Trial Outcomes & Findings for Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine. (NCT NCT00420316)

NCT ID: NCT00420316

Last Updated: 2018-08-28

Results Overview

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1613 participants
• Primary outcome timeframe: During the study period for the long-term follow-up (i.e. 6 months)
• Results posted on: 2018-08-28

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Measure	Rotarix Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Overall Study STARTED	1082	531
Overall Study COMPLETED	1070	522
Overall Study NOT COMPLETED	12	9

Reasons for withdrawal

Measure	Rotarix Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	12	8

Baseline Characteristics

Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

Baseline characteristics by cohort

Measure	Rotarix Group n=1082 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=531 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Total n=1613 Participants Total of all reporting groups
Age, Continuous	31.2 Months STANDARD_DEVIATION 1.12 • n=5 Participants	31.3 Months STANDARD_DEVIATION 1.19 • n=7 Participants	31.23 Months STANDARD_DEVIATION 1.14 • n=5 Participants
Sex: Female, Male Female	510 Participants n=5 Participants	266 Participants n=7 Participants	776 Participants n=5 Participants
Sex: Female, Male Male	572 Participants n=5 Participants	265 Participants n=7 Participants	837 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)	4 Subjects	3 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)	1 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype	0 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype	0 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype	4 Subjects	1 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period.

Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.

Outcome measures

Measure	Rotarix Group n=1065 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=525 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects With Severe Gastroenteritis (GE)	15 Subjects	6 Subjects

SECONDARY outcome

Timeframe: During the study period for the long-term follow-up (i.e. 6 months)

Population: The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.

An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Rotarix Group n=1082 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=531 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects Reporting Serious Adverse Events (SAEs)	4 Subjects	7 Subjects

SECONDARY outcome

Timeframe: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)

Population: The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.

Intussusception is defined as the telescoping of the intestine.

Outcome measures

Measure	Rotarix Group n=1082 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=531 Participants Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Number of Subjects Reporting Intussusception (IS)	0 Subjects	0 Subjects

Adverse Events

Rotarix Group

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rotarix Group n=1082 participants at risk Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.	Placebo Group n=531 participants at risk Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.
Respiratory, thoracic and mediastinal disorders Asthma	0.09% 1/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.19% 1/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Nervous system disorders Febrile convulsion	0.00% 0/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.19% 1/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Gastroenteritis	0.09% 1/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.19% 1/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Pneumonia	0.00% 0/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.38% 2/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Laryngitis	0.09% 1/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.00% 0/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Lower respiratory tract infection	0.00% 0/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.19% 1/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Tonsillitis	0.09% 1/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.00% 0/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)
Infections and infestations Urinary tract infection	0.00% 0/1082 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)	0.19% 1/531 • Serious adverse events (SAEs): during the study period for the long-term follow-up (i.e. 6 months)

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