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 number	NCT00263666
Secondary identifying numbers	444563-022

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

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)227913752
Email	steeled@who.int

Study information

Study design	Phase II double-blind randomised placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)
Primary outcome measure	Percentage of subjects who report grade "2" or grade "3" fever, vomiting or diarrhoea during the 15-day f/u period after each dose.
Secondary outcome measures	1. Reactogenicity 2. Serious adverse events (SAEs) 3. CD4 count and human immunodeficiency virus (HIV) viral load at screening and visit 4 4. Immunogenicity 5. Rotavirus shedding until ceases 6. Enteric pathogens 7. Immunogenicity of antigens contained in concomitantly administered routine vaccine DTPw-HBV/Hib + OPV
Overall study start date	01/01/2004
Completion date	01/01/2006

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Weeks
Upper age limit	10 Weeks
Sex	Both
Target number of participants	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

Sponsor information

World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
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

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No
Results article	results	05/01/2006		Yes	No

Editorial Notes

01/03/2019: Internal review.
21/03/2016: added link to results - basic reporting.