Pneumococcal InfectionPhase 3NCT00560950

Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)

A Phase 3 study testing pneumococcal 23v polysaccharide vaccine in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC.

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 purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults. Read more about this study

Who is it for?: Ages 59 years and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infection
What is being tested?: pneumococcal 23v polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 143 participants
Where: No sites listed yet
Study dates: Jul 2007to May 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 59 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Postmenopausal or negative urine pregnancy test if female
No fever on the day of vaccination

Who cannot join

History of allergy to vaccine components
History of pneumococcal disease
Received any live virus vaccination within 4 weeks prior to study start
Received any inactivated vaccination within 7 days prior to study start
Received any blood products within 5 months prior to study start
Participated in an investigational drug or vaccine study in the past 30 days
Received immunosuppressive therapy
Patient has an immune deficiency

About this study

Official title: A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

Read the detailed description

This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Conditions: Pneumococcal Infection
Being tested: pneumococcal 23v polysaccharide 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.

pneumococcal 23v polysaccharide vaccineBiological
Also called V110, PNEUMOVAX
Duration of Treatment: Single vaccination on Day 1

Study groups in NCT00560950
Study group	Role	What they receive
1st Revaccination Group	Experimental	Not described Receives: Biological: pneumococcal 23v polysaccharide vaccine
2nd Revaccination Group	Experimental	Not described Receives: Biological: pneumococcal 23v polysaccharide vaccine

What is being measured

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

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B
Blood drawn at Day 1 and Day 30 of the
extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8
Blood drawn at Day 1 and Day 30 of the
extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Measured: Day 1 & Day 30

Timeline

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

Jul 2007May 2008

First posted20 Nov 2007 (estimated)
Study startJul 2007
Primary completionMay 2008
Study completionMay 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00560950
Sponsor's protocol ID: V110-007
Other IDs: 2007_540
Status last verified: Mar 2017
First submitted: 19 Nov 2007
Last updated: 11 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Musher DM, Manoff SB, McFetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vaccin. 2011 Sep;7(9):919-28. doi: 10.4161/hv.7.9.15996. Epub 2011 Sep 1.
PubMed 21860256
Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, Carlone GM. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years. J Infect Dis. 2010 Feb 15;201(4):525-33. doi: 10.1086/651131.
PubMed 20088694

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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All Pneumococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults
ClinicalTrials.gov ID: NCT00560950
Acronym / sponsor ID: V110-007
Conditions: Pneumococcal Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 20 Nov 2007 (estimated)
Results: Posted 25 May 2009

Clinical summary

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

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

Detailed description

Study design

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

Arm	Type	Receives
1st Revaccination Group	Experimental	Biological: pneumococcal 23v polysaccharide vaccine
2nd Revaccination Group	Experimental	Biological: pneumococcal 23v polysaccharide vaccine

Who may qualify

Ages: 59 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Postmenopausal or negative urine pregnancy test if female
No fever on the day of vaccination

Key exclusion criteria (8 listed)

History of allergy to vaccine components
History of pneumococcal disease
Received any live virus vaccination within 4 weeks prior to study start
Received any inactivated vaccination within 7 days prior to study start
Received any blood products within 5 months prior to study start

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 23v polysaccharide vaccineAlso: V110, PNEUMOVAXDuration of Treatment: Single vaccination on Day 1	Biological	1st Revaccination Group, 2nd Revaccination Group

Primary outcome

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F
Time frame: Day 1 & Day 30
Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Results and safety

Results posted to the registry on 25 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1st Revaccination Group	72	71
2nd Revaccination Group	71	71

Primary outcome: Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3

Time frame: Day 1 & Day 30. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	1st Revaccination Group Day 1 n = 68	1st Revaccination Group Day 30 n = 67	2nd Revaccination Group Day 1 n = 67	2nd Revaccination Group Day 30 n = 67
Value	0.6 (0.5 to 0.8)	1.4 (1.1 to 1.8)	0.7 (0.5 to 0.8)	1.2 (0.9 to 1.6)

Population analysed: All eligible participants

Primary outcome: Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4

Time frame: Day 1 & Day 30. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	1st Revaccination Group Day 1 n = 68	1st Revaccination Group Day 30 n = 67	2nd Revaccination Group Day 1 n = 67	2nd Revaccination Group Day 30 n = 67
Value	1.1 (0.8 to 1.5)	3.0 (2.2 to 3.9)	1.7 (1.4 to 2.2)	3.0 (2.2 to 4.0)

Population analysed: All eligible participants

Primary outcome: Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B

Time frame: Day 1 & Day 30. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	1st Revaccination Group Day 1 n = 68	1st Revaccination Group Day 30 n = 67	2nd Revaccination Group Day 1 n = 67	2nd Revaccination Group Day 30 n = 67
Value	2.0 (1.5 to 2.7)	4.6 (3.3 to 6.4)	3.0 (2.2 to 4.2)	5.2 (3.6 to 7.5)

Population analysed: All eligible participants

Primary outcome: Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8

Time frame: Day 1 & Day 30. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	1st Revaccination Group Day 1 n = 68	1st Revaccination Group Day 30 n = 67	2nd Revaccination Group Day 1 n = 67	2nd Revaccination Group Day 30 n = 67
Value	3.0 (2.4 to 3.7)	9.3 (7.4 to 11.8)	3.4 (2.7 to 4.4)	7.4 (5.8 to 9.3)

Population analysed: All eligible participants

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1st Revaccination Group	0 of 71 (0%)	48 of ?	Not reported
2nd Revaccination Group	0 of 71 (0%)	60 of ?	Not reported

Limitations and caveats (from the sponsor): Open-label non-randomized group of subjects enrolled in this extension. Subjects recruited from original study which completed five years previously.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21860256Musher DM, Manoff SB, McFetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vaccin. 2011 Sep;7(9):919-28. doi: 10.4161/hv.7.9.15996. Epub 2011 Sep 1.
Results publication: PubMed 20088694Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, Carlone GM. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years. J Infect Dis. 2010 Feb 15;201(4):525-33. doi: 10.1086/651131.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Pneumococcal Infection

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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

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pneumococcal 23v polysaccharide vaccine in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC.

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 2 inclusion and 8 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 11 Apr 2017. 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 25 May 2009). 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 for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 (time frame: Day 1 & Day 30). The study lists 8 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 NCT00560950, which also lists 2 linked publications.

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 11 Apr 2017.