Trial record 1 of 1 for: A3L04

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Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.

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ClinicalTrials.gov Identifier: NCT00313911

Recruitment Status : Completed

First Posted : April 12, 2006

Results First Posted : November 19, 2012

Last Update Posted : April 21, 2014

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention
Conditions	Diphtheria Tetanus Pertussis Haemophilus Influenzae Type b Hepatitis B
Interventions	Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib
Enrollment	2133

Participant Flow

Recruitment Details	Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.
Pre-assignment Details	A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description	Participants received Diphtheria (D...	Participants received Tritanrix-Hep...
Arm/Group Description	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Period Title: Overall Study
Started	1422 ^[1]	711 ^[2]
Completed	1328	670
Not Completed	94	41
Reason Not Completed
Serious adverse event	6	1
Adverse Event	2	3
Protocol Violation	19	10
Lost to Follow-up	27	14
Withdrawal by Subject	39	12
Did not meet age criteria	1	1
[1] N for outcomes adjusted to include participant in Group 2 that got vaccine assigned to this group. [2] A participant in this group mistakenly got Group 1 vaccine. N in outcomes adjusted accordingly.

Baseline Characteristics

Arm/Group Title		DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV	Total
Arm/Group Description		Participants received Diphtheria (D...	Participants received Tritanrix-Hep...	Total of all reporting groups
Arm/Group Description		Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Total of all reporting groups
Overall Number of Baseline Participants		1422	711	2133
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1422 participants	711 participants	2133 participants
	<=18 years	1422 100.0%	711 100.0%	2133 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Months
Age Continuous	Number Analyzed	1422 participants	711 participants	2133 participants
Age Continuous		1.89 (0.195)	1.88 (0.197)	1.88 (0.196)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1422 participants	711 participants	2133 participants
	Female	706 49.6%	344 48.4%	1050 49.2%
	Male	716 50.4%	367 51.6%	1083 50.8%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	1422 participants	711 participants	2133 participants
Mexico		712	355	1067
Peru		710	356	1066

Outcome Measures

1.Primary Outcome


Title	Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
Description	High fever was defined as rectal temperature equivalent to ≥ 39....
Description	High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Time Frame	Day 0 up to Day 7 post-injection

Outcome Measure Data

Analysis Population Description

The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description:	Participants received Diphtheria (D...	Participants received Tritanrix-Hep...
Arm/Group Description:	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed	1423	710
Measure Type: Number Unit of Measure: Participants
Post Any Dose (N = 1411, 703)	56	39
Post Dose 1 (N = 1408, 703)	5	4
Post Dose 2 (N = 1348, 681)	25	15
Post Dose 3 (N = 1328, 672)	26	23

2.Secondary Outcome


Title	Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Description	Anti-hepatitis B (Hep B) antibodies were measured by automated enhance...
Description	Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Time Frame	Day 30 post-dose 3

Outcome Measure Data

Analysis Population Description

Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description:	Participants received Diphtheria (D...	Participants received Tritanrix-Hep...
Arm/Group Description:	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed	184	95
Geometric Mean (95% Confidence Interval) Unit of Measure: Titers
	1075 (891 to 1298)	3376 (2672 to 4338)

3.Secondary Outcome


Title	Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Description	Anti hepatitis B (Hep B)...
Description	Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Time Frame	Day 30 post-dose 3

Outcome Measure Data

Analysis Population Description

Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description:	Participants received Diphtheria (D...	Participants received Tritanrix-Hep...
Arm/Group Description:	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed	184	95
Measure Type: Number Unit of Measure: Percentage of Participants
≥ 10 mIU/mL	100	100
≥ 100 mIU/mL	96	99

4.Secondary Outcome


Title	Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Description	Solicited Injection Site...
Description	Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Time Frame	Day 0 up to Day 7 Post-injection

Outcome Measure Data

Analysis Population Description

Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.


Arm/Group Title	DTaP-IPV-Hep B-PRP~T	Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description:	Participants received Diphtheria (D...	Participants received Tritanrix-Hep...
Arm/Group Description:	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.	Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed	1423	710
Measure Type: Number Unit of Measure: Participants
Any Pain Post Dose 1 (N=1410, 703)	831	574
Severe Pain Post Dose 1 (N=1408, 703)	175	193
Any Pain Post Dose 2 (N=1348, 681)	744	506
Severe Pain Post Dose 2 (N=1348, 681)	105	95
Any Pain Post Dose 3 (N=1327, 672)	519	448
Severe Pain Post Dose 3 (N=1327, 672)	29	65
Any Erythema Post Dose 1 (N=1408, 703)	245	234
Severe Erythema Post Dose 1 (N=1408, 703)	11	15
Any Erythema Post Dose 2 (N=1348, 681)	427	308
Severe Erythema Post Dose 2 (N=1348, 681)	6	16
Any Erythema Post Dose 3 (N=1327, 672)	587	340
Severe Erythema Post Dose 3 (N=1327, 672)	23	12
Any Swelling Post Dose 1 (N=1406, 703)	151	188
Severe Swelling Post Dose 1 (N=1406, 703)	8	24
Any Swelling Post Dose 2 (N=1348, 681)	259	270
Severe Swelling Post Dose 2 (N=1348, 681)	3	11
Any Swelling Post Dose 3 (N=1327, 672)	400	323
Severe Swelling Post Dose 3 (N=1327, 672)	3	7
Any Pyrexia Post Dose 1 (N=1408, 703)	538	473
Severe Pyrexia Post Dose 1 (N=1408, 703)	5	4
Any Pyrexia Post Dose 2 (N=1348, 681)	675	457
Severe Pyrexia Post Dose 2 (N=1348, 681)	27	16
Any Pyrexia Post Dose 3 (N=1328, 672)	552	445
Severe Pyrexia Post Dose 3 (N=1328, 672)	30	23
Any Vomiting Post Dose 1 (N=1408, 703)	230	120
Severe Vomiting Post Dose 1 (N=1408, 703)	10	4
Any Vomiting Post Dose 2 (N=1348, 681)	152	75
Severe Vomiting Post Dose 2 (N=1348, 681)	2	4
Any Vomiting Post Dose 3 (N=1328, 672)	167	95
Severe Vomiting Post Dose 3 (N=1328, 672)	17	10
Any Crying Post Dose 1 (N=1409, 703)	800	564
Severe Crying Post Dose 1 (N=1409, 703)	21	26
Any Crying Post Dose 2 (N=1348, 681)	721	481
Severe Crying Post Dose 2 (N=1348, 681)	9	8
Any Crying Post Dose 3 (N=1327, 672)	466	391
Severe Crying Post Dose 3 (N=1327, 672)	9	8
Any Somnolence Post Dose 1 (N=1408, 703)	635	375
Severe Somnolence Post Dose 1 (N=1408, 703)	46	26
Any Somnolence Post Dose 2 (N=1348, 681)	405	247
Severe Somnolence Post Dose 2 (N=1348, 681)	16	12
Any Somnolence Post Dose 3 (N=1327, 672)	272	204
Severe Somnolence Post Dose 3 (N=1327, 672)	12	11
Any Anorexia Post Dose 1 (N=1408, 703)	388	278
Severe Anorexia Post Dose 1 (N=1408, 703)	11	14
Any Anorexia Post Dose 2 (N=1348, 681)	327	195
Severe Anorexia Post Dose 2 (N=1348, 681)	12	11
Any Anorexia Post Dose 3 (N=1327, 672)	294	189
Severe Anorexia Post Dose 3 (N=1327, 672)	18	17
Any Irritability Post Dose 1 (N=1408, 703)	945	576
Severe Irritability Post Dose 1 (N=1408, 703)	42	47
Any Irritability Post Dose 2 (N=1348, 681)	799	492
Severe Irritability Post Dose 2 (N=1348, 681)	41	25
Any Irritability Post Dose 3 (N=1327, 672)	546	416
Severe Irritability Post Dose 3 (N=1327, 672)	11	17

Adverse Events

Time Frame	Adverse event data were collected from the day of the first injection (Day 0) through 6 months after the last injection.
Adverse Event Reporting Description	Total number of participants in each group adjusted for the participant that got a vaccine assigned for the other group. The number at risk for the solicited injection site and systemic reactions also reflects numbers with data.

Arm/Group Title	DTaP-IPV-Hep B-PRP~T		Tritanrix-Hep B/Hib™ + OPV
Arm/Group Description	Participants received Diphtheria (D...		Participants received Tritanrix-Hep...
Arm/Group Description	Participants received 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) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.		Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
All-Cause Mortality
	DTaP-IPV-Hep B-PRP~T		Tritanrix-Hep B/Hib™ + OPV
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	DTaP-IPV-Hep B-PRP~T		Tritanrix-Hep B/Hib™ + OPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	91/1423 (6.39%)		46/710 (6.48%)
Cardiac disorders
Cardio Respiratory Distress ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Congenital, familial and genetic disorders
Hip Dysplasia ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Gastrointestinal disorders
Intussusception ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Diarrhoea ^* 1	2/1423 (0.14%)	2	0/710 (0.00%)	0
Gastric Haemorrhage ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Gastrooesophageal reflux disease ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Inguinal Hernia, Obstructive ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
General disorders
Pyrexia ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Hepatobiliary disorders
Choledochal Cyst ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Infections and infestations
Abscess Neck ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Bronchiolitis ^* 1	12/1423 (0.84%)	12	6/710 (0.85%)	6
Bronchopneumonia ^* 1	13/1423 (0.91%)	13	3/710 (0.42%)	3
Encephalitis viral ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Gastroenteritis ^* 1	21/1423 (1.48%)	21	18/710 (2.54%)	18
Gastroenteritis rotavirus ^* 1	1/1423 (0.07%)	1	1/710 (0.14%)	1
Kawasaki's disease ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Laryngotracheitis ^* 1	2/1423 (0.14%)	2	0/710 (0.00%)	0
Lymphangitis ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Periorbital Cellulitis ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Pharyngitis ^* 1	2/1423 (0.14%)	2	0/710 (0.00%)	0
Pneumonia ^* 1	5/1423 (0.35%)	5	3/710 (0.42%)	3
Pneumonia viral ^* 1	6/1423 (0.42%)	6	2/710 (0.28%)	2
Postoperative Wound Infection ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Pyoderma ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Pyoderma Streptococcal ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Urinary Tract Infection ^* 1	1/1423 (0.07%)	1	1/710 (0.14%)	1
Injury, poisoning and procedural complications
Head Injury ^* 1	2/1423 (0.14%)	2	3/710 (0.42%)	3
Nervous system disorders
Encephalitis ^* 1	1/1423 (0.07%)	1	1/710 (0.14%)	1
Epilepsy ^* 1	1/1423 (0.07%)	1	1/710 (0.14%)	1
Febrile Convulsion ^* 1	4/1423 (0.28%)	4	1/710 (0.14%)	1
Hypotonic Hyporesponsive Episode ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Subarachnoid Haemorrhage ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperactivity ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Bronchial Obstruction ^* 1	9/1423 (0.63%)	9	1/710 (0.14%)	1
Bronchospasm ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Foreign Body Aspiration ^* 1	1/1423 (0.07%)	1	0/710 (0.00%)	0
Obstructive Airways Disorder ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
Skin and subcutaneous tissue disorders
Purpura ^* 1	0/1423 (0.00%)	0	1/710 (0.14%)	1
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 9.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.00%
	DTaP-IPV-Hep B-PRP~T		Tritanrix-Hep B/Hib™ + OPV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	945/1423 (66.41%)		576/710 (81.13%)
Gastrointestinal disorders
Abdominal Pain ^* 1	131/1411 (9.28%)	131	70/703 (9.96%)	70
Diarrhoea ^* 1	264/1411 (18.71%)	264	123/703 (17.50%)	123
Solicited Vomiting Post-dose 1 ^† 1	230/1410 (16.31%)	230	120/703 (17.07%)	120
General disorders
Solicited Injection site Erythema Post-dose 3 ^† 1	587/1410 (41.63%)	587	340/703 (48.36%)	340
Injection Site Haemorrhage ^* 1	39/1411 (2.76%)	39	63/703 (8.96%)	63
Injection Site Nodule ^* 1	81/1411 (5.74%)	81	79/703 (11.24%)	79
Solicited Injection Site Pain Post-dose 1 ^† 1	831/1410 (58.94%)	831	574/703 (81.65%)	574
Solicited Injection Site Swelling Post-dose 3 ^† 1	400/1408 (28.41%)	400	323/703 (45.95%)	323
Solicited Irritability post-dose 1 ^† 1	945/1410 (67.02%)	945	576/703 (81.93%)	576
Solicited Pyrexia Post-dose 2 ^† 1	675/1411 (47.84%)	675	457/703 (65.01%)	457
Infections and infestations
Gastroenteritis ^* 1	101/1411 (7.16%)	101	40/703 (5.69%)	40
Nasopharyngitis ^* 1	742/1411 (52.59%)	742	353/703 (50.21%)	353
Pharyngitis ^* 1	395/1411 (27.99%)	395	161/703 (22.90%)	161
Rhinitis ^* 1	136/1411 (9.64%)	136	56/703 (7.97%)	56
Metabolism and nutrition disorders
Solicited Anorexia Post-dose 1 ^† 1	388/1410 (27.52%)	388	278/703 (39.54%)	278
Nervous system disorders
Solicited Somnolence Post-dose 1 ^† 1	635/1410 (45.04%)	635	375/703 (53.34%)	375
Psychiatric disorders
Solicited Crying Post-dose 1 ^† 1	800/1411 (56.70%)	800	564/703 (80.23%)	564
Respiratory, thoracic and mediastinal disorders
Bronchospasm ^* 1	163/1411 (11.55%)	163	74/703 (10.53%)	74
Rhinitis Allergic ^* 1	75/1411 (5.32%)	75	36/703 (5.12%)	36
Skin and subcutaneous tissue disorders
Dermatitis Diaper ^* 1	160/1411 (11.34%)	160	54/703 (7.68%)	54
† Indicates events were collected by systematic assessment * Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 9.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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

Layout table for Results Point of Contact information

Name/Title:	Medical Director
Organization:	Sanofi Pasteur Inc.
EMail:	RegistryContactUs@sanofipasteur.com

Publications of Results:

Macías M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126-32. doi: 10.1097/INF.0b013e318258400d.

Layout table for additonal information

Responsible Party:	Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:	NCT00313911
Other Study ID Numbers:	A3L04
First Submitted:	April 11, 2006
First Posted:	April 12, 2006
Results First Submitted:	September 18, 2012
Results First Posted:	November 19, 2012
Last Update Posted:	April 21, 2014

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