Pneumococcal VaccinesPhase 3NCT00824655

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

A Phase 3 study testing 13vPnC in people with Pneumococcal Vaccines, run by Pfizer at 7 sites in Sweden.

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

Who is it for?: Ages 140 to 392 daysHealthy volunteers can take part
Conditions the study is for: Pneumococcal Vaccines
What is being tested?: 13vPnC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 7 sitesSweden
Study dates: Mar 2009to Jun 2010
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 140 to 392 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children previously immunized with 1 or 2 doses of Prevenar.
Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
Available for entire study period.

Who cannot join

Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Sweden7 sites

Pfizer Investigational Site
Eskilstuna, SE-63188
Pfizer Investigational Site
Gothenburg, SE-40014
Pfizer Investigational Site
Malmö, SE-20502
Pfizer Investigational Site
Örebro, SE-70185
Pfizer Investigational Site
Östersund, SE-83183
Pfizer Investigational Site
Uddevalla, SE-45180
Pfizer Investigational Site
Umeå, SE-90185

Other trials in Sweden

About this study

Official title: A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar

The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.

Conditions: Pneumococcal Vaccines
Being tested: 13vPnC
Keywords: Healthy Subjects, Vaccines, Pneumococcal

What participants receive

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

13vPnCBiological
13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.
13vPnCBiological
13vPnC will be administered by intramuscular injection at approximately 12 months of age.

Study groups in NCT00824655
Study group	Role	What they receive
Group 1	Experimental	Not described Receives: Biological: 13vPnC
Group 2	Experimental	Not described Receives: Biological: 13vPnC

What is being measured

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

Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after the toddler dose (13 months of age)

Secondary outcomes (3)

Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Measured: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Measured: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.
Measured: 12 months of age (prior to toddler dose)

Timeline

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

Mar 2009Jun 2010

First posted19 Jan 2009 (estimated)
Study startMar 2009
Primary completionJun 2010
Study completionJun 2010

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 VaccinesStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00824655
Sponsor's protocol ID: 6096A1-3012
Status last verified: Aug 2011
First submitted: 16 Jan 2009
Last updated: 10 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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All Pneumococcal Vaccines trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label Trial, Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Previously Partially Immunized With Prevenar
ClinicalTrials.gov ID: NCT00824655
Acronym / sponsor ID: 6096A1-3012
Conditions: Pneumococcal Vaccines
Keywords: Healthy Subjects, Vaccines, Pneumococcal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 19 Jan 2009 (estimated)
Results: Posted 18 Jul 2011

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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Biological: 13vPnC
Group 2	Experimental	Biological: 13vPnC

Who may qualify

Ages: 140 to 392 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Healthy children previously immunized with 1 or 2 doses of Prevenar.
Group 1: Male or female subjects between the age of >=140 and <=196 days of age at time of enrollment.
Group 2: Male or female subjects between the age of >=336 and <=392 days of age at time of enrollment
Available for entire study period.

Key exclusion criteria (2 listed)

Previous reaction or contra-indication to pneumococcal vaccine or vaccine related component.
Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.

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
13vPnC13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.	Biological	Group 1
13vPnC13vPnC will be administered by intramuscular injection at approximately 12 months of age.	Biological	Group 2

Primary outcome

Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose
Time frame: 1 month after the toddler dose (13 months of age)
Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

3 secondary outcomes

Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose
Time frame: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose
Time frame: 1 Month after the infant series (6 months of age)
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose
Time frame: 12 months of age (prior to toddler dose)

Results and safety

Results posted to the registry on 18 Jul 2011, 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/13vPnC	118	118
13vPnC	0	0

Primary outcome: Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose

Time frame: 1 month after the toddler dose (13 months of age). Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	13vPnC/13vPnC n = 114	13vPnC n = 115
Common Serotype 4	5.27 (4.43 to 6.26)	5.06 (4.22 to 6.06)
Common Serotype 6B	9.63 (8.01 to 11.57)	8.75 (6.76 to 11.32)
Common Serotype 9V	3.50 (3.01 to 4.07)	3.33 (2.88 to 3.84)
Common Serotype 14	9.22 (7.66 to 11.09)	9.30 (7.90 to 10.95)
Common Serotype 18C	2.93 (2.50 to 3.44)	3.87 (3.30 to 4.53)
Common Serotype 19F	7.70 (6.12 to 9.69)	8.31 (6.39 to 10.81)
Common Serotype 23F	3.27 (2.68 to 3.99)	4.40 (3.70 to 5.22)
Additional Serotype 1	14.65 (12.50 to 17.17)	1.58 (1.30 to 1.93)

Population analysed: Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC/13vPnC at 5 Months	1 of 118 (0.8%)	92 of 118 (78%)	Not reported
13vPnC/13vPnC at 6 Months of Age	4 of 118 (3.4%)	4 of 118 (3.4%)	Not reported
13vPnC/13vPnC at 12 Months	1 of 116 (0.9%)	91 of 116 (78.4%)	Not reported
13vPnC at 12 Months	0 of 116 (0%)	86 of 116 (74.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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.

Related trials for Pneumococcal Vaccines

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy 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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Active, not recruitingPhase 3
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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

7 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 13vPnC in people with Pneumococcal Vaccines, run by Pfizer at 7 sites in Sweden.

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 4 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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. 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 18 Jul 2011). 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 Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose (time frame: 1 month after the toddler dose (13 months of age)). 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 NCT00824655.

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 Aug 2011.