Contact information
Type
Scientific
Contact name
Dr Duncan Steele
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3752
steeled@who.int
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
RPC103
Study information
Scientific title
Acronym
Rota013
Study hypothesis
The aim of this study was to determine if there was a difference in immune response between the two different schedules that were tested.
Ethics approval(s)
Approved prior to 2002
Study design
A double blind, randomised placebo controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Prevention
Patient information sheet
Condition
Vaccine/immunization
Intervention
Two doses of GSK Biologicals oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase II
Drug/device/biological/vaccine name(s)
Human rotavirus vaccine (RIX4414)
Primary outcome measure
Proportion of subjects who seroconverted at visit 4 (2 months after dose 3) in the vaccine groups.
Secondary outcome measures
Immunogenicity:
1. Proportion of subjects with vaccine take at visit 2 (dose 2) and visit 4 in a subset of subjects
2. Serum rotavirus IgA (immunoglobulin A) antibody concentrations in all subjects at visits 1, 2 and 4
3. Proportion of subjects with anti-poliovirus type 1, 2 and 3 antibody titre greater than or equal to 1:8, at visit 4
4. Antibody titres for anti-poliovirus types 1, 2 and 3, at visit 4
5. Viral shedding in a subset of subjects
Safety:
1. For each type of solicited symptom, occurrence of the symptom within the 15-day (day 0-14) solicited follow-up period after each dose
2. Occurrence of unsolicited adverse events within 43 days (day 0 - 42) after each dose, according to MedDRA (medical dictionary for adverse events) classification
3. Presence of rotavirus in diarrhoeal stool collected until visit 4
4. Occurrence of serious adverse events throughout the entire study period
Efficacy:
1. Occurrence of rotavirus gastroenteritis/severe rotavirus gastroenteritis during the period starting from dose 1 up to visit 5
2. Occurrence of severe rotavirus gastroenteritis during the entire study period
Overall study start date
01/01/2002
Overall study end date
25/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Parents/guardians of subjects who could comply with the protocol requirements (e.g. completion of diary cards, return for follow-up visits)
2. Male or female 6 - 10 weeks of age at the time of first vaccination
3. Written informed consent from parents/guardians
4. Born after a gestation period of 36 - 42 weeks
Participant type(s)
Patient
Age group
Child
Lower age limit
6 Weeks
Upper age limit
10 Weeks
Sex
Both
Target number of participants
285
Participant exclusion criteria
1. Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period
2. Previous routine vaccination except Bacillus Calmette-Guerin (BCG) and hepatits B virus (HBV)
3. Clinically significant history of chronic gastrointestinal tract (GIT) disease including any incorrected congenital malformation of GIT
4. History of allergic disease or reaction likely to be exacerbated by any component of the vaccine
5. Acute illness at the time of enrolement
6. Diarrhoea with in 7 days preceding the study vaccination
7. Administration of immunoglobulins and/or blood products since birth or planned during study period
8. Use of any investigational or non-registered drug or vaccine other than study vaccines during the study period
Recruitment start date
01/01/2002
Recruitment end date
25/10/2004
Locations
Countries of recruitment
South Africa, Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
RAPID trials (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|