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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN37373664
• Date of registration: 25/11/2005
• Prospective Registration: No
• Primary sponsor: World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
• Public title: 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
• Date of first enrolment: 01/01/2002
• Target sample size: 285
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37373664
• Study type: Interventional
• Study design: A double blind, randomised placebo controlled study (Prevention)

Countries of recruitment

South Africa

Contacts

• Name: Duncan Steele

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vaccine/immunization
Infections and Infestations
Vaccination

Intervention(s)

Two doses of GSK Biologicals? oral live attenuated human rotavirus (HRV) vaccine (RIX4414) at 106.5 CCID50 viral concentration
Control: placebo

Primary Outcome(s)

Proportion of subjects who seroconverted at visit 4 (2 months after dose 3) in the vaccine groups.

Secondary Outcome(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

Secondary ID(s)

RPC103

Source(s) of Monetary Support

RAPID trials (USA), World Health Organization (WHO) (Switzerland)