Trial Outcomes & Findings for Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months (NCT NCT00197236)

NCT ID: NCT00197236

Last Updated: 2018-08-20

Results Overview

Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 468 participants
• Primary outcome timeframe: 31 days following the second dose of Havrix™
• Results posted on: 2018-08-20

Participant Flow

Of the total of 468 subjects enrolled, only 394 were vaccinated and as such considered as 'started'.

Participant milestones

Measure	Havrix Group Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Overall Study STARTED	135	127	132
Overall Study COMPLETED	121	110	109
Overall Study NOT COMPLETED	14	17	23

Reasons for withdrawal

Measure	Havrix Group Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Overall Study Adverse Event	1	0	1
Overall Study Lost to Follow-up	5	14	6
Overall Study Protocol Violation	0	0	1
Overall Study Withdrawal by Subject	7	3	11
Overall Study Study drug/medication expiration	1	0	3
Overall Study Returned out of specified time window	0	0	1

Baseline Characteristics

Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

Baseline characteristics by cohort

Measure	Havrix Group n=135 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=127 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=132 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.	Total n=394 Participants Total of all reporting groups
Age, Continuous	15.1 months STANDARD_DEVIATION 0.36 • n=5 Participants	15.1 months STANDARD_DEVIATION 0.3 • n=7 Participants	15.0 months STANDARD_DEVIATION 0.21 • n=5 Participants	15.1 months STANDARD_DEVIATION 0.30 • n=4 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	64 Participants n=7 Participants	67 Participants n=5 Participants	186 Participants n=4 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	63 Participants n=7 Participants	65 Participants n=5 Participants	208 Participants n=4 Participants

PRIMARY outcome

Timeframe: 31 days following the second dose of Havrix™

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Havrix Group n=88 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=84 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=77 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix	88 Participants	84 Participants	77 Participants

PRIMARY outcome

Timeframe: 31 days following the administration of Infanrix™ and ActHIB

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively.

Outcome measures

Measure	Havrix Group n=90 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=80 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects Anti-tetanus	88 Participants	80 Participants	—
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects Anti-PRP	90 Participants	77 Participants	—
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects Anti-diphtheria	89 Participants	80 Participants	—

PRIMARY outcome

Timeframe: 31 days following the administration of Infanrix™ and ActHIB

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations.

Outcome measures

Measure	Havrix Group n=88 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=76 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) Anti-PT	87 Participants	71 Participants	—
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) Anti-FHA	85 Participants	75 Participants	—
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) Anti-PRN	86 Participants	74 Participants	—

SECONDARY outcome

Timeframe: 31 days following the administration of Infanrix™ and ActHIB

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

GMCs are expressed as International Units per milliliter (IU/mL).

Outcome measures

Measure	Havrix Group n=89 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=80 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) Anti-tetanus	7.0 IU/mL Interval 5.9 to 8.2	7.3 IU/mL Interval 6.0 to 8.8	—
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) Anti-diphtheria	11.3 IU/mL Interval 9.8 to 13.1	10.3 IU/mL Interval 8.7 to 12.3	—

SECONDARY outcome

Timeframe: 31 days following the administration of Infanrix™ and ActHIB

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

GMCs are expressed as microgram/milliliter (µg/mL).

Outcome measures

Measure	Havrix Group n=90 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=79 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)	60.8 µg/mL Interval 45.9 to 80.4	41.0 µg/mL Interval 30.0 to 55.9	—

SECONDARY outcome

Timeframe: 31 days following the administration of Infanrix™ and ActHIB

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines.

Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies.

Outcome measures

Measure	Havrix Group n=90 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=80 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) Anti-PT	89 Participants	80 Participants	—
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) Anti-FHA	89 Participants	80 Participants	—
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) Anti-PRN	89 Participants	80 Participants	—
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) Anti-PRP	90 Participants	79 Participants	—

SECONDARY outcome

Timeframe: 31 days following the first dose of Havrix™

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.

Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Havrix Group n=94 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=89 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix	82 Participants	77 Participants	—

SECONDARY outcome

Timeframe: 31 days following the first dose of Havrix™

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group.

Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Havrix Group n=94 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=89 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix	51.5 mIU/mL Interval 41.7 to 63.7	51.5 mIU/mL Interval 41.8 to 63.5	—

SECONDARY outcome

Timeframe: 31 days following the second dose of Havrix™

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity.

Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL).

Outcome measures

Measure	Havrix Group n=88 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=84 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=77 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix	1700.4 mIU/mL Interval 1306.0 to 2213.7	1904.4 mIU/mL Interval 1552.7 to 2335.7	1625.1 mIU/mL Interval 1378.2 to 1916.3

SECONDARY outcome

Timeframe: 31 days following the second dose

Population: Analysis was performed on the According-to-Protocol cohort for immunogenicity

Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects.

Outcome measures

Measure	Havrix Group n=86 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=83 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=74 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects With Vaccine Response to Havrix™.	86 Participants	83 Participants	74 Participants

SECONDARY outcome

Timeframe: 4-day period following each dose of study vaccine(s)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table.

Outcome measures

Measure	Havrix Group n=130 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=118 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=122 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects Reporting Solicited Local Adverse Events (AEs) Redness	34 Participants	54 Participants	63 Participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) Swelling	21 Participants	38 Participants	46 Participants
Number of Subjects Reporting Solicited Local Adverse Events (AEs) Pain	44 Participants	60 Participants	70 Participants

SECONDARY outcome

Timeframe: 4-day period following each dose of study vaccine(s)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.

Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table.

Outcome measures

Measure	Havrix Group n=130 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=118 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=123 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects Reporting Solicited General Adverse Events (AEs) Drowsiness	44 Participants	50 Participants	53 Participants
Number of Subjects Reporting Solicited General Adverse Events (AEs) Fever	16 Participants	26 Participants	31 Participants
Number of Subjects Reporting Solicited General Adverse Events (AEs) Irritability	56 Participants	62 Participants	70 Participants
Number of Subjects Reporting Solicited General Adverse Events (AEs) Loss of appetite	33 Participants	40 Participants	48 Participants

SECONDARY outcome

Timeframe: 31-day period following each dose of study vaccine(s)

Population: The analysis was performed on the Total Vaccinated Cohort

An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Measure	Havrix Group n=135 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=127 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=132 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	75 Participants	69 Participants	71 Participants

SECONDARY outcome

Timeframe: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase.

Population: The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase.

Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness.

Outcome measures

Measure	Havrix Group n=135 Participants Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=127 Participants Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=132 Participants Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events SAEs	5 Participants	2 Participants	4 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events AEs during Active Phase	80 Participants	74 Participants	72 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events AEs during ESFU	11 Participants	10 Participants	7 Participants

Adverse Events

Havrix Group

Serious events: 5 serious events

Other events: 95 other events

Deaths: 0 deaths

Havrix + Infanrix + ActHIB Group

Serious events: 2 serious events

Other events: 105 other events

Deaths: 0 deaths

Infanrix + ActHIB→Havrix Group

Serious events: 4 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Measure	Havrix Group n=135 participants at risk Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=127 participants at risk Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=132 participants at risk Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Metabolism and nutrition disorders Dehydration	1.5% 2/135	0.00% 0/127	0.76% 1/132
Infections and infestations Gastroenteritis	0.74% 1/135	0.79% 1/127	0.00% 0/132
General disorders Developmental delay	0.74% 1/135	0.00% 0/127	0.76% 1/132
Psychiatric disorders Expressive language disorder	0.74% 1/135	0.00% 0/127	0.76% 1/132
Infections and infestations Arthritis bacterial	0.74% 1/135	0.00% 0/127	0.00% 0/132
Respiratory, thoracic and mediastinal disorders Asthma	0.74% 1/135	0.00% 0/127	0.00% 0/132
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/135	0.00% 0/127	0.76% 1/132
Metabolism and nutrition disorders Failure to thrive	0.74% 1/135	0.00% 0/127	0.00% 0/132
General disorders Pyrexia	0.00% 0/135	0.79% 1/127	0.00% 0/132
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/135	0.00% 0/127	0.76% 1/132
Cardiac disorders Tachycardia	0.00% 0/135	0.79% 1/127	0.00% 0/132
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/135	0.00% 0/127	0.76% 1/132

Other adverse events

Measure	Havrix Group n=135 participants at risk Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.	Havrix + Infanrix + ActHIB Group n=127 participants at risk Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.	Infanrix + ActHIB→Havrix Group n=132 participants at risk Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Gastrointestinal disorders Vomiting	5.2% 7/135	3.1% 4/127	3.0% 4/132
General disorders Pyrexia	6.7% 9/135	5.5% 7/127	6.8% 9/132
Infections and infestations Otitis media	9.6% 13/135	8.7% 11/127	16.7% 22/132
Infections and infestations Upper respiratory tract infection	13.3% 18/135	14.2% 18/127	12.1% 16/132
Infections and infestations Viral infection	2.2% 3/135	5.5% 7/127	2.3% 3/132
Respiratory, thoracic and mediastinal disorders Cough	5.9% 8/135	3.1% 4/127	10.6% 14/132
Respiratory, thoracic and mediastinal disorders Rhinorrhea	3.7% 5/135	3.1% 4/127	10.6% 14/132
General disorders Pain at the injection site	32.6% 44/135	47.2% 60/127	53.0% 70/132
General disorders Redness at the injection site	25.2% 34/135	42.5% 54/127	47.7% 63/132
General disorders Swelling at the injection site	15.6% 21/135	29.9% 38/127	34.8% 46/132
General disorders Drowsiness	32.6% 44/135	39.4% 50/127	40.2% 53/132
General disorders Fever	11.9% 16/135	20.5% 26/127	23.5% 31/132
General disorders Irritability	41.5% 56/135	48.8% 62/127	53.0% 70/132
Gastrointestinal disorders Diarrhea	6.7% 9/135	3.1% 4/127	5.3% 7/132
Gastrointestinal disorders Teething	2.2% 3/135	6.3% 8/127	3.0% 4/132
General disorders Loss of appetite	24.4% 33/135	31.5% 40/127	36.4% 48/132

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER