Pneumococcal InfectionPhase 4NCT02062281

Study of Evaluating Safety and Immunogenicity of 23-Valent Pneumococcal Polysaccharide Vaccine With Influenza Vaccine in Children and Adults

A Phase 4 study testing 23-valent pneumococcal polysaccharide vaccine, trivalent influenza vaccine and 23vPPV+TIV in people with Pneumococcal Infection and Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site 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 3 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infection, Influenza
What is being tested?: 23-valent pneumococcal polysaccharide vaccine, trivalent influenza vaccine and 23vPPV+TIV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,225 participants
Where: 1 siteChina
Study dates: Nov 2013to Jan 2014
Phase: Phase 4
Are there results?: None posted in the registry

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 3 to 65 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Generally healthy male or female, for adults 50-65 years of age, for children 3-7 years of age.
Available for the duration of the trial - approximately 2 months.
No history of severe adverse reaction associated with a vaccine.

Who cannot join

Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc.
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
Autoimmune disease or immunodeficiency.
Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids.
Diabetes mellitus (type I or II), with the exception of gestational diabetes History of thyroidectomy or thyroid disease that required medication within the past 12 months.
Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.

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Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing.
Administration of any other investigational research agents within 30 days before the dosing.
Administration of any live attenuated vaccine within 30 days before the dosing Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing.
Axillary temperature > 37.0 centigrade at the time of dosing.
Psychiatric condition that precludes compliance with the protocol.
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

Yangzhong Center for Disease Control and Prevention
Zhenjiang, Jiangsu, 212200

Other trials in China

About this study

Official title: A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.

The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.

Conditions: Pneumococcal Infection, Influenza
Being tested: 23-valent pneumococcal polysaccharide vaccine, trivalent influenza vaccine, 23vPPV+TIV
Keywords: Safety, Immunogenicity, vaccine, pneumococcal, influenza
Medical subject headings: Pneumococcal Infections, Influenza, Human

What participants receive

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

23-valent pneumococcal polysaccharide vaccineBiological
Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)
trivalent influenza vaccineBiological
Single 0.5ml trivalent influenza vaccine was administered IM
23vPPV+TIVBiological
Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.

Study groups in NCT02062281
Study group	Role	What they receive
23-valent Pneumococcal Polysaccharide vaccine	Active comparator	0.5ml 23-valent pneumococcal Polysaccharide vaccine made by Chengdu Institute of Biological Products Co.,Ltd. lot number: 20130106-1, duration:JAN,17,2015. Receives: Biological: 23-valent pneumococcal polysaccharide vaccine
Trivalent Influenza Vaccine	Active comparator	0.5ml trivalent influenza vaccine made by Shanghai Institute of Biological Products Co.,Ltd. lot number:20130713, duration:Jul,1,2014. Receives: Biological: trivalent influenza vaccine
23vPPV+TIV	Experimental	Not described Receives: Biological: 23vPPV+TIV

What is being measured

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

Immunogenicity of 23vPPV
IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.
Measured: 1 month after 23vPPV vaccination
Immunogenicity of TIV
Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Measured: 1 month after TIV vaccination

Secondary outcomes (1)

adverse events following the immunization (AEFI)
Measured: 28 days after 23vPPV and TIV vaccination

Timeline

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

Nov 2013Jan 2014

First posted13 Feb 2014 (estimated)
Study startNov 2013
Primary completionDec 2013
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal InfectionStudies 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 2,225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02062281
Sponsor's protocol ID: JSEPI-002
Status last verified: Feb 2014
First submitted: 12 Feb 2014
Last updated: 13 Feb 2014
Results posted: No
Data monitoring committee: Yes

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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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
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RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
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All Pneumococcal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Randomized, Single-blind Trial to Evaluate Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine When Administered Simultaneously With Trivalent Inactivated Influenza Vaccine in Healthy Children Aged 3-7years and Healthy Adults 65 Aged 50-65years.
ClinicalTrials.gov ID: NCT02062281
Acronym / sponsor ID: JSEPI-002
Conditions: Pneumococcal Infection, Influenza
Keywords: Safety, Immunogenicity, vaccine, pneumococcal, influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,225 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: Chengdu Institute of Biological Products Co.,Ltd., Shanghai Institute Of Biological Products
Study start: Nov 2013
Primary completion: Dec 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 13 Feb 2014 (estimated)
Results: Not posted in the source record

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: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
23-valent Pneumococcal Polysaccharide vaccine	Active comparator	Biological: 23-valent pneumococcal polysaccharide vaccine0.5ml 23-valent pneumococcal Polysaccharide vaccine made by Chengdu Institute of Biological Products Co.,Ltd. lot number: 20130106-1, duration:JAN,17,2015.
Trivalent Influenza Vaccine	Active comparator	Biological: trivalent influenza vaccine0.5ml trivalent influenza vaccine made by Shanghai Institute of Biological Products Co.,Ltd. lot number:20130713, duration:Jul,1,2014.
23vPPV+TIV	Experimental	Biological: 23vPPV+TIV

Who may qualify

Ages: 3 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Generally healthy male or female, for adults 50-65 years of age, for children 3-7 years of age.
Available for the duration of the trial - approximately 2 months.
No history of severe adverse reaction associated with a vaccine.

Key exclusion criteria (14 listed)

Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc.
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
Autoimmune disease or immunodeficiency.
Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids.
Diabetes mellitus (type I or II), with the exception of gestational diabetes History of thyroidectomy or thyroid disease that required medication within the past 12 months.

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
23-valent pneumococcal polysaccharide vaccineSingle 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)	Biological	23-valent Pneumococcal Polysaccharide vaccine
trivalent influenza vaccineSingle 0.5ml trivalent influenza vaccine was administered IM	Biological	Trivalent Influenza Vaccine
23vPPV+TIVSingle 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.	Biological	23vPPV+TIV

Primary outcome

Immunogenicity of 23vPPV
Time frame: 1 month after 23vPPV vaccination
IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.
Immunogenicity of TIV
Time frame: 1 month after TIV vaccination
Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)

1 secondary outcome

adverse events following the immunization (AEFI)
Time frame: 28 days after 23vPPV and TIV vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.

Related trials for Pneumococcal Infection

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
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

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.

ma fubao, doctor principal investigator

Jiangsu CDC

1 site 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 3 inclusion and 14 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 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immunogenicity of 23vPPV (time frame: 1 month after 23vPPV 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 NCT02062281.

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 13 Feb 2014.