DiphtheriaPhase 3NCT00348881

Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

A Phase 3 study testing DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine and Oral poliomyelitis vaccine (OPV) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age. Read more about this study

Who is it for?: Ages 42 to 50 daysHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine and Oral poliomyelitis vaccine (OPV)
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,133 participants
Where: 4 sitesPhilippines
Study dates: Jun 2006to Jun 2008
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 42 to 50 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

At Screening:
0 to 3 day old infants
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Apgar score ≥ 7 at three minutes after birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
At Inclusion:

Show all 9Show fewer

Six weeks of age
Received a dose of Hepatitis B (HB) in the first three days of life
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

At Screening:
Illness at a stage that could interfere with trial conduct or completion
Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
Acute illness on the day of screening.
At Screening and at Inclusion:

Show all 21Show fewer

Blood or blood-derived products received since birth
Planned participation in another clinical trial during the present trial period
Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)
At Inclusion:
Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
Participation in another clinical trial before the first trial vaccination
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy
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
Chronic illness at a stage that could interfere with trial conduct or completion
Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
History of seizures
Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Trial locations and contacts

4 sites in 1 country.

Philippines4 sites

Study site
Alabang, Muntinlupa City
Filinvest
Corporate City
Study site
Putatan, Muntinlupa City
Study site
Tunasan, Muntinlupa City

Other trials in Philippines

About this study

Official title: Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants

Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
Being tested: DTaP-HB-PRP~T combined vaccine, Tritanrix-HepB/Hib™ vaccine, Oral poliomyelitis vaccine (OPV)
Keywords: Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Influenza, Human, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DTaP-HB-PRP~T combined vaccineBiological
0.5 mL, Intramuscular
Tritanrix-HepB/Hib™ vaccineBiological
0.5 mL, Intramuscular
Oral poliomyelitis vaccine (OPV)Biological
Oral co-administered with study vaccine.

Study groups in NCT00348881
Study group	Role	What they receive
Group 1: DTaP-Hep B-PRP-T + OPV vaccine	Experimental	Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. Receives: Biological: DTaP-HB-PRP~T combined vaccine; Biological: Oral poliomyelitis vaccine (OPV)
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	Active comparator	Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age. Receives: Biological: Tritanrix-HepB/Hib™ vaccine; Biological: Oral poliomyelitis vaccine (OPV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.
Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Measured: 1 month post third vaccination
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Measured: Day 0 to Day 7 post-vaccination

Secondary outcomes (2)

Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
Measured: 1 month post third vaccination
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.
Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
Measured: Day 0 to Day 7 after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006Jun 2008

First posted6 Jul 2006 (estimated)
Study startJun 2006
Primary completionOct 2007
Study completionJun 2008

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00348881
Sponsor's protocol ID: AL201
Status last verified: Aug 2013
First submitted: 5 Jul 2006
Last updated: 22 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Large Scale Safety and Immunogenicity Study of a DTaP-Hep B-PRP-T Combined Vaccine Compared to Tritanrix HepB/Hib™, Both Given Concomitantly With OPV at 6, 10, and 14 Weeks of Age in Healthy Filipino Infants
ClinicalTrials.gov ID: NCT00348881
Acronym / sponsor ID: AL201
Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
Keywords: Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,133 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Oct 2007 (actual)
Study completion: Jun 2008 (actual)
First posted: 6 Jul 2006 (estimated)
Results: Posted 22 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1: DTaP-Hep B-PRP-T + OPV vaccine	Experimental	Biological: DTaP-HB-PRP~T combined vaccine, Biological: Oral poliomyelitis vaccine (OPV)Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Group 2: Tritanrix-HepB/Hib™ + OPV vaccine	Active comparator	Biological: Tritanrix-HepB/Hib™ vaccine, Biological: Oral poliomyelitis vaccine (OPV)Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Who may qualify

Ages: 42 to 50 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (9 listed)

0 to 3 day old infants
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
Apgar score ≥ 7 at three minutes after birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
Six weeks of age

Key exclusion criteria (21 listed)

Illness at a stage that could interfere with trial conduct or completion
Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
Acute illness on the day of screening.
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-HB-PRP~T combined vaccine0.5 mL, Intramuscular	Biological	Group 1: DTaP-Hep B-PRP-T + OPV vaccine
Tritanrix-HepB/Hib™ vaccine0.5 mL, Intramuscular	Biological	Group 2: Tritanrix-HepB/Hib™ + OPV vaccine
Oral poliomyelitis vaccine (OPV)Oral co-administered with study vaccine.	Biological	Group 1: DTaP-Hep B-PRP-T + OPV vaccine, Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Primary outcome

Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Time frame: 1 month post third vaccination
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Time frame: Day 0 to Day 7 post-vaccination
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.

2 secondary outcomes

Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Time frame: 1 month post third vaccination
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Time frame: Day 0 to Day 7 after vaccination

Results and safety

Results posted to the registry on 22 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: DTaP-Hep B-PRP~T + OPV	1,424	1,407
Group 2: Tritanrix-Hep B/ Hib™ + OPV	709	697

Primary outcome: Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV

Time frame: 1 month post third vaccination. Number. Unit: Participants

Measure	Group 1: DTaP-Hep B-PRP~T + OPV n = 246	Group 2: Tritanrix-Hep B/ Hib™ + OPV n = 123
Anti-Hep Bs (N = 246, 122)	239	119 (0 to 0)
Anti-PRP (N = 218, 122)	210	121 (0 to 0)
Anti-Diphtheria (N = 246, 123)	217	109 (0 to 0)
Anti-Tetanus (N = 246,123)	246	123 (0 to 0)

Population analysed: Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.

Primary outcome: Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.

Time frame: Day 0 to Day 7 post-vaccination. Number. Unit: Participants

Measure	Group 1: DTaP-Hep B-PRP~T + OPV n = 1425	Group 2: Tritanrix-Hep B/ Hib™ + OPV n = 708
Post-any Vaccination (N = 1419, 705)	5	8 (0 to 0)
Post-vaccination 1 (N = 1419, 705)	3	1 (0 to 0)
Post-vaccination 2 (N = 1408, 698)	1	3 (0 to 0)
Post-vaccination 3 (N = 1405, 698)	1	4 (0 to 0)

Population analysed: Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: DTaP-Hep B-PRP~T + OPV	31 of 1,425 (2.2%)	1,092 of 1,425 (76.6%)	Not reported
Group 2: Tritanrix-Hep B/ Hib™ + OPV	12 of 708 (1.7%)	636 of 708 (89.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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 Director study director

Sanofi Pasteur Inc.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 21 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 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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 22 Oct 2013). 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 for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV (time frame: 1 month post third vaccination). 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?

On the ClinicalTrials.gov record for NCT00348881.

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 22 Oct 2013.