Condition category
Infections and Infestations
Date applied
25/11/2005
Date assigned
25/11/2005
Last edited
28/01/2008
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

RPC103

Study information

Scientific title

Acronym

Rota013

Study hypothesis

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

Approved prior to 2002

Study design

A double blind, randomised placebo controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Human rotavirus vaccine (RIX4414)

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/01/2002

Overall trial end date

25/10/2004

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

285

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 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

Recruitment start date

01/01/2002

Recruitment end date

25/10/2004

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