Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery (NCT NCT02853929)

Last Updated: 2020-01-14

Results Overview

Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

551 participants

Primary outcome timeframe

At one month after the booster dose (Day 30)

Results posted on

2020-01-14

Participant Flow

Subjects enrolled in the study were infants aged 9 months at the time of enrollment, born to mothers vaccinated with Boostrix in study 116945 BOOSTRIX-047 \[NCT02377349\] and who received primary vaccination Infanrix hexa co-administered with Prevenar 13 in study 201330 BOOSTRIX-048 \[NCT0242264\]

551 subjects were enrolled in this trial, out of which 540 received the booster dose of Infanrix hexa co-administered with Prevenar 13. 11 subjects did not receive booster vaccination even though subject number had been allocated.

Participant milestones

Participant milestones
Measure	dTpa Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Overall Study STARTED	270	281
Overall Study Vaccinated	263	277
Overall Study COMPLETED	259	277
Overall Study NOT COMPLETED	11	4

Reasons for withdrawal

Reasons for withdrawal
Measure	dTpa Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	1	0
Overall Study Subjects enrolled but not vaccinated	7	4

Baseline Characteristics

Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	dTpa Group n=270 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=281 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Total n=551 Participants Total of all reporting groups
Age, Customized Infants and toddlers (28 days-23 months)	270 Participants n=5 Participants	281 Participants n=7 Participants	551 Participants n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	128 Participants n=7 Participants	255 Participants n=5 Participants
Sex: Female, Male Male	143 Participants n=5 Participants	153 Participants n=7 Participants	296 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage / African American	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	246 Participants n=5 Participants	262 Participants n=7 Participants	508 Participants n=5 Participants
Race/Ethnicity, Customized Other	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: At one month after the booster dose (Day 30)

Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination

Outcome measures

Outcome measures
Measure	dTpa Group n=221 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=247 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-D	221 Participants	247 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-T	221 Participants	247 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-HBs	215 Participants	239 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-polio 1	204 Participants	228 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-polio 2	201 Participants	227 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-polio 3	188 Participants	210 Participants
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Anti-PRP	221 Participants	246 Participants

PRIMARY outcome

Timeframe: At one month after the booster dose (Day 30)

Booster response to PT, FHA and PRN antigens was defined as: * for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off, * for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and * for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN

Outcome measures

Outcome measures
Measure	dTpa Group n=215 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=241 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PT, S-	62 Participants	40 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PT, S+ (< 4*assay cut-off)	98 Participants	124 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PT, S+ (≥ 4*assay cut-off)	38 Participants	71 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PT, Overall	198 Participants	235 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-FHA, S-	8 Participants	3 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-FHA, S+ (< 4*assay cut-off)	83 Participants	58 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-FHA, S+ (≥ 4*assay cut-off)	117 Participants	172 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-FHA, Overall	208 Participants	233 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PRN, S-	34 Participants	31 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PRN, S+ (< 4*assay cut-off)	90 Participants	76 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PRN, S+ (≥ 4*assay cut-off)	86 Participants	133 Participants
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) Anti-PRN, Overall	210 Participants	240 Participants

SECONDARY outcome

Timeframe: Before the booster dose (Day 0)

Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection.

Outcome measures

Outcome measures
Measure	dTpa Group n=223 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=244 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-D	181 Participants	220 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-T	215 Participants	232 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-HBs	206 Participants	229 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-polio 1	188 Participants	212 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-polio 2	188 Participants	215 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-polio 3	188 Participants	215 Participants
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. Anti-PRP	161 Participants	166 Participants

SECONDARY outcome

Timeframe: Before the booster dose (Day 0)

Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN

Outcome measures

Outcome measures
Measure	dTpa Group n=223 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=244 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT	153 Participants	201 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	215 Participants	241 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	187 Participants	213 Participants

SECONDARY outcome

Timeframe: Before the booster dose (Day 0)

Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively.

Outcome measures

Outcome measures
Measure	dTpa Group n=211 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=232 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 1	196 Participants	214 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 3	122 Participants	147 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 4	189 Participants	215 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 5	163 Participants	182 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 6A	196 Participants	219 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 6B	175 Participants	205 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 7F	210 Participants	232 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 9V	203 Participants	225 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 14	201 Participants	223 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 18C	168 Participants	190 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 19A	148 Participants	172 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 19F	183 Participants	202 Participants
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) Anti-pneumococcal serotype 23F	160 Participants	191 Participants

SECONDARY outcome

Timeframe: Before the booster dose (Day 0) and One month after the booster dose (Day 30)

Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL.

Outcome measures

Outcome measures
Measure	dTpa Group n=223 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=247 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-D at Day 0	0.207 IU/ml Interval 0.184 to 0.234	0.322 IU/ml Interval 0.285 to 0.363
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-D at Day 30	6.114 IU/ml Interval 5.577 to 6.703	8.402 IU/ml Interval 7.694 to 9.174
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-T at Day 0	0.753 IU/ml Interval 0.646 to 0.878	0.578 IU/ml Interval 0.506 to 0.659
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-T at Day 30	8.200 IU/ml Interval 7.324 to 9.18	6.758 IU/ml Interval 6.143 to 7.433
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-PT at Day 0	4.4 IU/ml Interval 3.8 to 5.0	6.3 IU/ml Interval 5.5 to 7.1
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-PT at Day 30	52.4 IU/ml Interval 46.9 to 58.4	80.3 IU/ml Interval 73.3 to 88.1
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-FHA at Day 0	11.2 IU/ml Interval 9.6 to 13.1	16.5 IU/ml Interval 14.4 to 18.8
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-FHA at Day 30	152.5 IU/ml Interval 136.3 to 170.6	187.2 IU/ml Interval 172.7 to 202.9
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-PRN at Day 0	6.9 IU/ml Interval 5.8 to 8.2	9.6 IU/ml Interval 8.3 to 11.2
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations Anti-PRN at Day 30	333.9 IU/ml Interval 285.4 to 390.7	262.3 IU/ml Interval 230.9 to 298.1

SECONDARY outcome

Timeframe: Before the booster dose (Day 0) and One month after the booster dose (Day 30)

Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT).

Outcome measures

Outcome measures
Measure	dTpa Group n=213 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=237 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 1 at Day 0	64.9 Titers Interval 52.0 to 80.9	83.3 Titers Interval 67.7 to 102.5
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 1 at Day 30	1611.7 Titers Interval 1381.2 to 1880.6	1532.1 Titers Interval 1322.2 to 1775.3
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 2 at Day 0	71.7 Titers Interval 57.6 to 89.4	79.2 Titers Interval 64.4 to 97.5
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 2 at Day 30	2232.4 Titers Interval 1931.2 to 2580.5	2371.2 Titers Interval 2097.9 to 2680.1
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 3 at Day 0	106.0 Titers Interval 84.1 to 133.4	118.4 Titers Interval 97.0 to 144.5
Anti-poliovirus Type 1, 2, 3 Antibody Titres Anti-polio 3 at Day 30	2944.6 Titers Interval 2529.4 to 3427.9	2891.8 Titers Interval 2496.2 to 3350.2

SECONDARY outcome

Timeframe: Before the booster dose (Day 0) and One month after the booster dose (Day 30)

Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL.

Outcome measures

Outcome measures
Measure	dTpa Group n=219 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=243 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Anti-HBs Antibody Concentrations Anti-HBs at Day 0	158.7 mIU/mL Interval 129.9 to 194.0	193.4 mIU/mL Interval 158.4 to 236.1
Anti-HBs Antibody Concentrations Anti-HBs at Day 30	4858.3 mIU/mL Interval 3918.4 to 6023.7	5031.2 mIU/mL Interval 4072.7 to 6215.4

SECONDARY outcome

Timeframe: Before the booster dose (Day 0) and One month after the booster dose (Day 30)

Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL.

Outcome measures

Outcome measures
Measure	dTpa Group n=222 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=247 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 1 at Day 0	0.22 µg/mL Interval 0.19 to 0.24	0.27 µg/mL Interval 0.24 to 0.3
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 1 at Day 30	3.22 µg/mL Interval 2.88 to 3.6	3.64 µg/mL Interval 3.28 to 4.04
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 3 at Day 0	0.08 µg/mL Interval 0.07 to 0.09	0.10 µg/mL Interval 0.09 to 0.11
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 3 at Day 30	0.59 µg/mL Interval 0.53 to 0.65	0.62 µg/mL Interval 0.57 to 0.69
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 4 at Day 0	0.15 µg/mL Interval 0.13 to 0.16	0.19 µg/mL Interval 0.17 to 0.22
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 4 at Day 30	2.91 µg/mL Interval 2.54 to 3.33	3.28 µg/mL Interval 2.89 to 3.72
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 5 at Day 0	0.33 µg/mL Interval 0.29 to 0.37	0.34 µg/mL Interval 0.31 to 0.38
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 5 at Day 30	2.66 µg/mL Interval 2.39 to 2.97	2.81 µg/mL Interval 2.52 to 3.14
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 6A at Day 0	0.38 µg/mL Interval 0.33 to 0.43	0.44 µg/mL Interval 0.39 to 0.5
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 6A at Day 30	9.07 µg/mL Interval 8.05 to 10.22	9.49 µg/mL Interval 8.45 to 10.67
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 6B at Day 0	0.29 µg/mL Interval 0.25 to 0.33	0.33 µg/mL Interval 0.29 to 0.38
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 6B at Day 30	7.83 µg/mL Interval 6.82 to 8.98	8.00 µg/mL Interval 7.06 to 9.06
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 7F at Day 0	0.49 µg/mL Interval 0.44 to 0.54	0.56 µg/mL Interval 0.51 to 0.61
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 7F at Day 30	5.00 µg/mL Interval 4.55 to 5.5	4.96 µg/mL Interval 4.5 to 5.48
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 9V at Day 0	0.26 µg/mL Interval 0.23 to 0.29	0.32 µg/mL Interval 0.28 to 0.36
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 9V at Day 30	3.74 µg/mL Interval 3.35 to 4.16	3.91 µg/mL Interval 3.52 to 4.35
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 14 at Day 0	0.97 µg/mL Interval 0.85 to 1.11	1.19 µg/mL Interval 1.04 to 1.37
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 14 at Day 30	10.36 µg/mL Interval 9.22 to 11.64	11.62 µg/mL Interval 10.34 to 13.06
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 18C at Day 0	0.19 µg/mL Interval 0.17 to 0.21	0.23 µg/mL Interval 0.21 to 0.26
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 18C at Day 30	3.23 µg/mL Interval 2.86 to 3.65	3.57 µg/mL Interval 3.21 to 3.98
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 19A at Day 0	0.32 µg/mL Interval 0.27 to 0.37	0.37 µg/mL Interval 0.32 to 0.43
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 19A at Day 30	7.90 µg/mL Interval 7.06 to 8.83	8.68 µg/mL Interval 7.82 to 9.63
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 19F at Day 0	0.37 µg/mL Interval 0.32 to 0.43	0.47 µg/mL Interval 0.41 to 0.55
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 19F at Day 30	7.66 µg/mL Interval 6.84 to 8.57	8.63 µg/mL Interval 7.75 to 9.62
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 23F at Day 0	0.14 µg/mL Interval 0.12 to 0.16	0.19 µg/mL Interval 0.16 to 0.22
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PnPS 23F at Day 30	2.07 µg/mL Interval 1.83 to 2.34	2.38 µg/mL Interval 2.1 to 2.69
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PRP at Day 0	0.371 µg/mL Interval 0.303 to 0.453	0.292 µg/mL Interval 0.244 to 0.349
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations Anti-PRP at Day 30	26.186 µg/mL Interval 22.61 to 30.327	19.714 µg/mL Interval 16.891 to 23.01

SECONDARY outcome

Timeframe: At one month after the booster dose (Day 30)

Outcome measures

Outcome measures
Measure	dTpa Group n=221 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=247 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PT	220 Participants	247 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-FHA	221 Participants	247 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. Anti-PRN	220 Participants	247 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)

Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.

Assessed solicited local symptoms were pain, redness, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter

Outcome measures

Outcome measures
Measure	dTpa Group n=257 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=275 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With Solicited Local Symptoms Swelling	119 Participants	122 Participants
Number of Subjects With Solicited Local Symptoms Pain	134 Participants	154 Participants
Number of Subjects With Solicited Local Symptoms Redness	143 Participants	169 Participants

SECONDARY outcome

Timeframe: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination

Assessed solicited general symptoms were Drowsiness, Fever, Irritability/Fussiness and Loss of appetite. Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route.

Outcome measures

Outcome measures
Measure	dTpa Group n=258 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=275 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With Solicited General Symptoms Drowsiness	128 Participants	138 Participants
Number of Subjects With Solicited General Symptoms Irritability	163 Participants	188 Participants
Number of Subjects With Solicited General Symptoms Loss of Appetite	104 Participants	116 Participants
Number of Subjects With Solicited General Symptoms Fever	73 Participants	85 Participants

SECONDARY outcome

Timeframe: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination

Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available

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

Outcome measures

Outcome measures
Measure	dTpa Group n=263 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=277 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With Unsolicited Adverse Events (AEs)	94 Participants	111 Participants

SECONDARY outcome

Timeframe: From booster dose up to study end (approximately 6 or 7 months, per subject)

Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available

SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity

Outcome measures

Outcome measures
Measure	dTpa Group n=263 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=277 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: At 9 months of age, 18 months of age, and 9 or 18 months of age

Population: The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.

Neurodevelopmental status was measured by ASQ-3 score scale \[ASQ-3, 2016\] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III \[BSID-III\])

Outcome measures

Outcome measures
Measure	dTpa Group n=269 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=281 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Any domain at Month 18	6 Participants	5 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Any domain at Month 9	27 Participants	28 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Communication at Month 9	1 Participants	3 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Gross motor skills at Month 9	14 Participants	19 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Fine motor at Month 9	8 Participants	3 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Problem solving at Month 9	7 Participants	6 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Personal- Social at Month 9	2 Participants	2 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Communication at Month 18	1 Participants	0 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Gross motor skills at Month 18	3 Participants	2 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Fine motor at Month 18	1 Participants	1 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Problem solving at Month 18	1 Participants	3 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Personal- Social at Month 18	0 Participants	0 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Any domain at Month 9 or 18	31 Participants	31 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Communication at Month 9 or 18	2 Participants	3 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Gross motor skills at Month 9 or 18	16 Participants	20 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Fine motor at Month 9 or 18	9 Participants	4 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Problem solving at Month 9 or 18	8 Participants	8 Participants
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone Personal- Social at Month 9 or 18	2 Participants	2 Participants

SECONDARY outcome

Timeframe: At 9 months of age, 18 months of age, and 9 or 18 months of age

Population: The analysis was performed on subjects from the Total enrolled cohort, who scored, below the defined cut-off in any of the 5 domains, when using the ASQ-3 score scale.

Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III)

Outcome measures

Outcome measures
Measure	dTpa Group n=31 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=31 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) Any Domain at Month 9	16 Participants	14 Participants
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) Any Domain at Month 18	6 Participants	3 Participants
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) Any Domain at Month 9 or 18	20 Participants	17 Participants

SECONDARY outcome

Timeframe: At 9 months of age, 18 months of age, and 9 or 18 months of age

Population: The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.

The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 \* (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) \* (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation)

Outcome measures

Outcome measures
Measure	dTpa Group n=269 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=281 Participants This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) Any domain at Month 9	4.39 Percentage of Infants Interval 2.1 to 8.0	5.69 Percentage of Infants Interval 3.0 to 9.6
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) Any domain at Month 18	1.17 Percentage of Infants Interval 0.2 to 3.4	0.61 Percentage of Infants Interval 0.1 to 2.8
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) Any domain at Month 9 or 18	4.61 Percentage of Infants Interval 2.3 to 8.2	5.84 Percentage of Infants Interval 3.2 to 9.7

Adverse Events

dTpa Group

Serious events: 0 serious events

Other events: 232 other events

Deaths: 0 deaths

Control Group

Serious events: 3 serious events

Other events: 257 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	dTpa Group n=263 participants at risk This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Control Group n=277 participants at risk This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure
Infections and infestations Periorbital cellulitis	0.00% 0/263 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects	0.36% 1/277 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects
Infections and infestations Pneumonia	0.00% 0/263 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects	0.36% 1/277 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/263 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects	0.36% 1/277 • Number of events 1 • Solicited symptoms were collected during the 4-day (Day 0 - Day 3) follow-up period after each vaccination. Unsolicited AEs were collected during the 31-day (Day 0 - Day 30) follow-up period after each vaccination. SAEs were collected from booster dose up to study end (approximately 6 or 7 months, per subject) Safety analysis has been performed on the vaccinated subjects

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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