Trial Outcomes & Findings for To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants) (NCT NCT00363545)

Last Updated: 2018-06-08

Results Overview

A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1274 participants

Primary outcome timeframe

At 1 to 2 months after the second vaccine dose (Months 3-4)

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Liquid Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Overall Study STARTED	636	638
Overall Study COMPLETED	592	581
Overall Study NOT COMPLETED	44	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Liquid Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Overall Study Serious Adverse Event	0	1
Overall Study Withdrawal by Subject	12	15
Overall Study Migrated/moved from study area	3	6
Overall Study Lost to follow-up (incompl. vaccination)	14	18
Overall Study Lost to follow-up (complete vaccination)	14	17
Overall Study Others	1	0

Baseline Characteristics

To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liquid Rotarix Group n=636 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Total n=1274 Participants Total of all reporting groups
Age, Continuous	8.6 Weeks STANDARD_DEVIATION 0.87 • n=5 Participants	8.6 Weeks STANDARD_DEVIATION 0.86 • n=7 Participants	8.6 Weeks STANDARD_DEVIATION 0.86 • n=5 Participants
Sex: Female, Male Female	294 Participants n=5 Participants	316 Participants n=7 Participants	610 Participants n=5 Participants
Sex: Female, Male Male	342 Participants n=5 Participants	322 Participants n=7 Participants	664 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=449 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=434 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Seroconverted Subjects Against Human Rotavirus	363 Subjects	319 Subjects

SECONDARY outcome

Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point.

Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=449 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=434 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Concentrations of Anti-rotavirus IgA Antibodies	151.2 U/mL Interval 128.0 to 178.7	111.7 U/mL Interval 93.5 to 133.4

SECONDARY outcome

Timeframe: At 1 to 2 months after the second vaccine dose (Months 3-4)

Population: The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4.

Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=81 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=71 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies	67 Subjects	51 Subjects

SECONDARY outcome

Timeframe: During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months.

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.

Assessed solicited general symptoms were cough/runny nose, diarrhea, fever \[defined as rectal temperature equal to or above 38 degrees Celsius (°C)\], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=636 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irr./Fuss., Dose 2	31 Subjects	23 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irr./Fuss., Dose 2	137 Subjects	155 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Cough/runny nose, Dose 2	19 Subjects	23 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Cough/runny nose, Dose 2	31 Subjects	42 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Diarrhea, Dose 2	23 Subjects	27 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Diarrhea, Dose 2	5 Subjects	9 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Diarrhea, Dose 2	7 Subjects	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Rectal), Dose 2	283 Subjects	274 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Rectal), Dose 2	23 Subjects	14 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever (Rectal), Dose 2	139 Subjects	148 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irr./Fuss., Dose 2	280 Subjects	298 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	136 Subjects	138 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	8 Subjects	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	45 Subjects	61 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting, Dose 2	85 Subjects	82 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting, Dose 2	20 Subjects	22 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting, Dose 2	5 Subjects	7 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Cough/runny nose, Across doses	335 Subjects	342 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Cough/runny nose, Across doses	36 Subjects	41 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Cough/runny nose, Across doses	56 Subjects	58 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Diarrhea, Across doses	61 Subjects	59 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Diarrhea, Across doses	13 Subjects	20 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Diarrhea, Across doses	24 Subjects	19 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Rectal), Across doses	405 Subjects	406 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Rectal), Across doses	34 Subjects	26 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever (Rectal), Across doses	220 Subjects	240 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irr./Fuss., Across doses	401 Subjects	427 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irr./Fuss., Across doses	55 Subjects	49 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irr./Fuss., Across doses	211 Subjects	238 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across doses	218 Subjects	234 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across doses	16 Subjects	11 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across doses	83 Subjects	95 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting, Across doses	162 Subjects	167 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting, Across doses	44 Subjects	43 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting, Across doses	29 Subjects	26 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Cough/runny nose, Dose 1	234 Subjects	252 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Cough/runny nose, Dose 1	22 Subjects	20 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Cough/runny nose, Dose 1	31 Subjects	22 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Diarrhea, Dose 1	43 Subjects	34 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Diarrhea, Dose 1	8 Subjects	11 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Diarrhea, Dose 1	19 Subjects	14 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever (Rectal), Dose 1	296 Subjects	292 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever (Rectal), Dose 1	12 Subjects	12 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever (Rectal), Dose 1	148 Subjects	161 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irr./Fuss., Dose 1	343 Subjects	352 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irr./Fuss., Dose 1	35 Subjects	35 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irr./Fuss., Dose 1	150 Subjects	156 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	152 Subjects	163 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	8 Subjects	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	48 Subjects	55 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Vomiting, Dose 1	131 Subjects	129 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Vomiting, Dose 1	36 Subjects	27 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Vomiting, Dose 1	24 Subjects	20 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Cough/runny nose, Dose 2	239 Subjects	239 Subjects

SECONDARY outcome

Timeframe: Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=636 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Subjects With Unsolicited Adverse Events (AEs)	276 Subjects	285 Subjects

SECONDARY outcome

Timeframe: Throughout the entire study period (from Day 0 to Month 4)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=636 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Subjects With Serious Adverse Events (SAEs)	37 Subjects	38 Subjects

SECONDARY outcome

Timeframe: From the first vaccine dose (Dose 1) up to Month 4

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in.

The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3.

Outcome measures

Outcome measures
Measure	Liquid Rotarix Group n=636 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 Participants Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes Dose 1-Dose 2 (N=636;638)	4 Subjects	2 Subjects
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes Dose 2-Visit 3 (N=605;597)	1 Subjects	0 Subjects
Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes Dose 1-Visit 3 (N=636;638)	5 Subjects	2 Subjects

Adverse Events

Liquid Rotarix Group

Serious events: 37 serious events

Other events: 553 other events

Deaths: 0 deaths

Lyophilized Rotarix Group

Serious events: 38 serious events

Other events: 556 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Liquid Rotarix Group n=636 participants at risk Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 participants at risk Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
General disorders Cough/runny nose	52.7% 335/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	53.6% 342/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
General disorders Diarrhea	9.6% 61/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	9.2% 59/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
General disorders Fever (Rectal)	63.7% 405/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	63.6% 406/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
General disorders Irritability/ Fussiness	63.1% 401/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	66.9% 427/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
General disorders Loss of appetite	34.3% 218/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	36.7% 234/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
General disorders Vomiting	25.5% 162/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	26.2% 167/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Nasopharyngitis	25.8% 164/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	25.4% 162/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Bronchiolitis	6.0% 38/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	7.5% 48/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).

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	Liquid Rotarix Group n=636 participants at risk Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.	Lyophilized Rotarix Group n=638 participants at risk Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Infections and infestations Bronchiolitis	3.5% 22/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	3.1% 20/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Pneumonia	1.6% 10/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	1.1% 7/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Gastroenteritis	0.63% 4/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.94% 6/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Bronchopneumonia	0.47% 3/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.63% 4/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Gastrointestinal disorders Gastro esophageal reflux disease	0.47% 3/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.16% 1/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.31% 2/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Urinary tract infection	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.31% 2/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Respiratory, thoracic and mediastinal disorders Asthma	0.31% 2/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.16% 1/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Cardiac disorders Cardio-respiratory arrest	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Metabolism and nutrition disorders Dehydration	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Enterococcal sepsis	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Escherichia urinary tract infection	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Nervous system disorders Hypoxic encephalopathy	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Nervous system disorders Infantile spasms	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Immune system disorders Milk allergy	0.00% 0/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.16% 1/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Renal and urinary disorders Nephropathy toxic	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Omphalitis	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Infections and infestations Pertussis	0.00% 0/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.16% 1/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Cardiac disorders Sinus tachycardia	0.00% 0/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.16% 1/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).
Gastrointestinal disorders Vomiting	0.16% 1/636 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).	0.00% 0/638 • Solicited general symptoms: within the 15-day (Day 0-14) follow-up period after each vaccine dose; Unsolicited AEs: within 31 days (Day 0-30) after any vaccine dose; SAEs: throughout the entire study period (from Day 0 to Month 4).