Last updated: 11/07/2018 07:43:03
Serological response to Porcine circovirus type 1 (PCV-1) and PCV-1 DNA in stools of infants following administration of Rotarix™
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Blinded retrospective laboratory evaluations to assess the serologic response to Porcine circovirus type 1 (PCV-1) and PCV-1 DNA in the stool of infants aged 6 to 12 weeks following administration of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus vaccine (444563)
Trial description: This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Presence of PCV-1 DNA and pattern of detection in the stool samples collected
Timeframe: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
Presence of serum anti-PCV-1 antibody
Timeframe: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
Secondary outcomes:
Not applicable
Interventions:
Procedure/surgery: Stool sample
Procedure/surgery: Serum sample
Enrollment:
1
Observational study model:
Other
Primary completion date:
2010-02-06
Time perspective:
Retrospective
Clinical publications:
Dubin G et al. (2013) Investigation of a regulatory agency enquiry into potential porcine circovirus type 1 contamination of the human rotavirus vaccine, Rotarix™: Approach and outcome. Hum Vaccin Immunother. 9(11):2398-2408.
Medical condition
Rotavirus Infection, Evidence of PCV-1 replication and/or immune response to the PCV-1 in HRV vaccinated infants
Product
SB444563
Collaborators
Not applicable
Study date(s)
April 2010 to June 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
No
- Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);
- Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;
- Infants for whom sufficient residual volume of the stool samples at predetermined time points is available;
- Infants for whom sufficient residual volume of the pre and post vaccination blood samples is available.
Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-02-06
Actual study completion date
2010-02-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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