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Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

Primary Purpose

Tetanus, Diphtheria, Pertussis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus focused on measuring Tetanus, Diphtheria, Pertussis, DTap-IPV, DAPTACEL®, VARIVAX®

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Study Group 1

Study Group 2

Study Group 3

Study Group 4

Arm Description

Participants will receive concomitantly a dose of DTap-IPV, a dose of M-M-R®II, and a dose of VARIVAX® vaccine on Day 0

Participants will receive concomitantly a dose of DAPTACEL®, a dose of IPOL®, a dose of M-M-R®II, and a dose of VARIVAX® vaccines on Day 0

Participants will receive concomitantly a dose of DTap-IPV with or without a dose of M-M-R®II and a dose of VARIVAX® on Day 0

Participants will receive concomitantly a dose of DAPTACEL® vaccine, a dose of IPOL® vaccine with or without a dose of M-M-R®II and a dose of VARIVAX® vaccines on Day 0

Outcomes

Primary Outcome Measures

Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome Measures

Full Information

First Posted
April 29, 2011
Last Updated
May 28, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01346293
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus, Diphtheria, Pertussis, Measles, Polio
Keywords
Tetanus, Diphtheria, Pertussis, DTap-IPV, DAPTACEL®, VARIVAX®

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3372 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1
Arm Type
Experimental
Arm Description
Participants will receive concomitantly a dose of DTap-IPV, a dose of M-M-R®II, and a dose of VARIVAX® vaccine on Day 0
Arm Title
Study Group 2
Arm Type
Experimental
Arm Description
Participants will receive concomitantly a dose of DAPTACEL®, a dose of IPOL®, a dose of M-M-R®II, and a dose of VARIVAX® vaccines on Day 0
Arm Title
Study Group 3
Arm Type
Experimental
Arm Description
Participants will receive concomitantly a dose of DTap-IPV with or without a dose of M-M-R®II and a dose of VARIVAX® on Day 0
Arm Title
Study Group 4
Arm Type
Experimental
Arm Description
Participants will receive concomitantly a dose of DAPTACEL® vaccine, a dose of IPOL® vaccine with or without a dose of M-M-R®II and a dose of VARIVAX® vaccines on Day 0
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Other Intervention Name(s)
DTap-IPV, M-M-R®II, VARIVAX®
Intervention Description
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Other Intervention Name(s)
DAPTACEL®, IPOL®, M-M-M R®II, VARIVAX®
Intervention Description
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
Other Intervention Name(s)
DTap-IPV, M-M-R®II, VARIVAX®
Intervention Description
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
Other Intervention Name(s)
DAPTACEL®, IPOL®, M-M-R®II, VARIVAX®
Intervention Description
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Primary Outcome Measure Information:
Title
Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose
Description
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.
Time Frame
Day 0 (pre-vaccination) and Day 28 post-vaccination
Title
Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose
Description
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
Time Frame
Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination
Title
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine
Description
Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference >50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Time Frame
Day 0 up to Day 28 post-final vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
City
Pinson
State/Province
Alabama
ZIP/Postal Code
35126
Country
United States
City
Trussville
State/Province
Alabama
ZIP/Postal Code
35173
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
La Puente
State/Province
California
ZIP/Postal Code
91744
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
City
Nicholasville
State/Province
Kentucky
ZIP/Postal Code
40356
Country
United States
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Frederick
State/Province
Massachusetts
ZIP/Postal Code
21702
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
City
Boys Town
State/Province
Nebraska
ZIP/Postal Code
68010
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
City
Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23113
Country
United States
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
27879555
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.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age

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