	51 83.6%	54 91.5%	28 93.3%
PLA [pre-vacc Normal; post-vacc Below] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 2	2 3.3%	1 1.7%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 2	1 1.6%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 4	52 85.2%	51 86.4%	26 86.7%
PLA [pre-vacc Normal; post-vacc Below] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 4	0 0%	1 1.7%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 4	1 1.6%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 6	53 86.9%	52 88.1%	26 86.7%
PLA [pre-vacc Normal; post-vacc Below] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 7	51 83.6%	50 84.7%	25 83.3%
PLA [pre-vacc Normal; post-vacc Below] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 7	1 1.6%	1 1.7%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 1	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 2	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 4	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 6	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 7	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Day 7	0 0%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Below] Day 7	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Day 7	2 3.3%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 1	1 1.6%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 1	2 3.3%	2 3.4%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 2	3 4.9%	2 3.4%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 4	2 3.3%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 4	1 1.6%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 6	3 4.9%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 6	0 0%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 7	2 3.3%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 7	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 7	1 1.6%	1 1.7%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

11. Primary Outcome

Title	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
Description	Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	48	50	26
WBC [pre-vacc Normal; post-vacc Normal] Day 7	9 14.8%	12 20.3%	12 40%
WBC [pre-vacc Normal; post-vacc Below] Day 7	4 6.6%	2 3.4%	1 3.3%
WBC [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 1	39 63.9%	43 72.9%	23 76.7%
WBC [pre-vacc Normal; post-vacc Below] Month 1	7 11.5%	6 10.2%	3 10%
WBC [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 2	38 62.3%	41 69.5%	24 80%
WBC [pre-vacc Normal; post-vacc Below] Month 2	6 9.8%	9 15.3%	2 6.7%
WBC [pre-vacc Normal; post-vacc Above] Month 2	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 4	37 60.7%	41 69.5%	22 73.3%
WBC [pre-vacc Normal; post-vacc Below] Month 4	6 9.8%	7 11.9%	2 6.7%
WBC [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 6	35 57.4%	38 64.4%	21 70%
WBC [pre-vacc Normal; post-vacc Below] Month 6	8 13.1%	8 13.6%	2 6.7%
WBC [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	1 3.3%
WBC [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 7	34 55.7%	38 64.4%	21 70%
WBC [pre-vacc Normal; post-vacc Below] Month 7	8 13.1%	8 13.6%	2 6.7%
WBC [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Day 7	1 1.6%	1 1.7%	1 3.3%
WBC [pre-vacc Low; post-vacc Below] Day 7	1 1.6%	0 0%	1 3.3%
WBC [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 1	9 14.8%	5 8.5%	2 6.7%
WBC [pre-vacc Low; post-vacc Below] Month 1	5 8.2%	3 5.1%	1 3.3%
WBC [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 2	10 16.4%	5 8.5%	0 0%
WBC [pre-vacc Low; post-vacc Below] Month 2	4 6.6%	2 3.4%	2 6.7%
WBC [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 4	8 13.1%	2 3.4%	1 3.3%
WBC [pre-vacc Low; post-vacc Below] Month 4	6 9.8%	4 6.8%	1 3.3%
WBC [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 6	6 9.8%	5 8.5%	0 0%
WBC [pre-vacc Low; post-vacc Below] Month 6	8 13.1%	3 5.1%	2 6.7%
WBC [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 7	6 9.8%	3 5.1%	1 3.3%
WBC [pre-vacc Low; post-vacc Below] Month 7	8 13.1%	4 6.8%	1 3.3%
WBC [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Day 7	9 14.8%	11 18.6%	12 40%
NEU [pre-vacc Normal; post-vacc Below] Day 7	4 6.6%	3 5.1%	1 3.3%
NEU [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 1	36 59%	36 61%	21 70%
NEU [pre-vacc Normal; post-vacc Below] Month 1	11 18%	5 8.5%	4 13.3%
NEU [pre-vacc Normal; post-vacc Above] Month 1	1 1.6%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 2	38 62.3%	35 59.3%	22 73.3%
NEU [pre-vacc Normal; post-vacc Below] Month 2	8 13.1%	6 10.2%	3 10%
NEU [pre-vacc Normal; post-vacc Above] Month 2	0 0%	1 1.7%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 4	36 59%	30 50.8%	19 63.3%
NEU [pre-vacc Normal; post-vacc Below] Month 4	9 14.8%	10 16.9%	4 13.3%
NEU [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 6	33 54.1%	33 55.9%	19 63.3%
NEU [pre-vacc Normal; post-vacc Below] Month 6	12 19.7%	5 8.5%	4 13.3%
NEU [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 7	35 57.4%	32 54.2%	18 60%
NEU [pre-vacc Normal; post-vacc Below] Month 7	9 14.8%	6 10.2%	4 13.3%
NEU [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Day 7	0 0%	1 1.7%	0 0%
NEU [pre-vacc Low; post-vacc Below] Day 7	2 3.3%	0 0%	2 6.7%
NEU [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 1	7 11.5%	6 10.2%	1 3.3%
NEU [pre-vacc Low; post-vacc Below] Month 1	5 8.2%	10 16.9%	3 10%
NEU [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 2	6 9.8%	7 11.9%	0 0%
NEU [pre-vacc Low; post-vacc Below] Month 2	6 9.8%	8 13.6%	3 10%
NEU [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 4	6 9.8%	7 11.9%	1 3.3%
NEU [pre-vacc Low; post-vacc Below] Month 4	6 9.8%	7 11.9%	2 6.7%
NEU [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 6	5 8.2%	6 10.2%	0 0%
NEU [pre-vacc Low; post-vacc Below] Month 6	7 11.5%	10 16.9%	3 10%
NEU [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 7	5 8.2%	6 10.2%	0 0%
NEU [pre-vacc Low; post-vacc Below] Month 7	7 11.5%	9 15.3%	3 10%
NEU [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

12. Primary Outcome

Title	Number of Subjects Reporting Clinically Relevant Abnormalities in Lymphocytes and Monocytes Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Description	Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and at Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	57	56	29
LYM [pre-vacc Normal; post-vacc Normal] Day 7	12 19.7%	14 23.7%	14 46.7%
LYM [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 1	52 85.2%	55 93.2%	27 90%
LYM [pre-vacc Normal; post-vacc Below] Month 1	2 3.3%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 1	0 0%	1 1.7%	0 0%
LYM [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 2	50 82%	54 91.5%	26 86.7%
LYM [pre-vacc Normal; post-vacc Below] Month 2	1 1.6%	2 3.4%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 2	1 1.6%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 4	49 80.3%	50 84.7%	23 76.7%
LYM [pre-vacc Normal; post-vacc Below] Month 4	2 3.3%	3 5.1%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	1 3.3%
LYM [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 6	48 78.7%	52 88.1%	22 73.3%
LYM [pre-vacc Normal; post-vacc Below] Month 6	3 4.9%	1 1.7%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	2 6.7%
LYM [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 7	48 78.7%	49 83.1%	22 73.3%
LYM [pre-vacc Normal; post-vacc Below] Month 7	2 3.3%	3 5.1%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	1 3.3%
LYM [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Day 7	2 3.3%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 1	3 4.9%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 1	2 3.3%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 2	4 6.6%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 2	1 1.6%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 4	3 4.9%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 4	2 3.3%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 6	3 4.9%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 6	2 3.3%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 7	3 4.9%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 7	2 3.3%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Day 7	1 1.6%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Below] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 1	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 2	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 4	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 6	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 7	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 7	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Day 7	13 21.3%	14 23.7%	15 50%
MON [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 1	56 91.8%	54 91.5%	28 93.3%
MON [pre-vacc Normal; post-vacc Below] Month 1	1 1.6%	1 1.7%	1 3.3%
MON [pre-vacc Normal; post-vacc Above] Month 1	0 0%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 2	52 85.2%	55 93.2%	28 93.3%
MON [pre-vacc Normal; post-vacc Below] Month 2	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Above] Month 2	1 1.6%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 4	51 83.6%	52 88.1%	26 86.7%
MON [pre-vacc Normal; post-vacc Below] Month 4	3 4.9%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 6	53 86.9%	52 88.1%	26 86.7%
MON [pre-vacc Normal; post-vacc Below] Month 6	1 1.6%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 7	50 82%	50 84.7%	24 80%
MON [pre-vacc Normal; post-vacc Below] Month 7	3 4.9%	2 3.4%	1 3.3%
MON [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Day 7	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 1	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 1	1 1.6%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 2	3 4.9%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 2	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 4	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 4	1 1.6%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 6	1 1.6%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 6	2 3.3%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 7	1 1.6%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 7	2 3.3%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

13. Primary Outcome

Title	Number of Subjects Reporting Clinically Relevant Abnormalities in Haemoglobin and Haematocrit Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Description	Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	49	48	26
Hgb [pre-vacc Normal; post-vacc Normal] Day 7	13 21.3%	11 18.6%	13 43.3%
Hgb [pre-vacc Normal; post-vacc Below] Day 7	1 1.6%	3 5.1%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 1	46 75.4%	43 72.9%	23 76.7%
Hgb [pre-vacc Normal; post-vacc Below] Month 1	3 4.9%	5 8.5%	2 6.7%
Hgb [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 2	46 75.4%	43 72.9%	24 80%
Hgb [pre-vacc Normal; post-vacc Below] Month 2	1 1.6%	4 6.8%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Month 2	0 0%	1 1.7%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 4	46 75.4%	43 72.9%	23 76.7%
Hgb [pre-vacc Normal; post-vacc Below] Month 4	1 1.6%	3 5.1%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 6	42 68.9%	39 66.1%	23 76.7%
Hgb [pre-vacc Normal; post-vacc Below] Month 6	5 8.2%	6 10.2%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 7	43 70.5%	38 64.4%	22 73.3%
Hgb [pre-vacc Normal; post-vacc Below] Month 7	3 4.9%	7 11.9%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Day 7	0 0%	0 0%	1 3.3%
Hgb [pre-vacc Low; post-vacc Below] Day 7	1 1.6%	1 1.7%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 1	1 1.6%	6 10.2%	3 10%
Hgb [pre-vacc Low; post-vacc Below] Month 1	10 16.4%	3 5.1%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 2	3 4.9%	2 3.4%	3 10%
Hgb [pre-vacc Low; post-vacc Below] Month 2	8 13.1%	7 11.9%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 4	5 8.2%	4 6.8%	2 6.7%
Hgb [pre-vacc Low; post-vacc Below] Month 4	5 8.2%	4 6.8%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 6	6 9.8%	3 5.1%	2 6.7%
Hgb [pre-vacc Low; post-vacc Below] Month 6	4 6.6%	6 10.2%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 7	4 6.6%	2 3.4%	2 6.7%
Hgb [pre-vacc Low; post-vacc Below] Month 7	6 9.8%	6 10.2%	1 3.3%
Hgb [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Day 7	11 18%	11 18.6%	13 43.3%
Hct [pre-vacc Normal; post-vacc Below] Day 7	3 4.9%	3 5.1%	1 3.3%
Hct [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 1	42 68.9%	37 62.7%	22 73.3%
Hct [pre-vacc Normal; post-vacc Below] Month 1	2 3.3%	6 10.2%	4 13.3%
Hct [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 2	37 60.7%	36 61%	24 80%
Hct [pre-vacc Normal; post-vacc Below] Month 2	5 8.2%	6 10.2%	1 3.3%
Hct [pre-vacc Normal; post-vacc Above] Month 2	0 0%	1 1.7%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 4	38 62.3%	36 61%	24 80%
Hct [pre-vacc Normal; post-vacc Below] Month 4	4 6.6%	5 8.5%	0 0%
Hct [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 6	36 59%	33 55.9%	22 73.3%
Hct [pre-vacc Normal; post-vacc Below] Month 6	6 9.8%	7 11.9%	1 3.3%
Hct [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	1 3.3%
Hct [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 7	34 55.7%	30 50.8%	20 66.7%
Hct [pre-vacc Normal; post-vacc Below] Month 7	7 11.5%	10 16.9%	2 6.7%
Hct [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	1 3.3%
Hct [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Day 7	0 0%	0 0%	1 3.3%
Hct [pre-vacc Low; post-vacc Below] Day 7	1 1.6%	1 1.7%	0 0%
Hct [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 1	4 6.6%	2 3.4%	1 3.3%
Hct [pre-vacc Low; post-vacc Below] Month 1	12 19.7%	11 18.6%	2 6.7%
Hct [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 2	4 6.6%	3 5.1%	2 6.7%
Hct [pre-vacc Low; post-vacc Below] Month 2	12 19.7%	10 16.9%	1 3.3%
Hct [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 4	6 9.8%	3 5.1%	1 3.3%
Hct [pre-vacc Low; post-vacc Below] Month 4	9 14.8%	9 15.3%	1 3.3%
Hct [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 6	8 13.1%	4 6.8%	2 6.7%
Hct [pre-vacc Low; post-vacc Below] Month 6	7 11.5%	9 15.3%	0 0%
Hct [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 7	8 13.1%	3 5.1%	2 6.7%
Hct [pre-vacc Low; post-vacc Below] Month 7	7 11.5%	9 15.3%	0 0%
Hct [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 1	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 2	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 4	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 6	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 7	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 7	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

14. Primary Outcome

Title	Number of Subjects With Clinically Relevant Abnormalities in Eosinophils, Basophils and Creatinine Parameters at Day 7 and Months 1, 2, 4, 6 and 7
Description	Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and at Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	60	57	29
EOS [pre-vacc Normal; post-vacc Normal] Day 7	13 21.3%	13 22%	15 50%
EOS [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Day 7	0 0%	1 1.7%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 1	53 86.9%	52 88.1%	28 93.3%
EOS [pre-vacc Normal; post-vacc Below] Month 1	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 1	1 1.6%	2 3.4%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 2	51 83.6%	51 86.4%	26 86.7%
EOS [pre-vacc Normal; post-vacc Below] Month 2	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 2	1 1.6%	3 5.1%	1 3.3%
EOS [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 4	48 78.7%	49 83.1%	25 83.3%
EOS [pre-vacc Normal; post-vacc Below] Month 4	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 4	3 4.9%	2 3.4%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 6	50 82%	51 86.4%	25 83.3%
EOS [pre-vacc Normal; post-vacc Below] Month 6	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 6	1 1.6%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 7	50 82%	49 83.1%	24 80%
EOS [pre-vacc Normal; post-vacc Below] Month 7	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 7	0 0%	1 1.7%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Day 7	1 1.6%	1 1.7%	0 0%
EOS [pre-vacc High; post-vacc Below] Day 7	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Day 7	1 1.6%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 1	5 8.2%	2 3.4%	1 3.3%
EOS [pre-vacc High; post-vacc Below] Month 1	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 1	1 1.6%	1 1.7%	0 0%
EOS [pre-vacc High; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 2	3 4.9%	2 3.4%	1 3.3%
EOS [pre-vacc High; post-vacc Below] Month 2	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 2	3 4.9%	1 1.7%	0 0%
EOS [pre-vacc High; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 4	5 8.2%	1 1.7%	1 3.3%
EOS [pre-vacc High; post-vacc Below] Month 4	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 4	1 1.6%	2 3.4%	0 0%
EOS [pre-vacc High; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 6	4 6.6%	2 3.4%	0 0%
EOS [pre-vacc High; post-vacc Below] Month 6	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 6	2 3.3%	1 1.7%	1 3.3%
EOS [pre-vacc High; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 7	4 6.6%	1 1.7%	0 0%
EOS [pre-vacc High; post-vacc Below] Month 7	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 7	2 3.3%	2 3.4%	1 3.3%
EOS [pre-vacc High; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Day 7	15 24.6%	15 25.4%	15 50%
BAS [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 1	60 98.4%	57 96.6%	29 96.7%
BAS [pre-vacc Normal; post-vacc Below] Month 1	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 2	58 95.1%	57 96.6%	28 93.3%
BAS [pre-vacc Normal; post-vacc Below] Month 2	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 2	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 4	57 93.4%	54 91.5%	26 86.7%
BAS [pre-vacc Normal; post-vacc Below] Month 4	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 6	57 93.4%	54 91.5%	26 86.7%
BAS [pre-vacc Normal; post-vacc Below] Month 6	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 7	56 91.8%	53 89.8%	25 83.3%
BAS [pre-vacc Normal; post-vacc Below] Month 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Day 7	6 9.8%	4 6.8%	11 36.7%
CREA [pre-vacc Normal; post-vacc Below] Day 7	1 1.6%	3 5.1%	1 3.3%
CREA [pre-vacc Normal; post-vacc Above] Day 7	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 1	24 39.3%	29 49.2%	17 56.7%
CREA [pre-vacc Normal; post-vacc Below] Month 1	4 6.6%	8 13.6%	5 16.7%
CREA [pre-vacc Normal; post-vacc Above] Month 1	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 2	26 42.6%	30 50.8%	15 50%
CREA [pre-vacc Normal; post-vacc Below] Month 2	1 1.6%	7 11.9%	6 20%
CREA [pre-vacc Normal; post-vacc Above] Month 2	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 4	24 39.3%	26 44.1%	17 56.7%
CREA [pre-vacc Normal; post-vacc Below] Month 4	2 3.3%	9 15.3%	3 10%
CREA [pre-vacc Normal; post-vacc Above] Month 4	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 6	20 32.8%	22 37.3%	17 56.7%
CREA [pre-vacc Normal; post-vacc Below] Month 6	6 9.8%	12 20.3%	3 10%
CREA [pre-vacc Normal; post-vacc Above] Month 6	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 7	22 36.1%	24 40.7%	15 50%
CREA [pre-vacc Normal; post-vacc Below] Month 7	3 4.9%	11 18.6%	5 16.7%
CREA [pre-vacc Normal; post-vacc Above] Month 7	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Day 7	2 3.3%	2 3.4%	0 0%
CREA [pre-vacc Low; post-vacc Below] Day 7	6 9.8%	6 10.2%	3 10%
CREA [pre-vacc Low; post-vacc Above] Day 7	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 1	5 8.2%	7 11.9%	1 3.3%
CREA [pre-vacc Low; post-vacc Below] Month 1	27 44.3%	13 22%	6 20%
CREA [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 2	8 13.1%	5 8.5%	2 6.7%
CREA [pre-vacc Low; post-vacc Below] Month 2	23 37.7%	15 25.4%	5 16.7%
CREA [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 4	6 9.8%	7 11.9%	1 3.3%
CREA [pre-vacc Low; post-vacc Below] Month 4	25 41%	12 20.3%	5 16.7%
CREA [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 6	10 16.4%	7 11.9%	3 10%
CREA [pre-vacc Low; post-vacc Below] Month 6	21 34.4%	13 22%	3 10%
CREA [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 7	7 11.5%	5 8.5%	1 3.3%
CREA [pre-vacc Low; post-vacc Below] Month 7	24 39.3%	13 22%	4 13.3%
CREA [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

15. Primary Outcome

Title	Number of Subjects With Clinically Relevant Abnormalities in Alanine Aminotransferase Parameter at Day 7 and Months 1, 2, 4, 6 and 7
Description	Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Day 7 and Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	50	46	26
ALAT [pre-vacc Normal; post-vacc Normal] Day 7	10 16.4%	12 20.3%	12 40%
ALAT [pre-vacc Normal; post-vacc Below] Day 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Day 7	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 1	48 78.7%	45 76.3%	25 83.3%
ALAT [pre-vacc Normal; post-vacc Below] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 1	2 3.3%	1 1.7%	1 3.3%
ALAT [pre-vacc Normal; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 2	47 77%	40 67.8%	24 80%
ALAT [pre-vacc Normal; post-vacc Below] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 2	1 1.6%	6 10.2%	1 3.3%
ALAT [pre-vacc Normal; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 4	44 72.1%	42 71.2%	23 76.7%
ALAT [pre-vacc Normal; post-vacc Below] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 4	3 4.9%	3 5.1%	0 0%
ALAT [pre-vacc Normal; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 6	46 75.4%	41 69.5%	21 70%
ALAT [pre-vacc Normal; post-vacc Below] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 6	1 1.6%	4 6.8%	2 6.7%
ALAT [pre-vacc Normal; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 7	40 65.6%	40 67.8%	22 73.3%
ALAT [pre-vacc Normal; post-vacc Below] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 7	6 9.8%	5 8.5%	0 0%
ALAT [pre-vacc Normal; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 1	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 2	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 4	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 6	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 7	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Day 7	2 3.3%	2 3.4%	2 6.7%
ALAT [pre-vacc High; post-vacc Below] Day 7	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Day 7	2 3.3%	1 1.7%	1 3.3%
ALAT [pre-vacc High; post-vacc Missing] Day 7	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 1	6 9.8%	6 10.2%	2 6.7%
ALAT [pre-vacc High; post-vacc Below] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 1	3 4.9%	5 8.5%	1 3.3%
ALAT [pre-vacc High; post-vacc Missing] Month 1	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 2	9 14.8%	8 13.6%	1 3.3%
ALAT [pre-vacc High; post-vacc Below] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 2	0 0%	3 5.1%	2 6.7%
ALAT [pre-vacc High; post-vacc Missing] Month 2	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 4	9 14.8%	7 11.9%	1 3.3%
ALAT [pre-vacc High; post-vacc Below] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 4	0 0%	2 3.4%	2 6.7%
ALAT [pre-vacc High; post-vacc Missing] Month 4	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 6	7 11.5%	6 10.2%	2 6.7%
ALAT [pre-vacc High; post-vacc Below] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 6	2 3.3%	3 5.1%	1 3.3%
ALAT [pre-vacc High; post-vacc Missing] Month 6	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 7	7 11.5%	5 8.5%	2 6.7%
ALAT [pre-vacc High; post-vacc Below] Month 7	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 7	2 3.3%	3 5.1%	1 3.3%
ALAT [pre-vacc High; post-vacc Missing] Month 7	0 0%	0 0%	0 0%

16. Primary Outcome

Title	Number of Subjects Reporting Clinically Relevant Abnormalities in Neutrophils, Platelets, Red Blood Cells and White Blood Cells at Month 10 and Month 12
Description	Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Month 10 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	51	50	24
NEU [pre-vacc Normal; post-vacc Normal] Month 10	32 52.5%	30 50.8%	16 53.3%
NEU [pre-vacc Normal; post-vacc Below] Month 10	11 18%	4 6.8%	5 16.7%
NEU [pre-vacc Normal; post-vacc Above] Month 10	0 0%	2 3.4%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Normal] Month 12	29 47.5%	32 54.2%	17 56.7%
NEU [pre-vacc Normal; post-vacc Below] Month 12	13 21.3%	6 10.2%	4 13.3%
NEU [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
NEU [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 10	6 9.8%	4 6.8%	0 0%
NEU [pre-vacc Low; post-vacc Below] Month 10	6 9.8%	10 16.9%	3 10%
NEU [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Normal] Month 12	3 4.9%	3 5.1%	1 3.3%
NEU [pre-vacc Low; post-vacc Below] Month 12	9 14.8%	11 18.6%	2 6.7%
NEU [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
NEU [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 10	48 78.7%	47 79.7%	24 80%
PLA [pre-vacc Normal; post-vacc Below] Month 10	1 1.6%	1 1.7%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 10	1 1.6%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 10	1 1.6%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Normal] Month 12	50 82%	49 83.1%	24 80%
PLA [pre-vacc Normal; post-vacc Below] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	1 1.7%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 10	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 10	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Normal] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Below] Month 12	1 1.6%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 10	2 3.3%	2 3.4%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 10	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 10	1 1.6%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Normal] Month 12	3 4.9%	2 3.4%	0 0%
PLA [pre-vacc High; post-vacc Below] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Above] Month 12	0 0%	0 0%	0 0%
PLA [pre-vacc High; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 10	40 65.6%	34 57.6%	23 76.7%
RBC [pre-vacc Normal; post-vacc Below] Month 10	8 13.1%	9 15.3%	1 3.3%
RBC [pre-vacc Normal; post-vacc Above] Month 10	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Normal] Month 12	40 65.6%	40 67.8%	24 80%
RBC [pre-vacc Normal; post-vacc Below] Month 12	7 11.5%	5 8.5%	0 0%
RBC [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
RBC [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 10	1 1.6%	1 1.7%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 10	6 9.8%	6 10.2%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Normal] Month 12	0 0%	2 3.4%	0 0%
RBC [pre-vacc Low; post-vacc Below] Month 12	7 11.5%	5 8.5%	0 0%
RBC [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
RBC [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 10	35 57.4%	36 61%	19 63.3%
WBC [pre-vacc Normal; post-vacc Below] Month 10	7 11.5%	6 10.2%	3 10%
WBC [pre-vacc Normal; post-vacc Above] Month 10	0 0%	1 1.7%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Normal] Month 12	34 55.7%	35 59.3%	17 56.7%
WBC [pre-vacc Normal; post-vacc Below] Month 12	7 11.5%	10 16.9%	5 16.7%
WBC [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
WBC [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 10	6 9.8%	4 6.8%	1 3.3%
WBC [pre-vacc Low; post-vacc Below] Month 10	7 11.5%	3 5.1%	1 3.3%
WBC [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Normal] Month 12	6 9.8%	4 6.8%	0 0%
WBC [pre-vacc Low; post-vacc Below] Month 12	7 11.5%	3 5.1%	2 6.7%
WBC [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
WBC [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%

17. Primary Outcome

Title	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
Description	Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).
Time Frame	At Month 10 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	55	52	24
ALAT [pre-vacc Normal; post-vacc Normal] Month 10	44 72.1%	40 67.8%	20 66.7%
ALAT [pre-vacc Normal; post-vacc Below] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 10	1 1.6%	4 6.8%	1 3.3%
ALAT [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Normal] Month 12	38 62.3%	39 66.1%	20 66.7%
ALAT [pre-vacc Normal; post-vacc Below] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc Normal; post-vacc Above] Month 12	6 9.8%	6 10.2%	1 3.3%
ALAT [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 10	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Normal] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Below] Month 12	1 1.6%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 10	8 13.1%	4 6.8%	1 3.3%
ALAT [pre-vacc High; post-vacc Below] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 10	1 1.6%	2 3.4%	2 6.7%
ALAT [pre-vacc High; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Normal] Month 12	8 13.1%	5 8.5%	2 6.7%
ALAT [pre-vacc High; post-vacc Below] Month 12	0 0%	0 0%	0 0%
ALAT [pre-vacc High; post-vacc Above] Month 12	1 1.6%	2 3.4%	1 3.3%
ALAT [pre-vacc High; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 10	55 90.2%	50 84.7%	24 80%
BAS [pre-vacc Normal; post-vacc Below] Month 10	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 10	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Normal] Month 12	54 88.5%	52 88.1%	24 80%
BAS [pre-vacc Normal; post-vacc Below] Month 12	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
BAS [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 10	20 32.8%	22 37.3%	15 50%
CREA [pre-vacc Normal; post-vacc Below] Month 10	4 6.6%	11 18.6%	4 13.3%
CREA [pre-vacc Normal; post-vacc Above] Month 10	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Normal] Month 12	18 29.5%	24 40.7%	13 43.3%
CREA [pre-vacc Normal; post-vacc Below] Month 12	6 9.8%	10 16.9%	6 20%
CREA [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
CREA [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 10	11 18%	4 6.8%	2 6.7%
CREA [pre-vacc Low; post-vacc Below] Month 10	20 32.8%	13 22%	3 10%
CREA [pre-vacc Low ; post-vacc Above] Month 10	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Normal] Month 12	4 6.6%	4 6.8%	3 10%
CREA [pre-vacc Low; post-vacc Below] Month 12	26 42.6%	14 23.7%	2 6.7%
CREA [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
CREA [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 10	46 75.4%	46 78%	22 73.3%
EOS [pre-vacc Normal; post-vacc Below] Month 10	0 0%	0 0%	0 0%
EOS [pre-vacc Normal ; post-vacc Above] Month 10	3 4.9%	2 3.4%	2 6.7%
EOS [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Normal] Month 12	46 75.4%	49 83.1%	24 80%
EOS [pre-vacc Normal; post-vacc Below] Month 12	0 0%	0 0%	0 0%
EOS [pre-vacc Normal; post-vacc Above] Month 12	2 3.3%	1 1.7%	0 0%
EOS [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 10	3 4.9%	2 3.4%	0 0%
EOS [pre-vacc High; post-vacc Below] Month 10	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 10	3 4.9%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Normal] Month 12	4 6.6%	2 3.4%	0 0%
EOS [pre-vacc High; post-vacc Below] Month 12	0 0%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Above] Month 12	2 3.3%	0 0%	0 0%
EOS [pre-vacc High; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 10	35 57.4%	31 52.5%	20 66.7%
Hct [pre-vacc Normal; post-vacc Below] Month 10	6 9.8%	7 11.9%	2 6.7%
Hct [pre-vacc Normal ; post-vacc Above] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Normal] Month 12	32 52.5%	32 54.2%	22 73.3%
Hct [pre-vacc Normal; post-vacc Below] Month 12	9 14.8%	8 13.6%	0 0%
Hct [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 10	6 9.8%	4 6.8%	1 3.3%
Hct [pre-vacc Low; post-vacc Below] Month 10	8 13.1%	7 11.9%	1 3.3%
Hct [pre-vacc Low ; post-vacc Above] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Normal] Month 12	4 6.6%	4 6.8%	1 3.3%
Hct [pre-vacc Low; post-vacc Below] Month 12	9 14.8%	7 11.9%	1 3.3%
Hct [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 10	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Normal] Month 12	0 0%	1 1.7%	0 0%
Hct [pre-vacc High; post-vacc Below] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Above] Month 12	0 0%	0 0%	0 0%
Hct [pre-vacc High; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 10	44 72.1%	38 64.4%	21 70%
Hgb [pre-vacc Normal; post-vacc Below] Month 10	2 3.3%	5 8.5%	0 0%
Hgb [pre-vacc Normal ; post-vacc Above] Month 10	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Normal] Month 12	43 70.5%	42 71.2%	21 70%
Hgb [pre-vacc Normal; post-vacc Below] Month 12	2 3.3%	3 5.1%	0 0%
Hgb [pre-vacc Normal; post-vacc Above] Month 12	0 0%	0 0%	0 0%
Hgb [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 10	2 3.3%	5 8.5%	1 3.3%
Hgb [pre-vacc Low; post-vacc Below] Month 10	7 11.5%	2 3.4%	2 6.7%
Hgb [pre-vacc Low ; post-vacc Above] Month 10	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Normal] Month 12	4 6.6%	4 6.8%	3 10%
Hgb [pre-vacc Low; post-vacc Below] Month 12	5 8.2%	3 5.1%	0 0%
Hgb [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
Hgb [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 10	46 75.4%	48 81.4%	21 70%
LYM [pre-vacc Normal; post-vacc Below] Month 10	3 4.9%	1 1.7%	0 0%
LYM [pre-vacc Normal; post-vacc Above] Month 10	0 0%	0 0%	1 3.3%
LYM [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc Normal; post-vacc Normal] Month 12	45 73.8%	48 81.4%	21 70%
LYM [pre-vacc Normal; post-vacc Below] Month 12	3 4.9%	2 3.4%	1 3.3%
LYM [pre-vacc Normal; post-vacc Above] Month 12	0 0%	1 1.7%	0 0%
LYM [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 10	4 6.6%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 10	1 1.6%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Normal] Month 12	3 4.9%	1 1.7%	1 3.3%
LYM [pre-vacc Low; post-vacc Below] Month 12	2 3.3%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 10	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Normal] Month 12	1 1.6%	0 0%	1 3.3%
LYM [pre-vacc High; post-vacc Below] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Above] Month 12	0 0%	0 0%	0 0%
LYM [pre-vacc High; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 10	50 82%	48 81.4%	24 80%
MON [pre-vacc Normal; post-vacc Below] Month 10	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Above] Month 10	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
MON [pre-vacc Normal; post-vacc Normal] Month 12	50 82%	45 76.3%	24 80%
MON [pre-vacc Normal; post-vacc Below] Month 12	1 1.6%	5 8.5%	0 0%
MON [pre-vacc Normal; post-vacc Above] Month 12	0 0%	1 1.7%	0 0%
MON [pre-vacc Normal; post-vacc Missing] Month 12	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 10	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 10	1 1.6%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 10	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 10	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Normal] Month 12	2 3.3%	1 1.7%	0 0%
MON [pre-vacc Low; post-vacc Below] Month 12	1 1.6%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Above] Month 12	0 0%	0 0%	0 0%
MON [pre-vacc Low; post-vacc Missing] Month 12	0 0%	0 0%	0 0%

18. Primary Outcome

Title	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
Description	The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.
Time Frame	At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	0
Pre-vaccination (Day 0)	451.0	458.0
Month 1	464.0	426.0
Month 2	436.0	438.0
Month 4	469.0	423.0
Month 6	452.0	426.0
Month 7	419.0	464.0

19. Primary Outcome

Title	Number of CD4+ Cells Per Cubic Millimeter in All HIV+ Subjects at Month 10 and Month 12
Description	The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at Month 10 and Month 12 is reported.
Time Frame	At Month 10 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	55	52	0
Month 10	427.0	442.0
Month 12	450.5	453.0

20. Primary Outcome

Title	HIV Viral Load in All HIV+ Subjects at Pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7
Description	The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) [RNA copies/mL (in log10)].
Time Frame	At pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	61	59	0
Pre-vaccination (Day 0)	4.4	4.4
Month 1	4.4	4.2
Month 2	4.4	4.6
Month 4	4.5	4.5
Month 6	4.6	4.5
Month 7	4.5	4.5

21. Primary Outcome

Title	HIV Viral Load in All HIV+ Subjects at Month 10 and Month 12
Description	The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).
Time Frame	At Month 10 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	54	52	0
Month 10	4.5	4.5
Month 12	4.5	4.5

22. Primary Outcome

Title	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
Description	CD4+ cell count categories, at baseline, assessed were (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.
Time Frame	At Months 1, 2, 4, 6 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	60	57	0
<200 CD4+cells/mm^3 [stage 1] Month 1	2 3.3%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 1	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 1	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 1	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 1	31 50.8%	33 55.9%
200-500 CD4+cells/mm^3 [stage 2] Month 1	2 3.3%	2 3.4%
200-500 CD4+cells/mm^3 [stage 3] Month 1	2 3.3%	1 1.7%
200-500 CD4+cells/mm^3 [stage 4] Month 1	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 1] Month 1	23 37.7%	20 33.9%
>500 CD4+cells/mm^3 [stage 2] Month 1	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 3] Month 1	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 1	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 1] Month 2	2 3.3%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 2	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 2	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 2	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 2	30 49.2%	33 55.9%
200-500 CD4+cells/mm^3 [stage 2] Month 2	2 3.3%	3 5.1%
200-500 CD4+cells/mm^3 [stage 3] Month 2	2 3.3%	1 1.7%
200-500 CD4+cells/mm^3 [stage 4] Month 2	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 1] Month 2	22 36.1%	19 32.2%
>500 CD4+cells/mm^3 [stage 2] Month 2	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 3] Month 2	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Mth 2	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 1] Month 4	2 3.3%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 4	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 4	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 4	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 4	28 45.9%	27 45.8%
200-500 CD4+cells/mm^3 [stage 2] Month 4	2 3.3%	1 1.7%
200-500 CD4+cells/mm^3 [stage 3] Month 4	2 3.3%	5 8.5%
200-500 CD4+cells/mm^3 [stage 4] Month 4	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 1] Month 4	23 37.7%	20 33.9%
>500 CD4+cells/mm^3 [stage 2] Month 4	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 3] Month 4	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 4	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 1] Month 6	2 3.3%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 6	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 6	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 6	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 6	28 45.9%	28 47.5%
200-500 CD4+cells/mm^3 [stage 2] Month 6	2 3.3%	1 1.7%
200-500 CD4+cells/mm^3 [stage 3] Month 6	2 3.3%	5 8.5%
200-500 CD4+cells/mm^3 [stage 4] Month 6	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 1] Month 6	23 37.7%	19 32.2%
>500 CD4+cells/mm^3 [stage 2] Month 6	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 3] Month 6	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 6	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 1] Month 7	2 3.3%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 7	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 7	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 7	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 7	28 45.9%	28 47.5%
200-500 CD4+cells/mm^3 [stage 2] Month 7	2 3.3%	0 0%
200-500 CD4+cells/mm^3 [stage 3] Month 7	2 3.3%	4 6.8%
200-500 CD4+cells/mm^3 [stage 4] Month 7	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 1] Month 7	21 34.4%	19 32.2%
>500 CD4+cells/mm^3 [stage 2] Month 7	1 1.6%	1 1.7%
>500 CD4+cells/mm^3 [stage 3] Month 7	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 7	0 0%	0 0%

23. Primary Outcome

Title	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
Description	CD4+ cell count categories, at baseline, assessed were: (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above (>) 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.
Time Frame	At Month 10 and Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	55	52	0
<200 CD4+cells/mm^3 [stage 1] Month 10	1 1.6%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 10	1 1.6%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 10	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 10	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 10	26 42.6%	25 42.4%
200-500 CD4+cells/mm^3 [stage 2] Month 10	1 1.6%	0 0%
200-500 CD4+cells/mm^3 [stage 3] Month 10	4 6.6%	4 6.8%
200-500 CD4+cells/mm^3 [stage 4] Month 10	0 0%	1 1.7%
>500 CD4+cells/mm^3 [stage 1] Month 10	21 34.4%	18 30.5%
>500 CD4+cells/mm^3 [stage 2] Month 10	1 1.6%	1 1.7%
>500 CD4+cells/mm^3 [stage 3] Month 10	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 10	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 1] Month 12	0 0%	1 1.7%
<200 CD4+cells/mm^3 [stage 2] Month 12	2 3.3%	0 0%
<200 CD4+cells/mm^3 [stage 3] Month 12	0 0%	0 0%
<200 CD4+cells/mm^3 [stage 4] Month 12	0 0%	0 0%
200-500 CD4+cells/mm^3 [stage 1] Month 12	24 39.3%	23 39%
200-500 CD4+cells/mm^3 [stage 2] Month 12	3 4.9%	2 3.4%
200-500 CD4+cells/mm^3 [stage 3] Month 12	4 6.6%	6 10.2%
200-500 CD4+cells/mm^3 [stage 4] Month 12	0 0%	1 1.7%
>500 CD4+cells/mm^3 [stage 1] Month 12	20 32.8%	17 28.8%
>500 CD4+cells/mm^3 [stage 2] Month 12	1 1.6%	2 3.4%
>500 CD4+cells/mm^3 [stage 3] Month 12	0 0%	0 0%
>500 CD4+cells/mm^3 [stage 4] Month 12	0 0%	0 0%

24. Primary Outcome

Title	Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
Description	Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.
Time Frame	At pre-vaccination (Day 0) and Months 2 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	43	40	24
anti-HPV-16, At Day 0	35 57.4%	30 50.8%	14 46.7%
anti-HPV-16, At Month 2	41 67.2%	31 52.5%	24 80%
anti-HPV-16, At Month 7	42 68.9%	31 52.5%	24 80%
anti-HPV-18, At Day 0	27 44.3%	24 40.7%	11 36.7%
anti-HPV-18, At Month 2	42 68.9%	26 44.1%	24 80%
anti-HPV-18, At Month 7	43 70.5%	25 42.4%	24 80%

25. Primary Outcome

Title	Number of Seroconverted Subjects for HPV-16 and HPV-18 Antibodies at Month 12
Description	Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
anti-HPV-16, At Month 12	41 67.2%	28 47.5%	22 73.3%
anti-HPV-18, At Month 12	42 68.9%	24 40.7%	22 73.3%

26. Primary Outcome

Title	Concentrations for HPV-16 and HPV-18 Antibodies at Pre-vaccination (Day 0) and Months 2 and 7
Description	Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.
Time Frame	At pre-vaccination (Day 0) and Months 2 and 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	43	40	24
anti-HPV-16, At Day 0	29.7	25.7	21.8
anti-HPV-16, At Month 2	2245.2	32.9	6166.8
anti-HPV-16, At Month 7	3583.1	27.2	7871.9
anti-HPV-18, At Day 0	13.2	12.5	11.1
anti-HPV-18, At Month 2	1339.3	16.9	2380.2
anti-HPV-18, At Month 7	1952.1	14.5	3755.3

27. Primary Outcome

Title	Concentrations for HPV-16 and HPV-18 Antibodies at Month 12
Description	Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
anti-HPV-16, At Month 12	748.1	20.7	2793.6
anti-HPV-18, At Month 12	343.1	13.0	1021.3

28. Primary Outcome

Title	Cell Mediated Immune (CMI) Response (B-cell Responses) Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Day 0
Description	The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.
Time Frame	At pre-vaccination (Day 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
VLP-16, =0	8 13.1%	13 22%	10 33.3%
VLP-16, >0	14 23%	13 22%	6 20%
VLP-16, Missing	20 32.8%	11 18.6%	6 20%
VLP-18, =0	5 8.2%	15 25.4%	6 20%
VLP-18, >0	16 26.2%	11 18.6%	10 33.3%
VLP-18, Missing	21 34.4%	11 18.6%	6 20%

29. Primary Outcome

Title	CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 2
Description	The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.
Time Frame	At Month 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
VLP-16, =0	8 13.1%	9 15.3%	2 6.7%
VLP-16, >0	20 32.8%	7 11.9%	11 36.7%
VLP-16, Missing	14 23%	21 35.6%	9 30%
VLP-18, =0	11 18%	9 15.3%	2 6.7%
VLP-18, >0	17 27.9%	8 13.6%	11 36.7%
VLP-18, Missing	14 23%	20 33.9%	9 30%

30. Primary Outcome

Title	CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 7
Description	The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.
Time Frame	At Month 7

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
VLP-16, =0	2 3.3%	9 15.3%	1 3.3%
VLP-16, >0	24 39.3%	16 27.1%	21 70%
VLP-16, Missing	16 26.2%	12 20.3%	0 0%
VLP-18, =0	0 0%	15 25.4%	1 3.3%
VLP-18, >0	25 41%	11 18.6%	19 63.3%
VLP-18, Missing	17 27.9%	11 18.6%	2 6.7%

31. Primary Outcome

Title	CMI B-cell Responses Related to HPV 16/18 Virus-like Particles (VLPs) Measured by Flow Cytometry at Month 12
Description	The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.
Time Frame	At Month 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	42	37	22
VLP-16, =0	8 13.1%	9 15.3%	2 6.7%
VLP-16, >0	21 34.4%	16 27.1%	18 60%
VLP-16, Missing	13 21.3%	12 20.3%	2 6.7%
VLP-18, =0	13 21.3%	10 16.9%	3 10%
VLP-18, >0	13 21.3%	14 23.7%	15 50%
VLP-18, Missing	16 26.2%	13 22%	4 13.3%

32. Primary Outcome

Title	CMI Response (T-cell Responses) Related to HPV-16 and HPV-18 Measured by Intracellular Cytokine Staining (ICS)
Description	The CMI response is the measure of the cytokines production [i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.
Time Frame	At pre-vaccination (Day 0) and at Months 2, 7 and 12

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Arm/Group Title	HIV+/Cervarix Group	HIV+/Aluminium Hydroxide Group	HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.	Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
Measure Participants	36	32	18
CD4-ALL DOUBLES [HPV-16], At Day 0	256.0	154.0	259.0
CD4-ALL DOUBLES [HPV-16], At Month 2	4082.0	154.5	1691.0
CD4-ALL DOUBLES [HPV-16], At Month 7	4717.5	177.5	3121.5
CD4-ALL DOUBLES [HPV-16], At Month 12	3063.5	184.5	2490.0
CD4-ALL DOUBLES [HPV-18], At Day 0	218.0	114.0	273.0
CD4-ALL DOUBLES [HPV-18], At Month 2	2658.0	156.5	1065.0
CD4-ALL DOUBLES [HPV-18], At Month 7	2917.5	143.5	1834.0
CD4-ALL DOUBLES [HPV-18], At Month 12	1694.5	220.0	1783.0
CD4-CD40L [HPV-16], At Day 0	200.0	101.0	208.0
CD4-CD40L [HPV-16], At Month 2	3940.0	125.5	1437.0
CD4-CD40L [HPV-16], At Month 7	3400.5	143.5	2303.0
CD4-CD40L [HPV-16], At Month 12	2569.0	162.5	2201.0
CD4-CD40L [HPV-18], At Day 0	150.0	98.0	222.0
CD4-CD40L [HPV-18], At Month 2	2467.0	142.5	974.0
CD4-CD40L [HPV-18], At Month 7	2247.5	108.5	1524.5
CD4-CD40L [HPV-18], At Month 12	1484.0	178.0	1587.0
CD4-IFN-γ [HPV-16], At Day 0	57.0	57.0	66.0
CD4-IFN-γ [HPV-16], At Month 2	1748.0	50.0	760.0
CD4- IFN-γ [HPV-16], At Month 7	1807.0	51.0	900.5
CD4- IFN-γ [HPV-16], At Month 12	735.0	49.5	592.0
CD4-IFN-γ [HPV-18], At Day 0	25.0	40.0	54.0
CD4-IFN-γ [HPV-18], At Month 2	1045.0	43.5	407.0
CD4- IFN-γ [HPV-18], At Month 7	915.0	31.5	626.5
CD4- IFN-γ [HPV-18], At Month 12	341.5	39.0	436.0
CD4-IL-2 [HPV-16], At Day 0	187.0	104.0	176.0
CD4-IL-2 [HPV-16], At Month 2	3716.0	79.0	1601.0
CD4- IL-2 [HPV-16], At Month 7	4329.0	113.5	2830.5
CD4- IL-2 [HPV-16], At Month 12	2946.0	135.5	2366.0
CD4-IL-2 [HPV-18], At Day 0	132.0	76.0	206.0
CD4-IL-2 [HPV-18], At Month 2	2527.0	103.5	921.0
CD4- IL-2 [HPV-18], At Month 7	2664.0	87.5	1572.5
CD4- IL-2 [HPV-18], At Month 12	1533.5	134.0	1633.0
CD4-TNF-α [HPV-16], At Day 0	148.0	132.0	185.0
CD4-TNF-α [HPV-16], At Month 2	3131.0	105.0	1332.0
CD4-TNF-α [HPV-16], At Month 7	4315.0	154.0	2479.0
CD4-TNF-α [HPV-16], At Month 12	2662.5	135.5	2133.0
CD4-TNF-α [HPV-18], At Day 0	150.0	84.0	229.0
CD4-TNF-α [HPV-18], At Month 2	2319.0	94.5	982.0
CD4-TNF-α [HPV-18], At Month 7	2689.0	109.0	1526.5
CD4-TNF-α [HPV-18], At Month 12	1542.5	138.0	1650.0
CD8-ALL DOUBLES [HPV-16], At Day 0	43.0	40.0	26.0
CD8-ALL DOUBLES [HPV-16], At Month 2	65.0	40.5	48.0
CD8-ALL DOUBLES [HPV-16], At Month 7	38.0	32.5	48.0
CD8-ALL DOUBLES [HPV-16], At Month 12	53.5	37.0	45.0
CD8-ALL DOUBLES [HPV-18], At Day 0	51.0	11.0	31.0
CD8-ALL DOUBLES [HPV-18], At Month 2	65.0	39.5	62.0
CD8-ALL DOUBLES [HPV-18], At Month 7	40.0	35.5	44.0
CD8-ALL DOUBLES [HPV-18], At Month 12	39.5	35.0	21.0
CD8-CD40L [HPV-16], At Day 0	7.0	7.0	7.0
CD8-CD40L [HPV-16], At Month 2	28.0	7.0	7.0
CD8-CD40L [HPV-16], At Month 7	26.5	7.0	24.0
CD8-CD40L [HPV-16], At Month 12	7.0	7.0	7.0
CD8-CD40L [HPV-18], At Day 0	18.5	7.0	7.0
CD8- CD40L [HPV-18], At Month 2	7.0	7.0	38.0
CD8-CD40L [HPV-18], At Month 7	7.0	7.0	7.0
CD8-CD40L [HPV-18], At Month 12	7.0	7.0	7.0
CD8-IFN-γ [HPV-16], At Day 0	35.5	25.0	7.0
CD8-IFN-γ [HPV-16], At Month 2	39.0	7.0	39.0
CD8-IFN-γ [HPV-16], At Month 7	25.0	23.5	28.5
CD8-IFN-γ [HPV-16], At Month 12	47.5	28.5	26.0
CD8-IFN-γ [HPV-18], At Day 0	39.0	7.0	9.0
CD8-IFN-γ [HPV-18], At Month 2	37.0	27.5	53.0
CD8-IFN-γ [HPV-18], At Month 7	33.0	22.0	38.0
CD8-IFN-γ [HPV-18], At Month 12	29.0	31.0	7.0
CD8-IL-2 [HPV-16], At Day 0	7.0	7.0	7.0
CD8-IL-2 [HPV-16], At Month 2	24.0	20.0	32.0
CD8-IL-2 [HPV-16], At Month 7	20.5	7.0	28.5
CD8-IL-2 [HPV-16], At Month 12	7.0	7.5	7.0
CD8-IL-2 [HPV-18], At Day 0	7.0	7.0	7.0
CD8-IL-2 [HPV-18], At Month 2	7.0	7.0	11.0
CD8-IL-2 [HPV-18], At Month 7	7.0	7.0	17.5
CD8-IL-2 [HPV-18], At Month 12	7.0	7.0	7.0
CD8-TNF-α [HPV-16], At Day 0	26.0	34.0	7.0
CD8-TNF-α [HPV-16], At Month 2	34.0	28.5	30.0
CD8-TNF-α [HPV-16], At Month 7	25.5	15.5	28.5
CD8-TNF-α [HPV-16], At Month 12	35.5	9.0	26.0
CD8-TNF-α [HPV-18], At Day 0	21.5	7.0	7.0
CD8-TNF-α [HPV-18], At Month 2	38.0	7.0	28.0
CD8-TNF-α [HPV-18], At Month 7	28.5	25.5	22.0
CD8-TNF-α [HPV-18], At Month 12	28.0	18.0	7.0

Adverse Events

Time Frame	Solicited local and general symptoms were assessed within 7 days post-vaccination. Unsolicited symptoms were assessed within 30 days post-vaccination. SAEs were assessed during the whole study period (from Day 0 up to Month 12).
Arm/Group Title	HIV+/Cervarix Group		HIV+/Aluminium Hydroxide Group		HIV-/Cervarix Group
Arm/Group Description	Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm, according to a 0, 1, 6-month schedule.		Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.		Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
All Cause Mortality
	HIV+/Cervarix Group		HIV+/Aluminium Hydroxide Group		HIV-/Cervarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/59 (0%)		0/30 (0%)
Serious Adverse Events
	HIV+/Cervarix Group		HIV+/Aluminium Hydroxide Group		HIV-/Cervarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/61 (4.9%)		2/59 (3.4%)		1/30 (3.3%)
Infections and infestations
Gastroenteritis	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Lobar pneumonia	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Pneumonia bacterial	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Injury, poisoning and procedural complications
Skull fracture	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Nervous system disorders
Migraine	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Psychiatric disorders
Psychotic disorder	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Suicide attempt	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Other (Not Including Serious) Adverse Events
	HIV+/Cervarix Group		HIV+/Aluminium Hydroxide Group		HIV-/Cervarix Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/61 (100%)		55/59 (93.2%)		29/30 (96.7%)
Blood and lymphatic system disorders
Anaemia	2/61 (3.3%)	2	0/59 (0%)	0	0/30 (0%)	0
Eosinophilia	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Neutropenia	2/61 (3.3%)	2	0/59 (0%)	0	1/30 (3.3%)	2
Ear and labyrinth disorders
Ear pain	1/61 (1.6%)	1	2/59 (3.4%)	2	1/30 (3.3%)	1
Eye disorders
Conjunctivitis	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Eye swelling	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Gastrointestinal disorders
Abdominal pain	2/61 (3.3%)	2	2/59 (3.4%)	2	1/30 (3.3%)	1
Diarrhoea	4/61 (6.6%)	4	6/59 (10.2%)	7	1/30 (3.3%)	1
Dyspepsia	1/61 (1.6%)	1	1/59 (1.7%)	1	2/30 (6.7%)	2
Gastritis	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Gastrointestinal disorder	15/61 (24.6%)	18	11/59 (18.6%)	11	13/30 (43.3%)	19
Nausea	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Peptic ulcer	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Toothache	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Vomiting	0/61 (0%)	0	1/59 (1.7%)	1	1/30 (3.3%)	1
General disorders
Pain	52/61 (85.2%)	102	27/59 (45.8%)	36	28/30 (93.3%)	59
Swelling	19/61 (31.1%)	23	2/59 (3.4%)	2	12/30 (40%)	15
Fatigue	18/61 (29.5%)	20	16/59 (27.1%)	20	8/30 (26.7%)	15
Influenza like illness	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Injection site erythema	7/61 (11.5%)	8	1/59 (1.7%)	1	4/30 (13.3%)	6
Injection site induration	4/61 (6.6%)	4	0/59 (0%)	0	4/30 (13.3%)	4
Injection site mass	3/61 (4.9%)	3	0/59 (0%)	0	0/30 (0%)	0
Injection site pruritus	3/61 (4.9%)	3	0/59 (0%)	0	2/30 (6.7%)	2
Oedema peripheral	0/61 (0%)	0	1/59 (1.7%)	2	0/30 (0%)	0
Pyrexia	2/61 (3.3%)	2	3/59 (5.1%)	3	2/30 (6.7%)	2
Vessel puncture site pain	2/61 (3.3%)	2	0/59 (0%)	0	0/30 (0%)	0
Infections and infestations
Bartholin's abscess	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Bronchitis	2/61 (3.3%)	3	1/59 (1.7%)	1	1/30 (3.3%)	1
Candidiasis	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Cellulitis	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Folliculitis	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Gastroenteritis	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Gastroenteritis viral	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Herpes simplex	0/61 (0%)	0	2/59 (3.4%)	2	0/30 (0%)	0
Herpes virus infection	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Herpes zoster	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Hordeolum	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Influenza	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Measles	2/61 (3.3%)	2	0/59 (0%)	0	0/30 (0%)	0
Nasopharyngitis	3/61 (4.9%)	3	6/59 (10.2%)	6	3/30 (10%)	3
Oral herpes	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Otitis media	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Paronychia	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Pharyngitis	1/61 (1.6%)	1	2/59 (3.4%)	2	0/30 (0%)	0
Rhinitis	3/61 (4.9%)	3	1/59 (1.7%)	1	1/30 (3.3%)	1
Sexually transmitted disease	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Sinusitis	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Subcutaneous abscess	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Tinea infection	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Tonsillitis	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Tooth abscess	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Upper respiratory tract infection	10/61 (16.4%)	11	10/59 (16.9%)	10	7/30 (23.3%)	7
Urinary tract infection	1/61 (1.6%)	1	2/59 (3.4%)	2	2/30 (6.7%)	2
Vaginitis bacterial	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Varicella	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Viral pharyngitis	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Vulvovaginal candidiasis	5/61 (8.2%)	5	4/59 (6.8%)	4	0/30 (0%)	0
Vulvovaginitis trichomonal	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Injury, poisoning and procedural complications
Arthropod bite	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Face injury	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Joint injury	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Stab wound	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Thermal burn	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Investigations
Cd4 lymphocytes decreased	2/61 (3.3%)	2	1/59 (1.7%)	1	0/30 (0%)	0
Neutrophil count decreased	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	4/61 (6.6%)	4	5/59 (8.5%)	5	2/30 (6.7%)	2
Axillary mass	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Back pain	5/61 (8.2%)	5	4/59 (6.8%)	4	3/30 (10%)	3
Flank pain	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Muscle spasms	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Muscular weakness	0/61 (0%)	0	1/59 (1.7%)	1	1/30 (3.3%)	1
Musculoskeletal pain	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Myalgia	4/61 (6.6%)	4	3/59 (5.1%)	4	7/30 (23.3%)	8
Neck pain	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvovaginal human papilloma virus infection	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Nervous system disorders
Dizziness	4/61 (6.6%)	4	4/59 (6.8%)	5	2/30 (6.7%)	3
Headache	31/61 (50.8%)	40	33/59 (55.9%)	48	18/30 (60%)	25
Paraesthesia	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Psychiatric disorders
Acute stress disorder	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Insomnia	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Renal and urinary disorders
Dysuria	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Reproductive system and breast disorders
Breast pain	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Dysmenorrhoea	1/61 (1.6%)	1	1/59 (1.7%)	1	1/30 (3.3%)	1
Menorrhagia	0/61 (0%)	0	2/59 (3.4%)	2	0/30 (0%)	0
Metrorrhagia	1/61 (1.6%)	1	0/59 (0%)	0	1/30 (3.3%)	1
Vulvovaginal pruritus	1/61 (1.6%)	1	2/59 (3.4%)	2	1/30 (3.3%)	1
Respiratory, thoracic and mediastinal disorders
Bronchospasm	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Cough	8/61 (13.1%)	8	5/59 (8.5%)	5	4/30 (13.3%)	4
Epistaxis	0/61 (0%)	0	3/59 (5.1%)	3	1/30 (3.3%)	1
Nasal obstruction	2/61 (3.3%)	2	0/59 (0%)	0	0/30 (0%)	0
Oropharyngeal pain	2/61 (3.3%)	2	1/59 (1.7%)	1	0/30 (0%)	0
Rhinitis allergic	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Rhinitis seasonal	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0
Throat irritation	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Skin and subcutaneous tissue disorders
Acne	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Dermatitis allergic	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Dermatitis contact	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Eczema	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Erythema	0/61 (0%)	0	0/59 (0%)	0	1/30 (3.3%)	1
Night sweats	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Pruritus generalised	1/61 (1.6%)	1	0/59 (0%)	0	0/30 (0%)	0
Rash	3/61 (4.9%)	3	2/59 (3.4%)	2	3/30 (10%)	3
Rash pruritic	0/61 (0%)	0	1/59 (1.7%)	1	0/30 (0%)	0
Surgical and medical procedures
Tooth extraction	1/61 (1.6%)	1	1/59 (1.7%)	1	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.