Trial Outcomes & Findings for Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants (NCT NCT00779779)

NCT ID: NCT00779779

Last Updated: 2018-08-28

Results Overview

Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

• Recruitment status: COMPLETED
• Target enrollment: 522 participants
• Primary outcome timeframe: During the 8-day solicited follow-up period
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	Rotarix Group Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Overall Study STARTED	522
Overall Study COMPLETED	498
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	Rotarix Group Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Overall Study Adverse Event	1
Overall Study Protocol Violation	14
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	5

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Rotarix Group n=522 Participants Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Age, Continuous	12.5 weeks STANDARD_DEVIATION 5.62 • n=5 Participants
Sex: Female, Male Female	267 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 8-day solicited follow-up period

Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.

Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.

Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.

Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

Outcome measures

Measure	Rotarix Group n=522 Participants Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea	78 subjects

SECONDARY outcome

Timeframe: During the 8-day follow-up period

Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.

Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.

Outcome measures

Measure	Rotarix Group n=522 Participants Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Number of Subjects Reporting Each Type of Solicited General Symptoms Loss of appetite	83 subjects
Number of Subjects Reporting Each Type of Solicited General Symptoms Cough	71 subjects
Number of Subjects Reporting Each Type of Solicited General Symptoms Diarrhoea	24 subjects
Number of Subjects Reporting Each Type of Solicited General Symptoms Irritability	124 subjects
Number of Subjects Reporting Each Type of Solicited General Symptoms Fever	152 subjects
Number of Subjects Reporting Each Type of Solicited General Symptoms Vomiting	45 subjects

SECONDARY outcome

Timeframe: During the 31-day follow-up period

Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.

Unsolicited AEs cover 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

Measure	Rotarix Group n=522 Participants Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	25 subjects

SECONDARY outcome

Timeframe: Throughout the study period (Day 0 to Month 3 or 4)

Population: Analysis was performed on the Total Vaccinated Cohort, which consisted of all vaccinated subjects with at least one vaccine administration documented.

SAEs 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

Outcome measures

Measure	Rotarix Group n=522 Participants Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Number of Subjects Reporting Serious Adverse Events (SAEs)	1 subjects

Adverse Events

Rotarix Group

Serious events: 1 serious events

Other events: 247 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rotarix Group n=522 participants at risk Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Nervous system disorders Crying	0.19% 1/522

Other adverse events

Measure	Rotarix Group n=522 participants at risk Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
General disorders Cough	13.6% 71/522
General disorders Diarrhoea	4.6% 24/522
General disorders Loss of appetite	15.9% 83/522
General disorders Irritability	23.8% 124/522
General disorders Fever	29.1% 152/522
General disorders Vomiting	8.6% 45/522

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