Rotavirus InfectionNCT01511133
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
An observational study of Rotavirus Infection and Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants, run by GlaxoSmithKline.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 weeks
- Conditions the study is for
- Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
- What is being tested?
- Stool sample and Serum sample
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo
Who may be able to join
- 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;
- 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.
Who cannot join
- Not applicable
About this study
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)
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.
Read the detailed description
Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
- Conditions
- Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
- Being tested
- Stool sample, Serum sample
- Keywords
- Laboratory evaluations, infants, Porcine circovirus type 1 (PCV-1), serologic response, human rotavirus (HRV) vaccine
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleProcedure or surgery
Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.
Serum sampleProcedure or surgery
Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.
| Study group | Role | What they receive |
|---|---|---|
| HRV Group | Subjects received two or three doses of HRV in previous studies. Receives: Procedure: Stool sample; Procedure: Serum sample | |
| Placebo Group | Subjects received two or three doses of placebo in previous studies. Receives: Procedure: Stool sample; Procedure: Serum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of PCV-1 DNA and pattern of detection in the stool samples collected
Measured: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
Presence of serum anti-PCV-1 antibody
Measured: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511133
- Sponsor's protocol ID
- 114444
- Other IDs
- 444563/022, 444563/033, 103477, 104480
- Status last verified
- May 2017
- First submitted
- 1 Dec 2011
- Last updated
- 16 May 2017
- Results posted
- No
Publications
Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.
PubMed 27657348
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01511133
- Acronym / sponsor ID
- 114444
- Conditions
- Rotavirus Infection, Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
- Keywords
- Laboratory evaluations, infants, Porcine circovirus type 1 (PCV-1), serologic response, human rotavirus (HRV) vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV Group | – | Procedure: Stool sample, Procedure: Serum sampleSubjects received two or three doses of HRV in previous studies. |
| Placebo Group | – | Procedure: Stool sample, Procedure: Serum sampleSubjects received two or three doses of placebo in previous studies. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo
Key inclusion criteria (4 listed)
- 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;
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool sampleStool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection. | Procedure or surgery | HRV Group, Placebo Group |
| Serum sampleSerum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody. | Procedure or surgery | HRV Group, Placebo Group |
Primary outcome
Presence of PCV-1 DNA and pattern of detection in the stool samples collected
Time frame: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
Presence of serum anti-PCV-1 antibody
Time frame: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Derived from this study: PubMed 27657348Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Infection and Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of PCV-1 DNA and pattern of detection in the stool samples collected (time frame: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.