Infections, StreptococcalPhase 3NCT00907777

Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

A Phase 3 study testing Pneumococcal conjugate vaccine GSK 1024850A and Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's) in people with Infections, Streptococcal and Streptococcus Pneumoniae, run by GlaxoSmithKline at 17 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of… Read more about this study

Who is it for?: Ages 46 to 50 monthsHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal, Streptococcus Pneumoniae
What is being tested?: Pneumococcal conjugate vaccine GSK 1024850A and Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 17 sitesGermany
Study dates: 23 Jun 2009to 5 Oct 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 46 to 50 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female between, and including, 46-50 months of age at the time of vaccination.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
Written informed consent obtained from both parents/guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
Administration of any pneumococcal vaccine since the end of study NCT00333450.
Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical

Show all 13Show fewer

History of any neurologic disorders or seizures
Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
History of hypotonic-hyporesponsive episode after any previous vaccination.
Major congenital defects or serious chronic illness.
History of invasive pneumococcal diseases.
Acute disease at the time of vaccination
Rectal temperature >= 38.0°C or oral/axillary/tympanic temperature >= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Germany17 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, 13055
GSK Investigational Site
Berlin, 14197
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, 68163
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877

Other trials in Germany

About this study

Official title: Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Conditions: Infections, Streptococcal, Streptococcus Pneumoniae
Being tested: Pneumococcal conjugate vaccine GSK 1024850A, Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)
Keywords: Haemophilus influenzae, Streptococcus pneumoniae, safety, Pneumococcal conjugate vaccine, immunogenicity
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 conjugate vaccine GSK 1024850ABiological
One dose of vaccine will be injected intramuscularly into the deltoid.
Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)Biological
One dose of vaccine will be injected intramuscularly into the deltoid.

Study groups in NCT00907777
Study group	Role	What they receive
Pn Group	Experimental	Subjects receiving GSK 1024850A vaccine. Receives: Biological: Pneumococcal conjugate vaccine GSK 1024850A
Prev Group	Active comparator	Subjects receiving Prevenar™ vaccine. Receives: Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)

What is being measured

The primary outcome is the main question the study is designed to answer.

Vaccine Pneumococcal Serotype Antibody Concentrations
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: Before (PRE) and one month after (POST) the additional dose

Secondary outcomes (8)

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Measured: Before (PRE) and one month after (POST) the additional dose
Cross-reactive Pneumococcal Serotype Antibody Concentrations
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Measured: Before (PRE) and one month after (POST) the additional dose
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
The opsonophagocytic activity cut-off value assessed was greater than or equal to ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Measured: Before (PRE) and one month after (POST) the additional dose
Anti-protein D Antibody Concentrations
The anti-protein D antibody cut-off value (greater than or equal to ≥100 EL.U/mL) was assessed by Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Measured: Before (PRE) and one month after (POST) the additional dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness, and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Measured: During the 8-day (Days 0-7) post-additional dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Measured: During the 8-day (Days 0-7) post-additional dose
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Measured: Within 31 days (Day 0-30) post-additional vaccination
Number of Subjects With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above.
Measured: Throughout the entire study period (approximately 1 month per subject)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 20095 Oct 2009

First posted25 May 2009 (estimated)
Study start23 Jun 2009
Primary completion5 Oct 2009
Study completion5 Oct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00907777
Sponsor's protocol ID: 112807
Other IDs: 2008-007605-37, 2008
Status last verified: Nov 2020
First submitted: 21 May 2009
Last updated: 23 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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All Infections, Streptococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vaccination With the Pneumococcal Vaccine GSK 1024850A or Prevenar™ at Approximately 4 Years of Age in Children Primed With 3 Doses of GSK 1024850A Vaccine or Prevenar™ and Boosted With 23-valent Pneumococcal Plain Polysaccharide Vaccine
ClinicalTrials.gov ID: NCT00907777
Acronym / sponsor ID: 112807
Conditions: Infections, Streptococcal, Streptococcus Pneumoniae
Keywords: Haemophilus influenzae, Streptococcus pneumoniae, safety, Pneumococcal conjugate vaccine, immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Jun 2009 (actual)
Primary completion: 5 Oct 2009 (actual)
Study completion: 5 Oct 2009 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 6 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pn Group	Experimental	Biological: Pneumococcal conjugate vaccine GSK 1024850ASubjects receiving GSK 1024850A vaccine.
Prev Group	Active comparator	Biological: Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)Subjects receiving Prevenar™ vaccine.

Who may qualify

Ages: 46 to 50 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female between, and including, 46-50 months of age at the time of vaccination.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
Written informed consent obtained from both parents/guardians of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (13 listed)

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
Administration of any pneumococcal vaccine since the end of study NCT00333450.
Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the 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 conjugate vaccine GSK 1024850AOne dose of vaccine will be injected intramuscularly into the deltoid.	Biological	Pn Group
Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's)One dose of vaccine will be injected intramuscularly into the deltoid.	Biological	Prev Group

Primary outcome

Vaccine Pneumococcal Serotype Antibody Concentrations
Time frame: Before (PRE) and one month after (POST) the additional dose
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

8 secondary outcomes

Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Time frame: Before (PRE) and one month after (POST) the additional dose
Cross-reactive Pneumococcal Serotype Antibody Concentrations
Time frame: Before (PRE) and one month after (POST) the additional dose
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
Time frame: Before (PRE) and one month after (POST) the additional dose
Anti-protein D Antibody Concentrations
Time frame: Before (PRE) and one month after (POST) the additional dose
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-additional dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-additional dose
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: Within 31 days (Day 0-30) post-additional vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the entire study period (approximately 1 month per subject)

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prevnar Group	25	25
GSK 1024850A Group	27	26

Primary outcome: Vaccine Pneumococcal Serotype Antibody Concentrations

Time frame: Before (PRE) and one month after (POST) the additional dose. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Prevnar Group n = 24	GSK 1024850A Group n = 26
ANTI-1 PRE	0.14 (0.09 to 0.23)	0.38 (0.25 to 0.56)
ANTI-1 POST	0.16 (0.1 to 0.25)	1.35 (1.05 to 1.73)
ANTI-4 PRE	0.27 (0.15 to 0.5)	0.12 (0.08 to 0.19)
ANTI-4 POST	4.3 (3.38 to 5.48)	6.76 (4.91 to 9.3)
ANTI-5 PRE	0.11 (0.08 to 0.16)	0.5 (0.34 to 0.75)
ANTI-5 POST	0.15 (0.1 to 0.22)	1.78 (1.34 to 2.37)
ANTI-6B PRE	0.65 (0.38 to 1.12)	0.48 (0.26 to 0.88)
ANTI-6B POST	7.46 (4.61 to 12.08)	1.68 (1.1 to 2.56)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity endpoint measures were available.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: during the entire study period (approximately 1 month per subject); Solicited local and general symptoms: within 8 days after the additional vaccination; Unsolicited symptoms: within 31 days after the additional vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prevnar Group	0 of 25 (0%)	17 of 25 (68%)	0 of 25
GSK 1024850A Group	0 of 27 (0%)	20 of 27 (74.1%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
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. 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

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 13 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vaccine Pneumococcal Serotype Antibody Concentrations (time frame: Before (PRE) and one month after (POST) the additional dose). 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 NCT00907777, 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 23 Nov 2020.