MeningitisPhase 3NCT01580033

Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine

A Phase 3 study testing A+C+hib Conjugate Vaccine, A+C Vaccine and Hib vaccine in people with Meningitis 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 5 months
Conditions the study is for: Meningitis, Influenza
What is being tested?: A+C+hib Conjugate Vaccine, A+C Vaccine and Hib vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 900 participants
Where: 1 siteChina
Study dates: Apr 2012to Nov 2012
Phase: Phase 3
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 5 months
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy subjects aged 3 to 5 months, normal intelligence.
The subjects' guardians are able to understand and sign the informed consent.
Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.
Subjects with temperature<=37°C on axillary setting.

Who cannot join

Subject who has a medical history of Meningitis;
Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
Subject who is allergic with tetanus toxoid components;
Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
Subject who has a history of allergic reactions;
Any known immunological dysfunction;

Show all 19Show fewer

Had received gamma globulin or immune globulin, in the past two weeks
Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
Any acute infections in last 7 days
Any prior administration of immunodepressant or corticosteroids in last 6month
Any prior administration of other research medicines in last 1 month
Any prior administration of attenuated live vaccine in last 28 days
Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
Subject suffering from congenital malformations, developmental delay or serious chronic disease;
Any acute infections
Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Had any Grade 3 or Grade 4 adverse reactions or events associated with investigational vaccine occurred since the vaccination
Any situation meets the exclusion criteria for first dose;
Any condition the investigator believed may affect the evaluation of the vaccine.

Trial locations and contacts

1 site in 1 country.

China1 site

Funing county Center for Disease Control and Prevention
Yancheng, Jiangsu

Other trials in China

About this study

Official title: Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Aged 3-5 Months: A Phase 3 Clinical Trial

Haemophilus influenzae is an important pathogen which can cause primary infection and respiratory viral infection in infants and leaded to secondary infections. The infection of haemophilus is a major cause of morbidity and mortality in infants and children. At present, the developed conjugant Hib vaccine is proved to be safe and effective. Because Hib vaccine can prevent meningitis, pneumonia, epiglottis inflammation and other serious infection caused by Hib bacteria, the WHO suggested that Hib vaccine should be included in the infant's normal immune programming.

Since the use of meningitis aureus polysaccharide vaccine, incidence of a disease in recent years is declined and maintain to the level of 0.5 per 1/100 thousand. But meningitis aureus polysaccharide vaccine with a relatively poor immune response in the infants under the age of two, and the remaining 60% with a low antibody level and a short duration.

The immunogenicity and safety of this vaccine has been proved in older children aged 6-23 months and 2-5 years. And in the phase I study which was conducted in February, 2012, the safety profile of this vaccine is proved to be acceptable in infants aged 3-5 months. The phase III study is aimed to further evaluate the safety and the immunization of the vaccine. The objective of this study is to evaluate the safety of the group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine.

Conditions: Meningitis, Influenza
Being tested: A+C+hib Conjugate Vaccine, Placebo, A+C Vaccine, Hib vaccine
Keywords: immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza
Medical subject headings: Meningitis, Influenza, Human

What participants receive

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

A+C+hib Conjugate VaccineBiological
The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered on one arm, intramuscularly, per 0.5ml dose
PlaceboBiological
Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose
A+C VaccineBiological
The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose
Hib vaccineBiological
The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose

Study groups in NCT01580033
Study group	Role	What they receive
A+C+hib Conjugate Vaccine	Experimental	600 infants aged 3-5 months, will be vaccinated on day0, 28, 56 Receives: Biological: A+C+hib Conjugate Vaccine; Biological: Placebo
Walvax AC vaccine, Pasteur Hib vaccine	Active comparator	300 infants aged 3-5 months, will be vaccinated on day0, 28, 56 Receives: Biological: A+C Vaccine; Biological: Hib vaccine

What is being measured

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

The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart).
Measured: 4 weeks (28±3 days) after the infant series
The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months
the seroconversion rate of antibody against type b haemophilus Influenza in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Measured: 4 weeks (28±3 days) after the infant series

Secondary outcomes (5)

adverse reactions after the first vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the first vaccination
Measured: 7 days after the first vaccination
adverse reactions after the second vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the second vaccination
Measured: 7 days after the second vaccination
adverse reactions after the third vaccination in infants aged 3-5 months
adverse reactions of the investigational vaccines in healthy infants aged 3-5 months for 7 days after the third vaccination
Measured: 7 days after the third vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Measured: 4 weeks (28±3 days) after the infant series
GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months
GMT of antibody against type b haemophilus Influenza in infants aged 3-5 months 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)
Measured: 4 weeks (28±3 days) after the infant series

Timeline

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

Apr 2012Nov 2012

First posted18 Apr 2012 (estimated)
Study startApr 2012
Primary completionSep 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MeningitisStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 900 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01580033
Sponsor's protocol ID: JSVCT009
Status last verified: May 2013
First submitted: 17 Apr 2012
Last updated: 8 May 2013
Results posted: No
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

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All Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Aged 3-5 Months: A Phase 3 Clinical Trial
ClinicalTrials.gov ID: NCT01580033
Acronym / sponsor ID: JSVCT009
Conditions: Meningitis, Influenza
Keywords: immunogenicity, safety, group A, C polysaccharide meningitis, type b haemophilus Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 900 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Collaborators: Royal (Wuxi) Biological Co., LTD
Study start: Apr 2012
Primary completion: Sep 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 18 Apr 2012 (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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
A+C+hib Conjugate Vaccine	Experimental	Biological: A+C+hib Conjugate Vaccine, Biological: Placebo600 infants aged 3-5 months, will be vaccinated on day0, 28, 56
Walvax AC vaccine, Pasteur Hib vaccine	Active comparator	Biological: A+C Vaccine, Biological: Hib vaccine300 infants aged 3-5 months, will be vaccinated on day0, 28, 56

Who may qualify

Ages: 3 to 5 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Healthy subjects aged 3 to 5 months, normal intelligence.
The subjects' guardians are able to understand and sign the informed consent.
Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine.
Subjects who can comply with the requirements of the clinical trial program according to the researcher's views.
Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine.

Key exclusion criteria (19 listed)

Subject who has a medical history of Meningitis;
Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on;
Subject who is allergic with tetanus toxoid components;
Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection;
Subject who has a history of allergic reactions;

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
A+C+hib Conjugate VaccineThe group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered on one arm, intramuscularly, per 0.5ml dose	Biological	A+C+hib Conjugate Vaccine
PlaceboPlacebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose	Biological	A+C+hib Conjugate Vaccine
A+C VaccineThe group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose	Biological	Walvax AC vaccine, Pasteur Hib vaccine
Hib vaccineThe type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose	Biological	Walvax AC vaccine, Pasteur Hib vaccine

Primary outcome

The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
Time frame: 4 weeks (28±3 days) after the infant series
the seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart).
The seroconversion rate of antibody against type b haemophilus influenza in infants aged 3-5 months
Time frame: 4 weeks (28±3 days) after the infant series
the seroconversion rate of antibody against type b haemophilus Influenza in infants aged 3-5 months when measured 4 weeks (28±3 days) after the infant series (three doses, 28 day apart)

5 secondary outcomes

adverse reactions after the first vaccination in infants aged 3-5 months
Time frame: 7 days after the first vaccination
adverse reactions after the second vaccination in infants aged 3-5 months
Time frame: 7 days after the second vaccination
adverse reactions after the third vaccination in infants aged 3-5 months
Time frame: 7 days after the third vaccination
GMT of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months
Time frame: 4 weeks (28±3 days) after the infant series
GMT of antibody against type b haemophilus Influenza in serum in infants aged 3-5 months
Time frame: 4 weeks (28±3 days) after the infant series

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 8 May 2013.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 6 inclusion and 19 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 8 May 2013. 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 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?

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?

The seroconversion rate of antibody against group A, C polysaccharide meningitis in infants aged 3-5 months (time frame: 4 weeks (28±3 days) after the infant series). 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 NCT01580033.

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 8 May 2013.