Clinical trial NCT01346293: Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Official title: Safety and Immunogenicity of DTap-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined With Inactivated Poliovirus Vaccine) Compared to DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) + IPOL® (Poliovirus Vaccine Inactivated) as the 5th Dose in Children 4 to 6 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tetanus
Diphtheria
Pertussis
Measles
Polio
Keywords: Tetanus
Diphtheria
Pertussis
DTap-IPV
DAPTACEL®
VARIVAX®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 3372
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to \< 7 years of age in the US and Puerto Rico who were previously vaccinated with DAPTACEL® and/or Pentacel® vaccines only.

Primary Objectives:

* To compare the pertussis \[Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN), and Fimbriae Types 2 and 3 (FIM)\] booster responses and geometric mean concentrations (GMCs) (as measured by enzyme-linked immunosorbent assay \[ELISA\]) following DTap-IPV vaccination to those elicited following DAPTACEL® + IPOL® vaccination when administered as a 5th dose.
* To compare the diphtheria and tetanus booster responses and GMCs (as measured by ELISA) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations when administered as a 5th dose .
* To compare the Inactivated Poliovirus Vaccine booster responses (as measured by neutralizing assay) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.

Observational Objectives:

* To compare the polio (types 1, 2, and 3) geometric mean titers (GMTs) following DTap-IPV vaccination with those elicited following DAPTACEL® + IPOL® vaccinations.
* To assess the safety of DTap-IPV vaccine or DAPTACEL® + IPOL® vaccine when administered as the fifth dose booster vaccine in participants previously vaccinated with DAPTACEL and/or Pentacel vaccines.

Detailed description: All participants will be randomized to receive either one dose each of DTap-IPV + Measles, Mumps, and Rubella Virus Vaccine Live (M-M-R®II) + VARIVAX® or one dose each of DAPTACEL® + IPOL® + M-M-R®II + VARIVAX® on Day 0.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 4 to \< 7 years on the day of inclusion
* Informed consent form has been signed and dated by the parent/guardian before the first study-related procedure
* Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
* Subject has documented completion of primary infant series and booster with DAPTACEL® and/or Pentacel® vaccine(s) only.

Exclusion Criteria:

* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for any influenza vaccine, which may be received at least 2 weeks before study vaccines
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination except for any influenza vaccine, which may be received at least 2 weeks after study vaccines
* Receipt of blood or blood-derived products in the past 3 months
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* History of diphtheria, tetanus, or pertussis infection, confirmed either clinically, serologically, or microbiologically
* Known systemic hypersensitivity to any of the vaccines' components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
* Laboratory-confirmed thrombocytopenia, contraindicating intramuscular vaccination
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
* Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the investigator.

Primary outcomes:
measure: Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
timeFrame: Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
measure: Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
timeFrame: Day 0 up to Day 28 post-final vaccination
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Pinson
country: United States
state: Alabama
city: Trussville
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: La Puente
country: United States
state: California
city: Paramount
country: United States
state: California
city: Roseville
country: United States
state: California
city: Santa Clara
country: United States
state: California
city: West Covina
country: United States
state: California
city: Longmont
country: United States
state: Colorado
city: Thornton
country: United States
state: Colorado
city: St. Petersburg
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: New Albany
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Crestview Hills
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Nicholasville
country: United States
state: Kentucky
city: Owensboro
country: United States
state: Kentucky
city: Bossier City
country: United States
state: Louisiana
city: Haughton
country: United States
state: Louisiana
city: Annapolis
country: United States
state: Maryland
city: Frederick
country: United States
state: Massachusetts
city: Woburn
country: United States
state: Massachusetts
city: Bridgeton
country: United States
state: Missouri
city: Bellevue
country: United States
state: Nebraska
city: Boys Town
country: United States
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Brooklyn
country: United States
state: New York
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Fairfield
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Midwest City
country: United States
state: Oklahoma
city: Gresham
country: United States
state: Oregon
city: Collegeville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Clinton
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: Murray
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Roy
country: United States
state: Utah
city: Springville
country: United States
state: Utah
city: Syracuse
country: United States
state: Utah
city: Burke
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Smith MJ, Jordanov E, Sheng X, Tsang PH. Safety and Immunogenicity of DTaP5-IPV Compared With DTaP5 Plus IPV as the Fifth Dose in Children 4-6 Years of Age. Pediatr Infect Dis J. 2017 Mar;36(3):319-325. doi: 10.1097/INF.0000000000001427.