Evaluation of Immunogenicity and Safety of a Booster Dose... | NCT02853929

ID	Type	Description	Link
2014-001120-30	EudraCT Number

Label	Type	Description	Intervention Names
dTpa Group	Experimental	This group will consist of 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 will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Biological: Infanrix hexa
Control Group	Active Comparator	This group will consist of 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 will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure	Biological: Infanrix hexa

Name	Type	Description	Arm Group Labels	Other Names
Infanrix hexa	Biological	All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.	Control Group dTpa Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	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.	At one month after the booster dose (Day 30)
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))	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	At one month after the booster dose (Day 30)

Secondary Outcomes

Measure	Description	Time Frame
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.	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects' parent(s)/Legally acceptable representatives (LAR(s)) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
A male or female child 9 months of age at the time of enrolment.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and having completed their primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048 PRI].

Exclusion Criteria:

Child in care
Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunization schedule, that are allowed at any time during the study period.
- In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Major congenital defects.
Serious chronic illness.
Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period.
Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients).
Hypersensitivity to latex.
History of any neurological disorders or seizures.
Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
Acute disease and/or fever at the time of vaccination.
- Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Carlton	Victoria	3053	Australia
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
33612341	Derived	Martinon-Torres F, Halperin SA, Nolan T, Tapiero B, Perrett KP, de la Cueva IS, Garcia-Sicilia J, Stranak Z, Vanderkooi OG, Kosina P, Rumlarova S, Virta M, Arribas JMM, Miranda-Valdivieso M, Novas BA, Bozensky J, Ortega MJC, Amador JTR, Baca M, Palomino EE, Zuccotti GV, Janota J, Marchisio PG, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Mesaros N. Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial. Vaccine. 2021 Mar 12;39(11):1598-1608. doi: 10.1016/j.vaccine.2021.02.001. Epub 2021 Feb 19.

ID	Title	Description
FG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 12, 2016	Dec 26, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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)

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.

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

Posted

Count of Participants

Participants

At one month after the booster dose (Day 30)

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000221 OG001247

Title

Denominators

Categories

Anti-D

- ParticipantsOG000221
- ParticipantsOG001247

Title	Measurements
	OG000221

Primary

Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))

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

Posted

Count of Participants

Participants

At one month after the booster dose (Day 30)

ID	Title	Description
OG000	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

Secondary

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.

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.

Posted

Count of Participants

Participants

Before the booster dose (Day 0)

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN

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

Posted

Count of Participants

Participants

Before the booster dose (Day 0)

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)

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.

Posted

Count of Participants

Participants

Before the booster dose (Day 0)

ID	Title	Description
OG000	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
OG001	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

Secondary

Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

IU/ml

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Anti-poliovirus Type 1, 2, 3 Antibody Titres

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

Posted

Geometric Mean

95% Confidence Interval

Titers

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Anti-HBs Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations

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

Posted

Geometric Mean

95% Confidence Interval

µg/mL

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.

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

Posted

Count of Participants

Participants

At one month after the booster dose (Day 30)

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Solicited Local Symptoms

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

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Solicited General Symptoms

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.

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Serious Adverse Events (SAEs)

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone

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])

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	Control Group

Secondary

Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)

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)

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)

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)

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

Posted

Number

95% Confidence Interval

Percentage of Infants

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

ID	Title	Description
OG000	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
OG001	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

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hydrocele	Congenital, familial and genetic disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0007 events6 affected263 at risk EG0016 events6 affected277 at risk
Enteritis	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Teething	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected263 at risk EG0012 events2 affected277 at risk
Toothache	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0011 events1 affected277 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG00011 events10 affected263 at risk EG0018 events8 affected277 at risk
Chills	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Crying	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected277 at risk
Discomfort	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events1 affected263 at risk EG0010 events0 affected277 at risk
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Injection site bruising	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Injection site erythema	General disorders	MedDRA 22.0	Systematic Assessment	EG000143 events143 affected263 at risk EG001169 events169 affected277 at risk
Injection site induration	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected277 at risk
Injection site mass	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected277 at risk
Injection site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG000134 events134 affected263 at risk EG001154 events154 affected277 at risk
Injection site swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG000119 events119 affected263 at risk EG001122 events122 affected277 at risk
Pyrexia	General disorders	MedDRA 22.0	Systematic Assessment	EG00085 events81 affected263 at risk EG001109 events101 affected277 at risk
Vaccination site irritation	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Vaccination site pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Hypersensitivity	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Seasonal allergy	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Bronchiolitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected263 at risk EG0016 events6 affected277 at risk
Candida infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Candida nappy	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected277 at risk
Cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Conjunctivitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0009 events9 affected263 at risk EG0015 events5 affected277 at risk
Croup infectious	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected277 at risk
Cystitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Ear infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0009 events9 affected263 at risk EG00113 events12 affected277 at risk
Exanthema subitum	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected277 at risk
Fungal skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected263 at risk EG0015 events5 affected277 at risk
Gastroenteritis adenovirus	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Gingivitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0012 events2 affected277 at risk
Herpangina	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Hordeolum	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Impetigo	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected277 at risk
Influenza	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0010 events0 affected277 at risk
Injection site cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Laryngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected263 at risk EG0012 events2 affected277 at risk
Lung infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG00013 events12 affected263 at risk EG00111 events10 affected277 at risk
Oral candidiasis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Oral fungal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Oral herpes	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Otitis media	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected263 at risk EG0011 events1 affected277 at risk
Otitis media acute	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0012 events2 affected277 at risk
Pharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events3 affected263 at risk EG0014 events4 affected277 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected277 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 events5 affected263 at risk EG0016 events5 affected277 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Rhinitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0013 events3 affected277 at risk
Roseola	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected277 at risk
Skin infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Tonsillitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0004 events4 affected263 at risk EG0014 events4 affected277 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0009 events9 affected263 at risk EG0019 events9 affected277 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Vaginal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Varicella	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Viral infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0013 events3 affected277 at risk
Viral rash	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0012 events1 affected277 at risk
Vulvovaginitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Mouth injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG000104 events104 affected263 at risk EG001116 events116 affected277 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Mastocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Somnolence	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG000128 events128 affected263 at risk EG001138 events138 affected277 at risk
Initial insomnia	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Irritability	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG000164 events163 affected263 at risk EG001191 events189 affected277 at risk
Genital erythema	Reproductive system and breast disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0010 events0 affected277 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0012 events2 affected277 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0015 events5 affected277 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected277 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0011 events1 affected277 at risk
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected263 at risk EG0012 events2 affected277 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected263 at risk EG0012 events2 affected277 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected263 at risk EG0016 events6 affected277 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0012 events2 affected277 at risk

ID	Term
D004165	Diphtheria
D006509	Hepatitis B
D006192	Haemophilus Infections
D013742	Tetanus
D011051	Poliomyelitis
D014917	Whooping Cough

ID	Term
D003354	Corynebacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections
D003015	Clostridium Infections
D009187	Myelitis
D002494	Central Nervous System Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D013118	Spinal Cord Diseases
D000090862	Neuroinflammatory Diseases
D009468	Neuromuscular Diseases
D001885	Bordetella Infections
D012141	Respiratory Tract Infections
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	263	0	263	232	263
EG001	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	0	277	3	277	257	277

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Periorbital cellulitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected263 at risk EG0011 events1 affected277 at risk