Pneumococcal InfectionsPhase 3NCT00492557

Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 13vPnC + TIV in people with Pneumococcal Infections, run by Pfizer.

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 65 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: 13-valent pneumococcal conjugate vaccine and 13vPnC + TIV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,185 participants
Where: No sites listed yet
Study dates: Sep 2007to Feb 2008
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Generally healthy male or female adults 65 years of age or older.
Available for the duration of the trial - approximately 2 months.
No previous vaccination with any pneumococcal vaccine.
No history of severe adverse reaction associated with a vaccine.
No allergy to egg proteins (eggs or egg products) and chicken proteins.

Who cannot join

None listed.

About this study

Official title: A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine

The 13-valent pneumococcal conjugate vaccine (13vPnC) is being developed for adults to prevent pneumococcal diseases such as meningitis (inflammation of the brain lining), septicemia (blood poisoning), and pneumonia (inflammation of the lungs). As trivalent influenza vaccine (TIV) is frequently given to adults, it is important to show that both vaccines can safely be given together without affecting the immune response (body's ability to protect against disease).

Conditions: Pneumococcal Infections
Being tested: 13-valent pneumococcal conjugate vaccine, 13vPnC + TIV
Keywords: Pneumococcal Disease, Pneumococcal Conjugate Vaccine
Medical subject headings: Pneumococcal Infections

What participants receive

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

13-valent pneumococcal conjugate vaccineBiological
Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.
13vPnC + TIVBiological
Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.

Study groups in NCT00492557
Study group	Role	What they receive
13vPnC+TIV Followed by Placebo 1 month later	Experimental	Not described Receives: Biological: 13-valent pneumococcal conjugate vaccine
Placebo+TIV Followed by 13vPnC 1 month later	Active comparator	Not described Receives: Biological: 13vPnC + TIV

What is being measured

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

TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
Measured: Baseline and 1 month after TIV vaccination
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: 1 month after 13vPnC vaccination

Timeline

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

Sep 2007Feb 2008

First posted27 Jun 2007 (estimated)
Study startSep 2007
Primary completionFeb 2008
Study completionFeb 2008

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 InfectionsStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00492557
Sponsor's protocol ID: 6115A1-3008
Status last verified: Jan 2012
First submitted: 26 Jun 2007
Last updated: 17 Feb 2012
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?

Official record

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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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RecruitingObservational study
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind Trial to Evaluate Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Trivalent Inactivated Influenza Vaccine in Healthy Adults 65 Years of Age or Older, Who Are Naive to 23-Valent Pneumococcal Polysaccharide Vaccine
ClinicalTrials.gov ID: NCT00492557
Acronym / sponsor ID: 6115A1-3008
Conditions: Pneumococcal Infections
Keywords: Pneumococcal Disease, Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,185 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 27 Jun 2007 (estimated)
Results: Posted 17 Feb 2012

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
13vPnC+TIV Followed by Placebo 1 month later	Experimental	Biological: 13-valent pneumococcal conjugate vaccine
Placebo+TIV Followed by 13vPnC 1 month later	Active comparator	Biological: 13vPnC + TIV

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Generally healthy male or female adults 65 years of age or older.
Available for the duration of the trial - approximately 2 months.
No previous vaccination with any pneumococcal vaccine.
No history of severe adverse reaction associated with a vaccine.
No allergy to egg proteins (eggs or egg products) and chicken proteins.

Key exclusion criteria (0 listed)

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 pneumococcal conjugate vaccineSingle 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL vaccine 13vPnC placebo, 1 month later.	Biological	13vPnC+TIV Followed by Placebo 1 month later
13vPnC + TIVSingle 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC vaccine, 1 month later.	Biological	Placebo+TIV Followed by 13vPnC 1 month later

Primary outcome

TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Time frame: Baseline and 1 month after TIV vaccination
Percentage of participants achieving at least a 4-fold increase in the titer of the standard HAI for each influenza virus subtype (A/H1N1, A/H3N2, and B) were compared.
13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)
Time frame: 1 month after 13vPnC vaccination
IgG GMC as measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

Results and safety

Results posted to the registry on 17 Feb 2012, 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+TIV Followed by Placebo 1 Month Later	580	556
Placebo+TIV Followed by 13vPnC 1 Month Later	580	557

Primary outcome: TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)

Time frame: Baseline and 1 month after TIV vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	13vPnC+TIV n = 549	Placebo+TIV n = 547
Influenza virus subtype: A/H1N1	80.3 (76.7 to 83.5)	78.6 (74.9 to 81.9)
Influenza virus subtype: A/H3N2	58.0 (53.7 to 62.2)	62.6 (58.4 to 66.6)
Influenza virus subtype: B	52.2 (47.9 to 56.4)	54.0 (49.7 to 58.3)

13vPnC+TIV vs Placebo+TIV: Percent Difference: 1.7 (95% CI -3.1 to 6.5)
13vPnC+TIV vs Placebo+TIV: Percent Difference: -4.6 (95% CI -10.4 to 1.3)
13vPnC+TIV vs Placebo+TIV: Percent Difference: -1.8 (95% CI -7.8 to 4.1)

Population analysed: Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.

Primary outcome: 13vPnC Comparisons: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC)

Time frame: 1 month after 13vPnC vaccination. Geometric mean (95% Confidence Interval). Unit: mcg/mL

Measure	13vPnC+TIV n = 549	13vPnC n = 547
Serotype 1	2.52 (2.07 to 3.06)	3.20 (2.61 to 3.91)
Serotype 3	1.08 (0.94 to 1.24)	1.15 (1.01 to 1.30)
Serotype 4	2.15 (1.79 to 2.60)	3.24 (2.65 to 3.96)
Serotype 5	4.74 (4.08 to 5.50)	6.90 (5.87 to 8.11)
Serotype 6A	4.61 (4.00 to 5.31)	6.10 (5.13 to 7.24)
Serotype 6B	6.24 (5.27 to 7.39)	6.43 (5.33 to 7.76)
Serotype 7F	7.63 (6.50 to 8.96)	9.04 (7.58 to 10.79)
Serotype 9V	4.97 (4.19 to 5.91)	6.21 (5.27 to 7.33)

13vPnC+TIV vs 13vPnC: Ratio of GMCs: 0.79 (95% CI 0.60 to 1.04)
13vPnC+TIV vs 13vPnC: Ratio of GMCs: 0.94 (95% CI 0.78 to 1.13)
13vPnC+TIV vs 13vPnC: Ratio of GMCs: 0.66 (95% CI 0.51 to 0.87)

Population analysed: Evaluable immunogenicity population: had participants who adhered to protocol requirements, had valid and determinate assay results, and had no major protocol violations.

Adverse events

Time frame: AEs/SAEs recorded from signing of informed consent form to completion of study (Visit 3).Participants recorded in the e-diary their local reactions,systemic events & use of antipyretic & pain medication (Day 1-Day 14 after study vaccine administration).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC+TIV	4 of 576 (0.7%)	307 of 576 (53.3%)	Not reported
Placebo	8 of 559 (1.4%)	194 of 559 (34.7%)	Not reported
Placebo+TIV	0 of 575 (0%)	256 of 575 (44.5%)	Not reported
13vPnC	5 of 558 (0.9%)	237 of 558 (42.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumococcal Infections

Active, not recruitingPhase 2
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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.

Medical Monitor study director

Wyeth is now a wholly owned subsidiary of Pfizer

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine and 13vPnC + TIV in people with Pneumococcal Infections, run by Pfizer.

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 0 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

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 17 Feb 2012). 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?

TIV Comparisons: Percentage of Participants Achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI) (time frame: Baseline and 1 month after TIV vaccination). The study lists 2 primary outcomes in all. 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 NCT00492557.

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 17 Feb 2012.