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To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

Primary Purpose

Infections, Rotavirus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rotavirus (vaccine)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Rotavirus

Eligibility Criteria

6 Weeks - 14 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight > 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.) History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae. History of use of experimental rotavirus vaccine. Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae. Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS or other medical condition determined to be serious by the investigator. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). A family history of congenital or hereditary immunodeficiency. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. History of any neurologic disorders or seizures. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Sites / Locations

  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.

Secondary Outcome Measures

Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.
Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Occurrence of any medical attention (medical provider contact, advice, visit; emergency room contact or visit or hospitalization) for RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the period starting from Dose 1 of the study vaccine until Visit 5.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who completed the two-dose vaccination course before the RV epidemic season.
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who were vaccinated during the RV epidemic season.
Immune response to HRV vaccine at Visit 1 and Visit 3.
Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable):
In a subset of subjects (N=1800), occurrence of each type of solicited symptom within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV/placebo.
For all subjects, occurrence of unsolicited symptoms within 31 days (Day 0 to Day 30) after each dose of HRV/placebo and SAEs throughout the entire study period.

Full Information

First Posted
August 31, 2005
Last Updated
March 21, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00140686
Brief Title
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
Official Title
A Multi-country & Multi-center Study to Assess the Efficacy, Safety & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The main objectives of this study is to determine vaccine efficacy against any rotavirus (RV) gastroenteritis (GE) during the first efficacy period.
Detailed Description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-14 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Rotavirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3994 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Rotavirus (vaccine)
Primary Outcome Measure Information:
Title
Occurrence of any RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period.
Secondary Outcome Measure Information:
Title
Occurrence of severe RV GE caused by the circulating wild-type RV strains during the each efficacy follow-up period.
Title
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of G1 serotype during each efficacy follow-up period.
Title
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains of non-G1 serotypes during each efficacy follow-up period.
Title
Occurrence of hospitalization due to RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Title
Occurrence of any medical attention (medical provider contact, advice, visit; emergency room contact or visit or hospitalization) for RV GE caused by the circulating wild-type RV strains during each efficacy follow-up period.
Title
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the period starting from Dose 1 of the study vaccine until Visit 5.
Title
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who completed the two-dose vaccination course before the RV epidemic season.
Title
Occurrence of any and severe RV GE caused by the circulating wild-type RV strains during the first efficacy follow-up period in subjects who were vaccinated during the RV epidemic season.
Title
Immune response to HRV vaccine at Visit 1 and Visit 3.
Title
Immune response to all antigens contained in each of the different childhood vaccines at Visit 3 and Visit 4 or Visit 6 (if applicable):
Title
In a subset of subjects (N=1800), occurrence of each type of solicited symptom within the 8-day solicited follow-up period (Day 0 to Day 7) after each dose of HRV/placebo.
Title
For all subjects, occurrence of unsolicited symptoms within 31 days (Day 0 to Day 30) after each dose of HRV/placebo and SAEs throughout the entire study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
14 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Healthy infants 6 -14 weeks of age at the time of the first study vaccination with birth weight > 2000g whose parent/guardian sign a written informed consent and whose parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after. Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids are allowed.) History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B disease (in all subjects). Only for subjects in Spain: history of meningococcal group C disease. Only for subjects in France and Germany: history of disease caused by Streptococcus pneumoniae. History of use of experimental rotavirus vaccine. Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (in all subjects). Only for subjects in Spain: previous vaccination against meningococcal group C. Only for subjects in France and Germany: previous vaccination against Streptococcus pneumoniae. Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract, IS or other medical condition determined to be serious by the investigator. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) Gastroenteritis within 7 days preceding the first study vaccine administration (warrants deferral of the vaccination). A family history of congenital or hereditary immunodeficiency. Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. History of any neurologic disorders or seizures. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Brno
ZIP/Postal Code
628 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Hradec kralove
ZIP/Postal Code
500 02
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Humpolec
ZIP/Postal Code
396 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
728 92
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Znojmo
ZIP/Postal Code
669 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
GSK Investigational Site
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Jyvaskyla
ZIP/Postal Code
40100
Country
Finland
Facility Name
GSK Investigational Site
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
GSK Investigational Site
City
Kotka
ZIP/Postal Code
48100
Country
Finland
Facility Name
GSK Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28120
Country
Finland
Facility Name
GSK Investigational Site
City
Riihimaki
ZIP/Postal Code
11120
Country
Finland
Facility Name
GSK Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
GSK Investigational Site
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
GSK Investigational Site
City
Chalons en Champagne
ZIP/Postal Code
51000
Country
France
Facility Name
GSK Investigational Site
City
Chambéry
ZIP/Postal Code
73000
Country
France
Facility Name
GSK Investigational Site
City
Courbevoie
ZIP/Postal Code
92400
Country
France
Facility Name
GSK Investigational Site
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
GSK Investigational Site
City
Essey les Nancy
ZIP/Postal Code
54270
Country
France
Facility Name
GSK Investigational Site
City
Floirac
ZIP/Postal Code
33270
Country
France
Facility Name
GSK Investigational Site
City
Gradignan
ZIP/Postal Code
33190
Country
France
Facility Name
GSK Investigational Site
City
Issy les Moulineaux
ZIP/Postal Code
92130
Country
France
Facility Name
GSK Investigational Site
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
GSK Investigational Site
City
Les Lilas
ZIP/Postal Code
93260
Country
France
Facility Name
GSK Investigational Site
City
Manosque
ZIP/Postal Code
04100
Country
France
Facility Name
GSK Investigational Site
City
Maromme
ZIP/Postal Code
76150
Country
France
Facility Name
GSK Investigational Site
City
Maurepas
ZIP/Postal Code
78310
Country
France
Facility Name
GSK Investigational Site
City
Nogent Sur Marne
ZIP/Postal Code
94130
Country
France
Facility Name
GSK Investigational Site
City
Nogent-sur-Marne
ZIP/Postal Code
94130
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
GSK Investigational Site
City
Rosny Sous Bois
ZIP/Postal Code
93100
Country
France
Facility Name
GSK Investigational Site
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
GSK Investigational Site
City
Saint Quentin
ZIP/Postal Code
02100
Country
France
Facility Name
GSK Investigational Site
City
Thionville
Country
France
Facility Name
GSK Investigational Site
City
Birkenfeld
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75217
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Oberkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77704
Country
Germany
Facility Name
GSK Investigational Site
City
Freising
State/Province
Bayern
ZIP/Postal Code
85354
Country
Germany
Facility Name
GSK Investigational Site
City
Kaufering
State/Province
Bayern
ZIP/Postal Code
86916
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65205
Country
Germany
Facility Name
GSK Investigational Site
City
Buetzow
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18246
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18146
Country
Germany
Facility Name
GSK Investigational Site
City
Salzgitter
State/Province
Niedersachsen
ZIP/Postal Code
38226
Country
Germany
Facility Name
GSK Investigational Site
City
Wolfenbuettel
State/Province
Niedersachsen
ZIP/Postal Code
38302
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44866
Country
Germany
Facility Name
GSK Investigational Site
City
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Espelkamp
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32339
Country
Germany
Facility Name
GSK Investigational Site
City
Goch
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47574
Country
Germany
Facility Name
GSK Investigational Site
City
Guetersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Facility Name
GSK Investigational Site
City
Loehne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
Country
Germany
Facility Name
GSK Investigational Site
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32427
Country
Germany
Facility Name
GSK Investigational Site
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Facility Name
GSK Investigational Site
City
Velbert
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42551
Country
Germany
Facility Name
GSK Investigational Site
City
Willich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47877
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
GSK Investigational Site
City
Cossebaude
State/Province
Sachsen
ZIP/Postal Code
01462
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04317
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Gluecksburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24960
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12679
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22089
Country
Germany
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00193
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16100
Country
Italy
Facility Name
GSK Investigational Site
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
GSK Investigational Site
City
Ragusa
State/Province
Sicilia
ZIP/Postal Code
97100
Country
Italy
Facility Name
GSK Investigational Site
City
Almería
ZIP/Postal Code
04009
Country
Spain
Facility Name
GSK Investigational Site
City
Baracaldo (Vizcaya)
ZIP/Postal Code
48902
Country
Spain
Facility Name
GSK Investigational Site
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
GSK Investigational Site
City
Berango (Vizcaya)
ZIP/Postal Code
48640
Country
Spain
Facility Name
GSK Investigational Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
GSK Investigational Site
City
Blanes
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
GSK Investigational Site
City
Munguía (Vizcaya)
ZIP/Postal Code
48100
Country
Spain
Facility Name
GSK Investigational Site
City
Móstoles/Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
GSK Investigational Site
City
San Vicent dels Horts
Country
Spain
Facility Name
GSK Investigational Site
City
Sant Adriá de Beyós, Barcelona
ZIP/Postal Code
08930
Country
Spain
Facility Name
GSK Investigational Site
City
Sant Eugenia de Berga, Barcelona
ZIP/Postal Code
08519
Country
Spain
Facility Name
GSK Investigational Site
City
Sodupe (Vizcaya)
ZIP/Postal Code
48840
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
19289978
Citation
De Vos B, Han HH, Bouckenooghe A, Debrus S, Gillard P, Ward R, Cheuvart B. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J. 2009 Apr;28(4):261-6. doi: 10.1097/INF.0b013e3181907177.
Results Reference
background
Citation
Soriano-Gabarró M et al. (2008) Potential impact of Rotarix according to rotavirus type distribution. Pediatr Infect Dis J. 27(1) Supplement: S28-S32.
Results Reference
background
PubMed Identifier
18037080
Citation
Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007 Nov 24;370(9601):1757-63. doi: 10.1016/S0140-6736(07)61744-9.
Results Reference
background
PubMed Identifier
22228235
Citation
Vesikari T, Prymula R, Schuster V, Tejedor JC, Cohen R, Bouckenooghe A, Damaso S, Han HH. Efficacy and immunogenicity of live-attenuated human rotavirus vaccine in breast-fed and formula-fed European infants. Pediatr Infect Dis J. 2012 May;31(5):509-13. doi: 10.1097/INF.0b013e3182489cac.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102247/036
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood Vaccines

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