Primary Vaccination Study With a Pneumococcal Conjugate V... | NCT00808444

NCT00808444

Status Module

Sponsor/Collaborators Module

Oversight Module

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Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

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Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synflorix Clinical Lot & Infanrix Group	Experimental	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).	Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Biological: Rotarix
Synflorix Commercial Lot Infanrix Group	Experimental	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).	Biological: Pneumococcal conjugate vaccine GSK1024850A (different lots) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Biological: Rotarix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal conjugate vaccine GSK1024850A (different lots)	Biological	Intramuscular injection, 3 doses	Synflorix Clinical Lot & Infanrix Group Synflorix Commercial Lot Infanrix Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine	Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.	One month after primary immunization (month 4)
Concentration of Antibody Against Protein D (PD)	Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	One month after primary immunization (month 4)

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL	Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.	One month after primary immunization (month 4)
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
Born after a gestation period of >= 36 to <= 42 weeks.

Exclusion Criteria:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
A family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Gastroenteritis within 7 days preceding the study vaccine administration.
Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Kuala Lumpur		59100	Malaysia
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25278086	Derived	Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.

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

ID	Type	URL	Comment
111654	Informed Consent Form	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
BG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Weeks

Title

Denominators

Categories

Anti-1

- ParticipantsOG000219
- ParticipantsOG001218

Title	Measurements
	OG0002.67(2.46 to 2.91)

Primary

Concentration of Antibody Against Protein D (PD)

Concentration was expressed as GMC in GSK's 22F enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Count of Participants

Participants

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL

Anti-pneumococcal cross-reactive serotypes were 6A and 19A.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Count of Participants

Participants

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes

Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.

Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Count of Participants

Participants

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes

Cross-reactive pneumococcal serotypes were 6A and 19A.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Count of Participants

Participants

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes

Opsonophagocytic titers were expressed as GMTs.

Cross-reactive pneumococcal serotypes included 6A and 19A.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

titer

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Poliovirus Types 1, 2 and 3 Titers

Titers were given as Geometric Mean Titers (GMTs).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

titer

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)

Concentrations were defined as GMCs in international units per milliter (IU/mL)

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).

Concentration was given as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete reanalysis.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)

Concentration was expressed as GMC in units per milliliter (U/mL).

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

U/mL

3 months after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Occurrence of Serious Adverse Events

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

Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Posted

Number

subjects

Following vaccination and throughout the entire study period (Month 0 to Month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes

Titers are presented as Geometric Mean Titers (GMTs).

Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

titer

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Number of Subjects With Solicited Local and General Symptoms.

Solicited local symptoms were pain, redness and swelling.

Solicited general symptoms were drowsiness, fever, irritability, loss of appetite, diarrhoea and vomiting.

Analysis was performed on the Total Vaccinated Cohort, which inlcuded all vaccinated subjects.

Posted

Count of Participants

Participants

Within 4 days (day 0-3) after vaccination

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)

Concentrations are expressed as GMCs in EL.U/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Least Squares Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)

Concentrain was expressed as GMC in µg/mL.

Analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One month after primary immunization (month 4)

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Secondary

Occurrence of Unsolicited Adverse Events

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

Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.

Posted

Count of Participants

Participants

Within 31 days (day 0-30) after vaccination

ID	Title	Description
OG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
OG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Synflorix Clinical Lot & Infanrix Group	Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).			18	233	230	233
EG001	Synflorix Commercial Lot & Infanrix Group	Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).			7	233	228	233

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedRA	Non-systematic Assessment	EG0005 affected233 at risk EG0010 affected233 at risk
Escherichia urinary tract infection	Infections and infestations	MedRA		EG0003 affected233 at risk EG0011 affected233 at risk
Gastroenteritis	Infections and infestations	MedRA	Non-systematic Assessment	EG0004 affected233 at risk EG0010 affected233 at risk
Bronchiolitis	Infections and infestations	MedRA	Non-systematic Assessment	EG0002 affected233 at risk EG0011 affected233 at risk
Head injury	Injury, poisoning and procedural complications	MedRA	Non-systematic Assessment	EG0002 affected233 at risk EG0010 affected233 at risk
Kawasaki's disease	Vascular disorders		Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected233 at risk
Urinary tract infection	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0011 affected233 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Bacteraemia	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Bronchopneumonia	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Gastritis	Gastrointestinal disorders		Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Influenza	Infections and infestations	MedRA	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected233 at risk
Meningitis tuberculous	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Meningitis viral	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Pharyngitis	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Pneumonia	Infections and infestations	MedRA	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected233 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedRA	Non-systematic Assessment	EG0001 affected233 at risk EG0010 affected233 at risk
Spinal muscular atrophy	Congenital, familial and genetic disorders	MedRA	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected233 at risk
Vith nerve parlysis	Nervous system disorders	MedRA	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected233 at risk
Viral upper respiratory tract infection	Infections and infestations	MedRA	Non-systematic Assessment	EG0000 affected233 at risk EG0011 affected233 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders		Systematic Assessment	EG000162 affected233 at risk EG001157 affected233 at risk
Redness	General disorders		Systematic Assessment	EG000149 affected233 at risk EG001142 affected233 at risk
Swelling	General disorders		Systematic Assessment	EG000133 affected233 at risk EG001124 affected233 at risk
Drowsiness	General disorders		Systematic Assessment	EG000151 affected233 at risk EG001136 affected233 at risk
Fever	General disorders		Systematic Assessment	EG000193 affected233 at risk EG001175 affected233 at risk
Irritability	General disorders		Systematic Assessment	EG000168 affected233 at risk EG001171 affected233 at risk
Diarrhoea	General disorders		Systematic Assessment	EG00053 affected233 at risk EG00154 affected233 at risk
Vomiting	General disorders		Systematic Assessment	EG00044 affected233 at risk EG00146 affected233 at risk
Upper respiratory tract infection	Infections and infestations	MedRA	Non-systematic Assessment	EG00028 affected233 at risk EG00140 affected233 at risk
Loss of appetite	General disorders		Systematic Assessment	EG000127 affected233 at risk EG001121 affected233 at risk

ID	Term
D013290	Streptococcal Infections
D011008	Pneumococcal Infections

ID	Term
C541235	diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
C451839	DTPa-HBV-IPV combined vaccine
C492457	RIX4414 vaccine

OG0012.46(2.25 to 2.69)

Units	Counts
Participants	OG00099 OG00193

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections