DiphtheriaPhase 3NCT00831753
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
A Phase 3 study testing DTaP IPV HB PRP~T vaccine and DTaP-HB-IPV and Haemophilus influenzae type b in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Peru.
Trial summary
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined… Read more about this study
- Who is it for?
- Ages 50 to 71 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP IPV HB PRP~T vaccine and DTaP-HB-IPV and Haemophilus influenzae type b
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 sitePeru
- Study dates
- May 2008to Nov 2009
- Phase
- Phase 3
- 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 50 to 71 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Two month old infant (50 to 71 days old) on the day of inclusion, of either gender
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum
- Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
- Able to attend all scheduled visits and to comply with all trial procedures
- Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
Show all 14Show fewer
- Any vaccination in the 4 weeks preceding the first trial vaccination
- Any planned vaccination during the trial (until Visit 06), except the study vaccines, rotavirus vaccine and pneumococcal conjugate vaccines
- Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically)
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s)
- Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity
- Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
- History of seizures
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa)
Primary Objective:
Read more
To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)
Secondary Objectives:
- To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.
- To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
Read the detailed description
The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
- Being tested
- DTaP IPV HB PRP~T vaccine, DTaP-HB-IPV and Haemophilus influenzae type b
- Keywords
- Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Haemophilus Infections, Hepatitis B, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP IPV HB PRP~T vaccineBiological
0.5 mL, Intramuscular
DTaP-HB-IPV and Haemophilus influenzae type bBiological
Also called Infanrix® Hexa
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | DTaP-IPV-Hep B-PRP~T vaccine group Receives: Biological: DTaP IPV HB PRP~T vaccine |
| Group 2 | Active comparator | Infanrix® Hexa vaccine group Receives: Biological: DTaP-HB-IPV and Haemophilus influenzae type b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Measured: Day 150 (1 month after dose 3)
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:
Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.
Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
Measured: Day 150 (1 month after dose 3)
Secondary outcomes (2)
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
Measured: Day 150 (1 month after dose 3)
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable.
Measured: Day 0 up to Day 7 after each injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionNov 2009
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.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831753
- Sponsor's protocol ID
- A3L17
- Status last verified
- Apr 2016
- First submitted
- 27 Jan 2009
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to Infanrix®Hexa, at 2-4-6 Months of Age in Healthy Peruvian Infants
- ClinicalTrials.gov ID
- NCT00831753
- Acronym / sponsor ID
- A3L17
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
- Keywords
- Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 2 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP~T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa)
Primary Objective:
To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP~T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months)
Secondary Objectives:
- To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP~T and Infanrix®Hexa) one month after the third dose of the primary series.
- To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
Detailed description
The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: DTaP IPV HB PRP~T vaccineDTaP-IPV-Hep B-PRP~T vaccine group |
| Group 2 | Active comparator | Biological: DTaP-HB-IPV and Haemophilus influenzae type bInfanrix® Hexa vaccine group |
Who may qualify
- Ages
- 50 to 71 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Two month old infant (50 to 71 days old) on the day of inclusion, of either gender
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
- Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum
- Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate
- Able to attend all scheduled visits and to comply with all trial procedures
Key exclusion criteria (14 listed)
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks
- Chronic illness at a stage that could interfere with trial conduct or completion
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 HB PRP~T vaccine0.5 mL, Intramuscular | Biological | Group 1 |
| DTaP-HB-IPV and Haemophilus influenzae type bAlso: Infanrix® Hexa0.5 mL, Intramuscular | Biological | Group 2 |
Primary outcome
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
Time frame: Day 150 (1 month after dose 3)
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Time frame: Day 150 (1 month after dose 3)
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
2 secondary outcomes
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Time frame: Day 150 (1 month after dose 3)
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Time frame: Day 0 up to Day 7 after each injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Diphtheria
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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.
Medical Monitor study director
Sanofi Pasteur Inc.
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 DTaP IPV HB PRP~T vaccine and DTaP-HB-IPV and Haemophilus influenzae type b in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in Peru.
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 14 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 13 May 2016. 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 Peru. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2014). 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?
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ (time frame: Day 150 (1 month after dose 3)). 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?
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 13 May 2016.