Pneumococcal DiseasePhase 4NCT01298544

A Study to Assess the Antibody Response of Healthy Chinese Children Who Have Been Vaccinated Previously With 4-doses of Prevenar (a Pneumococcal Vaccine) as Babies and Toddlers

A Phase 4 study testing Blood draw in people with Pneumococcal Disease, run by Pfizer at 10 sites in China.

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 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Disease
What is being tested?: Blood draw
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 335 participants
Where: 10 sitesChina
Study dates: Nov 2010to Mar 2011
Phase: Phase 4
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 4 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female subjects who participated in and completed Wyeth study 0887X 101518.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Who cannot join

Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Chengxiang Town Hospital
Longan County, Guangxi, 532700
Longan County CDC
Longan County, Guangxi, 532700
Nanyu Town Hospital
Longan County, Guangxi, 532701
Yanjiang Town Hospital
Longan County, Guangxi, 532702
Natong Town Hospital
Longan County, Guangxi, 532703
Qiaojian Town Hospital
Longan County, Guangxi, 532707
Gutan Village Hospital
Longan County, Guangxi, 532708
Dingdang Town Hospital
Longan County, Guangxi, 532709
Yangwan Hospital
Longan County, Guangxi, 532715
GuangXi Center for Disease Prevention and Control
Nanning, Guangxi, 530028

Other trials in China

About this study

Official title: A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518

In 2005, Wyeth conducted study 0887X-101518 (NCT00488826) in which Chinese infants received either Prevenar alone (Group 1), Prevenar given with a Diphtheria, Tetanus and acellular Pertussis (DTaP) vaccine (Group 2) or DTaP alone (Group 3). This follow up study (at least 3 years after the last vaccination) will assess the antibody concentrations in children who previously completed Wyeth study 0887X-101518.

Conditions: Pneumococcal Disease
Being tested: Blood draw
Keywords: Vaccine, Prevenar, Pneumococcal disease
Medical subject headings: Pneumococcal Infections

What participants receive

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

Blood drawProcedure or surgery
One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.

Study groups in NCT01298544
Study group	Role	What they receive
All subjects	Other	Not described Receives: Procedure: Blood draw

What is being measured

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

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Measured: Day 1 (36 months after toddler dose)

Timeline

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

Nov 2010Mar 2011

First posted17 Feb 2011 (estimated)
Study startNov 2010
Primary completionMar 2011
Study completionMar 2011

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 Pneumococcal DiseaseStudies 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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01298544
Sponsor's protocol ID: B1841009
Other IDs: 6114A1-4001
Status last verified: Nov 2018
First submitted: 29 Nov 2010
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Li R, Fang KX, Young M Jr, Zhou X, Chen Z, Liang JZ, Giardina PC, Scott DA. Long-term antibody persistence study (3 years after last dose) of the 7-valent pneumococcal conjugate vaccine in young children in China. Vaccine. 2016 Oct 17;34(44):5359-5365. doi: 10.1016/j.vaccine.2016.08.070. Epub 2016 Sep 8.
PubMed 27616471

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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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Prevenar in Healthy Children in China Who Have Been Previously Immunized With a 4-dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 0887x-101518
ClinicalTrials.gov ID: NCT01298544
Acronym / sponsor ID: B1841009
Conditions: Pneumococcal Disease
Keywords: Vaccine, Prevenar, Pneumococcal disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 17 Feb 2011 (estimated)
Results: Posted 16 Mar 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects	Other	Procedure: Blood draw

Who may qualify

Ages: 4 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Male or female subjects who participated in and completed Wyeth study 0887X 101518.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Key exclusion criteria (3 listed)

Vaccination with any licensed or investigational pneumococcal vaccine since completion of Wyeth study 0887X 101518.
History of culture proven invasive disease caused by S pneumoniae since the completion of Wyeth study 0887X 101518.
Known or suspected immune deficiency or suppression since participation in Wyeth study 0887X 101518.

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
Blood drawOne 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.	Procedure or surgery	All subjects

Primary outcome

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose
Time frame: Day 1 (36 months after toddler dose)
Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F). GMC (7vPnC, 7vPnC/DTaP, and DTap) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Results and safety

Results posted to the registry on 16 Mar 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
Entire Study Population	335	335

Primary outcome: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose

Time frame: Day 1 (36 months after toddler dose). Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (mcg/mL)

Measure	7vPnC n = 123	7vPnC and DTaP n = 121	DTaP Alone n = 91
Serotype 4	0.98 (0.77 to 1.23)	0.66 (0.52 to 0.84)	0.41 (0.29 to 0.58)
Serotype 6B	11.35 (9.71 to 13.27)	9.24 (7.66 to 11.16)	3.37 (2.76 to 4.13)
Serotype 9V	1.35 (1.13 to 1.62)	1.29 (1.08 to 1.54)	1.05 (0.83 to 1.32)
Serotype 14	4.50 (3.38 to 5.98)	3.02 (2.25 to 4.05)	0.55 (0.40 to 0.76)
Serotype 18C	0.80 (0.66 to 0.97)	0.77 (0.60 to 0.98)	0.34 (0.24 to 0.47)
Serotype 19F	10.14 (8.06 to 12.75)	5.67 (4.50 to 7.14)	1.70 (1.35 to 2.15)
Serotype 23F	3.31 (2.80 to 3.91)	2.71 (2.26 to 3.25)	1.44 (1.17 to 1.76)

7vPnC vs 7vPnC and DTaP: Ratio of GMCs: 0.68 (95% CI 0.48 to 0.94)
7vPnC vs 7vPnC and DTaP: Ratio of GMCs: 0.81 (95% CI 0.64 to 1.04)
7vPnC vs 7vPnC and DTaP: Ratio of GMCs: 0.95 (95% CI 0.74 to 1.23)

Population analysed: Evaluable Immunogenicity population: eligible participants who had blood drawn within required time frame, had at least 1 valid and determinate assay result for the proposed analysis, received no prohibited vaccines, and had no major protocol violations.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Entire Study Population	0 of 335 (0%)	0 of 335 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27616471Li R, Fang KX, Young M Jr, Zhou X, Chen Z, Liang JZ, Giardina PC, Scott DA. Long-term antibody persistence study (3 years after last dose) of the 7-valent pneumococcal conjugate vaccine in young children in China. Vaccine. 2016 Oct 17;34(44):5359-5365. doi: 10.1016/j.vaccine.2016.08.070. Epub 2016 Sep 8.

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RecruitingPhase 3
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Active, not recruitingObservational study
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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

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Blood draw in people with Pneumococcal Disease, run by Pfizer at 10 sites in China.

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 3 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 16 Mar 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?

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 36 Months After the Toddler Dose (time frame: Day 1 (36 months after toddler dose)). 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 NCT01298544, 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 19 Dec 2018.