A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa
| ISRCTN | ISRCTN11877362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11877362 |
| ClinicalTrials.gov (NCT) | NCT00263666 |
| Protocol serial number | 444563-022 |
| Sponsor | World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland) |
| Funders | RAPID trials (USA), World Health Organization (WHO) (Switzerland) |
- Submission date
- 25/11/2005
- Registration date
- 25/11/2005
- Last edited
- 01/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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)227913752 |
|---|---|
| steeled@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II double-blind randomised placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase II, double-blind, randomised, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals oral live attenuated human rotavirus (HRV) vaccine (RIX4414 at 106.5 CCID50) administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa |
| Study acronym | Rota022 |
| Study objectives | The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' HRV vaccine given concomitantly with routine vaccines including Oral Poliomyelitis Vaccine (OPV) in HIV positive infants. |
| Ethics approval(s) | Ethics approval received in 2004. |
| Health condition(s) or problem(s) studied | Vaccine/immunisation |
| Intervention | Intervention: three doses of GSK Biologicals oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration Control: placebo |
| Intervention type | Biological/Vaccine |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose. |
| Key secondary outcome measure(s) |
1. Reactogenicity |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Weeks |
| Upper age limit | 10 Weeks |
| Sex | All |
| Target sample size at registration | 100 |
| 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. Documented HIV status of the subject as confirmed by Polymerase Chain Reaction (PCR) 5. HIV asymptomatic and HIV mildly symptomatic 6. Categories N and A according to CDC HIV clinical classification 7. 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. Diarrhea 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 | 01/01/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- South Africa
- Switzerland
Study participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/01/2006 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/03/2019: Internal review.
21/03/2016: added link to results - basic reporting.
