Immunisation Against Streptococcus PneumoniaeNCT01803425
Post-marketing Safety Study of GlaxoSmithKline (GSK) Biologicals' Synflorix™ Vaccine, in Healthy Infants and Children in Sri Lanka
An observational study of Immunisation Against Streptococcus Pneumoniae, run by GlaxoSmithKline.
Trial summary
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority. Read more about this study
- Who is it for?
- Ages 6 weeks to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunisation Against Streptococcus Pneumoniae
- What is being tested?
- Synflorix™ data collection
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 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 weeks to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy Sri Lankan infants aged 6 weeks and above and children
Who may be able to join
- Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- Infants aged 6 weeks and above and children.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.
Who cannot join
- Subjects with contraindications according to the locally approved PI.
- Child in care.
- Previous administration of three doses of Synflorix™.
- Previous vaccination with a pneumococcal vaccine other than Synflorix™.
- Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.
About this study
Official title: Post-marketing Surveillance (PMS) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Conjugate Vaccine (Synflorix™) When Administered to Healthy Infants and Children According to the Prescribing Information in Sri Lanka
This PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Read the detailed description
The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
- Being tested
- Synflorix™ data collection
- Keywords
- Post-marketing surveillance, Prescribing Information (PI), Healthy infants and children, Streptococcus pneumoniae, Synflorix™, Sri Lanka
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synflorix™ data collectionOther
Safety monitoring and evaluation: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. Recording of SAEs throughout the study period for each subject.
| Study group | Role | What they receive |
|---|---|---|
| Synflorix™ cohort | Only those subjects to whom Synflorix™ will be administered as per normal clinical practice, according to the locally approved PI, will be included in the study. Receives: Other: Synflorix™ data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs)
Measured: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall
Occurrence of unsolicited AEs
Measured: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall
Occurrence of Serious Adverse Events (SAEs)
Measured: Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunisation Against Streptococcus PneumoniaeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 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
- NCT01803425
- Sponsor's protocol ID
- 116290
- Status last verified
- Sep 2013
- First submitted
- 28 Feb 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance (PMS) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Conjugate Vaccine (Synflorix™) When Administered to Healthy Infants and Children According to the Prescribing Information in Sri Lanka
- ClinicalTrials.gov ID
- NCT01803425
- Acronym / sponsor ID
- 116290
- Keywords
- Post-marketing surveillance, Prescribing Information (PI), Healthy infants and children, Streptococcus pneumoniae, Synflorix™, Sri Lanka
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of clarity regarding the PMS study requirement from the RA and Ethics committee hence it was concluded GSK will submit local PSURs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 4 Mar 2013 (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 PMS study aims to collect safety and reactogenicity data of Synflorix™ in healthy infants and children of the local population as per the licensing requirement of the Sri Lankan regulatory authority.
Detailed description
The participating physicians (investigators) will be asked to enrol only those subjects to whom they administer Synflorix™ in the course of their normal clinical practice according to the locally approved Prescribing Information.
Since there is lack of clarity regarding the PMS study requirement (both from Regulatory agency and Ethics Committee), it was decided that GSK will submit Local PSURs on a regular basis as desired by Local regulatory agency. The same is communicated to Regulatory agency and if they want something more they are requested to revert back with specific requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synflorix™ cohort | – | Other: Synflorix™ data collectionOnly those subjects to whom Synflorix™ will be administered as per normal clinical practice, according to the locally approved PI, will be included in the study. |
Who may qualify
- Ages
- 6 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Sri Lankan infants aged 6 weeks and above and children
Key inclusion criteria (4 listed)
- Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol should be enrolled in the PMS study.
- Infants aged 6 weeks and above and children.
- Written, signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the child. Where subject's parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an impartial witness.
- Note: Consent for this PMS study is solely for collection of safety and reactogenicity data and not for vaccination that is per routine practice. Data for demography, medical history and previous vaccination history, and concomitant medication/vaccination will also be collected.
Key exclusion criteria (5 listed)
- Subjects with contraindications according to the locally approved PI.
- Child in care.
- Previous administration of three doses of Synflorix™.
- Previous vaccination with a pneumococcal vaccine other than Synflorix™.
- Planned administration of another pneumococcal vaccine other than Synflorix™ during the PMS study.
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 |
|---|---|---|
| Synflorix™ data collectionSafety monitoring and evaluation: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. Recording of SAEs throughout the study period for each subject. | Other | Synflorix™ cohort |
Primary outcome
Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs)
Time frame: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall
Occurrence of unsolicited AEs
Time frame: During the 31-day period (Day 0 to Day 30) following any dose of Synflorix™ and overall
Occurrence of Serious Adverse Events (SAEs)
Time frame: Throughout the PMS study period, starting at Dose 1 (Visit 1) and ending 31 days (Day 0 to Day 30) after the last dose of Synflorix™ for each subject in the PMS study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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 Immunisation Against Streptococcus Pneumoniae, 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 5 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: withdrawn, as of the sponsor's last update on 9 Sep 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of solicited local (any intensity) and general (any intensity and causally related) adverse events (AEs) (time frame: During the 4-day follow-up period (Day 0 to Day 3) following any dose of Synflorix™ and overall). The study lists 3 primary outcomes in all. 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 9 Sep 2013.