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Vaccines

The A group includes subjects from communities where 70% of male and female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects were randomized to Cervarix). Finally, subjects from A group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

The B group includes subjects from communities where 70% of female adolescents were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate female participants to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated females were randomized to Cervarix). In this group, all male adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from B group were either vaccinated with Cervarix (females) or Engerix-B/not vaccinated (males and females). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

In this control group, all adolescents were to be vaccinated with Engerix-B control vaccine. Finally, subjects from this group were either vaccinated with Engerix-B or not vaccinated. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Cervarix

Engerix-B

GSK Clinical Trials

Genital infections with oncogenic human papillomaviruses (HPV) are common in both men and women. The most important disease associated with oncogenic HPV infection is cervical cancer, currently the second leading cause of cancer-related death among women globally. The current study is designed to evaluate the overall impact of HPV immunization in adolescents 12-15 years of age.

Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

Evaluation of the Effectiveness of Two Vaccination Strategies Using GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents

IPD is available via the Clinical Study Data Request site (click on the link provided below).

The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

The analysis of overall effectiveness of Cervarix vaccine against genital infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The overall vaccine effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the Cervarix/Engerix-B A Group/prevalence rate in all subjects from Engerix-B Group).

Note: As per Protocol and as the confirmatory objectives were not met, only exploratory interpretation could be performed for what concerns this secondary outcome measure.

The analysis of overall effectiveness of Cervarix vaccine against genital infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all subjects from the investigated group (prevalence rate in all subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with HPV-16/18 types was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in Cervarix vaccinated subjects from the investigated group (prevalence rate in Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

The analysis of total effectiveness of Cervarix vaccine against oropharyngeal infection with specific HPV types (16, 18, 31/45, 31/33/45, 31/33/45/51, 31/33/45/51/52, 31/33/35/39/45/51/52/56/58/59/66/68, 16/18/31/33/35/39/45/51/52/56/58/59/66/68, 6, 11, 6/11, 6/11/53/74) was based on stratified Mantel-Haenszel adjusted for clustering. The effectiveness was computed as 1- the prevalence odd ratio in all Cervarix vaccinated subjects from the investigated group (prevalence rate in all Cervarix vaccinated subjects from the investigated group/prevalence rate in all subjects from Engerix-B Group).

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (including nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the 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.

The number of subjects with urticaria/rash assessed within 30 minutes following each vaccine dose are reported. Confirmed urticaria/rash = subjects who reported urticaria/rash within the specified time frame. Not confirmed urticaria/rash = number of subjects who did not report urticaria/rash within the specified time frame.

MSCs are defined as AEs prompting emergency room or physician visits that are not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that are not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.

Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

NOADs include colitis ulcerative, juvenile arthritis, type 1 diabetes mellitus, coeliac disease and Chron's disease, Basedow's disease, erythema nodosum VIIth nerve paralysis and psoriasis.

Pregnancies with onset during the study were classified by their outcome. Outcomes included live infant with no apparent congenital anomaly, elective termination with no apparent congenital anomaly, spontaneous abortion with no apparent congenital anomaly, ectopic pregnancy, stillbirth with no apparent congenital anomaly and molar pregnancy.

Note: The analysis was performed based on the corrected demographical data. Please refer to the rationale provided in the Baseline characteristics section.

The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 8 ELISA units per milliliter (EL.U/mL) for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18 at Visits 1 and 4 and 19 EL.U/mL for HPV-16 and 18 EL.U/mL for HPV-18 at Visit 5.

GlaxoSmithKline

AEs were collected in the TVC-Diary Card subset. For this study, the Total Number of Participants Affected by Other (non-serious) AEs was analyzed separately for solicited AEs and for unsolicited AEs. A consolidated analysis of all solicited and unsolicited AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total Number of Participants Affected in Other AEs Table is currently populated with the highest value within the Other AEs table.

Male and female subjects vaccinated with Cervarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Cervarix Pooled Group

Male and female subjects vaccinated with Engerix-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Engerix-B Pooled Group

Total

Age, Continuous

After the database freeze, discrepancies in the gender of 10 subjects were detected, this leading to 12401 female and 2436 male subjects in the Cervarix Pooled Group, and 8111 female and 9227 male subjects in the Engerix-B Pooled Group.

These 10 subjects were not part of the Immunogenicity subset, the Diary Card subset or included in the active safety follow-up up to Month 12 for SAEs.

These 10 subjects did not report any AEs and did not have any sample results. The impact on the AEs and overall effectiveness analysis was limited to the number of subjects exposed and considered minor.

Sex: Female, Male

Geographic ancestry

Race/Ethnicity, Customized

GSK Response Center

Overall efectiveness against HPV-16/18 Cervarix/Engerix-B B Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B B Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.

Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Engerix-B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Engerix-B Group was based on stratified Mantel-Haenszel adjusted for clustering.

Cervarix/Engerix-B A Group

Cervarix/Engerix-B B Group

Engerix-B Group

The analysis was performed on female study participants from the Total Enrolled cohort on effectiveness, which included all study participants who were previously enrolled in the immunization phase, and those who joined the trial at Visit 5, for whom results were available.

Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group

Overall efectiveness against HPV-16/18 Cervarix/Engerix-B A Group vs Cervarix/Engerix-B B Group: The analysis of the overall effectiveness of GSK's HPV-16/18 vaccine against HPV-16/18 genital infection in Cervarix/Engerix-B A Group versus Cervarix/Engerix-B B was based on stratified Mantel-Haenszel adjusted for clustering.

Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With HPV-16/18 Types in Cervarix/Engerix-B A Group Versus Cervarix/Engerix-B B Group

HPV-16

HPV-18

HPV-31/45

HPV-31/33/45

HPV-31/33/45/51

HPV-31/33/45/51/52

HPV-31/33/35/39/45/51/52/56/58/59/66/68

HPV-16/18/31/33/35/39/45/51/52/56/58/59/66/68

HPV-6

HPV-11

HPV-6/11

HPV-6/11/53/74

Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Oncogenic Infection With Specific HPV Types

Pooled A and B group: This pooled group includes subjects from communities where 70% of male and female adolescents (A group) or 70% of female adolescents (B group) were to be vaccinated with Cervarix vaccine. To achieve a Cervarix vaccination coverage of 70%, a 9:1 ratio was used to allocate study participants (A group) or female participants (B group) to receive Cervarix vaccine versus control Engerix-B vaccine (meaning 90% of vaccinated subjects (A group) or vaccinated females (B group) were randomized to Cervarix). Finally, subjects from this pooled group were either vaccinated with Cervarix, Engerix-B (control vaccine), or not vaccinated (enrolled control without vaccination). Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Cervarix/Engerix-B Pooled Group

Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Infection With HPV-16/18 Types

Number of Female Subjects With Total Vaccine Effectiveness Against Oropharyngeal Oncogenic Infection With Specific HPV Types

Any Pain, Dose 1

Grade 3 Pain, Dose 1

Any Redness, Dose 1

Grade 3 Redness, Dose 1

Any Swelling, Dose 1

Grade 3 Swelling, Dose 1

Any Pain, Dose 2

Grade 3 Pain, Dose 2

Any Redness, Dose 2

Grade 3 Redness, Dose 2

Any Swelling, Dose 2

Grade 3 Swelling, Dose 2

Any Pain, Dose 3

Grade 3 Pain, Dose 3

Any Redness, Dose 3

Grade 3 Redness, Dose 3

Any Swelling, Dose 3

Grade 3 Swelling, Dose 3

Any Pain, Across doses

Grade 3 Pain, Across doses

Any Redness, Across doses

Grade 3 Redness, Across doses

Any Swelling, Across doses

Grade 3 Swelling, Across doses

The analysis was performed on the Total vaccinated cohort (TVC) - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.

Number of Male Subjects Reporting Any and Grade 3 Solicited Local Symptoms, in a Subset of Subjects

Any Arthralgia, Dose 1

Grade 3 Arthralgia, Dose 1

Related Arthralgia, Dose 1

Any Fatigue, Dose 1

Grade 3 Fatigue, Dose 1

Related Fatigue, Dose 1

Any Fever (axillary), Dose 1

Grade 3 Fever (axillary), Dose 1

Related Fever (axillary), Dose 1

Any Gastrointestinal, Dose 1

Grade 3 Gastrointestinal, Dose 1

Related Gastrointestinal, Dose 1

Any Headache, Dose 1

Grade 3 Headache, Dose 1

Related Headache, Dose 1

Any Myalgia, Dose 1

Grade 3 Myalgia, Dose 1

Related Myalgia, Dose 1

Any Rash, Dose 1

Grade 3 Rash, Dose 1

Related Rash, Dose 1

Any Urticaria, Dose 1

Grade 3 Urticaria, Dose 1

Related Urticaria, Dose 1

Any Arthralgia, Dose 2

Grade 3 Arthralgia, Dose 2

Related Arthralgia, Dose 2

Any Fatigue, Dose 2

Grade 3 Fatigue, Dose 2

Related Fatigue, Dose 2

Any Fever, Dose 2

Grade 3 Fever, Dose 2

Related Fever, Dose 2

Any Gastrointestinal, Dose 2

Grade 3 Gastrointestinal, Dose 2

Related Gastrointestinal, Dose 2

Any Headache, Dose 2

Grade 3 Headache, Dose 2

Related Headache, Dose 2

Any Myalgia, Dose 2

Grade 3 Myalgia, Dose 2

Related Myalgia, Dose 2

Any Rash, Dose 2

Grade 3 Rash, Dose 2

Related Rash, Dose 2

Any Urticaria, Dose 2

Grade 3 Urticaria, Dose 2

Related Urticaria, Dose 2

Any Arthralgia, Dose 3

Grade 3 Arthralgia, Dose 3

Related Arthralgia, Dose 3

Any Fatigue, Dose 3

Grade 3 Fatigue, Dose 3

Related Fatigue, Dose 3

Any Fever, Dose 3

Grade 3 Fever, Dose 3

Related Fever, Dose 3

Any Gastrointestinal, Dose 3

Grade 3 Gastrointestinal, Dose 3

Related Gastrointestinal, Dose 3

Any Headache, Dose 3

Grade 3 Headache, Dose 3

Related Headache, Dose 3

Any Myalgia, Dose 3

Grade 3 Myalgia, Dose 3

Related Myalgia, Dose 3

Any Rash, Dose 3

Grade 3 Rash, Dose 3

Related Rash, Dose 3

Any Urticaria, Dose 3

Grade 3 Urticaria, Dose 3

Related Urticaria, Dose 3

Any Arthralgia, Across doses

Grade 3 Arthralgia, Across doses

Related Arthralgia, Across doses

Any Fatigue, Across doses

Grade 3 Fatigue, Across doses

Related Fatigue, Across doses

Any Fever, Across doses

Grade 3 Fever, Across doses

Related Fever, Across doses

Any Gastrointestinal, Across doses

Grade 3 Gastrointestinal, Across doses

Related Gastrointestinal, Across doses

Any Headache, Across doses

Grade 3 Headache, Across doses

Related Headache, Across doses

Any Myalgia, Across doses

Grade 3 Myalgia, Across doses

Related Myalgia, Across doses

Any Rash, Across doses

Grade 3 Rash, Across doses

Related Rash, Across doses

Any Urticaria, Across doses

Grade 3 Urticaria, Across doses

Related Urticaria, Across doses

The analysis was performed on the TVC - the Diary card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group, with at least one study vaccine administration documented, who were selected for active assessment of safety using diary cards and for whom data were available.

Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Solicited General Symptoms, in a Subset of Subjects

Any AEs

Grade 3 AEs

Related AEs

This analysis was performed on the TVC - the Diary Card subset, which included a subset of male adolescents from Cervarix/Engerix-B A Group and Engerix-B Group who were selected for active assessment of safety using diary cards and for whom data were available.

Number of Male Subjects Reporting Any, Grade 3 and Related to Vaccination Unsolicited Adverse Events (AEs), in a Subset of Subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents	NCT00534638	Infections, Pap...	Cervarix Engerix-B	12 Years - 15 Years	GlaxoSmithKline
Effectiveness, Safety and Immunogenicity of GSK Biologicals' HPV Vaccine GSK580299 (Cervarix) Administered in Healthy Adolescents	NCT00534638	Infections, Pap...	Cervarix Engerix-B	12 Years - 15 Years	GlaxoSmithKline

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