Safety and Immune Response of Different Pediatric Combination Vaccines.
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ClinicalTrials.gov Identifier: NCT00255047 |
Recruitment Status :
Completed
First Posted : November 17, 2005
Results First Posted : November 10, 2010
Last Update Posted : February 14, 2014
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Condition or disease | Intervention/treatment | Phase |
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Diphtheria Polio Pertussis | Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. Biological: Pentacel®: DTaP-IPV/Hib combined Biological: DTaP-IPV and ActHIB® | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2167 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | July 2008 |
Actual Study Completion Date : | February 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
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Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
Other Names:
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Experimental: Study Group 2: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
|
Biological: Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Other Name: Pentacel® |
Experimental: Study Group 3: DTaP-IPV and ActHIB®
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
|
Biological: DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
Other Name: ActHIB® |
Experimental: Study Group 4: Pentacel®
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
|
Biological: Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
Other Name: Pentacel® |
- 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 ]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.
- Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [ Time Frame: 30 Days post-dose 3 vaccination ]
- Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination. ]
- Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 [ Time Frame: 7 days post-vaccination 3 ]Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.

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Ages Eligible for Study: | 42 Days to 89 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255047
United States, Alabama | |
Tuscaloosa, Alabama, United States, 35401 | |
United States, Arkansas | |
Fayetteville, Arkansas, United States, 72703 | |
Jonesboro, Arkansas, United States, 72401 | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Fountain Valley, California, United States | |
Oakland, California, United States, 94609 | |
Oakland, California, United States, 94613 | |
Oakland, California, United States, 94618 | |
Paramount, California, United States, 90723 | |
United States, Connecticut | |
Norwich, Connecticut, United States, 06360 | |
United States, Florida | |
Palm Beach Gardens, Florida, United States, 33410 | |
United States, Georgia | |
Marietta, Georgia, United States, 30062 | |
United States, Kentucky | |
Bardstown, Kentucky, United States, 40004 | |
United States, Louisiana | |
Bossier City, Louisiana, United States, 71111 | |
United States, Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Woburn, Massachusetts, United States, 01801 | |
United States, Nebraska | |
Omaha, Nebraska, United States, 68131 | |
United States, New York | |
Ithaca, New York, United States | |
Liverpool, New York, United States, 13088 | |
United States, Ohio | |
Huber Heights, Ohio, United States, 45424 | |
Youngstown, Ohio, United States, 44514 | |
United States, Pennsylvania | |
Norristown, Pennsylvania, United States, 19401 | |
Pittsburgh, Pennsylvania, United States, 15227 | |
Pittsburgh, Pennsylvania, United States, 15241 | |
United States, Tennessee | |
Kingsport, Tennessee, United States, 37660 | |
United States, Texas | |
Amarillo, Texas, United States, 79124 | |
Ft. Worth, Texas, United States, 76107 | |
San Antonio, Texas, United States, 78205 | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Provo, Utah, United States, 84604 | |
South Jordan, Utah, United States, 84095 | |
St George, Utah, United States, 84790 | |
United States, Washington | |
Spokane, Washington, United States, 99216 | |
Vancouver, Washington, United States, 98664 | |
United States, West Virginia | |
Huntington, West Virginia, United States, 25701 | |
United States, Wisconsin | |
Marshfield, Wisconsin, United States |
Study Director: | Medical Director | Sanofi Pasteur Inc |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00255047 |
Other Study ID Numbers: |
M5A10 |
First Posted: | November 17, 2005 Key Record Dates |
Results First Posted: | November 10, 2010 |
Last Update Posted: | February 14, 2014 |
Last Verified: | January 2014 |
Pertussis Whooping cough Filamentous Haemagglutinin Fimbriae Types 2 and 3; |
Pertactin Diphtheria Tetanus Poliovirus Types 1, 2, and 3. |
Whooping Cough Diphtheria Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |