Trial Outcomes & Findings for Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants (NCT NCT00750893)

NCT ID: NCT00750893

Last Updated: 2020-03-03

Results Overview

Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.

Recruitment status

COMPLETED

Target enrollment

3111 participants

Primary outcome timeframe

During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

Results posted on

2020-03-03

Participant Flow

This post marketing study (PMS) covered a period of 6 consecutive years. Results were presented for Years 1, 2, 3, 4, 5 (Year \[Y\] 1 \& Y2 data combined and presented at the Y2 time point and Y3 \& Y4 data combined and presented at the Y4 time point) along with consolidated surveillance data from Y1- Y6 timepoint.

Consolidated participant flow and baseline measure data were given for Years 1 to 6 time point in order to account for all the subjects participating in this study.

Participant milestones

Participant milestones
Measure	Rotarix Group Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Overall Study STARTED	3111
Overall Study COMPLETED	2569
Overall Study NOT COMPLETED	542

Reasons for withdrawal

Reasons for withdrawal
Measure	Rotarix Group Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	10
Overall Study Lost to Follow-up	510
Overall Study Other	17

Baseline Characteristics

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rotarix Group n=3111 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Age, Continuous	9.6 weeks STANDARD_DEVIATION 2.22 • n=5 Participants
Sex: Female, Male Female	1525 Participants n=5 Participants
Sex: Female, Male Male	1586 Participants n=5 Participants
Race/Ethnicity, Customized Korean	3107 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	2 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

Population: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.

Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.

Outcome measures

Outcome measures
Measure	Rotarix Group n=876 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Solicited General Symptoms Cough	204 Participants
Number of Subjects Reporting Solicited General Symptoms Diarrhoea	50 Participants
Number of Subjects Reporting Solicited General Symptoms Irritability	405 Participants
Number of Subjects Reporting Solicited General Symptoms Loss of appetite	259 Participants
Number of Subjects Reporting Solicited General Symptoms Temperature	135 Participants
Number of Subjects Reporting Solicited General Symptoms Vomiting	200 Participants

PRIMARY outcome

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

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.

Outcome measures

Outcome measures
Measure	Rotarix Group n=876 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period	334 Participants

PRIMARY outcome

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period

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.

Outcome measures

Outcome measures
Measure	Rotarix Group n=1052 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period	413 Participants

PRIMARY outcome

Timeframe: During the 31 day follow-up period after each vaccine dose for Year 5 study period

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.

Outcome measures

Outcome measures
Measure	Rotarix Group n=708 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period	254 Participants

PRIMARY outcome

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period

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.

Outcome measures

Outcome measures
Measure	Rotarix Group n=3111 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period	1201 Participants

PRIMARY outcome

Timeframe: During the post-marketing study period for Year 1 & Year 2 study period

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

Outcome measures

Outcome measures
Measure	Rotarix Group n=876 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period	6 Participants

PRIMARY outcome

Timeframe: During the post-marketing study period for Year 3 & Year 4 study period

Outcome measures

Outcome measures
Measure	Rotarix Group n=1052 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period	13 Participants

PRIMARY outcome

Timeframe: During the post-marketing study period for Year 5 study period

Outcome measures

Outcome measures
Measure	Rotarix Group n=708 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period	4 Participants

PRIMARY outcome

Timeframe: During the post-marketing study period for Year 1 to Year 6 study period

Outcome measures

Outcome measures
Measure	Rotarix Group n=3111 Participants Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period	26 Participants

Adverse Events

Rotarix Group

Serious events: 26 serious events

Other events: 684 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rotarix Group n=3111 participants at risk Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Renal and urinary disorders Urinary tract infection	0.10% 3/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
General disorders Fever	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Cytomegalovirus Gastrointestinal Infection	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Ileus paralytic	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Colitis	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Ear and labyrinth disorders Otitis Media	0.13% 4/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Infections and infestations Sepsis	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Gastroenteritis	0.10% 3/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Renal and urinary disorders Hydronephrosis	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Bronchopneumonia	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.13% 4/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Bronchiolitis	0.29% 9/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Croup	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.06% 2/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Gastroenteritis viral	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Pneumonia viral	0.03% 1/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.

Other adverse events

Other adverse events
Measure	Rotarix Group n=3111 participants at risk Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.
Respiratory, thoracic and mediastinal disorders Cough	6.6% 204/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	8.6% 268/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Metabolism and nutrition disorders Decreased appetite	8.3% 259/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
General disorders Irritability	13.0% 405/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.
Gastrointestinal disorders Vomiting	6.4% 200/3111 • Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively. Classification for AEs was performed differently across the study period, according to MedDRA preferred terms until Year 4, and to World Health Organisation's Adverse Reactions Terminology (WHO ART) Dictionary for Year 5 and for the consolidated results from Year 1 to Year 6. The data presented within the Adverse Events section represent the consolidated results for Year 1 to Year 6 period.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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