Invasive Pneumococcal DiseasePhase 3REPLAYNCT00853749

Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

A Phase 3 study testing 13-valent pneumococcal conjugate vaccine (13vPnC) and Blood draw in people with Invasive Pneumococcal Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 2 sites in Iceland.

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

The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). Read more about this study

Who is it for?: Ages 5 to 7 years
Conditions the study is for: Invasive Pneumococcal Disease
What is being tested?: 13-valent pneumococcal conjugate vaccine (13vPnC) and Blood draw
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 2 sitesIceland
Study dates: 5 May 2009to 16 Dec 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 5 to 7 years
All sexes
No healthy volunteers
Child

Who may be able to join

Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Who cannot join

Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
Receipt of immune-globulin within the past 3 months.
Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.

Trial locations and contacts

2 sites in 1 country.

Iceland2 sites

Landspitali University Hospital
Hringbraut, Reykjavik, 101
Midstod Heilsuverndar barna
Reykjavik, 109

Other trials in Iceland

About this study

Official title: REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).

Read the detailed description

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

Conditions: Invasive Pneumococcal Disease
Being tested: 13-valent pneumococcal conjugate vaccine (13vPnC), Blood draw
Keywords: Immune response, pneumococcal conjugate vaccine, polysaccharide

What participants receive

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

13-valent pneumococcal conjugate vaccine (13vPnC)Biological
0.5 mL intramuscular injection
Blood drawProcedure or surgery
Collection of 10 mL of blood

Study groups in NCT00853749
Study group	Role	What they receive
Single	Other	All subjects will receive a single dose of 13vPnC Receives: Biological: 13-valent pneumococcal conjugate vaccine (13vPnC); Procedure: Blood draw

What is being measured

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

Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (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: Day 28
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Percentage of participants achieving OPA 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: Day 28

Secondary outcomes (2)

Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
Measured: Day 28
Antibody Response Measured 1 Month After Vaccination (OPA)
Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Measured: Day 28

Timeline

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

5 May 200916 Dec 2009

First posted2 Mar 2009 (estimated)
Study start5 May 2009
Primary completion16 Dec 2009
Study completion16 Dec 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 Invasive Pneumococcal DiseaseStudies of the same condition, open and under way.
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: Other
Allocation: Non-randomised
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853749
Sponsor's protocol ID: 6096A1-3013
Other IDs: B1851012, 2008-006194-33, 2008
Acronym: REPLAY
Status last verified: Oct 2021
First submitted: 19 Feb 2009
Last updated: 11 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2.
PubMed 24300594

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

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Not yet recruitingObservational study
Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025
Sickle Cell Disease (SCD), Invasive Bacterial Infections
RecruitingPhase 1
Serum Collection Study for Assay Development
Pneumococcal Disease, Invasive, Pneumococcal Disease
Active, not recruitingPhase 2
Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants
Pneumococcal Disease, Invasive

All Invasive Pneumococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REVACCINATION WITH PREVENAR 13 - CHARACTERIZATION OF THE LATE IMMUNE RESPONSE AFTER POLYSACCHARIDE (REPLAY).
ClinicalTrials.gov ID: NCT00853749
Acronym / sponsor ID: REPLAY / 6096A1-3013
Conditions: Invasive Pneumococcal Disease
Keywords: Immune response, pneumococcal conjugate vaccine, polysaccharide
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 5 May 2009 (actual)
Primary completion: 16 Dec 2009 (actual)
Study completion: 16 Dec 2009 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 5 Jan 2011

Clinical summary

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

Detailed description

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

Study design

Primary purpose: Other
Allocation: Non-randomised
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Other	Biological: 13-valent pneumococcal conjugate vaccine (13vPnC), Procedure: Blood drawAll subjects will receive a single dose of 13vPnC

Who may qualify

Ages: 5 to 7 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Key exclusion criteria (5 listed)

Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
Receipt of immune-globulin within the past 3 months.
Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.

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 vaccine (13vPnC)0.5 mL intramuscular injection	Biological	Single
Blood drawCollection of 10 mL of blood	Procedure or surgery	Single

Primary outcome

Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination
Time frame: Day 28
Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (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.
Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
Time frame: Day 28
Percentage of participants achieving OPA 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.

2 secondary outcomes

Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
Time frame: Day 28
Antibody Response Measured 1 Month After Vaccination (OPA)
Time frame: Day 28

Results and safety

Results posted to the registry on 5 Jan 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
PCV/23vPS/13vPnC	50	50
PCV/PCV/13vPnC	39	38

Primary outcome: Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination

Time frame: Day 28. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PCV/23vPS/13vPnC n = 50	PCV/PCV/13vPnC n = 37
Common Serotype 4	100.0 (92.9 to 100.0)	97.3 (85.8 to 99.9)
Common Serotype 6B	100.0 (92.9 to 100.0)	100.0 (90.5 to 100.0)
Common Serotype 9V	100.0 (92.9 to 100.0)	100.0 (90.5 to 100.0)
Common Serotype 14	100.0 (92.7 to 100.0)	100.0 (90.5 to 100.0)
Common Serotype18C	100.0 (92.9 to 100.0)	97.3 (85.8 to 99.9)
Common Serotype 19F	100.0 (92.9 to 100.0)	100.0 (90.5 to 100.0)
Common Serotype 23F	100.0 (92.9 to 100.0)	100.0 (90.5 to 100.0)
Additional Serotype 1	100.0 (92.9 to 100.0)	97.3 (85.8 to 99.9)

PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 2.7 (95% CI -5.0 to 14.2)
PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 0.0 (95% CI -7.3 to 9.5)
PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 0.0 (95% CI -7.3 to 9.5)

Population analysed: Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines. N=number of participants with a determinate IgG antibody concentration to the given serotype.

Primary outcome: Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination

Time frame: Day 28. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PCV/23vPS/13vPnC n = 50	PCV/PCV/13vPnC n = 37
Common Serotype 4	98.0 (89.4 to 99.9)	97.2 (85.5 to 99.9)
Common Serotype 6B	100.0 (92.7 to 100.0)	100.0 (90.3 to 100.0)
Common Serotype 9V	100.0 (92.7 to 100.0)	100.0 (90.3 to 100.0)
Common Serotype 14	100.0 (92.7 to 100.0)	100.0 (90.3 to 100.0)
Common Serotype 18C	100.0 (92.9 to 100.0)	100.0 (90.0 to 100.0)
Common Serotype 19F	100.0 (92.7 to 100.0)	100.0 (90.0 to 100.0)
Common Serotype 23F	98.0 (89.4 to 99.9)	100.0 (89.7 to 100.0)
Additional Serotype 1	100.0 (92.9 to 100.0)	97.3 (85.8 to 99.9)

PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 0.8 (95% CI -8.6 to 12.7)
PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 0.0 (95% CI -7.5 to 9.7)
PCV/23vPS/13vPnC vs PCV/PCV/13vPnC: Difference in proportions (percentage): 0.0 (95% CI -7.5 to 9.7)

Population analysed: Evaluable Immunogenicity Population; N=number of participants with a determinate OPA antibody titer to the given serotype.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCV/23vPS/13vPnC	0 of 50 (0%)	44 of 50 (88%)	Not reported
PCV/PCV/13vPnC	0 of 39 (0%)	30 of 39 (76.9%)	Not reported

Limitations and caveats (from the sponsor): Primary analysis based on evaluable immunogenicity population as per analysis plan change.Data for a participant reported in PCV/23vPS/13vPnC instead of PCV/PCV/13vPnC due to data entry error on case report form;this did not affect result conclusion.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24300594Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Invasive Pneumococcal Disease

RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Not yet recruitingObservational study
Epidemiology of Invasive Bacterial Infections in Children With Sickle Cell Disease in France Between 2020 and 2025
Sickle Cell Disease (SCD), Invasive Bacterial Infections
RecruitingPhase 1
Serum Collection Study for Assay Development
Pneumococcal Disease, Invasive, Pneumococcal Disease
Active, not recruitingPhase 2
Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants
Pneumococcal Disease, Invasive

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

2 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 2 inclusion and 5 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 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Iceland. 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 5 Jan 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?

Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (mcg/mL) Measured 1 Month After Vaccination (time frame: Day 28). 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 NCT00853749, 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 11 Nov 2021.