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
N/A
Study information
Scientific title
Acronym
Rota014
Study hypothesis
This study was undertaken to identify whether the immunogenicity of live Oral Poliovirus (OPV) vaccine was affected by the concomitant administration of the candidate Human Rotavirus (HRV) vaccine and also to assess the safety of the candidate HRV vaccine given concomitantly with poliovirus vaccine (OPV or IPV). The study was conducted in two parts, the first part (subset enrolled before the start of the 2002 Rotavirus [RV] season) and the second part of the study (subset enrolled after the end of the 2002 rotavirus season).
Objective:
To demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of polio vaccine.
Ethics approval(s)
Ethics approval received in 2001
Study design
Randomised, controlled study with three parallel groups with balanced allocation (1:1:1).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Vaccine/immunisation
Intervention
Two doses of GSK Biologicals oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration, one dose of placebo
Control: three doses of placebo
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Live attenuated human rotavirus vaccine (RIX4414), oral poliovirus vaccine
Primary outcome measure
Seroprotection for each polio serotype:
1. Proportion of subjects with anti-poliovirus type 1 antibody titre greater than or equal to 1:8 one month after the third dose
2. Proportion of subjects with anti-poliovirus type 2 antibody titre greater than or equal to 1:8 one month after the third dose
3. Proportion of subjects with anti-poliovirus type 3 antibody titre greater than or equal to 1:8 one month after the third dose
Secondary outcome measures
1. Proportion of subjects with vaccine take one month after each dose of study vaccine at visits 2 and 3 for subset before RV season
2. Proportion of subjects with vaccine take one month after each dose of study vaccine at visits 3 and 4 for subset after RV season*
3. Viral shedding in a subset of subjects
4. Presence of rotavirus in diarrhoeal stools collected between visits 1 and 3 for subset before RV season, and between visits 1 and 4 for subset after RV season
5. Antibody titres for anti-poliovirus type 1, anti-poliovirus type 2, anti-poliovirus type 3 one month after the third dose
6. Serum anti-rotavirus IgA (immunoglobulin A) antibody titres in subjects in the subset before RV season at study visits 1 to 3
7. Serum anti-rotavirus IgA antibody titres in subjects in the subset after RV season at study visits 2 to 4
8. For each type of solicited symptom, occurrence of the symptom within the 15-day (day 0-14) solicited follow-up period after each study vaccine dose
9. Occurrence of unsolicited adverse events within 43 (day 042) days after each study vaccine dose, according to World Health Organization (WHO) classification
10. Occurrence of serious adverse events (SAEs) throughout the entire study period (including long term follow-up for 6 months after Dose 2 of HRV vaccine/placebo)
*Not done since no stool samples were collected after RV season
Overall study start date
01/01/2001
Overall study end date
01/01/2003
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
271
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 enrolment
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
01/01/2001
Recruitment end date
01/01/2003
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? |
|---|