DiphtheriaPhase 3NCT01983540
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
A Phase 3 study testing DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine and Infanrix hexa + Prevenar + Rotarix vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.
Trial summary
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781). Study Objective: To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep… Read more about this study
- Who is it for?
- Ages 42 to 54 monthsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Whooping Cough
- What is being tested?
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine and Infanrix hexa + Prevenar + Rotarix vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2013to Dec 2015
- 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 42 to 54 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7] and Rotarix) and a booster dose during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7]).
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Incomplete primary and booster immunization at trial A3L24 and A3L27
- Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
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- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection(s), confirmed either clinically, serologically, or microbiologically after completion of trial A3L27
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood drawn
- Acute or chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
Study Objective:
Read more
- To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.
Observational Objectives:
- To describe the long-term antibody persistence by group and by stratification on the age at inclusion of the A3L27 booster study.
- To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4 vs 5 doses of poliovirus administered).
Read the detailed description
No investigational vaccine will be administered in the study. Subjects who were previously randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be invited to take part in this study.
Any serious adverse events (SAEs) related to the vaccines administered during the preceding trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the trial.
No vaccine will be administered as part of this study.
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
- Being tested
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine, Infanrix hexa + Prevenar + Rotarix vaccine
- Keywords
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Pediatric combined vaccine
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccineBiological
DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study
DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccineBiological
DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study.
Infanrix hexa + Prevenar + Rotarix vaccineBiological
Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 | Experimental | Participants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. Receives: Biological: DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine |
| Study Group 2 | Experimental | Participants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of Infanrix hexa vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. Receives: Biological: DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine |
| Study Group 3 | Active comparator | Participants who received 3 doses of Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. Receives: Biological: Infanrix hexa + Prevenar + Rotarix vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥ 1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) antibody concentrations Lower Limit of Quantitation (LLOQ), ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
Measured: Up to 60 days following enrollment
Secondary outcomes (1)
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) Ab concentrations LLOQ, ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
Measured: Up to 12 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionDec 2015
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983540
- Sponsor's protocol ID
- A3L28
- Other IDs
- U1111-1122-2457
- Status last verified
- Jan 2016
- First submitted
- 7 Nov 2013
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or Infanrix Hexa™ Vaccines in Latin America
- ClinicalTrials.gov ID
- NCT01983540
- Acronym / sponsor ID
- A3L28
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type b
- Keywords
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Pediatric combined vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Nov 2013 (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.
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
Study Objective:
- To describe the long-term antibody persistence at 3.5 and 4.5 years of age following a 3-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) +Rotarix™ or Infanrix hexa™+Prevenar™ (PCV7) +Rotarix™ vaccination at 2, 4, 6 months of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T+Prevenar™ (PCV7) or Infanrix hexa™+Prevenar™ (PCV7) at 12 to 24 months of age.
Observational Objectives:
- To describe the long-term antibody persistence by group and by stratification on the age at inclusion of the A3L27 booster study.
- To describe the effect of one additional oral dose of stand alone poliovirus isotypes 1, 2 and 3 vaccine* on the antibody persistence immune response for poliovirus isotypes (4 vs 5 doses of poliovirus administered).
Detailed description
No investigational vaccine will be administered in the study. Subjects who were previously randomized and completed the primary series, Study A3L24 and the booster study A3L27 will be invited to take part in this study.
Any serious adverse events (SAEs) related to the vaccines administered during the preceding trial (A3L27;) and SAEs related to A3L28 study procedures will be collected throughout the trial.
No vaccine will be administered as part of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Experimental | Biological: DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccineParticipants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
| Study Group 2 | Experimental | Biological: DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccineParticipants who received 3 doses of DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of Infanrix hexa vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
| Study Group 3 | Active comparator | Biological: Infanrix hexa + Prevenar + Rotarix vaccineParticipants who received 3 doses of Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar (PCV7) and Rotarix (2 doses at 2 and 4 months of age), and a booster of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study. |
Who may qualify
- Ages
- 42 to 54 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 3 years and a half (42 months ± 60 days) on the day of the first study visit
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by independent witness/es if required by local regulations)
- Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- Receipt of primary vaccination with 3 doses of investigational vaccines during the primary series trial A3L24 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7] and Rotarix) and a booster dose during the trial A3L27 (either DTaP-IPV-Hep B-PRP-T or Infanrix hexa, concomitantly administered with Prevenar [PCV7]).
Key exclusion criteria (9 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial visit) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Incomplete primary and booster immunization at trial A3L24 and A3L27
- Receipt of any vaccine in the 4 weeks preceding the first trial visit or planned receipt of any vaccine in the 4 weeks preceding the second trial visit
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections with other vaccine(s) after completion of A3L27 study
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
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-Hep B- PRP~T + Prevenar + Rotarix vaccineDTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study | Biological | Study Group 1 |
| DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccineDTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study. | Biological | Study Group 2 |
| Infanrix hexa + Prevenar + Rotarix vaccineInfanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study. | Biological | Study Group 3 |
Primary outcome
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
Time frame: Up to 60 days following enrollment
Anti-D concentrations, ≥0.01 IU/mL, ≥0.1 IU/mL and ≥1.0 IU/mL: Anti-T antibody concentrations ≥0.01 IU/mL, ≥0.1 IU/mL and ≥ 1.0 IU/mL; Anti-Hep B antibody concentrations ≥10 mIU/mL and ≥100 mIU/mL; Anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL; Anti-pertussis toxin antibody and anti-filamentous haemagglutinin (FHA) antibody concentrations Lower Limit of Quantitation (LLOQ), ≥2x LLOQ and ≥4x LLOQ and Anti-poliovirus 1, 2, and 3 antibody titers ≥8 (1/dil)
1 secondary outcome
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine
Time frame: Up to 12 months following enrollment
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 5 Jan 2016.
- 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine and Infanrix hexa + Prevenar + Rotarix vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.
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 5 Jan 2016. 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 Colombia, Costa Rica. 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?
Summary of antibody persistence (for all valences) before the booster doses of DTaP-IPV-Hep B-PRP~T vaccine and Infanrix hexa™ vaccine (time frame: Up to 60 days following enrollment). 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 5 Jan 2016.