Last updated: 07/17/2024 15:45:16
Evaluation of immunogenicity and safety of two formulations of GSK Biologicals’ human rotavirus (HRV) vaccine (444563), in healthy infants starting at age 6-12 weeks
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Immunogenicity and safety study of two formulations of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563), in healthy infants starting at age 6-12 weeks
Trial description: The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) antibody concentrations in the Human Rotavirus (HRV) liquid formulation groups (Liq_A, Liq_B and Liq_C)
Timeframe: At Month 2-4 (i.e. approximately 1-month or 2-months interval after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Percentage of seroconverted subjects with RV antibody titers above or equal to cut-off value in the lyophilised and pooled liquid groups
Timeframe: At Month 2-4 (i.e. approximately 1-month or 2-months interval after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Anti-RV IgA antibody concentrations in the Porcine Circovirus (PCV) -free liquid HRV vaccine (pooled HRV liquid groups) and Control group
Timeframe: At Month 2-4 (i.e. approximately 1-month or 2-months interval after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Secondary outcomes:
Percentage of subjects with Anti-RV IgA concentrations
Timeframe: At Month 2-4 (i.e. approximately 1-month or 2-months interval after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)
Number of subjects with any solicited general Adverse Events (AEs).
Timeframe: During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine
Number of subjects with any unsolicited AEs.
Timeframe: During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination.
Number of subjects with any Serious Adverse Events (SAEs)
Timeframe: During the entire study period (Day 0 to Month 7-8)
Interventions:
Enrollment:
1612
Primary completion date:
2018-27-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Ignacio Salamanca de la Cueva, Barbara Pahud, Li-Min Huang, Michael Leonardi, José Garcia-Sicilia, Javier Céspedes, Arturo Abdelnour, Tsuyoshi Tamura, Haruo Kuroki, Nan-Chang Chiu, Miia Virta, Satu Kokko, Michael Horn, Falko Panzer, Jong-Hyun Kim, Lee Jin, Leentje Moerman, Christophe Debacq, Jose Parra, Ana Ugarte, Dan Bi, The Rota-081 Study Group. Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial. The Journal of Infectious Diseases. 2020. https://doi.org/10.1093/infdis/jiaa210.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
October 2016 to November 2018
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
Yes
- Subjects’ parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
- Child in care
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the parent(s)/LAR(s) (Legally acceptable representatives) of the subject prior to performing any study specific procedure.
- A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
- Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects’ parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day-29 to Day 0), or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
- Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
- History of IS.
- Family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Major congenital defects or serious chronic illness.
- Previous vaccination against RV.
- Previous confirmed occurrence of RVGE.
- GE within 7 days preceding the study vaccine administration.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity, the axilla and the rectum.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Child in care
Trial location(s)
Location
GSK Investigational Site
Anaheim, California, United States, 92804
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35235
Status
Study Complete
Showing 1 - 6 of 64 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2018-27-06
Actual study completion date
2018-26-11
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (Latin America), Finnish, German, Japanese, Korean, Spanish, Chinese (Taiwan)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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