Presence of Materials From PCV-1NCT01651247
Assessment of the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants and Toddlers, Following Administration of IPV (Inactivated Poliovirus Vaccine)-Containing Vaccines
An observational study of Presence of Materials From PCV-1, run by GlaxoSmithKline.
Trial summary
This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and… Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Presence of Materials From PCV-1
- 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
- May 2010to May 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 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged 2 and 6 months who were previously given a primary vaccination series consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6 months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®) vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.
Who may be able to join
- Subjects enrolled previously in randomized, open and multicentre studies [217744/085; 213503/048].
- Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
- Subjects 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) in the Serum of Infants Aged 2 and 6 Months and Toddlers Aged 4-6 Years Following Administration of GlaxoSmithKline (GSK) Biologicals' IPV-containing Vaccines
This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies [217744/085 and 213503/048] conducted in the United States.
Read the detailed description
Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.
- Conditions
- Presence of Materials From PCV-1
- Being tested
- Serum sample
- Keywords
- Toddlers, Retrospective, Porcine circovirus type 1 (PCV-1), Infants, Laboratory evaluations, IPV
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-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects received 3 doses of the combination DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines at 2, 4, and 6 months of age, in a previous study (217744/085). Receives: Procedure: Serum sample | |
| Group B | Subjects received a single dose of the combination DTaP-IPV vaccine or separately administered DTaP and IPV vaccines at 4-6 years of age, in a previous study (213503/048). Receives: Procedure: Serum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of serum anti-PCV-1 antibody.
Measured: At Day 0 and post vaccination time points (up to 1 month after vaccination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMay 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presence of Materials From PCV-1Studies 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
- NCT01651247
- Sponsor's protocol ID
- 114535
- Other IDs
- 213503/048, 217744/085
- Status last verified
- Jul 2012
- First submitted
- 12 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. 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 the Serum of Infants Aged 2 and 6 Months and Toddlers Aged 4-6 Years Following Administration of GlaxoSmithKline (GSK) Biologicals' IPV-containing Vaccines
- ClinicalTrials.gov ID
- NCT01651247
- Acronym / sponsor ID
- 114535
- Conditions
- Presence of Materials From PCV-1
- Keywords
- Toddlers, Retrospective, Porcine circovirus type 1 (PCV-1), Infants, Laboratory evaluations, IPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Jul 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 analyse the serologic response to PCV-1 in the PEDIARIX® [GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies [217744/085 and 213503/048] conducted in the United States.
Detailed description
Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Serum sampleSubjects received 3 doses of the combination DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines at 2, 4, and 6 months of age, in a previous study (217744/085). |
| Group B | – | Procedure: Serum sampleSubjects received a single dose of the combination DTaP-IPV vaccine or separately administered DTaP and IPV vaccines at 4-6 years of age, in a previous study (213503/048). |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged 2 and 6 months who were previously given a primary vaccination series consisting of a single dose of combination DTaP-HepB-IPV (PEDIARIX®) vaccine at 2, 4, and 6 months of age or separately administered DTaP (INFANRIX®), HepB (ENGERIX-B®), and IPV (Sanofi-Pasteur's IPOL) vaccines in the study 217744/085 and toddlers aged 4-6 years who were previously vaccinated with a single dose of either the combination DTaP-IPV (KINRIX®) vaccine or separately administered DTaP and IPV vaccines in the study 213503/048.
Key inclusion criteria (3 listed)
- Subjects enrolled previously in randomized, open and multicentre studies [217744/085; 213503/048].
- Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
- Subjects 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 |
|---|---|---|
| Serum sampleSerum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies. | Procedure or surgery | Group A, Group B |
Primary outcome
Presence of serum anti-PCV-1 antibody.
Time frame: At Day 0 and post vaccination time points (up to 1 month after 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 27 Jul 2012.
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 Presence of Materials From PCV-1, 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 3 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 27 Jul 2012. 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 serum anti-PCV-1 antibody. (time frame: At Day 0 and post vaccination time points (up to 1 month after vaccination).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2012.