Infections, RotavirusNCT02153333
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 weeks
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Serum sample
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Dec 2014
- 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 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.
Who may be able to join
- 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.
- 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.
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) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)
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.
Read the detailed description
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
- Conditions
- Infections, Rotavirus
- Being tested
- Serum sample
- Keywords
- Human rotavirus (HRV) vaccine, Serologic response, Porcine circovirus type 1 (PCV-1), Laboratory evaluations
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum sampleProcedure or surgery
Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| HRV Group | Subjects who had received 2 doses of HRV vaccine in previous studies. Receives: Procedure: Serum sample | |
| Placebo Group | Subjects who had received 2 doses of placebo in previous studies. Receives: Procedure: Serum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seropositivity rates for anti-PCV-1 antibodies.
Measured: At 1-2 months post dose 2 of HRV vaccine or placebo.
Seroconversion rates for anti-PCV-1 antibodies.
Measured: At 1-2 months post dose 2 of HRV vaccine or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Infections, RotavirusStudies 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
- 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
- NCT02153333
- Sponsor's protocol ID
- 114793
- Other IDs
- 444563/005 (Rota-005), 444563/023 (Rota-023), 444563/028 (Rota-028), 444563/029 (Rota-029), 102247 (Rota-036), 106481 (Rota-054)
- Status last verified
- Apr 2015
- First submitted
- 15 May 2014
- Last updated
- 6 Apr 2015
- 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 6 Apr 2015. 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) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)
- ClinicalTrials.gov ID
- NCT02153333
- Acronym / sponsor ID
- 114793
- Conditions
- Infections, Rotavirus
- Keywords
- Human rotavirus (HRV) vaccine, Serologic response, Porcine circovirus type 1 (PCV-1), Laboratory evaluations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Jun 2014 (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 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.
Detailed description
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRV Group | – | Procedure: Serum sampleSubjects who had received 2 doses of HRV vaccine in previous studies. |
| Placebo Group | – | Procedure: Serum sampleSubjects who had received 2 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 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.
Key inclusion criteria (4 listed)
- 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.
- 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.
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 |
|---|---|---|
| Serum sampleSerum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated. | Procedure or surgery | HRV Group, Placebo Group |
Primary outcome
Seropositivity rates for anti-PCV-1 antibodies.
Time frame: At 1-2 months post dose 2 of HRV vaccine or placebo.
Seroconversion rates for anti-PCV-1 antibodies.
Time frame: At 1-2 months post dose 2 of HRV vaccine or placebo.
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 6 Apr 2015.
- 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 Infections, Rotavirus, 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 6 Apr 2015. 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?
Seropositivity rates for anti-PCV-1 antibodies. (time frame: At 1-2 months post dose 2 of HRV vaccine or placebo.). 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 NCT02153333, 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 6 Apr 2015.