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Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) co-administered with Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule.

Subjects received 3 doses of Cervarix™ (Human Papillomavirus \[HPV\] vaccine) according to a 0, 1, 6-month schedule.

Subjects received 3 doses of Engerix™ (Hepatitis B \[HBV\] vaccine) according to a 0, 1, 6-month schedule.

HPV Vaccine (GSK580299) Cervarix TM

Engerix B

GSK Clinical Trials

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer. Thus, HPV vaccination could complement the existing pre-adolescent/adolescent vaccination programs. This Phase IIIb study is designed to evaluate the immunogenicity and safety of co-administering a commercially available vaccine with GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) vaccine as compared to the administration of either vaccine alone.

Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV Vaccine (580299) Co-administrated With a Commercially Available Vaccine in Healthy Female Adolescents

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination.

Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.

Only groups which had received the HPV vaccine were included in the analysis.

Anti-HPV-16 antibody cut-off value assessed included 8 Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed included 7 EL.U/mL.

Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.

Antibody titers for Anti-HPV-16 and Anti-HPV-18 are expressed as Geometric Mean Titers (GMTs).

Only groups which had received the HPV vaccine were included in the analysis.

Subjects included were seronegative for anti-HPV-16 (antibody titer \< 8 EL.U/mL) and anti-HPV-18 (antibody titer \< 7 EL.U/mL) prior to vaccination.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 mIU/mL) prior to vaccination.

Anti-HBs antibody cut-off value for seroconversion assessed included 3.3 mIU/mL.

Antibody titers for anti-HBs are given as Geometric Mean Titers (GMTs) in mIU/mL.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 mIU/mL) prior to vaccination.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 milli International Units per milliliter (mIU/mL)) prior to vaccination vaccination.

Anti-HBs antibody cut-off value for seroprotection assessed included 10 mIU/mL.

Anti-HBs antibody titers are given as GMTs in mIU/mL.

Only groups which had received the HBV vaccine were included in the analysis.

Subjects included were seronegative for anti-HBs (antibody titer \< 3.3 mIU/mL) prior to vaccination.

Solicited local symptoms included injection site pain, redness and swelling.

Any solicited local symptom is occurence of a symptom regardless of its intensity.

Solicited local symptoms include injection site pain, redness and swelling.

Grade 3 pain is pain that prevented normal everyday activities. Grade 3 redness is redness that was \> 50 mm. Grade 3 swelling is swelling that was \> 50 mm.

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Any solicited general symptom is the occurence of the symptom regardless of its intensity or relationship to study vaccination.

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Grade 3 arthralgia, fatigue, gastrointestinal, headache, myalgia and rash were symptoms that prevented normal activity.

Grade 3 temperature was temperature \> 39 degrees Celsius. Grade 3 urticaria was urticaria distributed on at least 4 body areas.

Solicited general symptoms included arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, temperature in degrees celsius (axillary) and urticaria.

Related solicited general symptoms were those symptoms assessed by the investigators as related to the study vaccination.

Unsolicited AE covers any AE 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.

Grade 3 AE was an AE that prevented normal activities. Related AE was an AE that was assessed by the investigator as related to the study vaccination.

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

Related SAEs were SAEs assessed by the investigators as related to the vaccination.

\* Grade 3 SAEs were not assessed.

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

\* Grade 3 SAEs were not assessed.

Medically significant conditions (i.e., 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).

GlaxoSmithKline

Cervarix&Engerix Group

Cervarix Group

Engerix Group

Total

Age, Continuous

Sex: Female, Male

GSK Response Center

The analysis was performed on the According-to-Protocol (ATP) Cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroprotection

Anti-HPV-16

Anti-HPV-18

Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Concentrations Above the Cut-off Value for Seroconversion

Anti-HPV-16/18 Antibody Titres

Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Value for Seroconversion

Anti-HBs Antibody Titres

Number of Subjects With Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations Above the Cut-off Value for Seroconversion

Number of Subjects With Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Value for Seroconversion

Anti-HBs Antibody Titers

Pain

Redness

Swelling

Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects	NCT00652938	Infections, Pap...	HPV Vaccine (GS... Engerix B	9 Years - 15 Years	GlaxoSmithKline
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects	NCT00652938	Infections, Pap...	HPV Vaccine (GS... Engerix B	9 Years - 15 Years	GlaxoSmithKline
Evaluation of Immunogenicity and Safety of Human Papillomavirus (HPV) Vaccine Co-administered With Another Vaccine in Healthy Female Subjects	NCT00652938	Infections, Pap...	HPV Vaccine (GS... Engerix B	9 Years - 15 Years	GlaxoSmithKline

Spots Global Cancer Trial Database for hpv vaccine (gsk580299) cervarix tm