Hepatitis BPhase 3NCT00362336
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
A Phase 3 study testing DTaP-IPV-HB-PRP~T, CombAct-HIB® and Engerix B® Pediatric in people with Hepatitis B and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Africa.
Trial summary
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B®… Read more about this study
- Who is it for?
- Ages Up to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Polio, Diphtheria
- What is being tested?
- DTaP-IPV-HB-PRP~T, CombAct-HIB® and Engerix B® Pediatric
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Aug 2006to Aug 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 Up to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0 to 3 day old infants
- Mother seronegative for Human Immunodeficiency Virus (HIV)
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score >7 at 5 or 10 minutes of life
- Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
- Able to attend all scheduled visits and to comply with all trial procedures.
Who cannot join
- Current or planned participation in another clinical trial during the entire duration of the present trial
- Suspected congenital or acquired immunodeficiency
- Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
- Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
Show all 11Show fewer
- Oral Poliovirus Vaccine (OPV) administration at birth
- Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
- History of seizures
- Febrile or acute illness on the day of inclusion.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Study site
Bertsham
Study site
Soweto, Johannesburg, 2013
About this study
Official title: Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.
Read more
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis, Haemophilus Influenzae Type b
- Being tested
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Keywords
- Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
- Medical subject headings
- Hepatitis B, Poliomyelitis, Diphtheria, Whooping Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV-HB-PRP~TBiological
0.5 mL, Intramuscular (IM)
CombAct-HIB®Biological
0.5 mL, IM
Engerix B® PediatricBiological
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T | Experimental | Not described Receives: Biological: DTaP-IPV-HB-PRP~T |
| Group 2: CombAct-HIB™ + OPV | Experimental | Not described Receives: Biological: CombAct-HIB® |
| Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth) | Active comparator | Not described Receives: Biological: Engerix B® Pediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).
Measured: 1 month post-Dose 3
Secondary outcomes (6)
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.
Measured: 1 month post-Dose 3
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
Measured: Day 42 before Dose 1 and 1 month post-Dose 3
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.
Measured: Day 540 pre-booster and Day 570 post-booster
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
Measured: Day 540 pre-booster and Day 570, post-booster
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.
Measured: Day 0 up to Day 7 post each dose
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.
Measured: Day 0 up to 7 post-booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2008
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies 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
- None (open label)
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362336
- Sponsor's protocol ID
- A3L15
- Status last verified
- Apr 2014
- First submitted
- 8 Aug 2006
- Last updated
- 2 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.
PubMed 21289531
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine in Comparison to CombAct-HIB® Concomitantly Administered With Engerix B® Paediatric and OPV at 6, 10, and 14 Weeks of Age in South African Infants
- ClinicalTrials.gov ID
- NCT00362336
- Acronym / sponsor ID
- A3L15
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis, Haemophilus Influenzae Type b
- Keywords
- Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- May 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 2 May 2014
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 document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule
The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: DTaP-IPV-Hep B-PRP-T | Experimental | Biological: DTaP-IPV-HB-PRP~T |
| Group 2: CombAct-HIB™ + OPV | Experimental | Biological: CombAct-HIB® |
| Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth) | Active comparator | Biological: Engerix B® Pediatric |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 0 to 3 day old infants
- Mother seronegative for Human Immunodeficiency Virus (HIV)
- Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
- Apgar score >7 at 5 or 10 minutes of life
- Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
Key exclusion criteria (11 listed)
- Current or planned participation in another clinical trial during the entire duration of the present trial
- Suspected congenital or acquired immunodeficiency
- Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received since birth
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~T0.5 mL, Intramuscular (IM) | Biological | Group 1: DTaP-IPV-Hep B-PRP-T |
| CombAct-HIB®0.5 mL, IM | Biological | Group 2: CombAct-HIB™ + OPV |
| Engerix B® Pediatric0.5 mL, IM | Biological | Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth) |
Primary outcome
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Time frame: 1 month post-Dose 3
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).
6 secondary outcomes
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Time frame: 1 month post-Dose 3
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Time frame: Day 42 before Dose 1 and 1 month post-Dose 3
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Time frame: Day 540 pre-booster and Day 570 post-booster
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Time frame: Day 540 pre-booster and Day 570, post-booster
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).
Time frame: Day 0 up to Day 7 post each dose
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Time frame: Day 0 up to 7 post-booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21289531Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.
- 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 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-IPV-HB-PRP~T, CombAct-HIB® and Engerix B® Pediatric in people with Hepatitis B and Polio, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Africa.
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 11 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 2 May 2014. 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 South Africa. 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 May 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 With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) (time frame: 1 month post-Dose 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362336, which also lists 1 linked publication.
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 2 May 2014; AzTrials last refreshed its copy on 8 Nov 2026.