A phase II, double blind randomised, placebo controlled study to assess the safety reactogenicity and immunogenicity of three doses of GSK Biologicals (South Africa)

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN86632774
• 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 phase II, double blind randomised, placebo controlled study to assess the safety reactogenicity and immunogenicity of three doses of GSK Biologicals (South Africa)
• Date of first enrolment: 01/01/2001
• Target sample size: 271
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN86632774
• Study type: Interventional
• Study design: Randomised, controlled study with three parallel groups with balanced allocation (1:1:1). (Not Specified)

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 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Vaccine/immunisation
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, one dose of placebo
Control: three doses of placebo

Primary Outcome(s)

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(s)

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 0?42) 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

Secondary ID(s)

N/A

Source(s) of Monetary Support

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