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DiphtheriaPhase 3NCT00255047

Safety and Immune Response of Different Pediatric Combination Vaccines.

A Phase 3 study testing DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined and DTaP-IPV and ActHIB® in people with Diphtheria and Polio, run by Sanofi Pasteur, a Sanofi Company at 36 sites in United States.

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

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®… Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
Conditions the study is for
Diphtheria, Polio, Pertussis
What is being tested?
DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined and DTaP-IPV and ActHIB®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,167 participants
Where
36 sitesUnited States
Study dates
Nov 2005to Feb 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 42 to 89 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged ≥ 42 days and ≤ 89 days on the day of inclusion
  • Born at full term of pregnancy (≥ 36 weeks)
  • Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
  • Vaccination with a hepatitis B vaccine at least 30 days before inclusion
  • Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
  • Provide blood sample prior to Dose 1
  • Parent or legal representative willing to take rectal temperatures after each vaccination.

Who cannot join

  • Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
  • Chronic illness that could interfere with trial conduct or completion
  • Received blood or blood-derived products since birth
Show all 12Show fewer
  • Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
  • Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
  • Coagulation disorder contraindicating intramuscular (IM) vaccination
  • Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
  • Developmental delay or neurological disorder
  • Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

United States36 sites

  • Study site

    Amarillo, Texas, 79124

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Bossier City, Louisiana, 71111

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Fort Worth, Texas, 76107

  • Study site

    Fountain Valley, California

  • Study site

    Huber Heights, Ohio, 45424

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Ithaca, New York

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Liverpool, New York, 13088

  • Study site

    Marietta, Georgia, 30062

  • Study site

    Marshfield, Wisconsin

  • Study site

    Norristown, Pennsylvania, 19401

  • Study site

    Norwich, Connecticut, 06360

  • Study site

    Oakland, California, 94609

  • Study site

    Oakland, California, 94613

  • Study site

    Oakland, California, 94618

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Paramount, California, 90723

  • Study site

    Pittsburgh, Pennsylvania, 15227

  • Study site

    Pittsburgh, Pennsylvania, 15241

  • Study site

    Provo, Utah, 84604

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78229

  • Study site

    South Jordan, Utah, 84095

  • Study site

    Spokane, Washington, 99216

  • Study site

    St. George, Utah, 84790

  • Study site

    Tuscaloosa, Alabama, 35401

  • Study site

    Vancouver, Washington, 98664

  • Study site

    Woburn, Massachusetts, 01801

  • Study site

    Youngstown, Ohio, 44514

Other trials in United States

About this study

Official title: Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Being tested
DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined, DTaP-IPV and ActHIB®
Keywords
Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.
Medical subject headings
Diphtheria, Poliomyelitis, Whooping Cough, Tetanus

What participants receive

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

  • DAPTACEL®. (DTaP), IPOL®., and ActHIB®.Biological

    Also called DAPTACEL®, IPOL®, ActHIB®

    0.5 mL, Intramuscular

  • Pentacel®: DTaP-IPV/Hib combinedBiological

    Also called Pentacel®

    0.5 mL, Intramuscular

  • DTaP-IPV and ActHIB®Biological

    Also called ActHIB®

    0.5 mL, Intramuscular

  • Pentacel®: DTaP-IPV/Hib combinedBiological

    Also called Pentacel®

    0.5 mL, Intramuscular

Study groups in NCT00255047
Study groupRoleWhat they receive
Study Group 1: DAPTACEL®, ActHIB®, and IPOL®ExperimentalParticipants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
Receives: Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
Study Group 2: Pentacel®ExperimentalParticipants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Receives: Biological: Pentacel®: DTaP-IPV/Hib combined
Study Group 3: DTaP-IPV and ActHIB®ExperimentalParticipants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
Receives: Biological: DTaP-IPV and ActHIB®
Study Group 4: Pentacel®ExperimentalParticipants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Receives: Biological: Pentacel®: DTaP-IPV/Hib combined

What is being measured

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

  1. Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.

    Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.

    Measured: 30 Days post-dose 3 vaccination

  2. Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)

    Measured: 30 Days post-dose 3 vaccination

  3. Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.

    Measured: 30 Days post-dose 3 vaccination.

Timeline

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

  1. First posted17 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJul 2008
  4. Study completionFeb 2009

Resources

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
2,167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00255047
Sponsor's protocol ID
M5A10
Status last verified
Jan 2014
First submitted
15 Nov 2005
Last updated
14 Feb 2014
Data monitoring committee
No

Publications

  • Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1.

    PubMed 22475857

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DAPTACEL®. (DTaP), IPOL®., and ActHIB®., Pentacel®: DTaP-IPV/Hib combined and DTaP-IPV and ActHIB® in people with Diphtheria and Polio, run by Sanofi Pasteur, a Sanofi Company at 36 sites in United States.

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 7 inclusion and 12 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 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. 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 10 Nov 2010). 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?

Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. (time frame: 30 Days post-dose 3 vaccination). The study lists 3 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 NCT00255047, 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 14 Feb 2014.

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