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

ISRCTN	ISRCTN86632774
DOI	https://doi.org/10.1186/ISRCTN86632774
Protocol serial number	N/A
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: 29/01/2008

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	Randomised, controlled study with three parallel groups with balanced allocation (1:1:1).
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Rota014
Study objectives	This study was undertaken to identify whether the immunogenicity of live Oral Poliovirus (OPV) vaccine was affected by the concomitant administration of the candidate Human Rotavirus (HRV) vaccine and also to assess the safety of the candidate HRV vaccine given concomitantly with poliovirus vaccine (OPV or IPV). The study was conducted in two parts, the first part (subset enrolled before the start of the 2002 Rotavirus [RV] season) and the second part of the study (subset enrolled after the end of the 2002 rotavirus season). Objective: To demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of polio vaccine.
Ethics approval(s)	Ethics approval received in 2001
Health condition(s) or problem(s) studied	Vaccine/immunisation
Intervention	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
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Live attenuated human rotavirus vaccine (RIX4414), oral poliovirus vaccine
Primary outcome measure(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
Key secondary outcome measure(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 042) 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
Completion date	01/01/2003

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	271
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 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
Date of first enrolment	01/01/2001
Date of final enrolment	01/01/2003

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