Infections, StreptococcalNCT01046097
Post-marketing Surveillance Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Philippines
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 2 sites in Philippines.
Trial summary
The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants. Read more about this study
- Who is it for?
- Ages 6 weeks to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Synflorix™
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 28 participants
- Where
- 2 sitesPhilippines
- Study dates
- May 2010to Jul 2013
- 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 Filipino infants and children aged 6 weeks of age to 5 years of age who will receive Synflorix™ as a part of routine practice as per the Prescribing Information in Philippines.
Who may be able to join
- Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
- Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
- Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
- Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
- Written and signed informed consent obtained from the parents/LAR(s) of the child. Where parents/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Who cannot join
- Acute disease and/or fever at the time of vaccine administration.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
- Hypersensitivity to latex (found in syringe-tip cap and plunger).
- Any contraindications as stated in the Prescribing Information.
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
GSK Investigational Site
Quezon City, 1113
GSK Investigational Site
Santa Mesa, Manila
About this study
Official title: Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines
The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.
- Conditions
- Infections, Streptococcal
- Being tested
- Synflorix™
- Keywords
- Pneumococcal vaccine
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synflorix™Biological
Intramuscular administration of three doses/two doses/one dose of primary vaccination/the booster dose/ catch-up dose(s) of Synflorix according to local prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Synflorix Group | Subjects receiving Synflorix™ according to local Prescribing Information. Subjects were administered with Synflorix by investigators in the course of their normal clinical practice. The vaccination schedule consisted of three doses/two doses/one dose or the booster dose of 10Pn-PD-DiT to be administered as per the local PI. First dose of the vaccine could be administered to infants as early as 6 weeks of age and minimum interval between subsequent primary doses was 4 weeks. Receives: Biological: Synflorix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of grade 3 unsolicited adverse events.
Measured: Within 31 days (Day 0 - Day 30) after each vaccination.
Secondary outcomes (2)
Occurrence of unsolicited adverse events.
Measured: During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.
Occurrence of serious adverse events.
Measured: From the Dose 1 up to study end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: Local authorities no longer require routine PMS studies;GSK does not believe the study would add meaningfully to the safety data already available for Synflorix
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, StreptococcalStudies 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
- Prospective
- Enrolment
- 28 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
- NCT01046097
- Sponsor's protocol ID
- 113381
- Status last verified
- May 2016
- First submitted
- 7 Jan 2010
- Last updated
- 16 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study of GSK Biologicals' Pneumococcal Conjugate Vaccine, Synflorix, When Administered According to the Local Prescribing Information in Philippines
- ClinicalTrials.gov ID
- NCT01046097
- Acronym / sponsor ID
- 113381
- Conditions
- Infections, Streptococcal
- Keywords
- Pneumococcal vaccine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Local authorities no longer require routine PMS studies;GSK does not believe the study would add meaningfully to the safety data already available for Synflorix
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Jan 2010 (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.
The purpose of this post-marketing surveillance study is to evaluate the safety of Synflorix™ when administered according to the local Prescribing Information to healthy Filipino infants.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Synflorix Group | – | Biological: Synflorix™Subjects receiving Synflorix™ according to local Prescribing Information. Subjects were administered with Synflorix by investigators in the course of their normal clinical practice. The vaccination schedule consisted of three doses/two doses/one dose or the booster dose of 10Pn-PD-DiT to be administered as per the local PI. First dose of the vaccine could be administered to infants as early as 6 weeks of age and minimum interval between subsequent primary doses was 4 weeks. |
Who may qualify
- Ages
- 6 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy Filipino infants and children aged 6 weeks of age to 5 years of age who will receive Synflorix™ as a part of routine practice as per the Prescribing Information in Philippines.
Key inclusion criteria (7 listed)
- Subjects who the investigator believes that their parents/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
- Filipino male or female subjects whose age at the first vaccination with Synflorix™ in this PMS should not be less than 6 weeks of age.
- Filipino male or female subjects who enter the PMS at the second dose should not be less than 10 weeks of age.
- Filipino male or female subjects who enter the PMS at the third dose should not be less than 14 weeks of age.
- Filipino male or female subjects who enter the PMS at the booster dose (i.e. if they have received Synflorix™ in the previous dose/s outside the PMS) should not be less than 10 months of age. The time interval between the primary vaccination and booster dose should be at least 6 months. For the booster dose, subjects who received PCV-7/-13 or Synflorix™ in their primary vaccination series will be allowed to take part in the PMS.
Key exclusion criteria (7 listed)
- Acute disease and/or fever at the time of vaccine administration.
- Fever is defined as temperature ≥ 37.5°C (99.5°F) on axillary, infrared or tympanic setting.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- History of chronic condition(s) requiring treatment such as cancer or autoimmune diseases.
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™Intramuscular administration of three doses/two doses/one dose of primary vaccination/the booster dose/ catch-up dose(s) of Synflorix according to local prescribing information. | Biological | Synflorix Group |
Primary outcome
Occurrence of grade 3 unsolicited adverse events.
Time frame: Within 31 days (Day 0 - Day 30) after each vaccination.
2 secondary outcomes
Occurrence of unsolicited adverse events.
Time frame: During 31 days (Day 0 - Day 30) follow-up period after each vaccination/vaccine dose.
Occurrence of serious adverse events.
Time frame: From the Dose 1 up to study end.
Results and safety
The study was stopped early (reason given: Local authorities no longer require routine PMS studies;GSK does not believe the study would add meaningfully to the safety data already available for Synflorix). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections, Streptococcal, run by GlaxoSmithKline at 2 sites in Philippines.
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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Local authorities no longer require routine PMS studies;GSK does not believe the study would add meaningfully to the safety data already available for Synflorix). Results are not available in the source record.
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 grade 3 unsolicited adverse events. (time frame: Within 31 days (Day 0 - Day 30) after each 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 16 May 2016.