RRV-TV Rotavirus Vaccine Administration to Neonates [retrospectively registered]

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201110000333955
• Date of registration: 26/10/2011
• Primary sponsor: International Medica Foundation
• Public title: RRV-TV Rotavirus Vaccine Administration to Neonates [retrospectively registered]
• 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
• Date of first enrolment: 2009-08-28
• Target sample size: 949
• Recruitment status: Completed: recruitment & data analysis complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201110000333955
• Study type: interventional
• Study design: Single group: all participants receive same intervention throughout study,; Randomised,; Simple randomisation,; Numbered containers,

Countries of recruitment

South Africa

Contacts

• Name: Leonard Ruiz
• Affiliation: President, International Medica Foundation

• Name: Leonard Ruiz
• Affiliation: President, International Medica Foundation

Key inclusion & exclusion criteria

Inclusion criteria: 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 b2000 g or, if birth weight was unknown, gestation period b37 weeks.

Exclusion criteria: 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.


Age minimum: 1 Day
Age maximum: 59 Day
Gender: Both

Health Condition(s) or Problem(s) studied

Rotavirus

Primary Outcome(s)

Efficacy of two doses of RRV TV in neonate/infant subjects against gastroenteritis with presence of rotavirus (RV GE).

Secondary Outcome(s)

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.

Secondary ID(s)

IMF-001

Source(s) of Monetary Support

International Medica Foundation