Safety and Immune Response of Different Pediatric Combination Vaccines.

Diphtheria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255047
• Other study ID #: M5A10
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: January 21, 2014
• Start date: November 2005
• Est. completion date: February 2009

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2167
• Est. completion date: February 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 89 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Polio
• Whooping Cough

Intervention

Biological:
• DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
0.5 mL, Intramuscular
• Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
• DTaP-IPV and ActHIB®
0.5 mL, Intramuscular
• Pentacel®: DTaP-IPV/Hib combined
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions 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.	7 days post-vaccination 3	No
Primary	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.	30 Days post-dose 3 vaccination	No
Primary	Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)		30 Days post-dose 3 vaccination	No
Primary	Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.		30 Days post-dose 3 vaccination.	No

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