Condition category
Infections and Infestations
Date applied
25/11/2005
Date assigned
25/11/2005
Last edited
29/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Duncan Steele

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3752
steeled@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Rota014

Study hypothesis

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

Ethics approval received in 2001

Study design

Randomised, controlled study with three parallel groups with balanced allocation (1:1:1).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Live attenuated human rotavirus vaccine (RIX4414), oral poliovirus vaccine

Primary outcome measures

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 measures

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

Overall trial start date

01/01/2001

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

271

Participant 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

Recruitment start date

01/01/2001

Recruitment end date

01/01/2003

Locations

Countries of recruitment

South Africa

Trial participating centre

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

20
Avenue Appia
Geneva -27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

RAPID trials (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO) (Switzerland)

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

Switzerland

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes