Pneumococcal Conjugate VaccinePhase 3NCT00918580

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

A Phase 3 study testing 13-valent Pneumoccocal Conjugate Vaccine in people with Pneumococcal Conjugate Vaccine, run by Pfizer at 19 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Pneumococcal Conjugate Vaccine
What is being tested?: 13-valent Pneumoccocal Conjugate Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 19 sitesin 7 countries
Study dates: Nov 2009to Mar 2013
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 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female subject between the ages of >=6 to <18 years.
Diagnosis of SCD
23vPS vaccination at least 6 months prior to enrollment.

Who cannot join

Previous vaccination with pneumococcal conjugate vaccine.
Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.

Trial locations and contacts

19 sites in 7 countries.

Country

City, postcode or hospital

19 sites in 7 countries

United Kingdom6 sites

Pfizer Investigational Site
London, United Kingdom, E1 1BB
Pfizer Investigational Site
London, SE1 7RH
Pfizer Investigational Site
London, SE1 9RT
Pfizer Investigational Site
London, SE5 9RS
Pfizer Investigational Site
London, SW17 0RE
Pfizer Investigational Site
Manchester, Cheshire, M27 4HA

Other trials in United Kingdom

United States5 sites

Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Louisville, Kentucky, 40202-3830
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
The Bronx, New York, 10467

Other trials in United States

Egypt2 sites

Pfizer Investigational Site
Cairo, Cairo Governorate, 11361
Pfizer Investigational Site
Cairo, Cairo Governorate, 11511

Other trials in Egypt

Italy2 sites

Pfizer Investigational Site
Orbassano (TO), 10043
Pfizer Investigational Site
Roma, 00165

Other trials in Italy

Lebanon2 sites

Pfizer Investigational Site
Beirut, Lebanon, 2833-7401
Pfizer Investigational Site
Beirut

Other trials in Lebanon

France1 site

Pfizer Investigational Site
Paris, 75015

Other trials in France

Saudi Arabia1 site

Pfizer Investigational Site
Riyadh, Saudi

Other trials in Saudi Arabia

About this study

Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine

This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.

Conditions: Pneumococcal Conjugate Vaccine
Being tested: 13-valent Pneumoccocal Conjugate Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

13-valent Pneumoccocal Conjugate VaccineBiological
Also called 13vPnC
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.

Study groups in NCT00918580
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: 13-valent Pneumoccocal Conjugate Vaccine

What is being measured

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

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Measured: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2

Secondary outcomes (7)

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 1 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 1 and 1 month after 13vPnC Dose 1 blood draws. Participants may be represented in more than 1 category.
Measured: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 2 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at both the before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Measured: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were computed using the logarithmically transformed assay results for Dose 1 (after Dose 1/before Dose 1) and for Dose 2 (after Dose 2/before Dose 2). CI for the ratio of GMFR (Dose 2/Dose 1) were back transformations of a CI based on the Student t distribution for the mean logarithm of the measures (Dose 2 - Dose 1). Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for given serotype at before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2 and 1 month after 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.
Measured: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate IgG antibody concentration for the given serotype at specified time point. Participants may be represented in more than 1 category.
Measured: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for the specified blood draw. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate IgG antibody concentration for the given serotype. Participants may be represented in more than 1 category.
Measured: 1 year after 13vPnC Dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with determinate OPA antibody titer for the given serotype at specified time point. Participants may be represented in more than 1 category.
Measured: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Antibody GMTs as measured by OPA assay for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). GMT and corresponding 2-sided 95% CIs were evaluated. CIs for the GMTs are back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here number of participants analyzed signifies the evaluable immunogenicity population at 1-year follow-up and "N" signifies participants with determinate OPA antibody titer for the given serotype. Participants may be represented in more than 1 category.
Measured: 1 year after 13vPnC Dose 2

Timeline

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

Nov 2009Mar 2013

First posted11 Jun 2009 (estimated)
Study startNov 2009
Primary completionMar 2013
Study completionMar 2013

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.
Other trials for Pneumococcal Conjugate VaccineStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00918580
Sponsor's protocol ID: 6096A1-3014
Other IDs: B1851013
Status last verified: Mar 2014
First submitted: 9 Jun 2009
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Active, not recruitingPhase 2
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Active, not recruitingObservational study
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RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
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Active, not recruitingPhase 1
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All Pneumococcal Conjugate Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine
ClinicalTrials.gov ID: NCT00918580
Acronym / sponsor ID: 6096A1-3014
Conditions: Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 11 Jun 2009 (estimated)
Results: Posted 21 Apr 2014

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Biological: 13-valent Pneumoccocal Conjugate Vaccine

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Male or female subject between the ages of >=6 to <18 years.
Diagnosis of SCD
23vPS vaccination at least 6 months prior to enrollment.

Key exclusion criteria (2 listed)

Previous vaccination with pneumococcal conjugate vaccine.
Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.

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
13-valent Pneumoccocal Conjugate VaccineAlso: 13vPnC2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.	Biological	1

Primary outcome

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2
Time frame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 1 to 1 month after 13vPnC Dose 2 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both 1 month after 13vPnC Dose 1 and after 13vPnC Dose 2 blood draws. Here number of participants analyzed signifies the evaluable immunogenicity population and "N" signifies participants with a determinate IgG antibody concentration for the given serotype at both 1 Month After 13vPnC Dose 1 and 1 Month After 13vPnC Dose 2 blood draws. Participants may be represented in more than 1 category.

7 secondary outcomes

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 1
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1
Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From Before 13vPnC Dose 2 to 1 Month After 13vPnC Dose 2
Time frame: Before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Ratio of Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 13vPnC Dose 1 to 13vPnC Dose 2
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Year After 13vPnC Dose 2
Time frame: 1 year after 13vPnC Dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT)
Time frame: Before 13vPnC Dose 1, 1 month after 13vPnC Dose 1, before 13vPnC Dose 2, 1 month after 13vPnC Dose 2
Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) 1 Year After 13vPnC Dose 2
Time frame: 1 year after 13vPnC Dose 2

Results and safety

Results posted to the registry on 21 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC	158	147

Primary outcome: Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2

Time frame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2. Geometric mean (95% Confidence Interval). Unit: fold rise

Measure	13vPnC n = 138
Serotype 4 (N = 137)	0.75 (0.66 to 0.84)
Serotype 6B (N = 136)	0.89 (0.78 to 1.02)
Serotype 9V (N = 136)	0.82 (0.75 to 0.91)
Serotype 14 (N = 137)	0.75 (0.67 to 0.85)
Serotype 18C (N = 137)	0.70 (0.62 to 0.80)
Serotype 19F (N = 136)	1.05 (0.91 to 1.20)
Serotype 23F (N = 135)	0.91 (0.77 to 1.08)
Serotype 1 (N = 137)	0.88 (0.77 to 0.99)

Population analysed: Evaluable immunogenicity population: eligible participants who received all study vaccinations; had valid and determinate assay result; had blood drawn within pre-specified time-frames; had no major protocol violation (including use of prohibited vaccine/medication, immunoglobulins or chronic systemic corticosteroids).

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: 13vPnC Dose 1 through 1-year follow-up after 13vPnC Dose 2. AEs: 13vPnC Dose 1; 13vPnC Dose 2; 6-month follow-up after 13vPnC Dose 2; 1-year follow-up after 13vPnC Dose 2. Local reactions/systemic events: within 7 days after 13vPnC Dose 1 and Dose 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Dose 1	40 of 158 (25.3%)	133 of 158 (84.2%)	Not reported
13vPnC Dose 2	11 of 140 (7.9%)	100 of 140 (71.4%)	Not reported
6-Month Follow-up	28 of 147 (19%)	1 of 147 (0.7%)	Not reported
1-Year Follow-up	16 of 87 (18.4%)	1 of 87 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

19 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent Pneumoccocal Conjugate Vaccine in people with Pneumococcal Conjugate Vaccine, run by Pfizer at 19 sites in 7 countries.

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 3 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United Kingdom, United States, Egypt, Italy, Lebanon and 2 more countries. 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 21 Apr 2014). 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?

Geometric Mean Fold Rise (GMFR) in Serotype-Specific Pneumococcal Immunoglobulin G (IgG) From 1 Month After 13vPnC Dose 1 to 1 Month After 13vPnC Dose 2 (time frame: 1 Month After 13vPnC Dose 1, 1 Month After 13vPnC Dose 2). 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 NCT00918580.

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 21 Apr 2014.