Infections, StreptococcalPhase 3NCT00333450
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
A Phase 3 study testing Pneumococcal vaccine in people with Infections, Streptococcal, run by GlaxoSmithKline at 30 sites in Germany.
Trial summary
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 11 to 14 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine
- Type of treatment
- Vaccines
- How many people
- 120 participants
- Where
- 30 sitesGermany
- Study dates
- Aug 2006to Dec 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 11 to 14 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
Who cannot join
- children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
- children having received any additional pneumococcal vaccine than in the primary study;
- children with any disease that affect the immune system and history of seizures and/or allergic disease.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Germany30 sites
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 12627
GSK Investigational Site
Berlin, State of Berlin, 12679
GSK Investigational Site
Berlin, State of Berlin, 13055
GSK Investigational Site
Berlin, State of Berlin, 14197
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
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: Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
Read the detailed description
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
- Conditions
- Infections, Streptococcal
- 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 vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody concentrations against pneumococcal serotypes 1 month post-booster
Secondary outcomes (1)
Immunogenicity pre and post-booster and safety (follow up of SAEs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startAug 2006
- Study completionDec 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
- None (open label)
- 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
- NCT00333450
- Sponsor's protocol ID
- 106623
- Status last verified
- Oct 2016
- First submitted
- 2 Jun 2006
- Last updated
- 7 Oct 2016
- 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.
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 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23
- ClinicalTrials.gov ID
- NCT00333450
- Acronym / sponsor ID
- 106623
- Conditions
- Infections, Streptococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 5 Jun 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.
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
Detailed description
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 11 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
Key exclusion criteria (3 listed)
- children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
- children having received any additional pneumococcal vaccine than in the primary study;
- children with any disease that affect the immune system and history of seizures and/or allergic disease.
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
Antibody concentrations against pneumococcal serotypes 1 month post-booster
1 secondary outcome
Immunogenicity pre and post-booster and safety (follow up of SAEs)
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 7 Oct 2016.
- 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.
- Primary StudyLink 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
30 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, run by GlaxoSmithKline at 30 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 3 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Antibody concentrations against pneumococcal serotypes 1 month post-booster. 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 NCT00333450, 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 7 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.