Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the... | NCT01346293

ID	Type	Description	Link
U1111-1116-4842	Other Identifier	WHO

Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the... | NCT01346293 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group 1	Experimental	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
Study Group 2	Experimental	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
Study Group 3	Experimental	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
Study Group 4	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus	Biological	0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 (\	Day 0 (pre-vaccination) and Day 28 post-vaccination
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).	Day 0 (pre-vaccination) and Day 28 post-vaccination
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.	Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

Other Outcomes

Measure	Description	Time Frame
Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine	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.

Eligibility Module

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.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Sanofi Pasteur Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27879555	Derived	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.

Label	URL
Related Info	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DTaP-IPV	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
FG001	DAPTACEL®+IPOL®

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Protocol Violation		FG00030 subjects FG0019 subjects
Lost to Follow-up		FG00021 subjects FG0018 subjects
Withdrawal by Subject		FG00015 subjects FG0014 subjects
Other		FG0001 subjects FG0010 subjects

Arm/Group Information

ID	Title	Description
BG000	DTaP-IPV	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
BG001	DAPTACEL®+IPOL®	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®
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0002743 BG001629 BG0023372
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG0004.4± 0.5 BG0014.4± 0.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001330 BG001306 BG002

Region of Enrollment

Number

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0002743 BG001629 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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 (\

Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants	OG000263 OG001253

Title

Denominators

Categories

Anti-Pertussis toxoid (N=252, 247)

Title	Measurements
	OG000240 OG001222

Anti-Filamentous hemagglutinin (N=255, 248)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.					Mean Difference (Final Values)	5.4			2-Sided	95	0.7	10.2				Yes	Non-Inferiority or Equivalence	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%.

Primary

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).

Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Primary

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.

Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Primary

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).

Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Primary

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.

Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Primary

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).

Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

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.

Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Other Pre-specified

Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

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.

Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Other Pre-specified

Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose

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.

Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.

Posted

Number

Participants

Day 0 (pre-vaccination) and Day 28 post-vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants

Other Pre-specified

Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose

Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.

Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine

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.

Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.

Posted

Number

Participants

Day 0 up to Day 28 post-final vaccination

ID	Title	Description
OG000	DTaP-IPV	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
OG001	DAPTACEL®+IPOL®	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®

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DTaP-IPV	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			21	2,733	2,081	2,733
EG001	DAPTACEL®+IPOL®	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®			3	621	461	621

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Immunodeficiency common variable	Immune system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Clostridial infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Croup infectious	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Lobar pneumonia	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0002 events2 affected2,733 at risk EG0010 events0 affected621 at risk
Sinusitis	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Urinary tract infection	Infections and infestations	MedDRA 13.0	Non-systematic Assessment	EG0000 events0 affected2,733 at risk EG0011 events1 affected621 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Non-systematic Assessment	EG0000 events0 affected2,733 at risk EG0011 events1 affected621 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Non-systematic Assessment	EG0000 events0 affected2,733 at risk EG0011 events1 affected621 at risk
Autism	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG0006 events6 affected2,733 at risk EG0010 events0 affected621 at risk
Kawasaki's disease	Vascular disorders	MedDRA 13.0	Non-systematic Assessment	EG0001 events1 affected2,733 at risk EG0010 events0 affected621 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site induration	General disorders	MedDRA 13.0	Non-systematic Assessment	EG000142 events139 affected2,733 at risk EG00120 events20 affected621 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Non-systematic Assessment	EG000147 events142 affected2,733 at risk EG00126 events26 affected621 at risk
Injection site Pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0002,081 events2,081 affected2,689 at risk EG001461 events461 affected603 at risk
Injection site Erythema	General disorders	MedDRA 13.0	Systematic Assessment	EG0001,587 events1,587 affected2,687 at risk EG001322 events322 affected603 at risk
Injection site Swelling	General disorders	MedDRA 13.0	Systematic Assessment	EG0001,076 events1,076 affected2,678 at risk EG001219 events219 affected602 at risk
Change in limb circumference	General disorders	MedDRA 13.0	Systematic Assessment	EG0001,703 events1,703 affected2,500 at risk EG001302 events302 affected464 at risk
Fever	General disorders	MedDRA 13.0	Systematic Assessment	EG000161 events161 affected2,668 at risk EG00141 events41 affected598 at risk
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG000419 events419 affected2,688 at risk EG001100 events100 affected603 at risk
Malaise	General disorders	MedDRA 13.0	Systematic Assessment	EG000940 events940 affected2,687 at risk EG001200 events200 affected603 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001,445 events1,445 affected2,688 at risk EG001317 events317 affected621 at risk

Ancestor Terms

ID	Term
D003015	Clostridium Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D001885	Bordetella Infections
D016905	Gram-Negative Bacterial Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases
D018185	Morbillivirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D009187	Myelitis
D002494	Central Nervous System Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013118	Spinal Cord Diseases
D000090862	Neuroinflammatory Diseases
D009468	Neuromuscular Diseases

Ancestor Terms

ID	Term
D014121	Toxoids
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D022283	Herpesvirus Vaccines
D014765	Viral Vaccines
D010567	Pertussis Vaccine
D001428	Bacterial Vaccines
D004168	Diphtheria Toxoid
D017778	Vaccines, Combined
D022282	Vaccines, Acellular
D022223	Vaccines, Subunit

Title

Denominators

Categories

Anti-PT pre-vaccination (N=254, 248)

Title	Measurements
	OG0005.16(4.48 to 5.94) OG0014.74(4.18 to 5.39)

Anti-PT post-vaccination (N=261, 252)

Title	Measurements
	OG000121(108 to 134) OG00161.3(54.5 to 68.9)

Anti-FHA pre-vaccination (N=255, 248)

Title	Measurements
	OG0007.93(6.63 to 9.47) OG0019.42(7.85 to 11.3)

Anti-FHA post-vaccination (N=263, 253)

Title	Measurements
	OG000123(108 to 141) OG00179.0(69.3 to 90.0)

Anti-PRN pre-vaccination (N=255, 249)

Title	Measurements
	OG00018.6(16.2 to 21.3) OG00116.7(14.6 to 19.1)

Anti-PRN post-vaccination (N=262, 252)

Title	Measurements
	OG000283(252 to 317) OG001187(164 to 214)

Anti-FIM pre-vaccination (N=253, 249)

Title	Measurements
	OG00031.9(27.0 to 37.6) OG00133.3(28.3 to 39.2)

Anti-FIM post-vaccination (N=260, 253)

Title	Measurements
	OG000506(448 to 571) OG001379(331 to 433)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	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.	Mean Difference (Final Values)	1.97	2-Sided	95	1.68	2.31	Yes	Non-Inferiority or Equivalence	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.
OG000 OG001	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.	Mean Difference (Final Values)	1.56	2-Sided	95	1.30	1.88	Yes	Non-Inferiority or Equivalence	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.
OG000 OG001	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.	Mean Difference (Final Values)	1.51	2-Sided	95	1.27	1.79	Yes	Non-Inferiority or Equivalence	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.
OG000 OG001	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.	Mean Difference (Final Values)	1.33	2-Sided	95	1.12	1.60	Yes	Non-Inferiority or Equivalence	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.

Title

Denominators

Categories

Anti-Tetanus pre-vaccination (N=254, 248)

Title	Measurements
	OG0000.644(0.548 to 0.758) OG0010.608(0.518 to 0.715)

Anti-Tetanus post-vaccination (N=262, 253)

Title	Measurements
	OG0006.42(5.74 to 7.18) OG0015.48(4.88 to 6.15)

Anti-Diphtheria pre-vaccination (N=257, 249)

Title	Measurements
	OG0000.510(0.437 to 0.596) OG0010.426(0.362 to 0.501)

Anti-Diphtheria post-vaccination (N=262, 253)

Title	Measurements
	OG00018.6(16.6 to 20.8) OG00115.5(13.7 to 17.6)

Title

Denominators

Categories

Anti-Polio 1 (N=249, 248)

Title	Measurements
	OG000214 OG001204

Anti-Polio 2 (N=249, 248)

Title	Measurements
	OG000195 OG001196

Anti-Polio 3 (N=247, 248)

Title	Measurements
	OG000210 OG001210

Title

Denominators

Categories

Anti-Polio 1 pre-vaccination (N=254, 248)

Title	Measurements
	OG000135(114 to 160) OG001129(110 to 151)

Anti-Polio 1 post-vaccination (N=258, 253)

Title	Measurements
	OG0003477(3088 to 3915) OG0012731(2384 to 3128)

Anti-Polio 2 pre-vaccination (N=254, 248)

Title	Measurements
	OG000214(183 to 249) OG001188(160 to 221)

Anti-Polio 2 post-vaccination (N=258, 253)

Title	Measurements
	OG0003491(3111 to 3917) OG0013894(3393 to 4468)

Anti-Polio 3 pre-vaccination (N=252, 248)

Title	Measurements
	OG000102(85.1 to 123) OG00190.9(74.5 to 111)

Anti-Polio 3 post-vaccination (N=258, 252)

Title	Measurements
	OG0004591(4011 to 5256) OG0013419(2946 to 3969)

Title

Denominators

Categories

Anti-Tetanus pre-vacc. ≥0.1 IU/ml (N=254, 248)

Title	Measurements
	OG000233 OG001221

Anti-Tetanus pre-vacc. ≥1.0 IU/ml (N=254, 248)

Title	Measurements
	OG00093 OG00189

Anti-Tetanus post-vacc. ≥0.1 IU/ml (N=262, 253)

Title	Measurements
	OG000262 OG001251

Anti-Tetanus post-vacc. ≥1.0 IU/ml (N=262, 253)

Title	Measurements
	OG000259 OG001245

Anti-Diphtheria pre-vacc. ≥0.1 IU/ml (N=257, 249)

Title	Measurements
	OG000233 OG001207

Anti-Diphtheria pre-vacc. ≥1.0 IU/ml (N=257, 249)

Title	Measurements
	OG00078 OG00172

Anti-Diphtheria post-vacc. ≥0.1 IU/ml (N=262, 253)

Title	Measurements
	OG000262 OG001252

Anti-Diphtheria post-vacc. ≥1.0 IU/ml (N=262, 253)

Title	Measurements
	OG000261 OG001252

Title

Denominators

Categories

Anti-Polio 1 pre-vaccination (N=254, 248)

Title	Measurements
	OG000250 OG001245

Anti-Polio 1 post-vaccinatin (N=258, 253)

Title	Measurements
	OG000258 OG001252

Anti-Polio 2 pre-vaccination (N=254, 248)

Title	Measurements
	OG000253 OG001247

Anti-Polio 2 post-vaccination (N=258, 253)

Title	Measurements
	OG000258 OG001253

Anti-Polio 3 pre-vaccination (N=252, 248)

Title	Measurements
	OG000244 OG001231

Anti-Polio 3 post-vaccination (N=258, 252)

Title	Measurements
	OG000258 OG001252

Title

Denominators

Categories

Anti-Polio 1 4th dose (N=238, 235)

Title	Measurements
	OG000205 OG001199

Anti-Polio 1 5th dose (N=10, 12)

Title	Measurements
	OG0008 OG0014

Anti-Polio 2 4th dose (N=238, 235)

Title	Measurements
	OG000188 OG001190

Anti-Polio 2 5th dose (N=10, 12)

Title	Measurements
	OG0007 OG0015

Anti-Polio 3 4th dose (N=236, 235)

Title	Measurements
	OG000203 OG001202

Anti-Polio 3 5th dose (N=10, 12)

Title	Measurements
	OG0006 OG0017

Title

Denominators

Categories

Anti-Polio 1 pre-4th dose (N=243, 235)

Title	Measurements
	OG000134(112 to 159) OG001123(105 to 144)

Anti-Polio 1 post-4th dose (N=247, 240)

Title	Measurements
	OG0003471(3072 to 3921) OG0012774(2420 to 3179)

Anti-Polio 1 pre-5th dose (N=10, 12)

Title	Measurements
	OG000194(70.6 to 533) OG001342(131 to 890)

Anti-Polio 1 post-5th dose (N=10, 12)

Title	Measurements
	OG0003327(1769 to 6256) OG0011773(692 to 4543)

Anti-Polio 2 pre-4th dose (N=243, 235)

Title	Measurements
	OG000210(179 to 246) OG001181(153 to 213)

Anti-Polio 2 post-4th dose (N=247, 240)

Title	Measurements
	OG0003495(3117 to 3920) OG0013991(3470 to 4590)

Anti-Polio 2 pre-5th dose (N=10, 12)

Title	Measurements
	OG000274(135 to 558) OG001431(166 to 1119)

Anti-Polio 2 post-5th dose (N=10, 12)

Title	Measurements
	OG0003566(1205 to 10554) OG0012048(1002 to 4187)

Anti-Polio 3 pre-4th dose (N=241, 235)

Title	Measurements
	OG00099.5(82.1 to 121) OG00186.3(70.6 to 106)

Anti-Polio 3 post-4th dose (N=247, 239)

Title	Measurements
	OG0004773(4168 to 5466) OG0013500(3007 to 4075)

Anti-Polio 3 pre-5th dose (N=10, 12)

Title	Measurements
	OG000239(137 to 417) OG001323(139 to 748)

Anti-Polio 3 post-5th dose (N=10, 12)

Title	Measurements
	OG0001663(687 to 4026) OG0012436(1033 to 5744)

Title

Denominators

Categories

Injection-site Pain (N=2689, 603)

Title	Measurements
	OG0002081 OG001461

Grade 3 Injection-site Pain (N=2689, 603)

Title	Measurements
	OG00053 OG00118

Injection-site Erythema (N=2687, 603)

Title	Measurements
	OG0001587 OG001322

Grade 3 Injection-site Erythema (N=2687, 603)

Title	Measurements
	OG000484 OG00172

Injection-site Swelling (N=2678, 602)

Title	Measurements
	OG0001076 OG001219

Grade 3 Injection-site Swelling (N=2678, 602)

Title	Measurements
	OG000229 OG00143

Extensive limb swelling (N=2666, 598)

Title	Measurements
	OG00039 OG0018

Grade 3 Extensive limb swelling (N=2666, 598)

Title	Measurements
	OG00039 OG0018

Change in limb circumference (N=2500, 464)

Title	Measurements
	OG0001703 OG001302

Grade 3 Change in limb circumference (N=2500, 464)

Title	Measurements
	OG0004 OG0010

Fever (N=2668, 598)

Title	Measurements
	OG000161 OG00141

Grade 3 Fever (N=2668, 598)

Title	Measurements
	OG00035 OG00112

Headache (N=2688, 603)

Title	Measurements
	OG000419 OG001100

Grade 3 Headache (N=2688, 603)

Title	Measurements
	OG00015 OG0014

Malaise (N=2687, 603)

Title	Measurements
	OG000940 OG001200

Grade 3 Malaise (N=2687, 603)

Title	Measurements
	OG00071 OG00120

Myalgia (N=2688, 603)

Title	Measurements
	OG0001445 OG001317

Grade 3 Myalgia (N=2688, 603)

Title	Measurements
	OG00052 OG00117

ID	Term
D013742	Tetanus
D004165	Diphtheria
D014917	Whooping Cough
D008457	Measles
D011051	Poliomyelitis

ID	Term
D013745	Tetanus Toxoid
D019433	Chickenpox Vaccine
D022681	Diphtheria-Tetanus-acellular Pertussis Vaccines