Streptococcal InfectionsPhase 2NCT00169481
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
A Phase 2 study testing Pneumococcal (vaccine) in people with Streptococcal Infections, run by GlaxoSmithKline at 56 sites in Germany.
Trial summary
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination. Read more about this study
- Who is it for?
- Ages 8 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Streptococcal Infections
- What is being tested?
- Pneumococcal (vaccine)
- Type of treatment
- Vaccines
- How many people
- 689 participants
- Where
- 56 sitesGermany
- Study dates
- Oct 2004to May 2005
- Phase
- Phase 2
- 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 8 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Germany56 sites
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 12627
GSK Investigational Site
Berlin, State of Berlin, 13355
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Bodenheim, Rhineland-Palatinate, 55294
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Bretten, Baden-Wurttemberg, 75015
GSK Investigational Site
Cham, Bavaria, 93413
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44329
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, 69214
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24939
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22307
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Herzogenaurach, Bavaria, 91074
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Koenigstein, Hesse, 61462
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Ludwigshafen am Rhein, Rhineland-Palatinate, 67059
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Marburg/Lahn, Hesse, 35039
GSK Investigational Site
Munich, Bavaria, 80939
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Wolfenbüttel, Lower Saxony, 38302
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
GSK Investigational Site
Zwiesel, Bavaria, 94227
About this study
Official title: A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
Read the detailed description
Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa
- Conditions
- Streptococcal Infections
- Being tested
- 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.
Pneumococcal (vaccine)Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
Measured: 1 Month after dose 3
Secondary outcomes (1)
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.
Measured: 1 Month after dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal InfectionsStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 689 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
- NCT00169481
- Sponsor's protocol ID
- 103488
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2005
- Last updated
- 10 Jan 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase II Study to Evaluate the Safety and Immunogenicity of Different Formulations of GlaxoSmithKline Biologicals' 11-valent Pneumococcal Conjugate Vaccine, When Administered Intramuscularly as a 3-dose Primary Immunization (2-3-4 Month Schedule) Before 6 Months of Age
- ClinicalTrials.gov ID
- NCT00169481
- Acronym / sponsor ID
- 103488
- Conditions
- Streptococcal Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 689 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 15 Sep 2005 (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.
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
Detailed description
Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 8 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.
Key exclusion criteria (2 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
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) | Biological | – |
Primary outcome
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
Time frame: 1 Month after dose 3
1 secondary outcome
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.
Time frame: 1 Month after dose 3
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 Jan 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pneumococcal (vaccine) in people with Streptococcal Infections, run by GlaxoSmithKline at 56 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 1 inclusion and 2 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 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination (time frame: 1 Month after dose 3). 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 10 Jan 2017.