Active ImmunizationPhase 3NCT00655148
Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
A Phase 3 study testing DTaP-IPV vero vaccine and DTaP-IPV mkc vaccine in people with Active Immunization, run by Statens Serum Institut at 5 sites in Poland.
Trial summary
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines: A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing… Read more about this study
- Who is it for?
- Ages 28 to 49 days
- Conditions the study is for
- Active Immunization
- What is being tested?
- DTaP-IPV vero vaccine and DTaP-IPV mkc vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 817 participants
- Where
- 5 sitesPoland
- Study dates
- Sep 2003to Oct 2006
- 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 28 to 49 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The parents were informed about the trial and have signed the consent form
- The subject is healthy
- The subject has an age of 28 to 49 days at hepatitis B vaccination
- The subject had a birth weight of ≥2500 g
- The subject has received a hepatitis B vaccination at birth
- The parents grant access to the subject's medical records
- The parents are likely to comply with instructions
Who cannot join
- The subject suffers from a severe chronic disease
- The subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or Hib vaccines
- The subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including Act-HIB® and hepatitis B vaccines
- The subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections
- The subject has a known congenital or acquired immunodeficiency
- The subject is in treatment with or has been in treatment with a product which is likely to modify the immune response (i.e. immunoglobulin, systemic corticosteroids, blood products, other vaccines)
- The subject is participating in another clinical trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Centre Bydgoszcz
Bydgoszcz
Centre Krakow
Krakow
Centre Lodz
Lodz
Centre Poznan
Poznan
Centre Wroclaw
Wroclaw
About this study
Official title: Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.
- Conditions
- Active Immunization
- Being tested
- DTaP-IPV vero vaccine, DTaP-IPV mkc vaccine
- Keywords
- DTaP-IPV, Clinical Trial, Safety, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV vero vaccineBiological
DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age
DTaP-IPV mkc vaccineBiological
DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | DTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age Receives: Biological: DTaP-IPV vero vaccine |
| B | Active comparator | DTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age Receives: Biological: DTaP-IPV mkc vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types
Measured: One 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 posted9 Apr 2008 (estimated)
- Study startSep 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active ImmunizationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacek Pietrzyk, Proffessor M.D., Principal investigator, Jagellonian University, Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655148
- Sponsor's protocol ID
- VIPV-03
- Status last verified
- Jan 2013
- First submitted
- 3 Apr 2008
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing the Safety and Immunogenicity of Two Combined Diphtheria, Tetanus, Acellular Pertussis, and Inactivated Poliovirus (DTaP-IPV) Vaccines Administered to Healthy Children at 2, 3½, and 16 Months of Age
- ClinicalTrials.gov ID
- NCT00655148
- Acronym / sponsor ID
- VIPV-03
- Conditions
- Active Immunization
- Keywords
- DTaP-IPV, Clinical Trial, Safety, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 9 Apr 2008 (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.
The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:
A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5, and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection in the opposite thigh.
Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for antibodies against diphtheria, tetanus, pertussis, polio and prp.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Biological: DTaP-IPV vero vaccineDTaP-IPV vero vaccination at 2, 3½, 5 and 16 months of age |
| B | Active comparator | Biological: DTaP-IPV mkc vaccineDTaP-IPV mkc vaccination at 2, 3½, 5 and 16 months of age |
Who may qualify
- Ages
- 28 to 49 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The parents were informed about the trial and have signed the consent form
- The subject is healthy
- The subject has an age of 28 to 49 days at hepatitis B vaccination
- The subject had a birth weight of ≥2500 g
- The subject has received a hepatitis B vaccination at birth
Key exclusion criteria (7 listed)
- The subject suffers from a severe chronic disease
- The subject has already been immunized with one or more doses of diphtheria, tetanus, pertussis, poliomyelitis, or Hib vaccines
- The subject has a known allergy to one of the vaccine components or to any of the constituents of the vaccines, including Act-HIB® and hepatitis B vaccines
- The subject has a history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections
- The subject has a known congenital or acquired immunodeficiency
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 |
|---|---|---|
| DTaP-IPV vero vaccineDTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age | Biological | A |
| DTaP-IPV mkc vaccineDTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age | Biological | B |
Primary outcome
Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types
Time frame: One 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 21 Jan 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.
Jacek Pietrzyk, Proffessor M.D. principal investigator
Jagellonian University, Krakow, Poland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTaP-IPV vero vaccine and DTaP-IPV mkc vaccine in people with Active Immunization, run by Statens Serum Institut at 5 sites in Poland.
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 7 inclusion and 7 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 21 Jan 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 Poland. 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?
Simultaneous seroprotection percentages for neutralizing poliovirus antibodies (types 1, 2 and 3), when the defined limits of seroprotection is a titre value of >=4 for each of the three poliovirus types (time frame: One month after the third vaccination). 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 21 Jan 2013.