DiphtheriaPhase 4NCT00254917
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
A Phase 4 study testing Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Philippines.
Trial summary
The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year… Read more about this study
- Who is it for?
- Ages 6 weeks to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Polio
- What is being tested?
- Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 387 participants
- Where
- 1 sitePhilippines
- Study dates
- Oct 2003to Feb 2006
- 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 6 weeks to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
- Healthy male or female newborn
- Age ranging from birth to 48 hours of life (included)
- Birth weight >2.5 kg and gestational age >37 weeks
- Born to HBs antigen-negative mother
Who cannot join
- Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
- Infant presently enrolled or scheduled to be enrolled in another clinical trial
- Infant with moderate or severe illness, mainly infectious diseases
- Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
- Infant with severe congenital defects or abnormalities
- Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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- Known immunological deficiency (including a known HIV seropositive mother)
- Administration of vaccine since birth (other than BCG)
- Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)
Trial locations and contacts
1 site in 1 country.
About this study
The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.
WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.
To assess the safety of Pentaxim.
Read the detailed description
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:
Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.
Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.
All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis, Haemophilus Influenzae Type B
- Being tested
- Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine
- Keywords
- Pentaxim
- Medical subject headings
- Diphtheria, Tetanus, Poliomyelitis, Whooping Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineBiological
Also called PENTAXIM™
0.5 mL, IM
Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineBiological
Also called PENTAXIM™
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Concommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age Receives: Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine |
| 2 | Experimental | Concommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age. Receives: Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the safety of PENTAXIM™ Vaccine.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2005 (estimated)
- Study startOct 2003
- Primary completionFeb 2006
- Study completionFeb 2006
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.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254917
- Sponsor's protocol ID
- E2I29
- Status last verified
- Apr 2012
- First submitted
- 15 Nov 2005
- Last updated
- 16 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
- ClinicalTrials.gov ID
- NCT00254917
- Acronym / sponsor ID
- E2I29
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis, Haemophilus Influenzae Type B
- Keywords
- Pentaxim
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 17 Nov 2005 (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 present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-dose primary vaccination in 6, 10 and 14 weeks of age schedule followed by a booster vaccination during the second year of life with the aim to cover the WHO EPI primary vaccination schedule at this age for diphtheria, tetanus, pertussis, poliomyelitis and Hib vaccines.
WHO EPI vaccination schedules for hepatitis B (either 0, 6 and 14 weeks or 6, 10 and 14 weeks of age) will be also assessed in infants born to HBsAg seronegative mothers.
To assess the safety of Pentaxim.
Detailed description
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:
Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.
Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.
All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineConcommitant recombinant hepatitis B vaccine at 0, 6 and 14 weeks of age |
| 2 | Experimental | Biological: Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineConcommitant recombinant hepatitis B vaccine at 6, 10, and 14 weeks of age. |
Who may qualify
- Ages
- 6 weeks to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
- Healthy male or female newborn
- Age ranging from birth to 48 hours of life (included)
- Birth weight >2.5 kg and gestational age >37 weeks
- Born to HBs antigen-negative mother
Key exclusion criteria (9 listed)
- Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
- Infant presently enrolled or scheduled to be enrolled in another clinical trial
- Infant with moderate or severe illness, mainly infectious diseases
- Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
- Infant with severe congenital defects or abnormalities
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 |
|---|---|---|
| Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineAlso: PENTAXIM™0.5 mL, IM | Biological | 1 |
| Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccineAlso: PENTAXIM™0.5 mL, IM | Biological | 2 |
Primary outcome
To provide information concerning the safety of PENTAXIM™ Vaccine.
Time frame: 20 months
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 16 Apr 2012.
- Related InfoLink provided by the sponsor.
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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.
Clinical Trials study director
Sanofi Pasteur, a Sanofi Company
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 Diphteria, Tetanus, Polio, Acellular Pertussis, Hib vaccine in people with Diphtheria and Tetanus, run by Sanofi 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 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 16 Apr 2012. 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?
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?
To provide information concerning the safety of PENTAXIM™ Vaccine. (time frame: 20 months). 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 16 Apr 2012.