Infections, StreptococcalPhase 1NCT01485406
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers
A Phase 1 study testing Pneumococcal vaccine GSK2830930A and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 4 sites in Germany.
Trial summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine GSK2830930A and Synflorix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 4 sitesGermany
- Study dates
- 12 Dec 2011to 15 Mar 2012
- Phase
- Phase 1
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
- A male or female between, and including 12 to 23 months of age at the time of vaccination.
- Written informed consent obtained from the parents/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
- Previously completed three-dose vaccination course with Synflorix.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.
- The licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines but should be documented in the "Concomitant vaccination" of the electronic Case Report Form.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
- History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding vaccination or planned administration during study period.
- Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
- Previous receipt of a booster dose (fourth dose) of Synflorix.
- Anaphylaxis following previous administration of vaccines.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
GSK Investigational Site
Berchtesgaden, Bavaria, 83471
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Braunatal, Hesse, 34225
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
About this study
Official title: Safety and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine 2830930A When Administered as a Single Dose in Healthy Toddlers Aged 12-23 Months
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal vaccine GSK2830930A, Synflorix™
- Keywords
- Haemophilus influenzae, Safety, Pneumococcal vaccine, Streptococcus pneumoniae, Immunogenicity, Toddlers
- Medical subject headings
- Streptococcal Infections, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal vaccine GSK2830930ABiological
1 dose administered intramuscularly
Synflorix™Biological
1 dose administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Pn Group | Experimental | Toddlers 12-23 months of age receiving GSK2830930A vaccine. Receives: Biological: Pneumococcal vaccine GSK2830930A |
| Control Group | Active comparator | Toddlers 12-23 months of age receiving Synflorix. Receives: Biological: Synflorix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Measured: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Measured: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse events with relationship to vaccination
Measured: During the entire study (from Month 0 up to Month 1)
Secondary outcomes (4)
Occurrence of each solicited adverse event
Measured: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of each unsolicited adverse event
Measured: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse event
Measured: During the entire study (from Month 0 up to Month 1)
Evaluation of the immune responses to the components of the 2830930A vaccine
Measured: One month post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start12 Dec 2011
- Primary completion15 Mar 2012
- Study completion15 Mar 2012
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, 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 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
- NCT01485406
- Sponsor's protocol ID
- 115373
- Other IDs
- 2011-002225-22
- Status last verified
- Feb 2021
- First submitted
- 1 Dec 2011
- Last updated
- 10 Feb 2021
- Results posted
- No
- Individual data sharing
- Yes: IPD for this study is available via the Clinical Study Data Request site.
Publications
Horn M, Behre U, Traskine M, Dobbelaere K, Borys D. Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial. Hum Vaccin Immunother. 2021 May 4;17(5):1463-1469. doi: 10.1080/21645515.2020.1810493. Epub 2020 Nov 11.
PubMed 33175600
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine 2830930A When Administered as a Single Dose in Healthy Toddlers Aged 12-23 Months
- ClinicalTrials.gov ID
- NCT01485406
- Acronym / sponsor ID
- 115373
- Conditions
- Infections, Streptococcal
- Keywords
- Haemophilus influenzae, Safety, Pneumococcal vaccine, Streptococcus pneumoniae, Immunogenicity, Toddlers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2011 (actual)
- Primary completion
- 15 Mar 2012 (actual)
- Study completion
- 15 Mar 2012 (actual)
- First posted
- 5 Dec 2011 (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 study is to assess the safety, reactogenicity and immunogenicity of the GSK Biologicals' pneumococcal vaccine 2830930A in toddlers aged 12 to 23 months at study entry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pn Group | Experimental | Biological: Pneumococcal vaccine GSK2830930AToddlers 12-23 months of age receiving GSK2830930A vaccine. |
| Control Group | Active comparator | Biological: Synflorix™Toddlers 12-23 months of age receiving Synflorix. |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
- A male or female between, and including 12 to 23 months of age at the time of vaccination.
- Written informed consent obtained from the parents/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
Key exclusion criteria (16 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/administration of a vaccine containing diphtheria- or tetanus- toxoid or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before the vaccine dose and ending 30 days after, with the exception of licensed influenza vaccines.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
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 |
|---|---|---|
| Pneumococcal vaccine GSK2830930A1 dose administered intramuscularly | Biological | Pn Group |
| Synflorix™1 dose administered intramuscularly | Biological | Control Group |
Primary outcome
Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Time frame: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Time frame: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse events with relationship to vaccination
Time frame: During the entire study (from Month 0 up to Month 1)
4 secondary outcomes
Occurrence of each solicited adverse event
Time frame: Within 7 days (Day 0-Day 6) after vaccination
Occurrence of each unsolicited adverse event
Time frame: Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse event
Time frame: During the entire study (from Month 0 up to Month 1)
Evaluation of the immune responses to the components of the 2830930A vaccine
Time frame: One month post-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 10 Feb 2021.
- Background: PubMed 33175600Horn M, Behre U, Traskine M, Dobbelaere K, Borys D. Safety, reactogenicity, and immunogenicity of a 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine in healthy toddlers: results from a phase I, randomized trial. Hum Vaccin Immunother. 2021 May 4;17(5):1463-1469. doi: 10.1080/21645515.2020.1810493. Epub 2020 Nov 11.
- Results for study 115373 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study is available via the Clinical Study Data Request site.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pneumococcal vaccine GSK2830930A and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 4 sites in Germany.
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 6 inclusion and 16 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Occurrence of each grade 3 solicited adverse event with relationship to vaccination (time frame: Within 7 days (Day 0-Day 6) after vaccination). 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?
On the ClinicalTrials.gov record for NCT01485406, 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 10 Feb 2021.