A double blind, randomised placebo controlled study of the safety, reactogenicity and immunogenicity of two doses of orally administered human rotavirus vaccine (RIX4414) in healthy infants in South Africa
| ISRCTN | ISRCTN37373664 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37373664 |
| Secondary identifying numbers | RPC103 |
- Submission date
- 25/11/2005
- Registration date
- 25/11/2005
- Last edited
- 28/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Duncan Steele
Scientific
Scientific
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3752 |
|---|---|
| steeled@who.int |
Study information
| 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 |
| Scientific title | |
| Study acronym | Rota013 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 25/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 10 Weeks |
| Sex | Both |
| Target number of participants | 285 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 25/10/2004 |
Locations
Countries of recruitment
- South Africa
- Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Research organisation
Research organisation
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
RAPID trials (USA)
No information available
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
