DiphtheriaPhase 4NCT01357720
Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination
A Phase 4 study testing Quinvaxem and Quinvaxem/Tritanrix 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 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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 and Quinvaxem/Tritanrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePhilippines
- Study dates
- May 2011to Sep 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 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 guardian of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits
Who cannot join
- Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or 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 Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 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 Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)
- History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate
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- Significant acute infection
- Any condition which, 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 IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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) 1 month after completion of the 6-10-14 week vaccination course.
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections
- Being tested
- Quinvaxem, Quinvaxem/Tritanrix
- 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.
QuinvaxemBiological
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 at Weeks 6, 10 and 14
Quinvaxem/TritanrixBiological
A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at Weeks 6, 10 and 14
| Study group | Role | What they receive |
|---|---|---|
| Quinvaxem | Experimental | Not described Receives: Biological: Quinvaxem |
| Tritanrix Hib/HepB + Quinvaxem | Active comparator | Not described Receives: Biological: Quinvaxem/Tritanrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection Rate: Anti-PRP Antibodies
Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Measured: 1 month after the third vaccination
Seroprotection Rate: Anti-B. Pertussis Antibodies
Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)
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 posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- 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
- NCT01357720
- Sponsor's protocol ID
- QVX-V-A001
- Status last verified
- Aug 2013
- First submitted
- 19 May 2011
- Last updated
- 9 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.
PubMed 24176498
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age
- ClinicalTrials.gov ID
- NCT01357720
- Acronym / sponsor ID
- QVX-V-A001
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Infections
- Keywords
- Vaccination, Immunisation, Virus, Diphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 22 May 2013
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 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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) 1 month after completion of the 6-10-14 week vaccination course.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinvaxem | Experimental | Biological: Quinvaxem |
| Tritanrix Hib/HepB + Quinvaxem | Active comparator | Biological: Quinvaxem/Tritanrix |
Who may qualify
- Ages
- 42 to 64 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 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 guardian of the subject
- Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits
Key exclusion criteria (9 listed)
- Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or 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 Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 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 Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (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 |
|---|---|---|
| QuinvaxemA 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 at Weeks 6, 10 and 14 | Biological | Quinvaxem |
| Quinvaxem/TritanrixA single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14 | Biological | Tritanrix Hib/HepB + Quinvaxem |
Primary outcome
Seroprotection Rate: Anti-PRP Antibodies
Time frame: 1 month after the third vaccination
Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
Time frame: 1 month after the third vaccination
Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
Time frame: 1 month after the third vaccination
Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
Time frame: 1 month after the third vaccination
Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-B. Pertussis Antibodies
Time frame: 1 month after the third vaccination
Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24176498Capeding MR, Jica C, Macura-Biegun A, Rauscher M, Alberto E. Interchangeability of Quinvaxem during primary vaccination schedules: results from a phase IV, single-blind, randomized, controlled, single-center, non-inferiority study. Vaccine. 2014 Feb 7;32(7):888-94. doi: 10.1016/j.vaccine.2013.10.059. Epub 2013 Oct 29.
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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 4 study testing Quinvaxem and Quinvaxem/Tritanrix 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 4 inclusion and 9 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 9 Sep 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 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 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 22 May 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?
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?
On the ClinicalTrials.gov record for NCT01357720, 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 9 Sep 2013.