Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00480324
• Collaborator: (none)
• Enrollment: 765
• Locations: 20
• Arms: 2
• Actual Duration (Months): 29.1
• Patients Per Site: 38.3
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

This study is undertaken to provide the regulatory authorities in Japan with immunogenicity, efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine, given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition or Disease	Intervention/Treatment	Phase
Infections, Rotavirus; Rotavirus Vaccines	Biological: Rotarix; Biological: Placebo	Phase 3

Detailed Description

Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV) vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.

Study Design

• Study Type: Interventional
• Actual Enrollment: 765 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Efficacy, Safety, Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
• Actual Study Start Date: Jun 19, 2007
• Actual Primary Completion Date: Mar 31, 2009
• Actual Study Completion Date: Nov 21, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rotarix Group Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Biological: Rotarix; Two-dose oral vaccination.
Placebo Comparator: Placebo Group Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.	Biological: Placebo; Two-dose oral administration.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [From 2 weeks after Dose 2 up to 2 years of age]

   Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

Secondary Outcome Measures

1. Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [From 2 weeks after Dose 2 up to 2 years of age]

   A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).

2. Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type [From 2 weeks after Dose 2 up to 2 years of age]

   Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).

3. Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types [From 2 weeks after Dose 2 up to 2 years of age]

   Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).

4. Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains [From 2 weeks after Dose 2 up to 2 years of age]

   Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.

5. Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [From Dose 1 up to 2 years of age]

   Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).

6. Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration [2 months after Dose 2]

   Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).

7. Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies [2 months after Dose 2]

   Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.

8. Number of Subjects Reporting Solicited Symptoms [During the 8-day follow-up period after each dose]

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

9. Number of Subjects Reporting Unsolicited Adverse Events (AEs) [During the 31-day follow-up period after each dose]

   Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

10. Number of Subjects Reporting Serious Adverse Events (SAEs) [Up to 2 years of age]

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 14 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male or female infant between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study

• Healthy subjects as established by medical history and clinical examination before entering into the study.

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

• Born between a gestation period of 36 and 42 weeks inclusive.

Exclusion Criteria:

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

• History of use of experimental rotavirus vaccine.

• Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

• Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for intussusception.

• Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition determined by the investigator.

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

• Previous confirmed occurrence of RV GE.

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

• A family history of congenital or hereditary immunodeficiency.

• Acute disease at the time of enrolment.

• Gastroenteritis within 7 days preceding the study vaccine administration.

• 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	Aichi		Japan	451-0052
2	GSK Investigational Site	Chiba		Japan	275-8580
3	GSK Investigational Site	Fukuoka		Japan	802-8533
4	GSK Investigational Site	Hiroshima		Japan	720-8520
5	GSK Investigational Site	Hiroshima		Japan	730-8518
6	GSK Investigational Site	Hiroshima		Japan	730-8798
7	GSK Investigational Site	Hiroshima		Japan	734-8530
8	GSK Investigational Site	Hiroshima		Japan	737-0811
9	GSK Investigational Site	Hokkaido		Japan	003-0021
10	GSK Investigational Site	Hokkaido		Japan	065-0033
11	GSK Investigational Site	Kagawa		Japan	765-8501
12	GSK Investigational Site	Kanagawa		Japan	247-8533
13	GSK Investigational Site	Miyagi		Japan	981-3203
14	GSK Investigational Site	Miyagi		Japan	983-8520
15	GSK Investigational Site	Nagano		Japan	386-8610
16	GSK Investigational Site	Nagasaki		Japan	856-8562
17	GSK Investigational Site	Niigata		Japan	957-8588
18	GSK Investigational Site	Okayama		Japan	701-0204
19	GSK Investigational Site	Okayama		Japan	701-1192
20	GSK Investigational Site	Osaka		Japan	591-8025

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

• Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix™ in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
• Kawamura N et al. Efficacy of Human Rotavirus (G1P[8] strain) Vaccine (HRV) RIX4414 in Japanese Infants during the Two-year Efficacy Follow-up Period. Abstract presented at the 114th Annual Meeting of Japan Pediatric Society (JPS). Tokyo, Japan, 12-14 August 2011.
• Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
• Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine. 2011 Aug 26;29(37):6335-41. doi: 10.1016/j.vaccine.2011.05.017. Epub 2011 Jun 2.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00480324
• Other Study ID Numbers: 107625; 2015-001543-36
• First Posted: May 30, 2007
• Last Update Posted: Jan 2, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Rotavirus Infections

Study Results

Participant Flow

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Period Title: Overall Study
STARTED	508	257
COMPLETED	476	241
NOT COMPLETED	32	16

Baseline Characteristics

Arm/Group Title	Rotarix Group	Placebo Group	Total
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.	Total of all reporting groups
Overall Participants	508	257	765
Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	7.7 (1.99)	7.7 (2.05)	7.7 (2.01)
Sex: Female, Male (Count of Participants)
Female	229 45.1%	134 52.1%	363 47.5%
Male	279 54.9%	123 47.9%	402 52.5%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Description	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Time Frame	From 2 weeks after Dose 2 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	498	250
Number [subjects]	14	34

2. Secondary Outcome

Title	Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Description	A subject was considered as reporting severe rotavirus gastroenteritis when the subject scored 11 or more on a 20-point scoring system (Vesikari scoring system).
Time Frame	From 2 weeks after Dose 2 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	498	250
Number [subjects]	2	12

3. Secondary Outcome

Title	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type
Description	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe RV GE was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Time Frame	From 2 weeks after Dose 2 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	498	250
Any RV GE	4	13
Severe RV GE	1	6

4. Secondary Outcome

Title	Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types
Description	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Time Frame	From 2 weeks after Dose 2 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	498	250
Any RV GE	10	21
Severe RV GE	1	6

5. Secondary Outcome

Title	Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains
Description	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode.
Time Frame	From 2 weeks after Dose 2 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for efficacy.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	498	250
Number [subjects]	1	2

6. Secondary Outcome

Title	Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains
Description	Rotavirus (RV) gastroenteritis (GE) was defined as an episode of any severity GE leading to a medical intervention occurring at least two weeks after dose 2 in which rotavirus other than vaccine strain is identified in a stool sample collected as soon as possible but preferably not later than 7 days after the start of the episode. Severe rotavirus gastroenteritis was defined as an episode of rotavirus gastroenteritis with score ≥ 11 on a 20-point scoring system (Vesikari scoring system).
Time Frame	From Dose 1 up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	508	257
Any RV GE	14	36
Severe RV GE	2	13

7. Secondary Outcome

Title	Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration
Description	Anti-rotavirus immunoglobulin A antibody concentrations are given as geometric mean concentrations (GMCs). Arbitrary 'zero' values were set in the Placebo Group since the GMC was below the assay cut-off value (20 U/mL).
Time Frame	2 months after Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	34	20
Geometric Mean (95% Confidence Interval) [Units per milliliter (U/mL)]	217.0	0

8. Secondary Outcome

Title	Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies
Description	Seroconversion was defined as the appearance of anti-rotavirus immunoglobulin A antibody concentration ≥ 20 units (U)/milliliter (mL) in subjects initially (i.e. prior to the first dose of rotarix) seronegative.
Time Frame	2 months after Dose 2

Outcome Measure Data

Analysis Population Description

The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	34	20
Number [subjects]	29	1

9. Secondary Outcome

Title	Number of Subjects Reporting Solicited Symptoms
Description	Solicited symptoms assessed include cough, diarrhoea, fever, irritability, loss of appetite and vomiting.
Time Frame	During the 8-day follow-up period after each dose

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	508	257
Cough	184	92
Diarrhoea	43	14
Fever	62	22
Irritability	261	125
Loss of appetite	81	33
Vomiting	74	36

10. Secondary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description	Unsolicited adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame	During the 31-day follow-up period after each dose

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	508	257
Number [subjects]	279	144

11. Secondary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are 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.
Time Frame	Up to 2 years of age

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort.

Arm/Group Title	Rotarix Group	Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
Measure Participants	508	257
Number [subjects]	72	44

Adverse Events

Arm/Group Title	Rotarix Group		Placebo Group
Arm/Group Description	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.		Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
All Cause Mortality
	Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	72/508 (14.2%)		44/257 (17.1%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/508 (0.2%)		2/257 (0.8%)
Aplasia pure red cell	0/508 (0%)		1/257 (0.4%)
Congenital, familial and genetic disorders
Cryptorchism	0/508 (0%)		1/257 (0.4%)
Eye disorders
Conjunctivitis	1/508 (0.2%)		0/257 (0%)
Gastrointestinal disorders
Enterocolitis	2/508 (0.4%)		1/257 (0.4%)
Gastrointestinal disorder	1/508 (0.2%)		2/257 (0.8%)
Haematochezia	2/508 (0.4%)		0/257 (0%)
Colitis	1/508 (0.2%)		0/257 (0%)
Diarrhoea	1/508 (0.2%)		0/257 (0%)
Enteritis	1/508 (0.2%)		0/257 (0%)
Inguinal hernia	1/508 (0.2%)		0/257 (0%)
General disorders
Pyrexia	3/508 (0.6%)		1/257 (0.4%)
Hepatobiliary disorders
Hepatic function abnormal	0/508 (0%)		2/257 (0.8%)
Hepatic failure	1/508 (0.2%)		0/257 (0%)
Infections and infestations
Pneumonia	12/508 (2.4%)		4/257 (1.6%)
Bronchitis	14/508 (2.8%)		0/257 (0%)
Gastroenteritis	11/508 (2.2%)		2/257 (0.8%)
Pharyngitis	5/508 (1%)		3/257 (1.2%)
Respiratory syncytial virus bronchiolitis	6/508 (1.2%)		2/257 (0.8%)
Respiratory syncytial virus infection	5/508 (1%)		3/257 (1.2%)
Exanthema subitum	3/508 (0.6%)		2/257 (0.8%)
Upper respiratory tract infection	4/508 (0.8%)		1/257 (0.4%)
Bronchopneumonia	2/508 (0.4%)		2/257 (0.8%)
Otitis media acute	1/508 (0.2%)		3/257 (1.2%)
Urinary tract infection	2/508 (0.4%)		2/257 (0.8%)
Gastroenteritis rotavirus	1/508 (0.2%)		2/257 (0.8%)
Influenza	1/508 (0.2%)		2/257 (0.8%)
Acute tonsilitis	1/508 (0.2%)		1/257 (0.4%)
Adenovirus infection	0/508 (0%)		2/257 (0.8%)
Cellulitis	0/508 (0%)		2/257 (0.8%)
Enterocolitis viral	2/508 (0.4%)		0/257 (0%)
Gastroenteritis viral	1/508 (0.2%)		1/257 (0.4%)
Laryngitis	2/508 (0.4%)		0/257 (0%)
Bacteraemia	0/508 (0%)		1/257 (0.4%)
Bacterial infection	1/508 (0.2%)		0/257 (0%)
Croup infectious	1/508 (0.2%)		0/257 (0%)
Erythema infectiosum	0/508 (0%)		1/257 (0.4%)
Nasopharyngitis	0/508 (0%)		1/257 (0.4%)
Otitis media	1/508 (0.2%)		0/257 (0%)
Pertussis	0/508 (0%)		1/257 (0.4%)
Pneumonia respiratory syncytial viral	1/508 (0.2%)		0/257 (0%)
Sinusitis	0/508 (0%)		1/257 (0.4%)
Subcutaneous abscess	0/508 (0%)		1/257 (0.4%)
Tonsillitis	0/508 (0%)		1/257 (0.4%)
Injury, poisoning and procedural complications
Contusion	0/508 (0%)		1/257 (0.4%)
Skull fracture	0/508 (0%)		1/257 (0.4%)
Subdural haematoma	1/508 (0.2%)		0/257 (0%)
Metabolism and nutrition disorders
Dehydration	3/508 (0.6%)		1/257 (0.4%)
Weight gain poor	0/508 (0%)		1/257 (0.4%)
Musculoskeletal and connective tissue disorders
Arthritis	0/508 (0%)		1/257 (0.4%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma	1/508 (0.2%)		0/257 (0%)
Neoplasm	1/508 (0.2%)		0/257 (0%)
Teratoma	1/508 (0.2%)		0/257 (0%)
Nervous system disorders
Febrile convulsion	4/508 (0.8%)		1/257 (0.4%)
Convulsion	1/508 (0.2%)		2/257 (0.8%)
Status epilepticus	0/508 (0%)		1/257 (0.4%)
Subarachnoid haemorrhage	0/508 (0%)		1/257 (0.4%)
Psychiatric disorders
Breath holding	0/508 (0%)		1/257 (0.4%)
Respiratory, thoracic and mediastinal disorders
Asthma	5/508 (1%)		3/257 (1.2%)
Adenoidal hypertrophy	0/508 (0%)		1/257 (0.4%)
Rhinorrhoea	1/508 (0.2%)		0/257 (0%)
Upper respiratory tract inflammation	0/508 (0%)		1/257 (0.4%)
Vascular disorders
Kawasaki's disease	1/508 (0.2%)		1/257 (0.4%)
Other (Not Including Serious) Adverse Events
	Rotarix Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	411/508 (80.9%)		204/257 (79.4%)
General disorders
Cough	184/508 (36.2%)		92/257 (35.8%)
Diarrhoea	43/508 (8.5%)		14/257 (5.4%)
Fever	62/508 (12.2%)		22/257 (8.6%)
Irritability	261/508 (51.4%)		125/257 (48.6%)
Loss of appetite	81/508 (15.9%)		33/257 (12.8%)
Vomiting	74/508 (14.6%)		36/257 (14%)
Infections and infestations
Upper respiratory tract infection	50/508 (9.8%)		25/257 (9.7%)
Nasopharyngitis	31/508 (6.1%)		13/257 (5.1%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation	33/508 (6.5%)		16/257 (6.2%)
Rhinorrhoea	19/508 (3.7%)		21/257 (8.2%)
Skin and subcutaneous tissue disorders
Eczema	72/508 (14.2%)		29/257 (11.3%)

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.