Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01346293
Collaborator
(none)
3,372
72
4
29
46.8
1.6
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
3372 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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 Start Date
:
Apr 1, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
Sep 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Study Group 1 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 |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Other Names:
|
| Experimental: Study Group 2 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 |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Other Names:
|
| Experimental: Study Group 3 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 |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus
0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
Other Names:
|
| Experimental: Study Group 4 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 |
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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 [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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 [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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 [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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 [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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 [Day 0 (pre-vaccination) and Day 28 post-vaccination]
Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).
Other Outcome Measures
- Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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.
- Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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.
- Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose [Day 0 (pre-vaccination) and Day 28 post-vaccination]
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.
- Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose [Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination]
Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.
- Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine [Day 0 up to Day 28 post-final vaccination]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
4 Years
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | 35205 | |
| 2 | Birmingham | Alabama | United States | 35235 | |
| 3 | Birmingham | Alabama | United States | 35244 | |
| 4 | Pinson | Alabama | United States | 35126 | |
| 5 | Trussville | Alabama | United States | 35173 | |
| 6 | Chandler | Arizona | United States | 85224 | |
| 7 | Scottsdale | Arizona | United States | 85255 | |
| 8 | Scottsdale | Arizona | United States | 85258 | |
| 9 | Jonesboro | Arkansas | United States | 72401 | |
| 10 | Little Rock | Arkansas | United States | 72205 | |
| 11 | La Puente | California | United States | 91744 | |
| 12 | Paramount | California | United States | 90723 | |
| 13 | Roseville | California | United States | 95661 | |
| 14 | Santa Clara | California | United States | 95051 | |
| 15 | West Covina | California | United States | 91790 | |
| 16 | Longmont | Colorado | United States | 80501 | |
| 17 | Thornton | Colorado | United States | 80233 | |
| 18 | St. Petersburg | Florida | United States | 33713 | |
| 19 | Marietta | Georgia | United States | 30062 | |
| 20 | Woodstock | Georgia | United States | 30189 | |
| 21 | Indianapolis | Indiana | United States | 46256 | |
| 22 | New Albany | Indiana | United States | 47150 | |
| 23 | Overland Park | Kansas | United States | 66213 | |
| 24 | Topeka | Kansas | United States | 66604 | |
| 25 | Crestview Hills | Kentucky | United States | 41017 | |
| 26 | Louisville | Kentucky | United States | 40202 | |
| 27 | Louisville | Kentucky | United States | 40207 | |
| 28 | Nicholasville | Kentucky | United States | 40356 | |
| 29 | Owensboro | Kentucky | United States | 42303 | |
| 30 | Bossier City | Louisiana | United States | 71111 | |
| 31 | Haughton | Louisiana | United States | 71037 | |
| 32 | Annapolis | Maryland | United States | 21401 | |
| 33 | Frederick | Massachusetts | United States | 21702 | |
| 34 | Woburn | Massachusetts | United States | 01801 | |
| 35 | Bridgeton | Missouri | United States | 63044 | |
| 36 | Bellevue | Nebraska | United States | 68005 | |
| 37 | Boys Town | Nebraska | United States | 68010 | |
| 38 | Lincoln | Nebraska | United States | 68504 | |
| 39 | Lincoln | Nebraska | United States | 68516 | |
| 40 | Omaha | Nebraska | United States | 68198 | |
| 41 | Brooklyn | New York | United States | 11201 | |
| 42 | Fargo | North Dakota | United States | 58104 | |
| 43 | Cincinnati | Ohio | United States | 45245 | |
| 44 | Fairfield | Ohio | United States | 45014 | |
| 45 | Youngstown | Ohio | United States | 44505 | |
| 46 | Midwest City | Oklahoma | United States | 73110 | |
| 47 | Gresham | Oregon | United States | 97030 | |
| 48 | Collegeville | Pennsylvania | United States | 19426 | |
| 49 | Pittsburgh | Pennsylvania | United States | 15241 | |
| 50 | Scranton | Pennsylvania | United States | 18510 | |
| 51 | Bristol | Tennessee | United States | 37620 | |
| 52 | Austin | Texas | United States | 78745 | |
| 53 | Dallas | Texas | United States | 75230 | |
| 54 | Houston | Texas | United States | 77025 | |
| 55 | San Antonio | Texas | United States | 78229 | |
| 56 | Clinton | Utah | United States | 84015 | |
| 57 | Layton | Utah | United States | 84041 | |
| 58 | Murray | Utah | United States | 84107 | |
| 59 | Orem | Utah | United States | 84057 | |
| 60 | Roy | Utah | United States | 84067 | |
| 61 | Springville | Utah | United States | 84663 | |
| 62 | Syracuse | Utah | United States | 84075 | |
| 63 | Burke | Virginia | United States | 22015 | |
| 64 | Charlottesville | Virginia | United States | 22902 | |
| 65 | Charlottesville | Virginia | United States | 22903 | |
| 66 | Charlottesville | Virginia | United States | 22911 | |
| 67 | Midlothian | Virginia | United States | 23113 | |
| 68 | Vienna | Virginia | United States | 22180 | |
| 69 | Spokane | Washington | United States | 99202 | |
| 70 | Spokane | Washington | United States | 99218 | |
| 71 | Huntington | West Virginia | United States | 25701 | |
| 72 | San Juan | Puerto Rico | 00918 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Director, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01346293
Other Study ID Numbers:
- M5I02
- U1111-1116-4842
First Posted:
May 2, 2011
Last Update Posted:
Jun 3, 2015
Last Verified:
May 1, 2015
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study participants were enrolled from 28 April to 16 November 2012 at 70 clinic sites in the United States and Puerto Rico. |
|---|---|
| Pre-assignment Detail | A total of 3372 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Period Title: Overall Study | ||
| STARTED | 2743 | 629 |
| COMPLETED | 2676 | 608 |
| NOT COMPLETED | 67 | 21 |
Baseline Characteristics
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® | Total |
|---|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® | Total of all reporting groups |
| Overall Participants | 2743 | 629 | 3372 |
| Age (Count of Participants) | |||
| <=18 years |
2743
100%
|
629
100%
|
3372
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
4.4
(0.5)
|
4.4
(0.5)
|
4.4
(0.5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1330
48.5%
|
306
48.6%
|
1636
48.5%
|
| Male |
1413
51.5%
|
323
51.4%
|
1736
51.5%
|
| Region of Enrollment (Number) [Number] | |||
| United States |
2743
100%
|
629
100%
|
3372
100%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Pertussis toxoid (N=252, 247) |
240
8.7%
|
222
35.3%
|
| Anti-Filamentous hemagglutinin (N=255, 248) |
242
8.8%
|
217
34.5%
|
| Anti-Pertactin (N=254, 248) |
246
9%
|
231
36.7%
|
| Anti-Fimbriae types 2 and 3 (N=250, 249) |
243
8.9%
|
230
36.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% Confidence intervals (CIs) of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Pertussis toxoid antigen between groups were > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 5.4 | |
| Confidence Interval |
(2-Sided) 95% 0.7 to 10.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Anti-Filamentous Haemagglutinin between groups were > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 7.4 | |
| Confidence Interval |
(2-Sided) 95% 2.5 to 21.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for the Pertactin antigens between groups were > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.7 | |
| Confidence Interval |
(2-Sided) 3.7% -0.2 to 7.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Non-inferiority comparison of post-vaccination anti-pertussis booster response rates in the Per-protocol Analysis Set. The hypothesis was based on testing the difference between 2 proportion parameters. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the difference (DTaP-IPV minus DAPTACEL® + IPOL®) in post-vaccination booster response rates for Fimbriae types 2 and 3 antigens between groups were > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 4.8 | |
| Confidence Interval |
(2-Sided) 95% 0.9 to 9.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean concentrations were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-PT pre-vaccination (N=254, 248) |
5.16
|
4.74
|
| Anti-PT post-vaccination (N=261, 252) |
121
|
61.3
|
| Anti-FHA pre-vaccination (N=255, 248) |
7.93
|
9.42
|
| Anti-FHA post-vaccination (N=263, 253) |
123
|
79.0
|
| Anti-PRN pre-vaccination (N=255, 249) |
18.6
|
16.7
|
| Anti-PRN post-vaccination (N=262, 252) |
283
|
187
|
| Anti-FIM pre-vaccination (N=253, 249) |
31.9
|
33.3
|
| Anti-FIM post-vaccination (N=260, 253) |
506
|
379
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each Pertussis antigen and their 2-sided 95% Confidence Intervals. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertussis Toxoid antigens between groups were > 2/3. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.97 | |
| Confidence Interval |
(2-Sided) 95% 1.68 to 2.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Filamentous Haemagglutinin antigens between groups were > 2/3. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.56 | |
| Confidence Interval |
(2-Sided) 95% 1.30 to 1.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL®) in post-vaccination GMCs for the Pertactin antigens between groups were > 2/3. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.51 | |
| Confidence Interval |
(2-Sided) 95% 1.27 to 1.79 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | DTaP-IPV, DAPTACEL®+IPOL® |
|---|---|---|
| Comments | Hypothesis was based on testing the ratio between the 2 post-vaccination GMCs (GMCQ / GMCD) for each pertussis antigen and their 2-sided 95% Confidence Intervals. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority of DTaP-IPV was demonstrated if the lower limits of the 2-sided 95% CIs of the ratio (DTaP-IPV / DAPTACEL® + IPOL® ) in post-vaccination GMCs for the Fimbriae types 2 and 3 antigens between groups were > 2/3. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.33 | |
| Confidence Interval |
(2-Sided) 95% 1.12 to 1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Tetanus (N=253, 248) |
213
7.8%
|
209
33.2%
|
| Anti-Diphtheria (N=256, 249) |
249
9.1%
|
247
39.3%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Tetanus pre-vaccination (N=254, 248) |
0.644
|
0.608
|
| Anti-Tetanus post-vaccination (N=262, 253) |
6.42
|
5.48
|
| Anti-Diphtheria pre-vaccination (N=257, 249) |
0.510
|
0.426
|
| Anti-Diphtheria post-vaccination (N=262, 253) |
18.6
|
15.5
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-polio booster responses were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Polio 1 (N=249, 248) |
214
7.8%
|
204
32.4%
|
| Anti-Polio 2 (N=249, 248) |
195
7.1%
|
196
31.2%
|
| Anti-Polio 3 (N=247, 248) |
210
7.7%
|
210
33.4%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Polio 1 pre-vaccination (N=254, 248) |
135
|
129
|
| Anti-Polio 1 post-vaccination (N=258, 253) |
3477
|
2731
|
| Anti-Polio 2 pre-vaccination (N=254, 248) |
214
|
188
|
| Anti-Polio 2 post-vaccination (N=258, 253) |
3491
|
3894
|
| Anti-Polio 3 pre-vaccination (N=252, 248) |
102
|
90.9
|
| Anti-Polio 3 post-vaccination (N=258, 252) |
4591
|
3419
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248) |
233
8.5%
|
221
35.1%
|
| Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248) |
93
3.4%
|
89
14.1%
|
| Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253) |
262
9.6%
|
251
39.9%
|
| Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253) |
259
9.4%
|
245
39%
|
| Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249) |
233
8.5%
|
207
32.9%
|
| Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249) |
78
2.8%
|
72
11.4%
|
| Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253) |
262
9.6%
|
252
40.1%
|
| Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253) |
261
9.5%
|
252
40.1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 253 |
| Anti-Polio 1 pre-vaccination (N=254, 248) |
250
9.1%
|
245
39%
|
| Anti-Polio 1 post-vaccinatin (N=258, 253) |
258
9.4%
|
252
40.1%
|
| Anti-Polio 2 pre-vaccination (N=254, 248) |
253
9.2%
|
247
39.3%
|
| Anti-Polio 2 post-vaccination (N=258, 253) |
258
9.4%
|
253
40.2%
|
| Anti-Polio 3 pre-vaccination (N=252, 248) |
244
8.9%
|
231
36.7%
|
| Anti-Polio 3 post-vaccination (N=258, 252) |
258
9.4%
|
252
40.1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 262 | 252 |
| Anti-Polio 1 4th dose (N=238, 235) |
205
7.5%
|
199
31.6%
|
| Anti-Polio 1 5th dose (N=10, 12) |
8
0.3%
|
4
0.6%
|
| Anti-Polio 2 4th dose (N=238, 235) |
188
6.9%
|
190
30.2%
|
| Anti-Polio 2 5th dose (N=10, 12) |
7
0.3%
|
5
0.8%
|
| Anti-Polio 3 4th dose (N=236, 235) |
203
7.4%
|
202
32.1%
|
| Anti-Polio 3 5th dose (N=10, 12) |
6
0.2%
|
7
1.1%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 263 | 252 |
| Anti-Polio 1 pre-4th dose (N=243, 235) |
134
|
123
|
| Anti-Polio 1 post-4th dose (N=247, 240) |
3471
|
2774
|
| Anti-Polio 1 pre-5th dose (N=10, 12) |
194
|
342
|
| Anti-Polio 1 post-5th dose (N=10, 12) |
3327
|
1773
|
| Anti-Polio 2 pre-4th dose (N=243, 235) |
210
|
181
|
| Anti-Polio 2 post-4th dose (N=247, 240) |
3495
|
3991
|
| Anti-Polio 2 pre-5th dose (N=10, 12) |
274
|
431
|
| Anti-Polio 2 post-5th dose (N=10, 12) |
3566
|
2048
|
| Anti-Polio 3 pre-4th dose (N=241, 235) |
99.5
|
86.3
|
| Anti-Polio 3 post-4th dose (N=247, 239) |
4773
|
3500
|
| Anti-Polio 3 pre-5th dose (N=10, 12) |
239
|
323
|
| Anti-Polio 3 post-5th dose (N=10, 12) |
1663
|
2436
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set. |
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® |
|---|---|---|
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® |
| Measure Participants | 2733 | 621 |
| Injection-site Pain (N=2689, 603) |
2081
75.9%
|
461
73.3%
|
| Grade 3 Injection-site Pain (N=2689, 603) |
53
1.9%
|
18
2.9%
|
| Injection-site Erythema (N=2687, 603) |
1587
57.9%
|
322
51.2%
|
| Grade 3 Injection-site Erythema (N=2687, 603) |
484
17.6%
|
72
11.4%
|
| Injection-site Swelling (N=2678, 602) |
1076
39.2%
|
219
34.8%
|
| Grade 3 Injection-site Swelling (N=2678, 602) |
229
8.3%
|
43
6.8%
|
| Extensive limb swelling (N=2666, 598) |
39
1.4%
|
8
1.3%
|
| Grade 3 Extensive limb swelling (N=2666, 598) |
39
1.4%
|
8
1.3%
|
| Change in limb circumference (N=2500, 464) |
1703
62.1%
|
302
48%
|
| Grade 3 Change in limb circumference (N=2500, 464) |
4
0.1%
|
0
0%
|
| Fever (N=2668, 598) |
161
5.9%
|
41
6.5%
|
| Grade 3 Fever (N=2668, 598) |
35
1.3%
|
12
1.9%
|
| Headache (N=2688, 603) |
419
15.3%
|
100
15.9%
|
| Grade 3 Headache (N=2688, 603) |
15
0.5%
|
4
0.6%
|
| Malaise (N=2687, 603) |
940
34.3%
|
200
31.8%
|
| Grade 3 Malaise (N=2687, 603) |
71
2.6%
|
20
3.2%
|
| Myalgia (N=2688, 603) |
1445
52.7%
|
317
50.4%
|
| Grade 3 Myalgia (N=2688, 603) |
52
1.9%
|
17
2.7%
|
Adverse Events
| Time Frame | Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The number of participants at risk for each specific solicited injection site and systemic reactions (reported as Other Adverse Events) was based on the number of participants who completed and returned diary cards used for the period. | |||
| Arm/Group Title | DTaP-IPV | DAPTACEL®+IPOL® | ||
| Arm/Group Description | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly | Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL® | ||
All Cause Mortality |
||||
| DTaP-IPV | DAPTACEL®+IPOL® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| DTaP-IPV | DAPTACEL®+IPOL® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/2733 (0.8%) | 3/621 (0.5%) | ||
| Gastrointestinal disorders | ||||
| Intestinal obstruction | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Intestinal perforation | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Rectal prolapse | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Vomiting | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Immune system disorders | ||||
| Immunodeficiency common variable | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Infections and infestations | ||||
| Clostridial infection | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Croup infectious | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Gastroenteritis | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Gastroenteritis viral | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Lobar pneumonia | 2/2733 (0.1%) | 2 | 0/621 (0%) | 0 |
| Sinusitis | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Urinary tract infection | 0/2733 (0%) | 0 | 1/621 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Skull fracture | 0/2733 (0%) | 0 | 1/621 (0.2%) | 1 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Type 1 diabetes mellitus | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Synovitis | 0/2733 (0%) | 0 | 1/621 (0.2%) | 1 |
| Nervous system disorders | ||||
| Autism | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Petit mal epilepsy | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 6/2733 (0.2%) | 6 | 0/621 (0%) | 0 |
| Vascular disorders | ||||
| Kawasaki's disease | 1/2733 (0%) | 1 | 0/621 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| DTaP-IPV | DAPTACEL®+IPOL® | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2081/2733 (76.1%) | 461/621 (74.2%) | ||
| General disorders | ||||
| Injection site induration | 139/2733 (5.1%) | 142 | 20/621 (3.2%) | 20 |
| Injection site Pain | 2081/2689 (77.4%) | 2081 | 461/603 (76.5%) | 461 |
| Injection site Erythema | 1587/2687 (59.1%) | 1587 | 322/603 (53.4%) | 322 |
| Injection site Swelling | 1076/2678 (40.2%) | 1076 | 219/602 (36.4%) | 219 |
| Change in limb circumference | 1703/2500 (68.1%) | 1703 | 302/464 (65.1%) | 302 |
| Fever | 161/2668 (6%) | 161 | 41/598 (6.9%) | 41 |
| Malaise | 940/2687 (35%) | 940 | 200/603 (33.2%) | 200 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 1445/2688 (53.8%) | 1445 | 317/621 (51%) | 317 |
| Nervous system disorders | ||||
| Headache | 419/2688 (15.6%) | 419 | 100/603 (16.6%) | 100 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 142/2733 (5.2%) | 147 | 26/621 (4.2%) | 26 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01346293
Other Study ID Numbers:
- M5I02
- U1111-1116-4842
First Posted:
May 2, 2011
Last Update Posted:
Jun 3, 2015
Last Verified:
May 1, 2015