Last updated: 06/26/2019 11:30:29
Serologic response to Porcine circovirus type 1 (PCV-1) in infants following administration of Rotarix™
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Blinded retrospective laboratory evaluations to assess the serologic response to Porcine circovirus type 1 (PCV-1) in infants following the administration of GlaxoSmithKline (GSK) Biologicals’ human rotavirus vaccine (444563)
Trial description: This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Seropositivity rates for anti-PCV-1 antibodies.
Timeframe: At 1-2 months post dose 2 of HRV vaccine or placebo.
Seroconversion rates for anti-PCV-1 antibodies.
Timeframe: At 1-2 months post dose 2 of HRV vaccine or placebo.
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
2014-12-12
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Han HH et al. (2017) Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix™: A retrospective laboratory analysis. Hum Vaccin Immunother. 3(1):237-244.
Medical condition
Infections, Rotavirus
Product
SB444563
Collaborators
Not applicable
Study date(s)
February 2014 to December 2014
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 12 weeks
Accepts healthy volunteers
No
- Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
- Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
- Not Applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
- Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.
- Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.
Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
Exclusion criteria:
- Not Applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
Study complete
Actual primary completion date
2014-12-12
Actual study completion date
2014-12-12
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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