Trial Outcomes & Findings for Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years (NCT NCT00197119)

NCT ID: NCT00197119

Last Updated: 2017-04-20

Results Overview

Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

244 participants

Primary outcome timeframe

Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination

Results posted on

2017-04-20

Participant Flow

At the time of initiation of the long-term follow-up study, the investigators contacted the subjects who had consented to participate in the long-term follow-up studies. At each subsequent visit, subjects who were present at the previous long-term blood sampling time points were contacted again.

Participant milestones

Participant milestones
Measure	Group Twinrix Junior Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.	Group Twinrix Adult Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Year 6 STARTED	126	118
Year 6 COMPLETED	126	118
Year 6 NOT COMPLETED	0	0
Year 7 STARTED	122	114
Year 7 COMPLETED	122	114
Year 7 NOT COMPLETED	0	0
Year 8 STARTED	122	115
Year 8 COMPLETED	122	115
Year 8 NOT COMPLETED	0	0
Year 9 STARTED	121	114
Year 9 COMPLETED	121	114
Year 9 NOT COMPLETED	0	0
Year 10 STARTED	120	108
Year 10 COMPLETED	120	108
Year 10 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Twinrix Junior n=126 Participants Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.	Group Twinrix Adult n=118 Participants Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.	Total n=244 Participants Total of all reporting groups
Age, Continuous	19.4 years STANDARD_DEVIATION 1.04 • n=5 Participants	19.4 years STANDARD_DEVIATION 1.12 • n=7 Participants	19.4 years STANDARD_DEVIATION 1.08 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	61 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	57 Participants n=7 Participants	121 Participants n=5 Participants

PRIMARY outcome

Timeframe: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination

Population: Analysis was performed on the Long Term According To Protocol (ATP) cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.

Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Group Twinrix Junior n=113 Participants Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.	Group Twinrix Adult n=100 Participants Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value Year 6 (n=113, 100)	113 subjects	100 subjects
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value Year 7 (n= 105, 92)	105 subjects	92 subjects
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value Year 8 (n= 104, 93)	104 subjects	93 subjects
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value Year 9 (n= 103, 90)	103 subjects	90 subjects
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value Year 10 (n= 100, 77)	100 subjects	77 subjects

PRIMARY outcome

Timeframe: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination

Population: Analysis was performed on the ATP cohort for immunogenicity, which included all subjects for whom serology results were available for a particular blood sampling visit.

Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.

Outcome measures

Outcome measures
Measure	Group Twinrix Junior n=113 Participants Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.	Group Twinrix Adult n=100 Participants Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Year 7 (n= 105, 92)	98 subjects	85 subjects
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Year 6 (n= 113, 100)	100 subjects	93 subjects
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Year 8 (n= 104, 93)	96 subjects	84 subjects
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Year 9 (n= 103, 90)	96 subjects	86 subjects
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value Year 10 (n= 101, 78)	97 subjects	75 subjects

PRIMARY outcome

Timeframe: From Year 6 through to Year 10

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Group Twinrix Junior n=126 Participants Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.	Group Twinrix Adult n=118 Participants Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)	0 subjects	0 subjects

Adverse Events

Group Twinrix Junior

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group Twinrix Adult

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

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