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
Protocol serial number	RPC103
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: 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

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3752
Email	steeled@who.int

Study information

Primary study design	Interventional
Study design	A double blind, randomised placebo controlled study
Secondary study design	Randomised controlled trial
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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Human rotavirus vaccine (RIX4414)
Primary outcome measure(s)	Proportion of subjects who seroconverted at visit 4 (2 months after dose 3) in the vaccine groups.
Key secondary outcome measure(s)	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
Completion date	25/10/2004

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	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan