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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201110000333955 Date registered: 2011/10/26
TRIAL DESCRIPTION
Public title RRV-TV Rotavirus Vaccine Administration to Neonates [retrospectively registered]
Official scientific title A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy, Immunogenicity, and Safety of Two Single Doses of RRV TV in Neonates/Infants
Brief summary describing the background
and objectives of the trial
Phase II dosing clincal trial with the primary objective of the study was to evaluate the efficacy of two doses of the oral rotavirus vaccine, RRV-TV, in neonate/infant subjects against gastroenteritis with presence of rotavirus (RV GE). The first dose of the vaccine was to be administered at age 0 to 29 days, and the second dose was to be administered at age 30 to 59 days.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 2009-08-28
Actual trial start date 2009-08-28
Anticipated date of last follow up 2010-10-28
Actual date of last follow up 2010-10-28
Anticipated target sample size (number of participants) 998   
Actual target sample size (number of participants) 949   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
IMF-001

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Single group: all participants receive same intervention throughout study Randomised Simple randomisation Numbered containers Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group RRV-TV 2.5ml X 2, at 0 to 29 days and 30 to 59 days 59 days rotavirus vaccine 500
Control group Placebo 2.5ml X 2, at 0 to 29 days and 30 to 59 days 59 days Buffer 498 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
To be eligible for study entry, subjects had to satisfy all of the following criteria. If a subject failed to satisfy the eligibility criteria, he/she could be re-screened for the study. 1.The investigator considered that the subject¿s parent(s)/caregiver(s) could and would comply with the requirements of the protocol (e.g., return for follow up visits). 2.A male or female child, aged 0 to 29 days at the time of administration of the first dose of IP. 3.Informed consent was obtained from the parent(s)/caregiver(s) of the subject, who was/were of legal age as prescribed by the national regulations in Ghana. Because the study was conducted in a largely illiterate population, the consent was verbal and was obtained in accordance with center-specific SOPs for obtaining consent. The thumbprint of the subject¿s parent, obtained in the presence of an independent witness, served as confirmation of the understanding of the consent. 4.Healthy subjects, as established by medical history and clinical examination. 5.Birth weight >2000 g or, if birth weight was unknown, gestation period >37 weeks. Subjects were excluded from the study if one or more of the following statements were applicable: 1.Use, or planned use during the study period, of any investigational or non registered product (drug or vaccine) other than the study vaccine before administration of the first dose of IP. 2.Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non investigational product (pharmaceutical product or device). 3.Planned administration of a vaccine not recommended by the routine national vaccination program within 14 days before or after each dose of IP. 4.Chronic administration (defined as more than 14 days) of immunosuppressants since birth. (Topical steroids were allowed.) 5.Any clinically significant history of chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract, intussusception, or other medical condition determined to be serious by the investigator. 6.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 7.History of allergic disease or reaction likely to be exacerbated by any component of the vaccine. 8.Acute disease at the time of enrollment. (Acute disease was defined as the presence of a moderate or severe illness with or without fever. All vaccines were to be administered to subjects with a minor illness, such as mild upper respiratory infection with or without low grade febrile illness, i.e., axillary temperature <37.5°C, higher temperatures warranted deferral of vaccination). 9.GE (diarrhea [¿3 looser than normal or watery stools/24 h], with or without vomiting) within 7 days before administration of the first dose of IP (warrants deferral of the vaccination). 10.Previous confirmed occurrence of RV GE. 11.A family history of congenital or hereditary immunodeficiency. 12.Administration of immunoglobulins and/or blood products (excluding hepatitis B immune globulin [HBIG] since birth or planned administration during the study period. 13.History of any neurologic disorders or seizures. 14.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. 1 Day 59 Days Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes IRB of the Noguchi Memorial Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes IRB of the Navrongo Health Research Centre (NHRC)
Ethics Committee Address
Street address City Postal code Country
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes Ghana Health Services Ethical Review Committee (GHSERC)
Ethics Committee Address
Street address City Postal code Country

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Efficacy of two doses of RRV TV in neonate/infant subjects against gastroenteritis with presence of rotavirus (RV GE). Over 12 months
Secondary Outcome Efficacy of two doses of RRV TV in neonate/infant subjects against severe RV GE, in which the stool sample contained at least one of the serotypes present in the RRV TV vaccine, analyzed by serotype. Over 12 months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana PO Box LG 581 Legon, Accra Ghana

FUNDING SOURCES
Name of source Street address City Postal code Country
International Medica Foundation 421 First Ave. S.W., Suite 304 Rochester, MN 55902 United States of America

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor International Medica Foundation 421 First Street S.W., Suite 304 Rochester, MN 55902 United States of America Foundation

COLLABORATORS
Name Street address City Postal code Country
INC Research 13 Fredman Drive, 1st Floor, Fredman Towers Sandown 2196 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof George Armah GArmah@noguchi.mimcom.org 233 21 501179 233 21 502182
Street address City Postal code Country Position / Affiliation
PO Box LG 581 Legon, Accra Ghana Professor, Noguchi Memorial Institute for Medical Research (NMIMR), University of Ghana
Role Name Email Phone Fax
Public Enquiries Dr Leonard Ruiz lpruiz@intl-medica.org +1 651-490-0212 none
Street address City Postal code Country Position / Affiliation
5264 Oxford Street Shoreview, MN 55126 United States of America President, International Medica Foundation
Role Name Email Phone Fax
Scientific Enquiries Dr Leonard Ruiz lpruiz@intl-medica.org +1 651 4900212
Street address City Postal code Country Position / Affiliation
5264 Oxford Street Shoreview, MN 55126 United States of America President, International Medica Foundation