A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00432380
• Collaborator: (none)
• Enrollment: 375
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 63.8

Study Details

Study Description

Brief Summary

This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.

Condition or Disease	Intervention/Treatment	Phase
Infections, Rotavirus; Rotavirus Vaccines	Biological: Rotarix™; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.
• Actual Study Start Date: Mar 9, 2007
• Actual Primary Completion Date: Sep 4, 2007
• Actual Study Completion Date: Sep 4, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PLACEBO-ROTARIX-ROTARIX GROUP Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Biological: Rotarix™; oral doses; Biological: Placebo; oral dose
Experimental: ROTARIX-PLACEBO-ROTARIX GROUP Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Biological: Rotarix™; oral doses; Biological: Placebo; oral dose
Placebo Comparator: PLACEBO GROUP Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Biological: Placebo; oral dose

Outcome Measures

Primary Outcome Measures

1. Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody [At Month 3]

   Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.

Secondary Outcome Measures

1. Number of Seroconverted Subjects for Anti-RV IgA Antibody [At Month 3]

   Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.

2. Serum IgA Antibody Concentrations Against Rotavirus [At Month 3]

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.

3. Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea [During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses]

   Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.

4. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses]

   Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

5. Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes [From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3]

   Presence of RV (vaccine strain or wild-type) in GE stools.

6. Number of Subjects Reporting Any Unsolicited Adverse Event (AE) [During the 31-day (Days 0-30) period following any study vaccine dose or placebo]

   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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

7. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (from Day 0 to Month 3)]

   Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Weeks to 10 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.

• Birth weight of the subject should be > 2000 grams.

• Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.

• Concurrently participating in another clinical study, at any time during the study period.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Muntinlupa		Philippines

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Anh DD, Carlos CC, Thiem DV, Hutagalung Y, Gatchalian S, Bock HL, Smolenov I, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 (Rotarix™) oral suspension (liquid formulation) when co-administered with expanded program on immunization (EPI) vaccines in Vietnam and the Philippines in 2006-2007. Vaccine. 2011 Mar 3;29(11):2029-36. doi: 10.1016/j.vaccine.2011.01.018. Epub 2011 Jan 21.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00432380
• Other Study ID Numbers: 109216; 2015-001544-11
• First Posted: Feb 7, 2007
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Placebo; Double blind; Gastroenteritis; Randomized; Oral live attenuated human rotavirus liquid vaccine
• Additional relevant MeSH terms: Rotavirus Infections

Study Results

Participant Flow

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

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Period Title: Overall Study
STARTED	150	150	75
COMPLETED	146	146	74
NOT COMPLETED	4	4	1

Baseline Characteristics

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group	Total
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Total of all reporting groups
Overall Participants	150	150	75	375
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	6.6 (1.07)	6.5 (1)	6.6 (1.02)	6.56 (1.02)
Sex: Female, Male (Count of Participants)
Female	59 39.3%	76 50.7%	40 53.3%	175 46.7%
Male	91 60.7%	74 49.3%	35 46.7%	200 53.3%

Outcome Measures

1. Primary Outcome

Title	Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody
Description	Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.

Arm/Group Title	Placebo-Rotarix-Rotarix Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	120
Number [Subjects]	84

2. Secondary Outcome

Title	Number of Seroconverted Subjects for Anti-RV IgA Antibody
Description	Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations ≥ 20 U/mL in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the first and third routine EPI immunization. This outcome measure only concerns subjects in the Rotarix-Placebo-Rotarix Group.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.

Arm/Group Title	Rotarix-Placebo-Rotarix Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	120
Number [Subjects]	71

3. Secondary Outcome

Title	Serum IgA Antibody Concentrations Against Rotavirus
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). This outcome measure only concerns subjects in Placebo-Rotarix-Rotarix and Rotarix-Placebo-Rotarix Groups.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all subjects who were seronegative for anti-RV IgA antibodies on the day of Dose 1 of Rotarix™ liquid vaccine or placebo and for whom immunogenicity data were available, at pre-sampling and post-sampling time points.

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	120	120
Geometric Mean (95% Confidence Interval) [U/mL]	68	75.6

4. Secondary Outcome

Title	Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea
Description	Any symptom = occurrence of the symptom (i.e. fever or vomiting or diarrhea) regardless of intensity grade or relationship to vaccination. Grade 2 fever = rectal temperature greater than (>) 38.5 - less than or equal to (≤) 39.5degrees Celsius (°C) or axillary temperature > 38.0 - ≤ 39.0°C. Grade 3 fever = rectal temperature > 39.5°C or axillary temperature > 39.0°C. Grade 2 vomiting = 2 episodes of vomiting/ day. Grade 3 vomiting = 3 or more episodes of vomiting/ day. Grade 2 diarrhea = 4-5 looser than normal stools/ day. Grade 3 diarrhea = 6 or more looser than normal stools/ day.
Time Frame	During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	150	150	75
Any symptom, Dose 1 [N=150, 150, 75]	57	68	35
Any symptom, Dose 2 [N=149, 147, 75]	52	36	19
Any symptom, Dose 3 [N= 146, 147, 75]	29	38	24
Any symptom, Across doses [N= 150, 150, 75]	86	91	48

5. Secondary Outcome

Title	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Description	Assessed solicited general symptoms were cough/runny nose, diarrhea, fever (rectally), irritability, loss of appetite and vomiting. Any = any solicited symptom irrespective of intensity grade or relationship to vaccination. Grade 3 cough/runny nose = cough/runny nose which prevented daily activity. Grade 2 diarrhea: 4-5 looser than normal stools/ day. Grade 3 diarrhea = ≥ 6 looser than normal stools/ day. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 2 vomiting= 2 episodes of vomiting/ day. Grade 3 vomiting = ≥ 3 episodes of vomiting/ day. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
Time Frame	During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total vaccinated Cohort, which included all vaccinated subjects with at least one study vaccine/placebo administration documented.

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	150	150	75
Any Cough/ runny nose, D1 [N=150, 150, 75]	52	44	23
Grade 3 Cough/ runny nose, D1 [N=150, 150, 75]	0	1	1
Related Cough/ runny nose, D1 [N=150, 150, 75]	1	0	1
Any Diarrhea, D1 [N=150, 150, 75]	5	4	6
Grade 3 Diarrhea, D1 [N=150, 150, 75]	2	0	0
Related Diarrhea, D1 [N=150, 150, 75]	5	4	5
Any Fever, D1 [N=150, 150, 75]	122	117	54
Grade 3 Fever, D1 [N=150, 150, 75]	3	5	0
Related Fever, D1 [N=150, 150, 75]	121	114	53
Any Irritability, D1 [N=150, 150, 75]	87	72	34
Grade 3 Irritability, D1 [N=150, 150, 75]	3	5	0
Related Irritability, D1 [N=150, 150, 75]	81	70	34
Any Loss of appetite, D1 [N=150, 150, 75]	26	35	17
Grade 3 Loss of appetite, D1 [N=150, 150, 75]	1	0	0
Related Loss of appetite, D1 [N=150, 150, 75]	20	31	15
Any Vomiting, D1 [N=150, 150, 75]	32	24	5
Grade 3 Vomiting, D1 [N=150, 150, 75]	2	1	2
Related Vomiting, D1 [N=150, 150, 75]	23	21	5
Any Cough/ runny nose, D2 [N=149, 147, 75]	48	37	21
Grade 3 Cough/ runny nose, D2 [N=149, 147, 75]	2	0	1
Related Cough/ runny nose, D2 [N=149, 147, 75]	0	0	1
Any Diarrhea, D2 [N=149, 147, 75]	3	1	0
Grade 3 Diarrhea, D2 [N=149, 147, 75]	1	0	0
Related Diarrhea, D2 [N=149, 147, 75]	1	1	0
Any Fever, D2 [N=149, 147, 75]	103	94	45
Grade 3 Fever, D2 [N=149, 147, 75]	3	4	2
Related Fever, D2 [N=149, 147, 75]	102	93	45
Any Irritability, D2 [N=149, 147, 75]	55	45	24
Grade 3 Irritability, D2 [N=149, 147, 75]	0	0	0
Related Irritability, D2 [N=149, 147, 75]	52	43	24
Any Loss of appetite, D2 [N=149, 147, 75]	20	21	8
Grade 3 Loss of appetite, D2 [N=149, 147, 75]	0	0	1
Related Loss of appetite, D2 [N=149, 147, 75]	16	20	7
Any Vomiting, D2 [N=149, 147, 75]	15	17	5
Grade 3 Vomiting, D2 [N=149, 147, 75]	0	1	0
Related Vomiting, D2 [N=149, 147, 75]	11	14	4
Any Cough/ runny nose, D3 [N=146, 147, 75]	36	31	23
Grade 3 Cough/ runny nose, D3 [N=146, 147, 75]	0	6	1
Related Cough/ runny nose, D3 [N=146, 147, 75]	0	0	0
Any Diarrhea, D3 [N=146, 147, 75]	2	1	1
Grade 3 Diarrhea, D3 [N=146, 147, 75]	0	0	0
Related Diarrhea, D3 [N=146, 147, 75]	2	1	1
Any Fever, D3 [N=146, 147, 75]	91	91	48
Grade 3 Fever, D3 [N=146, 147, 75]	3	5	2
Related Fever, D3 [N=146, 147, 75]	87	89	47
Any Irritability, D3 [N=146, 147, 75]	33	40	21
Grade 3 Irritability, D3 [N=146, 147, 75]	0	3	2
Related Irritability, D3 [N=146, 147, 75]	31	38	20
Any Loss of appetite, D3 [N=146, 147, 75]	19	18	7
Grade 3 Loss of appetite, D3 [N=146, 147, 75]	0	1	0
Related Loss of appetite, D3 [N=146, 147, 75]	19	17	7
Any Vomiting, D3 [N=146, 147, 75]	10	8	1
Grade 3 Vomiting, D3 [N=146, 147, 75]	0	2	0
Related Vomiting, D3 [N=146, 147, 75]	8	4	1
Any Cough/runny nose, Across [N=150, 150, 75]	82	69	40
Grade 3 Cough/runny nose, Across [N=150, 150, 75]	2	6	2
Related Cough/runny nose, Across [N=150, 150, 75]	1	0	2
Any Diarrhea, Across [N=150, 150, 75]	8	6	7
Grade 3 Diarrhea, Across [N=150, 150, 75]	3	0	0
Related Diarrhea, Across [N=150, 150, 75]	6	6	6
Any Temperature, Across [N=150, 150, 75]	139	137	69
Grade 3 Temperature, Across [N=150, 150, 75]	8	13	3
Related Temperature, Across [N=150, 150, 75]	138	135	69
Any Irritability, Across [N=150, 150, 75]	93	78	40
Grade 3 Irritability, Across [N=150, 150, 75]	3	7	2
Related Irritability, Across [N=150, 150, 75]	90	76	40
Any Loss of appetite, Across [N=150, 150, 75]	40	46	23
Grade 3 Loss of appetite, Across [N=150, 150, 75]	1	1	1
Related Loss of appetite, Across [N=150, 150, 75]	35	42	21
Any Vomiting, Across [N=150, 150, 75]	35	32	9
Grade 3 Vomiting, Across [N=150, 150, 75]	2	3	2
Related Vomiting, Across [N=150, 150, 75]	27	26	8

6. Secondary Outcome

Title	Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes
Description	Presence of RV (vaccine strain or wild-type) in GE stools.
Time Frame	From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	150	150	75
Between Dose 1 and before Dose 2 [N=150, 150, 75]	1	0	1
Between Dose 2 and before Dose 3 [N=149, 147, 75]	0	0	0
Between Dose 3 and Month 3 [N=146, 147, 75]	0	0	0
Between Dose 1 and Month 3 [N=150, 150, 75]	1	0	1

7. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Event (AE)
Description	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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame	During the 31-day (Days 0-30) period following any study vaccine dose or placebo

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	150	150	75
Number [Subjects]	53	60	19

8. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include any untoward medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
Time Frame	During the entire study period (from Day 0 to Month 3)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Placebo-Rotarix-Rotarix Group	Rotarix-Placebo-Rotarix Group	Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Measure Participants	150	150	75
Number [Subjects]	1	1	1

Adverse Events

Time Frame	Solicited symptoms were collected during the 8-day (Days 0-7) post-vaccination period. Unsolicited AEs were collected during the 31-day (Days 0-30) post-vaccination period. SAEs were collected throughout the entire study period (Months 0 to 3).
Arm/Group Title	Placebo-Rotarix-Rotarix Group		Rotarix-Placebo-Rotarix Group		Placebo Group
Arm/Group Description	Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.		Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.		Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
All Cause Mortality
	Placebo-Rotarix-Rotarix Group		Rotarix-Placebo-Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo-Rotarix-Rotarix Group		Rotarix-Placebo-Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/150 (0.7%)		1/150 (0.7%)		1/75 (1.3%)
Immune system disorders
Milk allergy	0/150 (0%)		1/150 (0.7%)		0/75 (0%)
Infections and infestations
Gastroenteritis salmonella	1/150 (0.7%)		0/150 (0%)		0/75 (0%)
Meningitis	0/150 (0%)		0/150 (0%)		1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	Placebo-Rotarix-Rotarix Group		Rotarix-Placebo-Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	139/150 (92.7%)		137/150 (91.3%)		69/75 (92%)
General disorders
Cough/runny nose	82/150 (54.7%)		69/150 (46%)		40/75 (53.3%)
Diarrhea	8/150 (5.3%)		6/150 (4%)		7/75 (9.3%)
Fever (Rectally)	139/150 (92.7%)		137/150 (91.3%)		69/75 (92%)
Irritability	93/150 (62%)		78/150 (52%)		40/75 (53.3%)
Loss of appetite	40/150 (26.7%)		46/150 (30.7%)		23/75 (30.7%)
Vomiting	35/150 (23.3%)		32/150 (21.3%)		9/75 (12%)
Infections and infestations
Upper respiratory tract infection	19/150 (12.7%)		21/150 (14%)		6/75 (8%)
Rhinitis	13/150 (8.7%)		16/150 (10.7%)		6/75 (8%)
Bronchitis	7/150 (4.7%)		7/150 (4.7%)		4/75 (5.3%)
Diarrhea infectious	5/150 (3.3%)		9/150 (6%)		2/75 (2.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.