Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00345579
• Collaborator: (none)
• Enrollment: 4,432
• Locations: 63
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 70.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age.

This protocol posting deals with objectives & outcome measures of the primary phase of the study. The objectives & outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Condition or Disease	Intervention/Treatment	Phase
Haemophilus Influenzae Type b; Neisseria Meningitidis	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014; Biological: ActHIB; Biological: Pediarix/Infanrix Penta	Phase 3

Detailed Description

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4432 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Menhibrix Group Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of Menhibrix vaccine at 12-15 months of age in the study NCT00345683. Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014; 3-dose intramuscular injection; Biological: Pediarix/Infanrix Penta; 3-dose intramuscular injection
Active Comparator: ActHIB Group Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Biological: ActHIB; 3-dose intramuscular injection; Biological: Pediarix/Infanrix Penta; 3-dose intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting Serious Adverse Events (SAEs) [From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)]

   SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

2. Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) [From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)]

   NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

3. Number of Subjects Reporting Rash [From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)]

   Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

4. Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) [From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)]

5. Number of Subjects With Serious Adverse Events (SAEs) [From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)]

   SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

6. Number of Subjects With New Onset of Chronic Illnesses (NOCIs) [From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)]

   NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

7. Number of Subjects With Rash [From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)]

   Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae

8. Number of Subjects With Adverse Events Resulting in Emergency Room (ER) [From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Weeks to 12 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.

• A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.

• Written informed consent obtained from the parent or guardian of the subject.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Born after 36 weeks gestation.

• Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.

• Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).

• Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.

• In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.

• History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.

• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures.

• Acute disease at time of enrollment.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35235
2	GSK Investigational Site	Birmingham	Alabama	United States	35244
3	GSK Investigational Site	Benton	Arkansas	United States	72015
4	GSK Investigational Site	Fayetteville	Arkansas	United States	72703
5	GSK Investigational Site	Hot Springs	Arkansas	United States	71913
6	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
7	GSK Investigational Site	Little Rock	Arkansas	United States	72201
8	GSK Investigational Site	Little Rock	Arkansas	United States	72205
9	GSK Investigational Site	Fountain Valley	California	United States	92708
10	GSK Investigational Site	Fresno	California	United States	93710
11	GSK Investigational Site	Fresno	California	United States	93726
12	GSK Investigational Site	Madera	California	United States	93637
13	GSK Investigational Site	Slinas	California	United States	93901
14	GSK Investigational Site	West Covina	California	United States	91790
15	GSK Investigational Site	Boulder	Colorado	United States	80303
16	GSK Investigational Site	Longmont	Colorado	United States	80501
17	GSK Investigational Site	Plantation	Florida	United States	33324
18	GSK Investigational Site	Nampa	Idaho	United States	208 463 3126
19	GSK Investigational Site	Oaklawn	Illinois	United States	60453
20	GSK Investigational Site	Waukee	Iowa	United States	50263
21	GSK Investigational Site	West Desmoines	Iowa	United States	50266
22	GSK Investigational Site	Bardstown	Kentucky	United States	40004
23	GSK Investigational Site	Lexington	Kentucky	United States	40503
24	GSK Investigational Site	Bossier City	Louisiana	United States	71111
25	GSK Investigational Site	Boston	Massachusetts	United States	02111
26	GSK Investigational Site	Jamaica Plain	Massachusetts	United States	02130
27	GSK Investigational Site	Nies	Michigan	United States	49120
28	GSK Investigational Site	Portage	Michigan	United States	49024
29	GSK Investigational Site	Stevensville	Michigan	United States	49127
30	GSK Investigational Site	St. Paul	Minnesota	United States	55108
31	GSK Investigational Site	Las Vegas	Nevada	United States	89104
32	GSK Investigational Site	New Hartford	New York	United States	13413
33	GSK Investigational Site	Syracuse	New York	United States	13210
34	GSK Investigational Site	Clyde	North Carolina	United States	28721
35	GSK Investigational Site	Deerfield	North Carolina	United States	28607
36	GSK Investigational Site	Raleigh	North Carolina	United States	27609
37	GSK Investigational Site	Sylva	North Carolina	United States	28779
38	GSK Investigational Site	Akron	Ohio	United States	44308-1062
39	GSK Investigational Site	Canton	Ohio	United States	44718
40	GSK Investigational Site	Cleveland	Ohio	United States	44121
41	GSK Investigational Site	North Canton	Ohio	United States	44720
42	GSK Investigational Site	South Euclid	Ohio	United States	44121
43	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15202
44	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15227
45	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15236
46	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15241
47	GSK Investigational Site	Wexford	Pennsylvania	United States	15090
48	GSK Investigational Site	Charleston	South Carolina	United States	29406
49	GSK Investigational Site	Kingsport	Tennessee	United States	37660
50	GSK Investigational Site	Kingsport	Tennessee	United States	37664
51	GSK Investigational Site	Houston	Texas	United States	77084
52	GSK Investigational Site	Katy	Texas	United States	77450
53	GSK Investigational Site	Layton	Utah	United States	84041
54	GSK Investigational Site	Ogden	Utah	United States	84405
55	GSK Investigational Site	Orem	Utah	United States	84057
56	GSK Investigational Site	Pleasant Gorve	Utah	United States	84062
57	GSK Investigational Site	Salt Lake City	Utah	United States	84109
58	GSK Investigational Site	South Jordan	Utah	United States	84095
59	GSK Investigational Site	West Jordan	Utah	United States	84088
60	GSK Investigational Site	Madison	Wisconsin	United States	53792
61	GSK Investigational Site	Marshfield	Wisconsin	United States	54449
62	GSK Investigational Site	Mexico city		Mexico	04530
63	GSK Investigational Site	Mexico, D.F.		Mexico	06720

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

• Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90. Review.
• Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00345579
• Other Study ID Numbers: 105987
• First Posted: Jun 28, 2006
• Last Update Posted: Dec 16, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Prophylaxis; Neisseria meningitidis Vaccines, conjugate; Infants; Meningococcal vaccines; H. influenzae type B vaccine; Humans; Safety
• Additional relevant MeSH terms: Influenza, Human; PENTA

Study Results

Participant Flow

Recruitment Details	This summary presents results for the primary vaccination phase up to the end of the extended safety follow-up (until, but excluding, the booster dose at 12-15 months of age). For results about the booster/fourth dose phase, see study NCT00345683.
Pre-assignment Detail	Of the 4432 subjects enrolled, 4391 were vaccinated and 4162 completed the primary vaccination phase of the study (3114 in the MenHibrix Group and 1048 in the ActHIB Group).

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Period Title: Overall Study
STARTED	3278	1113
COMPLETED	3114	1048
NOT COMPLETED	164	65

Baseline Characteristics

Arm/Group Title	MenHibrix Group	ActHIB Group	Total
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Total of all reporting groups
Overall Participants	3278	1113	4391
Age (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	58.6 (10.45)	59.0 (10.39)	58.8 (10.42)
Gender (Count of Participants)
Female	1576 48.1%	557 50%	2133 48.6%
Male	1702 51.9%	556 50%	2258 51.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	109	33

2. Primary Outcome

Title	Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Description	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	50	18

3. Primary Outcome

Title	Number of Subjects Reporting Rash
Description	Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time Frame	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	243	81

4. Primary Outcome

Title	Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
Time Frame	From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	114	44

5. Primary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	157	48

6. Primary Outcome

Title	Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Description	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	66	25

7. Primary Outcome

Title	Number of Subjects With Rash
Description	Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time Frame	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	386	134

8. Primary Outcome

Title	Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
Time Frame	From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)

Outcome Measure Data

Analysis Population Description

The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.

Arm/Group Title	MenHibrix Group	ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.	Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Measure Participants	3278	1113
Number [Subjects]	198	69

Adverse Events

Time Frame	Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Adverse Event Reporting Description	Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
Arm/Group Title	MenHibrix Group		ActHIB Group
Arm/Group Description	Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.		Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
All Cause Mortality
	MenHibrix Group		ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	MenHibrix Group		ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	157/3278 (4.8%)		48/1113 (4.3%)
Blood and lymphatic system disorders
Anaemia	1/3278 (0%)		0/1113 (0%)
Cardiac disorders
Cardiac failure congestive	0/3278 (0%)		1/1113 (0.1%)
Gastrointestinal disorders
Ileus	1/3278 (0%)		0/1113 (0%)
Inguinal hernia, obstructive	1/3278 (0%)		0/1113 (0%)
Intussusception	0/3278 (0%)		1/1113 (0.1%)
Vomiting	0/3278 (0%)		1/1113 (0.1%)
Gastrooesophageal reflux disease	0/3278 (0%)		1/1113 (0.1%)
Abdominal distension	1/3278 (0%)		0/1113 (0%)
Constipation	0/3278 (0%)		1/1113 (0.1%)
General disorders
Oedema peripheral	1/3278 (0%)		0/1113 (0%)
Pyrexia	1/3278 (0%)		2/1113 (0.2%)
Sudden infant death syndrome	3/3278 (0.1%)		2/1113 (0.2%)
Immune system disorders
Anaphylactic reaction	0/3278 (0%)		1/1113 (0.1%)
Infections and infestations
Perirectal abscess	0/3278 (0%)		1/1113 (0.1%)
Septic shock	0/3278 (0%)		1/1113 (0.1%)
Varicella	1/3278 (0%)		0/1113 (0%)
Gastroenteritis	32/3278 (1%)		11/1113 (1%)
Bronchiolitis	39/3278 (1.2%)		6/1113 (0.5%)
Bronchopneumonia	17/3278 (0.5%)		9/1113 (0.8%)
Pneumonia	9/3278 (0.3%)		2/1113 (0.2%)
Respiratory syncytial virus bronchiolitis	10/3278 (0.3%)		1/1113 (0.1%)
Viral infection	0/3278 (0%)		2/1113 (0.2%)
Gastroenteritis rotavirus	2/3278 (0.1%)		1/1113 (0.1%)
Otitis media	1/3278 (0%)		0/1113 (0%)
Urinary tract infection	4/3278 (0.1%)		0/1113 (0%)
Respiratory syncytial virus infection	1/3278 (0%)		0/1113 (0%)
Croup infectious	2/3278 (0.1%)		0/1113 (0%)
Upper respiratory tract infection	1/3278 (0%)		1/1113 (0.1%)
Pyelonephritis	3/3278 (0.1%)		0/1113 (0%)
Cellulitis	1/3278 (0%)		0/1113 (0%)
Pharyngitis	2/3278 (0.1%)		2/1113 (0.2%)
Gastroenteritis viral	1/3278 (0%)		1/1113 (0.1%)
Tracheitis	1/3278 (0%)		2/1113 (0.2%)
Influenza	0/3278 (0%)		1/1113 (0.1%)
Lobar pneumonia	1/3278 (0%)		0/1113 (0%)
Nasopharyngitis	1/3278 (0%)		0/1113 (0%)
Subcutaneous abscess	2/3278 (0.1%)		0/1113 (0%)
Bronchitis	1/3278 (0%)		0/1113 (0%)
Pharyngitis streptococcal	1/3278 (0%)		0/1113 (0%)
Tonsillitis	0/3278 (0%)		1/1113 (0.1%)
Injury, poisoning and procedural complications
Fractured skull depressed	0/3278 (0%)		1/1113 (0.1%)
Humerus fracture	1/3278 (0%)		0/1113 (0%)
Skull fractured base	1/3278 (0%)		0/1113 (0%)
Subdural haematoma	2/3278 (0.1%)		0/1113 (0%)
Subdural haemorrhage	1/3278 (0%)		0/1113 (0%)
Head injury	9/3278 (0.3%)		2/1113 (0.2%)
Skull fracture	3/3278 (0.1%)		0/1113 (0%)
Anastomotic leak	0/3278 (0%)		1/1113 (0.1%)
Burns second degree	1/3278 (0%)		0/1113 (0%)
Eye injury	1/3278 (0%)		0/1113 (0%)
Skin injury	1/3278 (0%)		0/1113 (0%)
Metabolism and nutrition disorders
Dehydration	5/3278 (0.2%)		5/1113 (0.4%)
Failure to thrive	0/3278 (0%)		1/1113 (0.1%)
Malnutrition	0/3278 (0%)		1/1113 (0.1%)
Nervous system disorders
Febrile convulsion	5/3278 (0.2%)		1/1113 (0.1%)
Haemorrhage intracranial	1/3278 (0%)		0/1113 (0%)
Convulsion	1/3278 (0%)		0/1113 (0%)
Nystagmus	1/3278 (0%)		1/1113 (0.1%)
Depressed level of consciousness	0/3278 (0%)		1/1113 (0.1%)
Epilepsy	1/3278 (0%)		0/1113 (0%)
Psychiatric disorders
Breath holding	1/3278 (0%)		0/1113 (0%)
Renal and urinary disorders
Haematuria	1/3278 (0%)		0/1113 (0%)
Reproductive system and breast disorders
Ovarian cyst	1/3278 (0%)		0/1113 (0%)
Respiratory, thoracic and mediastinal disorders
Lung disorder	1/3278 (0%)		0/1113 (0%)
Bronchial hyperreactivity	3/3278 (0.1%)		1/1113 (0.1%)
Asthma	1/3278 (0%)		0/1113 (0%)
Hypoxia	1/3278 (0%)		0/1113 (0%)
Bronchospasm	2/3278 (0.1%)		1/1113 (0.1%)
Social circumstances
Child abuse	1/3278 (0%)		0/1113 (0%)
Vascular disorders
Haematoma	1/3278 (0%)		0/1113 (0%)
Haemorrhagic infarction	1/3278 (0%)		0/1113 (0%)
Hypovolaemic shock	2/3278 (0.1%)		0/1113 (0%)
Other (Not Including Serious) Adverse Events
	MenHibrix Group		ActHIB Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Solicited symptoms and unslocited AEs were not collected during this study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.

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Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.