DiphtheriaPhase 3NCT01062477
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
A Phase 3 study testing DTaP//PRP-T Combined Vaccine and DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine in people with Diphtheria and Tetanus, run by Sanofi at 2 sites in China.
Trial summary
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of… Read more about this study
- Who is it for?
- Ages 60 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP//PRP-T Combined Vaccine and DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,056 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2010to Dec 2011
- 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 60 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 2 months on the day of inclusion
- Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or legal representative
- Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures
Who cannot join
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
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- Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
- History of seizures
- Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity
- History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
- Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine
- Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- History of contraindication to vaccination with pertussis-containing vaccine
- Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment
- Temporary contraindications that must be resolved before vaccination:
- Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit
- Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
- Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months
Trial locations and contacts
2 sites in 1 country.
China2 sites
Study site
LingChuan County, Guilin City, Guangxi, 541200
Study site
Lipu County, Guilin City, Guangxi, 546600
About this study
Official title: Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China
Primary Objectives:
Read more
- To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
- To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.
Secondary Objectives:
- To describe the safety after administration of the study vaccines.
- To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Read the detailed description
Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type B
- Being tested
- DTaP//PRP-T Combined Vaccine, DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
- Keywords
- Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP//PRP-T Combined VaccineBiological
Also called ACTACEL
0.5 mL, Intramuscular
DTaP//PRP-T Combined VaccineBiological
Also called ACTACEL
0.5 mL, Intramuscular
DTaP Combined Vaccine and PRP-Tetanus Conjugate VaccineBiological
Also called Act-HIB™
0.5 mL, Intramuscular (each vaccine)
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age. Receives: Biological: DTaP//PRP-T Combined Vaccine |
| Study Group 2 | Experimental | Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age. Receives: Biological: DTaP//PRP-T Combined Vaccine |
| Study Group 3 | Active comparator | Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age. Receives: Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
Measured: One month post-vaccination
Secondary outcomes (1)
Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.
Measured: 0-7 days post-vaccination and entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2011
- Study completionDec 2011
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062477
- Sponsor's protocol ID
- C5A06
- Other IDs
- UTN: U1111-1112-2509
- Status last verified
- Dec 2011
- First submitted
- 3 Feb 2010
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of the Sanofi Pasteur's DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Hib Conjugate (Act-HIB) Monovalent Vaccine as a Three-dose Primary and Booster Vaccination in Healthy Infants in China
- ClinicalTrials.gov ID
- NCT01062477
- Acronym / sponsor ID
- C5A06
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type B
- Keywords
- Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,056 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Feb 2010 (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 purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China
Primary Objectives:
- To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
- To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.
Secondary Objectives:
- To describe the safety after administration of the study vaccines.
- To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Detailed description
Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Biological: DTaP//PRP-T Combined VaccineParticipants will receive ACTACEL vaccine at 2, 3, and 4 months of age. |
| Study Group 2 | Experimental | Biological: DTaP//PRP-T Combined VaccineParticipants will receive ACTACEL vaccine at 3, 4, and 5 months of age. |
| Study Group 3 | Active comparator | Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate VaccineParticipants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age. |
Who may qualify
- Ages
- 60 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 2 months on the day of inclusion
- Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or legal representative
- Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures
Key exclusion criteria (19 listed)
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
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//PRP-T Combined VaccineAlso: ACTACEL0.5 mL, Intramuscular | Biological | Study Group 1 |
| DTaP//PRP-T Combined VaccineAlso: ACTACEL0.5 mL, Intramuscular | Biological | Study Group 2 |
| DTaP Combined Vaccine and PRP-Tetanus Conjugate VaccineAlso: Act-HIB™0.5 mL, Intramuscular (each vaccine) | Biological | Study Group 3 |
Primary outcome
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination.
Time frame: One month post-vaccination
1 secondary outcome
Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine.
Time frame: 0-7 days post-vaccination and entire study duration
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 13 Dec 2011.
- 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.
Medical Director study director
Sanofi Pasteur Inc.
2 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//PRP-T Combined Vaccine and DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine in people with Diphtheria and Tetanus, run by Sanofi at 2 sites in China.
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 19 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 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. (time frame: One month post-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 13 Dec 2011.