Trial Outcomes & Findings for Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine (NCT NCT00316706)

Last Updated: 2012-09-18

Results Overview

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1245 participants

Primary outcome timeframe

At 18, 24, 36 and 48 months

Results posted on

2012-09-18

Participant Flow

Subjects from the Cervarix group continued the long-term follow-up study until Month 48 while subjects from the Havrix group completed the study at Month 24.

Participant milestones

Participant milestones
Measure	Cervarix Group Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Study STARTED	626	619
Overall Study COMPLETED	588	571
Overall Study NOT COMPLETED	38	48

Reasons for withdrawal

Reasons for withdrawal
Measure	Cervarix Group Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Overall Study Lost to Follow-up	38	48

Baseline Characteristics

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cervarix Group n=626 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group n=619 Participants Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.	Total n=1245 Participants Total of all reporting groups
Age Continuous	12.1 years STANDARD_DEVIATION 1.4 • n=5 Participants	12.1 years STANDARD_DEVIATION 1.4 • n=7 Participants	12.1 years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	626 Participants n=5 Participants	619 Participants n=7 Participants	1245 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 18, 24, 36 and 48 months

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on those subjects from the Cervarix Group with available data for the defined time point.

Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).

Outcome measures

Outcome measures
Measure	Cervarix Group n=588 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 18 (n= 588)	3901.6 EL.U/mL Interval 3626.2 to 4198.0	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 24 (n= 549)	3226.3 EL.U/mL Interval 2988.4 to 3483.1	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 36 (n= 571)	2688.6 EL.U/mL Interval 2503.6 to 2887.3	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-16 at Month 48 (n= 559)	2395.8 EL.U/mL Interval 2230.5 to 2573.3	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 18 (n= 587)	1570.8 EL.U/mL Interval 1448.3 to 1703.7	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 24 (n= 548)	1263.4 EL.U/mL Interval 1165.1 to 1370.1	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 36 (n= 570)	995.0 EL.U/mL Interval 918.1 to 1078.4	—
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies Anti-HPV-18 at Month 48 (n= 559)	885.6 EL.U/mL Interval 816.3 to 960.8	—

SECONDARY outcome

Timeframe: At Months 18 and 24

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point.

Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.

Outcome measures

Outcome measures
Measure	Cervarix Group n=551 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group n=338 Participants Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up Month 18 (n= 128, 129)	347.2 EL.U/mL Interval 297.8 to 404.7	117.7 EL.U/mL Interval 101.3 to 136.8
Titers of Anti-3-O-desacyl-4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Initial 2 Years Follow-up Month 24 (n= 551, 338)	271.5 EL.U/mL Interval 252.2 to 292.3	74.0 EL.U/mL Interval 66.3 to 82.6

SECONDARY outcome

Timeframe: At Month 36 and 48

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.

Titers are given as Geometric Mean Titers (GMTs) expressed as EL.U/mL.

Outcome measures

Outcome measures
Measure	Cervarix Group n=571 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up Month 36 (n= 571)	224.7 EL.U/mL Interval 204.8 to 246.6	—
Titers of Anti-3-O-desacyl 4'-Monophosphoryl Lipid A (Anti-MPL) Antibodies During the Last 2 Years Follow-up Month 48 (n= 558)	170.0 EL.U/mL Interval 156.6 to 184.4	—

SECONDARY outcome

Timeframe: From Month 18 to Month 24

Population: Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point.

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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

Outcome measures

Outcome measures
Measure	Cervarix Group n=626 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group n=619 Participants Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up Pregnancies (n=626, 619)	8 Subjects	1 Subjects
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up NOCDs (n=617, 571)	5 Subjects	3 Subjects
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up ER visits (n=617, 571)	40 Subjects	21 Subjects
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room (ER) Visits or Physician Visits That Are Not Related to Common Diseases During the First 2 Years Follow-up SAEs (n=617, 571)	8 Subjects	5 Subjects

SECONDARY outcome

Timeframe: From Month 24 to Month 48

Population: Analyses were performed on the Total Vaccinated Cohort, on subjects with available data at the defined time point. Analysis was only done for subjects in the Cervarix Group, as all subjects from the Havrix Group completed the study at Month 24.

Serious adverse events assessed include medical occurrences that result in death, is 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. New onset of chronic diseases (NOCDs) assessed include e.g. autoimmune disorders, asthma, type I diabetes.

Outcome measures

Outcome measures
Measure	Cervarix Group n=626 Participants Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up Pregnancies (Month 24 to 36) (n=626,0)	3 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up Pregnancies (Month 36 to 48) (n=588,0)	11 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up NOCDs (Month 24 to 36) (n=601,0)	7 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up NOCDs (Month 36 to 48) (n=588,0)	6 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up ER visits (Month 24 to 36) (n=601,0)	41 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up ER visits (Month 36 to 48) (n=588,0)	50 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up SAEs (Month 24 to 36) (n=601,0)	10 Subjects	—
Number of Subjects Reporting Pregnancies, Serious Adverse Events (SAEs), New Onset Chronic Diseases (NOCDs), and Conditions Prompting Emergency Room During the Last 2 Years Follow-up SAEs (Month 36 to 48) (n=588,0)	15 Subjects	—

Adverse Events

Cervarix Group

Serious events: 33 serious events

Other events: 0 other events

Deaths: 0 deaths

Havrix Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cervarix Group n=626 participants at risk Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.	Havrix Group n=619 participants at risk Subjects received 3 doses of Havrix™ (hepatitis A vaccine \[HAV\]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
Gastrointestinal disorders Abdominal pain	0.48% 3/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Cellulitis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Gastrointestinal disorders Constipation	0.32% 2/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Congenital, familial and genetic disorders Dermoid cyst of ovary	0.00% 0/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.16% 1/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Nervous system disorders Loss of consciousness	0.00% 0/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.16% 1/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Reproductive system and breast disorders Ovarian cyst	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.16% 1/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Pneumonia	0.00% 0/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.16% 1/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Pregnancy, puerperium and perinatal conditions Premature labor	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Skull fractured base	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.16% 1/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Psychiatric disorders Suicide attempt	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Gastrointestinal disorders Umbilical hernia	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
General disorders Pyrexia	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Appendicitis	0.80% 5/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Campylobacter gastroenteritis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Helicobacter gastritis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Subcutaneous abscess	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Traumatic brain injury	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Metabolism and nutrition disorders Dehydration	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Psychiatric disorders Depressed mood	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Reproductive system and breast disorders Ovarian cyst torsion	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Acute tonsilitis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Alcohol poisoning	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Hepatobiliary disorders Cholelithiasis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Concussion	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Gastroenteritis	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Gastroenteritis viral	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Investigations Investigation	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Injury, poisoning and procedural complications Lower limb fracture	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Gastrointestinal disorders Malocclusion	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Infections and infestations Meningitis viral	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.16% 1/626 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.	0.00% 0/619 • From Month 18 up to Month 24 in Havrix group and up to Month 48 in Cervarix group Other (non-serious) adverse event data were not collected in the framework of this long-term follow-up study.