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Clinical Trial Results:
Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP-T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants

Summary
EudraCT number	2011-004456-19
Trial protocol	Outside EU/EEA
Global end of trial date	28 May 2009

Results information
Results version number	v1(current)
This version publication date	10 Feb 2016
First version publication date	27 Sep 2014
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

A3L21

ISRCTN number

US NCT number

NCT00654901

WHO universal trial number (UTN)

Sponsor organisation name

Sanofi Pasteur SA

Sponsor organisation address

1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280

Public contact

Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com

Scientific contact

Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 58 43 , emmanuel.feroldi@sanofipasteur.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001201-PIP01-11

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

29 Jan 2010

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

28 May 2009

Was the trial ended prematurely?

Main objective of the trial

Immunogenicity -To describe the antibody (Ab) persistence at 15 to 18 months of age for all valences following a three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age in a subset of subjects, -To describe the immunogenicity of a booster dose of DTaP-IPV-Hep B-PRP-T given at 15 to 18 months of age in a subset of subjects. Safety - To describe the safety profile after a booster dose of DTaP-IPV-Hep B-PRP-T given at 15 to 18 months of age.

Protection of trial subjects

Only subjects that met all of the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.

Background therapy

All subjects were previously vaccinated at 2, 4, and 6 months of age with DTaP-IPV-Hep B-PRP-T (Group 1 [batch A], Group 2 [batch B] and Group 3 [batch C]) or Infanrix hexa™ (Group 4) and all were to receive one dose of DTaP-IPV-Hep B-PRP-T at 15 to 18 months of age in the current study.

Evidence for comparator

A fourth treatment group was added in order to provide an estimate of the immunogenicity and safety profile of a reference vaccine. Infanrix hexa™ was chosen as this vaccine is one of the standards of care in Mexico.

Actual start date of recruitment

26 Mar 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Mexico: 881

Worldwide total number of subjects

881

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

881

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled from 25 March 2008 to 28 November 2008 at 5 clinical centers in Mexico.

Screening details

A total of 881 participants who met the inclusion but none of the exclusion criteria were enrolled and vaccinated.

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

Not applicable

Are arms mutually exclusive

Yes

DTaP-IPV-Hep B-PRP~T Batch 1

Arm description

Subjects had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Arm type

Experimental

Investigational medicinal product name

Hexaxim

Investigational medicinal product code

DTaP-IPV-HepB-PRP-T vaccine

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, one dose each at 15 and 18 months of age.

DTaP-IPV-Hep B-PRP~T Batch 2

Arm description

Subjects had received 3 primary doses of Batch 2 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Arm type

Experimental

Investigational medicinal product name

Hexaxim

Investigational medicinal product code

DTaP-IPV-HepB-PRP-T vaccine

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, one dose each at 15 and 18 months of age.

DTaP-IPV-Hep B-PRP~T Batch 3

Arm description

Subjects had received 3 primary doses of Batch 3 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Arm type

Experimental

Investigational medicinal product name

Hexaxim

Investigational medicinal product code

DTaP-IPV-HepB-PRP-T vaccine

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, one dose each at 15 and 18 months of age.

Infanrix Hexa™

Arm description

Subjects had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 and received a booster dose of DTaP-IPV-Hep B-PRP~T at Day 0 in the present study.

Arm type

Active comparator

Investigational medicinal product name

Infanrix Hexa™

Investigational medicinal product code

DTaP-HBV-IPV vaccine

Other name

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL, intramuscular, one dose each at 15 and 18 months of age.

Number of subjects in period 1	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Started	254	262	252	113
Completed	250	262	250	113
Not completed	4	0	2	0
Consent withdrawn by subject	3	-	1	-
Lost to follow-up	1	-	1	-

Baseline characteristics

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Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 1

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 2

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 3

Reporting group description

Reporting group title

Infanrix Hexa™

Reporting group description

Reporting group values	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™	Total
Number of subjects	254	262	252	113	881
Age categorical
Units: Subjects
In utero	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0
Infants and toddlers (28 days-23 months)	254	262	252	113	881
Children (2-11 years)	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0
Adults (18-64 years)	0	0	0	0	0
From 65-84 years	0	0	0	0	0
85 years and over	0	0	0	0	0
Age continuous
Units: months
arithmetic mean (standard deviation)	17.3 ± 1.51	17.2 ± 1.47	17.4 ± 1.42	17.1 ± 1.51	-
Gender categorical
Units: Subjects
Female	125	125	130	58	438
Male	129	137	122	55	443

End points

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Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 1

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 2

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 3

Reporting group description

Reporting group title

Infanrix Hexa™

Reporting group description

Primary: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

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End point title

Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T ^[1]

End point description

Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.

End point type

Primary

End point timeframe

Day 0 (pre-booster) and Day 30 (one month post-booster)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.

End point values	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Number of subjects analysed	58	61	58	65
Units: Titers
geometric mean (confidence interval 95%)
Anti Hep B Pre-booster	91.1 (56.8 to 146)	127 (83.9 to 193)	69.2 (42.3 to 113)	127 (86.2 to 186)
Anti Hep B Post-booster	2167 (1314 to 3573)	3998 (2510 to 6368)	1877 (1152 to 3058)	4757 (3124 to 7243)
Anti PRP Pre-booster	1.09 (0.644 to 1.86)	1.32 (0.937 to 1.87)	0.88 (0.51 to 1.52)	1.33 (0.839 to 2.1)
Anti PRP Post-booster	64 (47.4 to 86.6)	94.8 (71.6 to 125)	49.7 (30.6 to 80.6)	102 (72.8 to 144)
Anti Diphtheria Pre-booster	0.116 (0.072 to 0.187)	0.19 (0.126 to 0.287)	0.101 (0.062 to 0.164)	0.081 (0.055 to 0.119)
Anti Diphtheria Post-booster	7.78 (4.88 to 12.4)	15.2 (10.1 to 23.1)	9.31 (5.8 to 14.9)	6.01 (3.99 to 9.06)
Anti Tetanus Pre-booster	0.33 (0.236 to 0.462)	0.331 (0.256 to 0.427)	0.231 (0.167 to 0.318)	0.297 (0.229 to 0.385)
Anti Tetanus Post-booster	5.26 (3.97 to 6.96)	8.49 (6.5 to 11.1)	5.55 (4.2 to 7.33)	6.98 (5.26 to 9.26)
Anti Polio 1 Pre-booster	614 (382 to 988)	663 (458 to 959)	551 (356 to 853)	887 (571 to 1378)
Anti Polio 1 Post-booster	7037 (4977 to 9949)	9938 (7418 to 13313)	8907 (6474 to 12254)	10173 (7909 to 13086)
Anti Polio 2 Pre-booster	936 (584 to 1501)	839 (530 to 1326)	531 (309 to 913)	1267 (747 to 2152)
Anti Polio 2 Post-booster	10756 (7636 to 15151)	10224 (7476 to 13981)	9232 (6549 to 13014)	13482 (10245 to 17742)
Anti Polio 3 Pre-booster	428 (255 to 719)	373 (224 to 619)	241 (130 to 446)	896 (508 to 1580)
Anti Polio 3 Post-booster	6597 (4281 to 10164)	9575 (6859 to 13365)	5296 (3503 to 8007)	13337 (9619 to 18491)
Anti PT Pre-booster	15.6 (11.6 to 20.9)	14.7 (11.8 to 18.4)	14.5 (11.3 to 18.6)	15.3 (11.6 to 20.2)
Anti PT Post-booster	186 (151 to 230)	200 (166 to 241)	171 (137 to 212)	162 (131 to 200)
Anti FHA Pre-booster	42.1 (30.6 to 57.9)	33.7 (26 to 43.8)	28.3 (21.5 to 37.3)	25.9 (19.6 to 34.2)
Anti FHA Post-booster	410 (336 to 499)	455 (387 to 536)	346 (284 to 421)	291 (242 to 349)

No statistical analyses for this end point

Primary: Number of Subjects With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

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End point title

Number of Subjects With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine ^[2]

End point description

Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.

End point type

Primary

End point timeframe

Day 0 (pre-booster) and Day 30 (one month post-booster)

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.

End point values	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Number of subjects analysed	58	61	58	65
Units: Subjects
number (not applicable)
Anti-Hep B Level 1 Pre-booster	51	56	51	62
Anti-Hep B Level 2 Pre-booster	29	39	25	38
Anti-Hep B Level 1 Post-booster	58	61	57	65
Anti-Hep B Level 2 Post-booster	52	58	55	63
Anti-PRP Level 1 Pre-booster	51	54	47	60
Anti-PRP Level 2 Pre-booster	27	36	25	32
Anti-PRP Level 1 Post-booster	58	61	58	65
Anti-PRP Level 2 Post booster	58	61	55	64
Anti-D Level 1 Pre-booster	51	59	51	62
Anti-D Level 2 Pre-booster	31	39	29	32
Anti-D Level 1 Post-booster	58	60	58	64
Anti-D Level 2 Post-booster	56	60	56	63
Anti-D Level 3 Post-booster	53	59	53	60
Anti-T Level 1 Pre-booster	58	60	57	65
Anti-T Level 2 Pre-booster	48	52	41	54
Anti-T Level 1 Post-booster	58	61	58	65
Anti-T Level 2 Post-booster	58	61	58	64
Anti-T Level 3 Post-booster	52	58	55	62
Anti-Polio 1 Pre-booster	57	59	57	65
Anti-Polio 1 Post-booster	57	61	58	64
Anti-Polio 2 Pre-booster	58	59	56	65
Anti-Polio 2 Post-booster	56	61	58	64
Anti-Polio 3 Pre-booster	57	57	53	64
Anti-Polio 3 Post-booster	56	60	58	64
Anti-PT Post-booster	48	57	52	51
Anti-FHA Post-booster	48	50	52	57

No statistical analyses for this end point

Primary: Number of Subjects With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

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End point title

Number of Subjects With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine ^[3]

End point description

Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.

End point type

Primary

End point timeframe

Days 0 up to 7 after any injection

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.

End point values	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Number of subjects analysed	254	262	252	113
Units: Subjects
number (not applicable)
Injection site Pain	174	193	177	80
Grade 3 injection site Pain	8	11	14	6
Injection site Erythema	135	127	135	63
Grade 3 injection site Erythema	3	4	5	1
Injection site Swelling	51	69	58	35
Grade 3 injection site Swelling	2	3	3	1
Extensive Swelling of Vaccinated Limb	0	1	0	0
Grade 3 Extensive Swelling of Vaccinated Limb	0	1	0	0
Pyrexia	25	35	28	22
Grade 3 Pyrexia	2	0	2	1
Vomiting	44	49	36	19
Grade 3 Vomiting	0	1	0	1
Crying	91	91	87	42
Grade 3 Crying	1	2	2	2
Somnolence	55	66	54	33
Grade 3 Somnolence	5	2	0	0
Anorexia	95	101	87	42
Grade 3 Anorexia	6	5	3	3
Irritability	145	166	166	75
Grade 3 Irritability	8	3	3	2

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

9.0

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 1

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 2

Reporting group description

Reporting group title

DTaP-IPV-Hep B-PRP~T Batch 3

Reporting group description

Reporting group title

Infanrix Hexa™

Reporting group description

Serious adverse events	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 254 (0.39%)	1 / 262 (0.38%)	1 / 252 (0.40%)	0 / 113 (0.00%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Infections and infestations
Bronchiolitis
subjects affected / exposed	1 / 254 (0.39%)	0 / 262 (0.00%)	0 / 252 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 254 (0.00%)	0 / 262 (0.00%)	1 / 252 (0.40%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 254 (0.00%)	1 / 262 (0.38%)	0 / 252 (0.00%)	0 / 113 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	DTaP-IPV-Hep B-PRP~T Batch 1	DTaP-IPV-Hep B-PRP~T Batch 2	DTaP-IPV-Hep B-PRP~T Batch 3	Infanrix Hexa™
Total subjects affected by non serious adverse events
subjects affected / exposed	188 / 254 (74.02%)	207 / 262 (79.01%)	197 / 252 (78.17%)	92 / 113 (81.42%)
Nervous system disorders
Somnolence
alternative assessment type: Systematic
subjects affected / exposed ^[1]	55 / 252 (21.83%)	66 / 262 (25.19%)	54 / 251 (21.51%)	33 / 113 (29.20%)
occurrences all number	55	66	54	33
General disorders and administration site conditions
Solicited Injection Site Erythema
alternative assessment type: Systematic
subjects affected / exposed ^[2]	135 / 252 (53.57%)	127 / 262 (48.47%)	135 / 251 (53.78%)	63 / 113 (55.75%)
occurrences all number	135	127	135	63
Solicited Injection Site Pain
alternative assessment type: Systematic
subjects affected / exposed ^[3]	174 / 252 (69.05%)	193 / 262 (73.66%)	177 / 251 (70.52%)	80 / 113 (70.80%)
occurrences all number	174	193	177	80
Solicited Injection Site Swelling
alternative assessment type: Systematic
subjects affected / exposed ^[4]	51 / 252 (20.24%)	69 / 262 (26.34%)	58 / 251 (23.11%)	35 / 113 (30.97%)
occurrences all number	51	69	58	35
Pyrexia
alternative assessment type: Systematic
subjects affected / exposed ^[5]	25 / 252 (9.92%)	35 / 262 (13.36%)	28 / 251 (11.16%)	22 / 113 (19.47%)
occurrences all number	25	35	28	22
Gastrointestinal disorders
Vomiting
alternative assessment type: Systematic
subjects affected / exposed ^[6]	44 / 252 (17.46%)	49 / 262 (18.70%)	36 / 251 (14.34%)	19 / 113 (16.81%)
occurrences all number	44	49	36	19
Psychiatric disorders
Irritability
alternative assessment type: Systematic
subjects affected / exposed ^[7]	145 / 252 (57.54%)	166 / 262 (63.36%)	166 / 251 (66.14%)	75 / 113 (66.37%)
occurrences all number	145	166	166	75
Crying
alternative assessment type: Systematic
subjects affected / exposed ^[8]	91 / 252 (36.11%)	91 / 262 (34.73%)	87 / 251 (34.66%)	42 / 113 (37.17%)
occurrences all number	91	91	87	42
Infections and infestations
Nasopharyngitis
subjects affected / exposed	13 / 254 (5.12%)	19 / 262 (7.25%)	14 / 252 (5.56%)	4 / 113 (3.54%)
occurrences all number	14	19	14	4
Metabolism and nutrition disorders
Anorexia
alternative assessment type: Systematic
subjects affected / exposed ^[9]	95 / 252 (37.70%)	101 / 262 (38.55%)	87 / 251 (34.66%)	42 / 113 (37.17%)
occurrences all number	95	101	87	42

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

Primary: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

Primary: Number of Subjects With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Primary: Number of Subjects With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Primary: Number of Subjects With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Primary: Number of Subjects With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Cyprus
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Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
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Italy
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Portugal
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Slovenia
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Outside EU/EEA