Infections, StreptococcalPhase 3NCT00307541
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
A Phase 3 study testing Pneumococcal (vaccine) in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 32 sites in Germany.
Trial summary
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age Read more about this study
- Who is it for?
- Ages 8 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
- What is being tested?
- Pneumococcal (vaccine)
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 32 sitesGermany
- Study dates
- 27 Oct 2005to 7 Apr 2006
- Phase
- Phase 3
- 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 between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.
Who cannot join
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding 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 one month before the first dose of vaccine(s) and during the entire study period.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Germany32 sites
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 12627
GSK Investigational Site
Berlin, 12679
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 13409
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18146
GSK Investigational Site
Stollberg, Saxony, 09366
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Tutzing, Bavaria, 82327
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
About this study
Official title: Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Read the detailed description
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
- 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 post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
Secondary outcomes (6)
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concns >= 0.05 µg/mL
Ab concns to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Unsolicited adverse events within 31 days, SAEs (whole study period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study start27 Oct 2005
- Primary completion7 Apr 2006
- Study completion7 Apr 2006
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants
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
- NCT00307541
- Sponsor's protocol ID
- 105554
- Other IDs
- 2005-003299-40, 2005
- Status last verified
- Dec 2019
- First submitted
- 7 Mar 2006
- Last updated
- 2 Jan 2020
- Results posted
- No
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.
PubMed 21909049
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age
- ClinicalTrials.gov ID
- NCT00307541
- Acronym / sponsor ID
- 105554
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2005 (actual)
- Primary completion
- 7 Apr 2006 (actual)
- Study completion
- 7 Apr 2006 (actual)
- First posted
- 28 Mar 2006 (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.
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age
Detailed description
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.
Key exclusion criteria (2 listed)
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding 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 one month before the first dose of vaccine(s) and during the entire study period.
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 post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL
6 secondary outcomes
1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
Antibody (Ab) concns >= 0.05 µg/mL
Ab concns to protein D and seropositivity (S+) status
S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
After each vaccination, occurrence of: solicited local, general symptoms within 4 days
Unsolicited adverse events within 31 days, SAEs (whole study period)
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 2 Jan 2020.
- Background: PubMed 21909049Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.
- Booster StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal (vaccine) in people with Infections, Streptococcal and Streptococcus Pneumoniae Vaccines, run by GlaxoSmithKline at 32 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL. 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 NCT00307541, 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 2 Jan 2020.