DiphtheriaPhase 3NCT00772928
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
A Phase 3 study testing Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® in people with Diphtheria and Tetanus, run by Sanofi at 23 sites in United States.
Trial summary
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine… Read more about this study
- Who is it for?
- Ages 42 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Haemophilus Infection
- What is being tested?
- Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,167 participants
- Where
- 23 sitesUnited States
- Study dates
- Oct 2003to Nov 2006
- 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
- Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
- Infants with at least 36 weeks of gestation at delivery.
- Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
- Able to attend the scheduled visits and to comply with the study procedures.
- Parent or legal guardian willing to take rectal temperatures during the infant series.
- Parent or legal guardian has access to a telephone.
- Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
- Able to obtain at least 1.5 mL of blood sample prior to Dose 1.
Who cannot join
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known Human Immunodeficiency Virus (HIV)-positive mother or child.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay or neurologic disorder.
Show all 10Show fewer
- Chronic medical, congenital, or developmental disease.
- Participation in any other clinical trial.
- 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.
- Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Austin, Texas, 78745
Study site
Bardstown, Kentucky, 40004
Study site
Boston, Massachusetts, 02115
Study site
Brooklyn, New York, 11201
Study site
Fayetteville, Arkansas, 72703
Study site
Fort Worth, Texas, 76107
Study site
Fountain Valley, California, 92708
Study site
Jonesboro, Arkansas, 72401
Study site
Kansas City, Missouri, 64112
Study site
La Crosse, Wisconsin, 54601
Study site
Layton, Utah, 84041
Study site
Little Rock, Arkansas, 72205
Study site
Louisville, Kentucky, 40202
Study site
Montgomery, Alabama, 36106
Study site
Norristown, Pennsylvania, 19401
Study site
Norwich, Connecticut, 06360
Study site
Oakland, California, 94612
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Rolling Hills Estate, California, 90274
Study site
San Antonio, Texas, 78229
Study site
San Antonio, Texas, 78745
Study site
Spokane, Washington, 99220
Study site
Vancouver, Washington, 98864
About this study
Official title: Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
Read the detailed description
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
- Conditions
- Diphtheria, Tetanus, Haemophilus Infection, Pertussis, Polio
- Being tested
- Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
- Keywords
- Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.
- Medical subject headings
- Diphtheria, Tetanus, Haemophilus Infections, Whooping Cough, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Biological
Also called Pentacel™, Prevnar®
0.5 mL, Intramuscular
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Biological
Also called Pentacel™, Prevnar®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Pentacel™ concurrently with Prevnar® | Experimental | Participants had Pentacel™ concurrently administered with Prevnar® Receives: Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® |
| Pentacel™ staggered schedule with Prevnar® | Experimental | Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule). Receives: Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
Measured: 28 to 48 days post-3rd vaccination
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
Measured: 60 Days Post-dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startOct 2003
- Primary completionMay 2006
- Study completionNov 2006
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 SanofiThe 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
- 1,167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772928
- Sponsor's protocol ID
- M5A07
- Status last verified
- Jan 2012
- First submitted
- 13 Oct 2008
- Last updated
- 1 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine
- ClinicalTrials.gov ID
- NCT00772928
- Acronym / sponsor ID
- M5A07
- Conditions
- Diphtheria, Tetanus, Haemophilus Infection, Pertussis, Polio
- Keywords
- Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,167 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Posted 12 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
Detailed description
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.
Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentacel™ concurrently with Prevnar® | Experimental | Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Participants had Pentacel™ concurrently administered with Prevnar® |
| Pentacel™ staggered schedule with Prevnar® | Experimental | Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule). |
Who may qualify
- Ages
- 42 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
- Infants with at least 36 weeks of gestation at delivery.
- Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
- Able to attend the scheduled visits and to comply with the study procedures.
- Parent or legal guardian willing to take rectal temperatures during the infant series.
Key exclusion criteria (10 listed)
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known Human Immunodeficiency Virus (HIV)-positive mother or child.
- Personal or immediate family history of congenital immune deficiency.
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 |
|---|---|---|
| Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Also: Pentacel™, Prevnar®0.5 mL, Intramuscular | Biological | Pentacel™ concurrently with Prevnar® |
| Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®Also: Pentacel™, Prevnar®0.5 mL, Intramuscular | Biological | Pentacel™ staggered schedule with Prevnar® |
Primary outcome
Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Time frame: 28 to 48 days post-3rd vaccination
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®)
Time frame: 60 Days Post-dose 3
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Monitor study director
Sanofi Pasteur Inc.
23 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 Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® in people with Diphtheria and Tetanus, run by Sanofi at 23 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 8 inclusion and 10 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 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 12 Feb 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 Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) (time frame: 28 to 48 days post-3rd 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?
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 1 Feb 2012.