Trial Outcomes & Findings for Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children (NCT NCT00611559)

NCT ID: NCT00611559

Last Updated: 2018-06-06

Results Overview

Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 283 participants
• Primary outcome timeframe: One month after the booster dose
• Results posted on: 2018-06-06

Participant Flow

Participant milestones

Measure	Infanrix Hexa Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Overall Study STARTED	111	115	57
Overall Study COMPLETED	110	114	56
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	Infanrix Hexa Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Overall Study Lost to Follow-up	0	1	0
Overall Study Protocol Violation	1	0	1

Baseline Characteristics

Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

Baseline characteristics by cohort

Measure	Infanrix Hexa Preservative-free Formulation Group n=111 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=115 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=57 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta	Total n=283 Participants Total of all reporting groups
Age, Continuous	21.2 months STANDARD_DEVIATION 1.61 • n=5 Participants	21.3 months STANDARD_DEVIATION 1.57 • n=7 Participants	21.2 months STANDARD_DEVIATION 1.62 • n=5 Participants	21.2 months STANDARD_DEVIATION 1.59 • n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	46 Participants n=7 Participants	35 Participants n=5 Participants	137 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	69 Participants n=7 Participants	22 Participants n=5 Participants	146 Participants n=4 Participants
Race/Ethnicity, Customized White - Caucasian/European Heritage	111 Participants n=5 Participants	115 Participants n=7 Participants	57 Participants n=5 Participants	283 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after the booster dose

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results

Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=91 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=92 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=48 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose	88 subjects	92 subjects	48 subjects

PRIMARY outcome

Timeframe: One month after the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=76 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=79 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose	74 subjects	78 subjects	27 subjects

PRIMARY outcome

Timeframe: One month after the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=77 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=79 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose Anti-diphtheria	76 subjects	76 subjects	40 subjects
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose Anti-tetanus	76 subjects	78 subjects	42 subjects

PRIMARY outcome

Timeframe: One month after the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=55 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=52 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=31 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose Anti-poliovirus type 1	55 subjects	51 subjects	31 subjects
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose Anti-poliovirus type 2	55 subjects	51 subjects	30 subjects
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose Anti-poliovirus type 3	55 subjects	52 subjects	29 subjects

PRIMARY outcome

Timeframe: One month after the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=89 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=77 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=41 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose Anti-PT	65.5 EL.U/mL Interval 49.8 to 86.3	84.2 EL.U/mL Interval 61.5 to 115.4	43.9 EL.U/mL Interval 22.4 to 85.8
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose Anti-FHA	476.6 EL.U/mL Interval 369.7 to 614.4	428.3 EL.U/mL Interval 311.2 to 589.5	221.1 EL.U/mL Interval 120.3 to 406.6
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose Anti-PRN	418.1 EL.U/mL Interval 303.2 to 576.6	384.1 EL.U/mL Interval 271.3 to 544.0	251.6 EL.U/mL Interval 143.9 to 439.7

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL

Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=93 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=93 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=48 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 10 mIU/mL Pre	87 subjects	86 subjects	44 subjects
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 100 mIU/mL Pre	57 subjects	57 subjects	35 subjects
Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 100 mIU/mL Post	85 subjects	87 subjects	39 subjects

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-HB antibodies given as GMC in mIU/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=93 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=93 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=48 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-HB Antibodies Concentration Pre	163.5 mIU/mL Interval 114.3 to 233.7	161.2 mIU/mL Interval 111.5 to 232.9	196.9 mIU/mL Interval 124.2 to 312.2
Anti-HB Antibodies Concentration Post	4668.0 mIU/mL Interval 2861.4 to 7615.3	4962.3 mIU/mL Interval 3289.7 to 7485.4	3867.8 mIU/mL Interval 1751.4 to 8541.5

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL

Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=76 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=79 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 0.15 µg/mL Pre	55 subjects	55 subjects	23 subjects
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 1.0 µg/mL Pre	12 subjects	14 subjects	7 subjects
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose ≥ 1.0 µg/mL Post	69 subjects	74 subjects	9 subjects

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-PRP antibodies given as GMC in µg/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=76 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=79 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-PRP Antibodies Concentration Pre	0.3 µg/mL Interval 0.2 to 0.4	0.4 µg/mL Interval 0.3 to 0.5	0.2 µg/mL Interval 0.1 to 0.4
Anti-PRP Antibodies Concentration Post	25.3 µg/mL Interval 16.0 to 40.0	34.7 µg/mL Interval 22.9 to 52.7	0.4 µg/mL Interval 0.2 to 0.7

SECONDARY outcome

Timeframe: Before the booster dose administration (at baseline)

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=75 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=72 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose Anti-diphtheria	45 subjects	47 subjects	23 subjects
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose Anti-tetanus	69 subjects	62 subjects	39 subjects

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=77 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=79 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=42 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-diphtheria and Anti-tetanus Antibodies Concentration Anti-tetanus Post	4.9 IU/mL Interval 3.6 to 6.7	6.9 IU/mL Interval 5.3 to 9.0	4.5 IU/mL Interval 2.8 to 7.4
Anti-diphtheria and Anti-tetanus Antibodies Concentration Anti-diphtheria Pre	0.2 IU/mL Interval 0.1 to 0.2	0.2 IU/mL Interval 0.1 to 0.3	0.1 IU/mL Interval 0.1 to 0.2
Anti-diphtheria and Anti-tetanus Antibodies Concentration Anti-diphtheria Post	2.7 IU/mL Interval 1.9 to 3.7	3.4 IU/mL Interval 2.5 to 4.5	2.2 IU/mL Interval 1.4 to 3.5
Anti-diphtheria and Anti-tetanus Antibodies Concentration Anti-tetanus Pre	0.5 IU/mL Interval 0.3 to 0.6	0.5 IU/mL Interval 0.3 to 0.7	0.3 IU/mL Interval 0.2 to 0.4

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=89 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=84 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=43 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-PT Pre	45 subjects	43 subjects	26 subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-PT Post	79 subjects	66 subjects	25 subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-FHA Pre	77 subjects	68 subjects	39 subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-FHA Post	86 subjects	69 subjects	37 subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-PRN Pre	75 subjects	67 subjects	35 subjects
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose Anti-PRN Post	88 subjects	77 subjects	40 subjects

SECONDARY outcome

Timeframe: Before the booster dose administration (at baseline)

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=85 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=84 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=43 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose Anti-PT	6.6 EL.U/mL Interval 5.2 to 8.4	6.2 EL.U/mL Interval 5.0 to 7.8	7.1 EL.U/mL Interval 5.3 to 9.4
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose Anti-FHA	24.5 EL.U/mL Interval 18.4 to 32.6	22.1 EL.U/mL Interval 16.3 to 30.0	23.8 EL.U/mL Interval 17.3 to 32.6
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose Anti-PRN	17.5 EL.U/mL Interval 13.4 to 23.0	13.7 EL.U/mL Interval 10.3 to 18.1	15.0 EL.U/mL Interval 10.3 to 21.9

SECONDARY outcome

Timeframe: Before the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=49 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=51 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=27 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose Anti-poliovirus type 1	46 subjects	47 subjects	24 subjects
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose Anti-poliovirus type 2	46 subjects	48 subjects	26 subjects
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose Anti-poliovirus type 3	47 subjects	48 subjects	23 subjects

SECONDARY outcome

Timeframe: Before (Pre) and one month after (Post) the booster dose

Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=55 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=51 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=31 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Anti-poliovirus Antibodies Titer Anti-poliovirus type 2 Pre	144.4 titer Interval 96.9 to 215.2	102.5 titer Interval 68.2 to 154.2	95.3 titer Interval 56.3 to 161.1
Anti-poliovirus Antibodies Titer Anti-poliovirus type 2 Post	1412.0 titer Interval 1096.4 to 1818.5	1900.6 titer Interval 1399.7 to 2580.7	916.3 titer Interval 498.1 to 1685.5
Anti-poliovirus Antibodies Titer Anti-poliovirus type 3 Pre	98.7 titer Interval 68.0 to 143.2	68.9 titer Interval 47.0 to 101.1	77.5 titer Interval 41.9 to 143.4
Anti-poliovirus Antibodies Titer Anti-poliovirus type 3 Post	1485.9 titer Interval 1041.4 to 2120.3	1828.7 titer Interval 1303.8 to 2565.1	605.6 titer Interval 264.0 to 1389.1
Anti-poliovirus Antibodies Titer Anti-poliovirus type 1 Pre	106.5 titer Interval 67.9 to 167.0	120.4 titer Interval 76.9 to 188.4	85.9 titer Interval 47.1 to 156.5
Anti-poliovirus Antibodies Titer Anti-poliovirus type 1 Post	1237.1 titer Interval 940.7 to 1626.9	1939.8 titer Interval 1465.1 to 2568.2	979.5 titer Interval 539.4 to 1778.8

SECONDARY outcome

Timeframe: Within the 4-day (Day 0-3) post-vaccination period

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=111 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=115 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=57 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects Reporting Solicited Symptoms Pain	35 subjects	36 subjects	14 subjects
Number of Subjects Reporting Solicited Symptoms Redness	54 subjects	54 subjects	22 subjects
Number of Subjects Reporting Solicited Symptoms Swelling	39 subjects	45 subjects	19 subjects
Number of Subjects Reporting Solicited Symptoms Drowsiness	21 subjects	18 subjects	8 subjects
Number of Subjects Reporting Solicited Symptoms Fever	18 subjects	15 subjects	6 subjects
Number of Subjects Reporting Solicited Symptoms Irritability	21 subjects	21 subjects	4 subjects
Number of Subjects Reporting Solicited Symptoms Loss of appetite	22 subjects	14 subjects	5 subjects

SECONDARY outcome

Timeframe: Within the 31-day (Day 0-30) post-vaccination period

An AE 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	Infanrix Hexa Preservative-free Formulation Group n=111 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=115 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=57 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects Reporting Unsolicited Adverse Events (AE)	8 subjects	9 subjects	2 subjects

SECONDARY outcome

Timeframe: Up to one month after the booster dose administration

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above

Outcome measures

Measure	Infanrix Hexa Preservative-free Formulation Group n=111 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=115 Participants Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=57 Participants Subjects received a booster dose of the preservative-free formulation of Infanrix penta
Number of Subjects Reporting Serious Adverse Events (SAE)	0 subjects	0 subjects	0 subjects

Adverse Events

Infanrix Hexa Preservative-free Formulation Group

Serious events: 0 serious events

Other events: 59 other events

Deaths: 0 deaths

Infanrix Hexa Preservative-containing Formulation Group

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Infanrix Penta Preservative-free Formulation Group

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Infanrix Hexa Preservative-free Formulation Group n=111 participants at risk Subjects received a booster dose of the preservative-free formulation of Infanrix hexa	Infanrix Hexa Preservative-containing Formulation Group n=115 participants at risk Subjects received a booster dose of the preservative-containing formulation of Infanrix hexa	Infanrix Penta Preservative-free Formulation Group n=57 participants at risk Subjects received a booster dose of the preservative-free formulation of Infanrix penta
General disorders Pain	31.5% 35/111	31.3% 36/115	24.6% 14/57
General disorders Redness	48.6% 54/111	47.0% 54/115	38.6% 22/57
General disorders Swelling	35.1% 39/111	39.1% 45/115	33.3% 19/57
General disorders Drowsiness	18.9% 21/111	15.7% 18/115	14.0% 8/57
General disorders Fever	16.2% 18/111	13.0% 15/115	10.5% 6/57
General disorders Irritability	18.9% 21/111	18.3% 21/115	7.0% 4/57
General disorders Loss of appetite	19.8% 22/111	12.2% 14/115	8.8% 5/57

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