A phase II, double blind randomised, placebo controlled study to assess the safety reactogenicity and immunogenicity of three doses of GSK Biologicals (South Africa)
| ISRCTN | ISRCTN86632774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86632774 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/11/2005
- Registration date
- 25/11/2005
- Last edited
- 29/01/2008
- 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 | 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 |
| Scientific title | |
| Study acronym | Rota014 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 10 Weeks |
| Sex | Both |
| Target number of participants | 271 |
| 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 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 |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2003 |
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 |
