DiphtheriaPhase 3NCT00514709

Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants

A Phase 3 study testing DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine and Oral Polio Vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 7 sites in Philippines.

Completed

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

Official record

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Trial summary

DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance. Read more about this study

Who is it for?: Ages 12 to 18 monthsHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine and Oral Polio Vaccine
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: 1,843 participants
Where: 7 sitesPhilippines
Study dates: Sep 2007to Apr 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 12 to 18 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
Able to attend all scheduled visits and to comply with all trial procedures

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
Chronic illness at a stage that could interfere with trial conduct or completion
Blood or blood-derived products received in the last 3 months

Show all 13Show fewer

Any vaccination in the 4 weeks preceding the trial vaccination
Vaccination planned in the 4 weeks following the trial vaccination
Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series
Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
Serious adverse event related to any vaccination in the AL201 study.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Philippines7 sites

Study site
City of Muntinlupa, Alabang Junction Alabang
Study site
City of Muntinlupa, Alabang
Study site
City of Muntinlupa, Bayanan Annex
Study site
City of Muntinlupa, Cupang
Study site
City of Muntinlupa, Filinvest
Study site
City of Muntinlupa, Putatan
Study site
City of Muntinlupa, Tunasan

Other trials in Philippines

About this study

Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth

Primary Objectives:

To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.

Secondary Objective:

To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Read the detailed description

This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).

Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Influenza
Being tested: DTaP-HB PRP~T Combined Vaccine, DTaP-HB-PRP~T vaccine, Oral Polio Vaccine
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 (IM)
DTaP-HB-PRP~T vaccineBiological
0.5 mL, IM
Oral Polio VaccineBiological
Oral co-administered with study vaccine.

Study groups in NCT00514709
Study group	Role	What they receive
Group 1	Experimental	DTaP-Hep B-PRP-T + OPV vaccine group Receives: Biological: DTaP-HB PRP~T Combined Vaccine; Biological: Oral Polio Vaccine
Group 2	Experimental	Tritanrix-HepB/Hib™ + OPV vaccine group Receives: Biological: DTaP-HB-PRP~T vaccine; Biological: Oral Polio Vaccine

What is being measured

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

Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (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, and serum neutralization (SN) for anti-Diphtheria.
Booster responses 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.
Measured: Day 0 (pre-vaccination) and Day 28 post-booster vaccination

Secondary outcomes (2)

Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (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, and serum neutralization (SN) for anti-Diphtheria following the booster vaccination.
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Pyrexia (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 ≥ 39.5ºC; 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 up 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.

Sep 2007Apr 2009

First posted10 Aug 2007 (estimated)
Study startSep 2007
Primary completionDec 2008
Study completionApr 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: None (open label)
Enrolment: 1,843 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00514709
Sponsor's protocol ID: AL204
Status last verified: Jul 2016
First submitted: 9 Aug 2007
Last updated: 2 Aug 2016
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
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
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP-Hep B-PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth
ClinicalTrials.gov ID: NCT00514709
Acronym / sponsor ID: AL204
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: 1,843 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Dec 2008 (actual)
Study completion: Apr 2009 (actual)
First posted: 10 Aug 2007 (estimated)
Results: Posted 14 Nov 2013

Clinical summary

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

Primary Objectives:

To describe the antibody persistence at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.
To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18 months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine given at birth.

Secondary Objective:

To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with Oral Polio Vaccine (OPV).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Biological: DTaP-HB PRP~T Combined Vaccine, Biological: Oral Polio VaccineDTaP-Hep B-PRP-T + OPV vaccine group
Group 2	Experimental	Biological: DTaP-HB-PRP~T vaccine, Biological: Oral Polio VaccineTritanrix-HepB/Hib™ + OPV vaccine group

Who may qualify

Ages: 12 to 18 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
Able to attend all scheduled visits and to comply with all trial procedures

Key exclusion criteria (13 listed)

Participation in another clinical trial in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
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-HB PRP~T Combined Vaccine0.5 mL, Intramuscular (IM)	Biological	Group 1
DTaP-HB-PRP~T vaccine0.5 mL, IM	Biological	Group 2
Oral Polio VaccineOral co-administered with study vaccine.	Biological	Group 1, Group 2

Primary outcome

Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)
Time frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination
Immunogenicity 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. Booster responses 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; Pertussis Toxoid and Filamentous Hemagglutinin (FHA) 4-fold increase and booster response.

2 secondary outcomes

Geometric Mean Titers (GMTs) of Vaccine Antibodies After Booster Vaccination With DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site Reaction or Systemic Reactions Following Vaccination With a Booster Dose of the DTaP-Hep B-PRP~T Combined Vaccine Concomitantly With Oral Polio Vaccine (OPV)
Time frame: Day 0 up to Day 7 after vaccination

Results and safety

Results posted to the registry on 14 Nov 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	1,230	1,230
Group 2: Tritanrix-Hep B/ Hib™ + OPV	613	613

Primary outcome: Number of Participants With Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV)

Time frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination. Number. Unit: Participants

Measure	Group 1: DTaP-Hep B-PRP~T + OPV n = 93	Group 2: Tritanrix-Hep B/ Hib™ + OPV n = 105
Anti-Hep B Pre-booster (N = 93, 103)	81	80 (0 to 0)
Anti-Hep B Post-booster (N = 93, 105)	91	103
Anti-PRP Pre-booster (N = 93, 105)	78	105 (0 to 0)
Anti-PRP Post-booster (N = 93, 105)	93	105
Anti-Diphtheria Pre-booster (N = 93, 105)	72	68 (0 to 0)
Anti-Diphtheria Post-booster (N = 93, 105)	93	103
Anti-Tetanus Pre-booster (N = 93, 105)	93	105 (0 to 0)
Anti-Tetanus Post-booster (N = 93, 105)	93	105

Population analysed: Antibody persistence and immunogenicity booster responses were assessed in a subset of participants available for the endpoint, the per-protocol population.

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 30 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	3 of 1,230 (0.2%)	411 of 1,230 (33.4%)	Not reported
Group 2: Tritanrix-Hep B/ Hib™ + OPV	0 of 613 (0%)	216 of 613 (35.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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
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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
Active, not recruitingPhase 2/3
A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus

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.

7 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 4 inclusion and 13 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 14 Nov 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 Antibody Persistence and Immunogenicity Booster Response to Vaccination With DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) (time frame: Day 0 (pre-vaccination) and Day 28 post-booster vaccination). 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 NCT00514709.

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 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.