Pneumococcal InfectionsPhase 46114A1-4000-CNNCT01193582

A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria

A Phase 4 study testing Prevenar in people with Pneumococcal Infections, run by Pfizer at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae. This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72… Read more about this study

Who is it for?: Ages 121 days to 72 monthsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: Prevenar
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 505 participants
Where: 5 sitesChina
Study dates: Sep 2010to Sep 2012
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 121 days to 72 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy Chinese male or female subjects.
Between 121 days to less than 72 months of age at the time of entry into the study.

Who cannot join

Receipt of previous vaccine against Pneumo
Previous anaphylactic reaction to any vaccine or part of a vaccine
Previous proven invasive Pneumo infection
Receipt of investigational drug or device within the proceeding 28 days

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Baolixiang Clinic
Baoli Town,Yongfu County, Guangxi, 541902
Guangfuxiang Clinic
Guangfu Town, Yongfu County, Guangxi, 541803
Luojin Clinic
Luojin Town, Yongfu County, Guangxi, 541801
Yongfu County CDC
Yongfu County, Guangxi, 541800
Yongfu County Clinic
Yongfu County, Guangxi, 541800

Other trials in China

About this study

Official title: A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

This study is to measure the amount of antibodies (antibodies help people fight off diseases) Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar. The study will also provide more data on how safe and well tolerated Prevenar is in Chinese children.

Conditions: Pneumococcal Infections
Being tested: Prevenar
Keywords: Prevenar, catch-up, pneumococcal, pneumonia
Medical subject headings: Pneumococcal Infections, Pneumonia

What participants receive

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

PrevenarBiological
Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
4 doses starting from 121 to < 212 days of age
PrevenarBiological
Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
3 doses starting from 212 days to < 12 months of age
PrevenarBiological
Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
2 doses starting from 12 months to < 24 months of age
PrevenarBiological
Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
1 dose starting from 24 months to < 72 months of age

Study groups in NCT01193582
Study group	Role	What they receive
Group 1	Experimental	Not described Receives: Biological: Prevenar
Group 2	Experimental	Not described Receives: Biological: Prevenar
Group 3	Experimental	Not described Receives: Biological: Prevenar
Group 4	Experimental	Not described Receives: Biological: Prevenar

What is being measured

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

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC 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: 1 month after last dose in each group
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: Baseline

Secondary outcomes (8)

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Serotype-specific Pneumococcal IgG antibody GMC one month after the third dose in Group 1 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after third dose of Prevenar in Group 1
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Measured: Pre-vaccination to 1 month after third dose of Prevenar in Group 1
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Serotype-specific Pneumococcal IgG antibody GMC 1 month after the second dose in Group 2 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after second dose of Prevenar in Group 2
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Measured: Pre-vaccination to 1 month after second dose of Prevenar in Group 2
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Serotype-specific Pneumococcal IgG antibody GMC one month after the first dose in Group 3 for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 1 month after first dose of Prevenar in Group 3
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Measured: Pre-vaccination to 1 month after first dose of Prevenar in Group 3
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Serotype-specific Pneumococcal IgG antibody GMC 12 months after the last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.
Measured: 12 months after the last dose
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
GMFRs for the 7 pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) from pre-vaccination to 12- month follow-up were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers.
Measured: Pre-vaccination to 12 months after the last dose

Timeline

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

Sep 2010Sep 2012

First posted2 Sep 2010 (estimated)
Study startSep 2010
Primary completionSep 2012
Study completionSep 2012

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 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 505 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01193582
Sponsor's protocol ID: B1841008
Other IDs: B1841008
Acronym: 6114A1-4000-CN
Status last verified: Sep 2013
First submitted: 31 Aug 2010
Last updated: 20 Nov 2013
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

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
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Open-label Trial to Assess the Safety, Tolerability and Immunogenicity of Prevenar in Older Infants and Young Children in China Who Are Naive to Previous Pneumococcal Vaccination.
ClinicalTrials.gov ID: NCT01193582
Acronym / sponsor ID: 6114A1-4000-CN / B1841008
Conditions: Pneumococcal Infections
Keywords: Prevenar, catch-up, pneumococcal, pneumonia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 505 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 2 Sep 2010 (estimated)
Results: Posted 20 Nov 2013

Clinical summary

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

A vaccine called Prevenar is already approved for use in China for vaccination of children younger than 6 years old against infections caused by Streptococcus pneumoniae.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1	Experimental	Biological: Prevenar
Group 2	Experimental	Biological: Prevenar
Group 3	Experimental	Biological: Prevenar
Group 4	Experimental	Biological: Prevenar

Who may qualify

Ages: 121 days to 72 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy Chinese male or female subjects.
Between 121 days to less than 72 months of age at the time of entry into the study.

Key exclusion criteria (4 listed)

Receipt of previous vaccine against Pneumo
Previous anaphylactic reaction to any vaccine or part of a vaccine
Previous proven invasive Pneumo infection
Receipt of investigational drug or device within the proceeding 28 days

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
PrevenarDosage form: intramuscular injection Dosage: 0.5 ml Frequency: 4 doses starting from 121 to < 212 days of age	Biological	Group 1
PrevenarDosage form: intramuscular injection Dosage: 0.5 ml Frequency: 3 doses starting from 212 days to < 12 months of age	Biological	Group 2
PrevenarDosage form: intramuscular injection Dosage: 0.5 ml Frequency: 2 doses starting from 12 months to < 24 months of age	Biological	Group 3
PrevenarDosage form: intramuscular injection Dosage: 0.5 ml Frequency: 1 dose starting from 24 months to < 72 months of age	Biological	Group 4

Primary outcome

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar
Time frame: 1 month after last dose in each group
Serotype-specific Pneumococcal Immunoglobulin G (IgG) antibody geometric mean concentration (GMC) after 1 month of last dose for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC 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.
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group
Time frame: Baseline
Serotype-specific Pneumococcal IgG antibody GMC at baseline for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) are presented. GMC and corresponding 2-sided 95% CI were evaluated. GMs were calculated using all participants with available data for the specified blood draw.

8 secondary outcomes

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Third Dose in Group 1
Time frame: 1 month after third dose of Prevenar in Group 1
Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 1.
Time frame: Pre-vaccination to 1 month after third dose of Prevenar in Group 1
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the Second Dose in Group 2
Time frame: 1 month after second dose of Prevenar in Group 2
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 2.
Time frame: Pre-vaccination to 1 month after second dose of Prevenar in Group 2
Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at 1 Month After the First Dose in Group 3
Time frame: 1 month after first dose of Prevenar in Group 3
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values in Group 3.
Time frame: Pre-vaccination to 1 month after first dose of Prevenar in Group 3
Antibody Concentrations Against the 7 Pneumococcal Serotypes Contained in Prevenar at 12 Months After the Last Dose.
Time frame: 12 months after the last dose
GMFR of Anti-Pneumococcal Antibody Levels to the 7 Pneumococcal Serotypes Contained in Prevenar Above Vaccination Baseline Values at 12 Months After the Last Dose.
Time frame: Pre-vaccination to 12 months after the last dose

Results and safety

Results posted to the registry on 20 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	100	89
Group 2	101	88
Group 3	125	117
Group 4	180	177

Primary outcome: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar

Time frame: 1 month after last dose in each group. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Group 1 n = 100	Group 2 n = 101	Group 3 n = 125	Group 4 n = 180
Serotype 4 (n= 88, 87, 115, 177)	6.90 (5.61 to 8.48)	7.16 (6.09 to 8.42)	7.53 (6.70 to 8.46)	9.45 (8.38 to 10.65)
Serotype 6B (n= 88, 87, 114, 177)	8.01 (6.24 to 10.30)	5.79 (4.64 to 7.23)	4.81 (3.89 to 5.96)	6.36 (5.32 to 7.59)
Serotype 9V (n= 88, 87, 115, 177)	4.11 (3.40 to 4.96)	4.64 (3.93 to 5.47)	4.67 (4.18 to 5.21)	6.14 (5.42 to 6.95)
Serotype 14 (n= 88, 87, 115, 177)	12.75 (10.32 to 15.76)	13.02 (10.89 to 15.57)	11.98 (10.51 to 13.65)	9.86 (8.03 to 12.10)
Serotype 18C (n= 88, 87, 115, 177)	4.65 (3.81 to 5.69)	4.65 (3.86 to 5.61)	5.40 (4.78 to 6.10)	7.39 (6.41 to 8.51)
Serotype 19F (n= 87, 87, 115, 177)	4.05 (3.07 to 5.36)	4.02 (3.05 to 5.31)	4.03 (3.26 to 4.98)	4.53 (3.73 to 5.49)
Serotype 23F (n= 88, 87, 115, 177)	4.75 (3.77 to 5.99)	3.95 (3.19 to 4.89)	4.18 (3.51 to 4.96)	5.64 (4.84 to 6.57)

Population analysed: Evaluable immunogenicity population consisted of eligible participants in the age range who had received all the assigned vaccination(s), had blood drawn within required time frames, had at least 1 valid and determinate assay result for the proposed analysis, had received no prohibited vaccines, and had no other major protocol violations.

Primary outcome: Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar at Baseline in Each Group

Time frame: Baseline. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Group 1 n = 100	Group 2 n = 101	Group 3 n = 125	Group 4 n = 180
Serotype 4 (n= 88, 87, 115, 172)	0.01 (0.01 to 0.02)	0.01 (0.01 to 0.02)	0.02 (0.01 to 0.02)	0.06 (0.05 to 0.08)
Serotype 6B (n= 86, 64, 100, 177)	0.12 (0.10 to 0.15)	0.16 (0.12 to 0.22)	0.27 (0.21 to 0.35)	1.30 (1.08 to 1.55)
Serotype 9V (n= 88, 84, 113, 177)	0.10 (0.08 to 0.12)	0.10 (0.08 to 0.13)	0.17 (0.13 to 0.21)	0.66 (0.56 to 0.77)
Serotype 14 (n= 88, 87, 115, 177)	0.16 (0.12 to 0.22)	0.04 (0.03 to 0.05)	0.03 (0.02 to 0.04)	0.36 (0.26 to 0.50)
Serotype 18C (n= 88, 87, 114, 172)	0.04 (0.03 to 0.06)	0.02 (0.01 to 0.02)	0.02 (0.02 to 0.03)	0.12 (0.10 to 0.16)
Serotype 19F (n= 88, 85, 115, 169)	0.11 (0.09 to 0.14)	0.09 (0.07 to 0.12)	0.13 (0.10 to 0.17)	0.71 (0.57 to 0.89)
Serotype 23F (n= 85, 75, 102, 174)	0.07 (0.06 to 0.09)	0.08 (0.06 to 0.11)	0.17 (0.12 to 0.23)	0.88 (0.74 to 1.04)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 12 months following last dose of Prevenar. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	1 of 100 (1%)	3 of 100 (3%)	Not reported
Group 2	0 of 100 (0%)	4 of 100 (4%)	Not reported
Group 3	1 of 125 (0.8%)	3 of 125 (2.4%)	Not reported
Group 4	0 of 180 (0%)	1 of 180 (0.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2013.
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.

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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

5 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 Prevenar in people with Pneumococcal Infections, run by Pfizer at 5 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 4 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 20 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 20 Nov 2013). 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?

Antibody Concentrations to the 7 Pneumococcal Serotypes Contained in Prevenar (time frame: 1 month after last dose in each group). 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 NCT01193582.

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 20 Nov 2013.