DiphtheriaPhase 3NCT01917357
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
A Phase 3 study testing Quinvaxem in Uniject and Quinvaxem in single dose vials in people with Diphtheria and Pertussis, run by Crucell Holland BV at 1 site in Philippines.
Trial summary
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP)… Read more about this study
- Who is it for?
- Ages 42 to 64 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Pertussis, Tetanus
- What is being tested?
- Quinvaxem in Uniject and Quinvaxem in single dose vials
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePhilippines
- Study dates
- Sep 2013to Apr 2014
- 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 42 to 64 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
- Written informed consent obtained from parents/legal guardians of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- HepB vaccination at birth (within 48 hours)
- Available for all scheduled study visits
Who cannot join
- Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
- Planned administration of a vaccine not foreseen by the Study Protocol
- Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
- Administration of parenteral immunoglobulin preparation and/or blood products since birth
- Previous vaccination against Hib and/or DTP
- History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal
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- Clinically significant acute infection
- Clinically significant acute illness
- Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Participation in another clinical study
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Research Institute for Tropical Medicine
City of Muntinlupa
About this study
Official title: A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections
- Being tested
- Quinvaxem in Uniject, Quinvaxem in single dose vials
- Keywords
- Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae, Immunity
- Medical subject headings
- Diphtheria, Whooping Cough, Tetanus, Hepatitis B, Haemophilus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinvaxem in UnijectBiological
Quinvaxem in single dose vialsBiological
| Study group | Role | What they receive |
|---|---|---|
| Quinvaxem in Uniject | Experimental | A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device Receives: Biological: Quinvaxem in Uniject |
| Quinvaxem in single dose vials | Active comparator | A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials Receives: Biological: Quinvaxem in single dose vials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection Rate: Anti-PRP Antibodies
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Measured: 1 month after the third vaccination
Anti-diphtheria Toxoid Antibodies
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-B. Pertussis Antibodies
Measured: 1 month after the third vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies 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
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria RZ Capeding, MD, Principal investigator, Research Institute for Tropical Medicine (RITM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917357
- Sponsor's protocol ID
- QVX-V-D001
- Status last verified
- Feb 2014
- First submitted
- 5 Aug 2013
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age
- ClinicalTrials.gov ID
- NCT01917357
- Acronym / sponsor ID
- QVX-V-D001
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections
- Keywords
- Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Aug 2013 (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.
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinvaxem in Uniject | Experimental | Biological: Quinvaxem in UnijectA single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device |
| Quinvaxem in single dose vials | Active comparator | Biological: Quinvaxem in single dose vialsA single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials |
Who may qualify
- Ages
- 42 to 64 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
- Written informed consent obtained from parents/legal guardians of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- HepB vaccination at birth (within 48 hours)
- Available for all scheduled study visits
Key exclusion criteria (10 listed)
- Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up
- Planned administration of a vaccine not foreseen by the Study Protocol
- Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)
- Administration of parenteral immunoglobulin preparation and/or blood products since birth
- Previous vaccination against Hib and/or DTP
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 |
|---|---|---|
| Quinvaxem in Uniject | Biological | Quinvaxem in Uniject |
| Quinvaxem in single dose vials | Biological | Quinvaxem in single dose vials |
Primary outcome
Seroprotection Rate: Anti-PRP Antibodies
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Time frame: 1 month after the third vaccination
Anti-diphtheria Toxoid Antibodies
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Time frame: 1 month after the third vaccination
Seroprotection Rate: Anti-B. Pertussis Antibodies
Time frame: 1 month after the third 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 15 Jul 2014.
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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.
Maria RZ Capeding, MD principal investigator
Research Institute for Tropical Medicine (RITM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quinvaxem in Uniject and Quinvaxem in single dose vials in people with Diphtheria and Pertussis, run by Crucell Holland BV at 1 site in Philippines.
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 5 inclusion and 10 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 15 Jul 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 Philippines. 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?
Seroprotection Rate: Anti-PRP Antibodies (time frame: 1 month after the third vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2014.