Primary and Booster Vaccination Study With Pneumococcal V... | NCT01235949

ID	Type	Description	Link
2010-019761-28	EudraCT Number

Primary and Booster Vaccination Study With Pneumococcal V... | NCT01235949 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group IIBU	Experimental	Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Drug: Ibuprofen
Group DIBU	Active Comparator	Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Drug: Ibuprofen
Group NIBU	Active Comparator	No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib
Group IPARA	Experimental	Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose	Biological: GSK1024850A (SynflorixTM) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Drug: Paracetamol
Group DPARA	Experimental

Name	Type	Description	Arm Group Labels	Other Names
GSK1024850A (SynflorixTM)	Biological	Intramuscular injection, 4 doses	Group DIBU Group DIBU-DIBU Group DIBU-IIBU Group DIBU-NIBU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off	Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).	One month after primary immunization (At Month 3)
Antibody Concentrations Against Vaccine Pneumococcal Serotypes	Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.	One month after primary immunization (At Month 3)
Antibody Concentrations Against Protein D (Anti-PD)	Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.	One month after primary immunization (At Month 3)

Secondary Outcomes

Measure	Description	Time Frame
Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A	Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.	One month after primary immunization (At Month 3)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Free of obvious 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 inclusive.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (.
Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
History of any seizures or progressive neurological disease.
Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
Body weight < 5 kg at the time of enrolment.
Child in care.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bacau		600316	Romania
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27541270	Background	Falup-Pecurariu O, Man SC, Neamtu ML, Chicin G, Baciu G, Pitic C, Cara AC, Neculau AE, Burlea M, Brinza IL, Schnell CN, Sas V, Lupu VV, Francois N, Swinnen K, Borys D. Effects of prophylactic ibuprofen and paracetamol administration on the immunogenicity and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugated vaccine (PHiD-CV) co-administered with DTPa-combined vaccines in children: An open-label, randomized, controlled, non-inferiority trial. Hum Vaccin Immunother. 2017 Mar 4;13(3):649-660. doi: 10.1080/21645515.2016.1223001. Epub 2016 Aug 19.

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
112921	Informed Consent Form	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Migrated/moved from study area		FG0001 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG0041 subjects FG0052 subjects FG0060 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0110 subjects FG0120 subjects FG0130 subjects FG0140 subjects FG0150 subjects FG0160 subjects FG0170 subjects
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004
Withdrawal by Subject		FG0003 subjects FG0012 subjects FG0022 subjects FG0030 subjects FG004
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004

Booster Phase

Type	Comment	Milestone Data
STARTED	After Primary Phase completion, 24 subjects were not willing to participate in the Booster Phase	FG0000 subjectsre-randomized to diverse treatments (IIBU-IIBU, IIBU-DIBU and IIBU-NIBU Groups) in booster phase FG0010 subjectsre-randomized to diverse treatments (DIBU-IIBU, DIBU-DIBU and DIBU-NIBU Groups) in booster phase FG0020 subjectsre-randomized to diverse treatments (NIBU-IIBU, NIBU-DIBU and NIBU-NIBU Groups) in booster phase FG0030 subjectssubjects re-randomized to IPARA-NPARA Group in booster phase FG0040 subjectssubjects re-randomized to DPARA-IPARA Group in booster phase FG0050 subjectssubjects re-randomized to NPARA-IPARA Group in booster phase FG00664 subjects1/3 of subjects from primary IIBU group re-randomized to receive diverse booster phase treatments FG00760 subjects1/3 of subjects from primary IIBU group re-randomized to receive diverse booster phase treatments FG00863 subjects1/3 of subjects from primary IIBU group re-randomized to receive diverse booster phase treatments FG00963 subjects1/3 of subjects from primary DIBU group re-randomized to receive diverse booster phase treatments FG01063 subjects1/3 of subjects from primary DIBU group re-randomized to receive diverse booster phase treatments FG01163 subjects1/3 of subjects from primary DIBU group re-randomized to receive diverse booster phase treatments FG01263 subjects1/3 of subjects from primary NIBU group re-randomized to receive diverse booster phase treatments FG01365 subjects1/3 of subjects from primary NIBU group re-randomized to receive diverse booster phase treatments FG01462 subjects1/3 of subjects from primary NIBU group re-randomized to receive diverse booster phase treatments FG01567 subjectssubjects from the primary IPARA group continuing in booster phase with different treatment FG01668 subjectssubjects from the primary DPARA group continuing in booster phase with different treatment FG01767 subjectssubjects from the primary NPARA group continuing in booster phase with different treatment
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Migrated/moved from study area		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
BG001	DIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
BG002	NIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
BG003	IPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
BG004	DPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
BG005	NPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
BG006	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG007	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG008	IIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG009	DIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG010	DIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG011	DIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG012	NIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG013	NIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG014	NIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG015	IPARA-NPARA Group	Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG016	DPARA-IPARA Group	Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG017	NPARA-IPARA Group	Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
BG018	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

Primary Phase Groups

This baseline measure refers only to the primary phase groups.

Mean

Standard Deviation

Weeks

Title	Denominators	Categories
	ParticipantsBG000198 ParticipantsBG001198 ParticipantsBG002199 ParticipantsBG003

Age, Continuous

Booster Phase Groups

This baseline measure refers only to the booster phase groups.

Mean

Standard Deviation

Months

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Sex: Female, Male

Primary Phase Groups

This baseline measure refers only to the primary phase groups.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000198 ParticipantsBG001198 ParticipantsBG002

Sex: Female, Male

Booster Phase Groups

This baseline measure refers only to the booster phase groups.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Race/Ethnicity, Customized

Primary Phase Groups

This baseline measure refers only to the primary phase groups.

Count of Participants

Participants

Title	Denominators	Categories
White- Caucasian/European heritage	ParticipantsBG000198 ParticipantsBG001198 ParticipantsBG002

Race/Ethnicity, Customized

Booster Phase Groups

This baseline measure refers only to the booster phase groups.

Count of Participants

Participants

Title	Denominators	Categories
White- Caucasian/European heritage	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

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 Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Posted

Count of Participants

Participants

One month after primary immunization (At Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
OG002	NIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
OG003	IPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
OG004	DPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.
OG005	NPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.

Units	Counts
Participants	OG000154 OG001158 OG002164 OG003

Title	Denominators	Categories
Anti-1	ParticipantsOG000144 ParticipantsOG001155 ParticipantsOG002161 ParticipantsOG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	At one month after primary immunization, the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL were calculated for anti-pneumococccal serotype 1.					Difference in percentages	-0.62			2-Sided	98.25	-4.52	3.17					Non-Inferiority	Criterion for evaluation of non-inferiority: The upper limit (UL) of the 2-sided 98.25% confidence interval (98.25% CI) (adjusted 1-sided alpha = 0.875%) of the difference between groups (NIBU minus IIBU), in terms of percentage of subjects with pneumococcal antibody concentrations ≥ 0.2 µg/mL, was lower than (<) 10% for at least 7 out of the 10 pneumococcal serotypes.

Primary

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One month after primary immunization (At Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001

Primary

Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (At Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group

Secondary

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

One month after primary immunization (At Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) period following booster vaccination

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within the 4-day (Days 0-3) period following booster vaccination

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001

Secondary

Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.

The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose.

Posted

Count of Participants

Participants

During the entire study period (Month 0 to 10)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.

Posted

Count of Participants

Participants

Within 31-days (Day 0-30) following each primary vaccination dose

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001

Secondary

Number of Subjects With Any Unsolicited Adverse Events (AEs)

The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose.

Posted

Number

Subjects

Within 31-days (Day 0-30) following booster vaccination

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group

Secondary

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results or antibodies against at least one study vaccine antigen component after vaccination were available.

Posted

Geometric Mean

95% Confidence Interval

Titers

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001

Secondary

Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (>) 1.0 E10.

Posted

Geometric Mean

95% Confidence Interval

Titers

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group

Secondary

Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

Posted

Geometric Mean

95% Confidence Interval

IU/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001

Secondary

Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Posted

Geometric Mean

95% Confidence Interval

EL.U/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group

Secondary

Antibody Concentrations Against Hepatitis B Surface Antigen

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group

Secondary

Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

Posted

Geometric Mean

95% Confidence Interval

µg/mL

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Secondary

Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Posted

Geometric Mean

95% Confidence Interval

Titers

One month after primary immunization (Month 3)

ID	Title	Description
OG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.
OG001	DIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.

Secondary

Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

Posted

Geometric Mean

95% Confidence Interval

Titers

Prior to (Month 9) and one month after booster vaccination (Month 10)

ID	Title	Description
OG000	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.
OG001	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate ibuprofen (IIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for Serious Adverse Event (SAE) follow-up for the entire study period.	198	4	198	181	198
EG001	DIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed ibuprofen (DIBU) administration with Nurofen™ for Children after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	198	4	198	171	198
EG002	NIBU Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic ibuprofen (NIBU) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	199	2	199	186	199
EG003	IPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received immediate paracetamol (IPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	71	4	71	60	71
EG004	DPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received delayed paracetamol (DPARA) administration with Panadol™ Baby after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. For delayed oral administration of Panadol™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	72	1	72	61	72
EG005	NPARA Group	Healthy male and female subjects between and including 12 and 16 weeks of age, who received no prophylactic paracetamol (NPARA) administration after each primary vaccination dose of Synflorix™ vaccine at 3, 4 and 5 months of age, co-administered with Infanrix hexa™ at 3 and 5 months of age and with Infanrix™-IPV/Hib at 4 months of age. All three vaccines were administered intramuscularly into the right or left thigh. This group is applicable for all analysis related to the primary phase of the study as well as for SAE follow-up for the entire study period.	74	0	74	73	74
EG006	IIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipryretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	64	0	64	44	64
EG007	IIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	60	1	60	41	60
EG008	IIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/Immediate Ibuprofen Group (IIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63	0	63	34	63
EG009	DIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63	0	63	43	63
EG010	DIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63	0	63	41	63
EG011	DIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/Delayed Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63	0	63	42	63
EG012	NIBU-IIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (NIBU Group) received immediate ibuprofen treatment (IIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Nurofen™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	63	0	63	50	63
EG013	NIBU-DIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received delayed ibuprofen treatment (DIBU) with Nurofen™ for Children after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For delayed oral administration of Nurofen™: antipyretic dose 1 was administered 4-6 hours after vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	65	1	65	51	65
EG014	NIBU-NIBU Group	1/3 of the subjects from the primary Synflorix/No Ibuprofen Group (DIBU Group) received no prophylactic ibuprofen treatment (NIBU) with Nurofen™ for Children after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	62	0	62	45	62
EG015	IPARA-NPARA Group	Subjects from the primary Synflorix/Immediate Paracetamol Group (IPARA Group) received no prophylactic paracetamol treatment (NPARA) with Panadol™ Baby after the booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	67	1	67	43	67
EG016	DPARA-IPARA Group	Subjects from the primary Synflorix/Delayed Paracetamol Group (DPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	68	0	68	45	68
EG017	NPARA-IPARA Group	Subjects from the primary Synflorix/No Paracetamol Group (NPARA Group) received immediate paracetamol treatment (IPARA) with Panadol™ Baby after booster vaccination with Synflorix™ vaccine co-administered with Infanrix hexa™ vaccine at 12-15 months of age. For immediate oral administration of Panadol™: antipyretic dose 1 was administered at the time of vaccination, antipyretic doses 2 and 3 were administered 6-8 hours after the previous dose of antipyretic. Both vaccines were administered intramuscularly into the right/left thigh or into the deltoid muscle.	67	0	67	45	67

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Accidental poisoning	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0021 affected199 at risk EG0030 affected71 at risk EG004
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0021 affected199 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Hypotonia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Rickets	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Laryngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Otitis media	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0010 affected198 at risk EG0021 affected199 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected198 at risk EG0011 affected198 at risk EG0020 affected199 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected198 at risk EG0010 affected198 at risk EG0020 affected199 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG000154 events92 affected198 at risk EG001145 events76 affected198 at risk EG002197 events107 affected199 at risk EG00358 events30 affected71 at risk EG00471 events37 affected72 at risk EG00580 events44 affected74 at risk EG00625 events25 affected64 at risk EG00722 events22 affected60 at risk EG00815 events15 affected63 at risk EG00922 events22 affected63 at risk EG01016 events16 affected63 at risk EG01125 events25 affected63 at risk EG01228 events28 affected63 at risk EG01332 events32 affected65 at risk EG01428 events28 affected62 at risk EG01523 events23 affected67 at risk EG01624 events24 affected68 at risk EG01724 events24 affected67 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG000205 events121 affected198 at risk EG001165 events102 affected198 at risk EG002200 events123 affected199 at risk EG003
Swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG00096 events61 affected198 at risk EG00187 events51 affected198 at risk EG00289 events57 affected199 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0005 events5 affected198 at risk EG0013 events3 affected198 at risk EG0024 events3 affected199 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0006 events5 affected198 at risk EG0016 events5 affected198 at risk EG00214 events10 affected199 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG000145 events84 affected198 at risk EG001150 events98 affected198 at risk EG002160 events100 affected199 at risk EG003
Somnolence	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG000197 events115 affected198 at risk EG001194 events111 affected198 at risk EG002209 events123 affected199 at risk EG003
Irritability	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG000244 events120 affected198 at risk EG001239 events121 affected198 at risk EG002275 events138 affected199 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG000217 events108 affected198 at risk EG001174 events89 affected198 at risk EG002205 events105 affected199 at risk EG003

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines

Title	Measurements
	BG00612.3± 0.64 BG00712.2± 0.49 BG00812.3± 0.57 BG00912.2± 0.45 BG01012.4± 0.63 BG01112.4± 0.73 BG01212.3± 0.63 BG01312.3± 0.57 BG01412.3± 0.70 BG01512.3± 0.73 BG01612.3± 0.56 BG01712.4± 0.63 BG01812.3± 0.61

White - Arabic/North African Heritage

- ParticipantsBG000198
- ParticipantsBG001198
- ParticipantsBG002199
- ParticipantsBG00371
- ParticipantsBG00472
- ParticipantsBG00574
- ParticipantsBG0060
- ParticipantsBG0070
- ParticipantsBG0080
- ParticipantsBG0090
- ParticipantsBG0100
- ParticipantsBG0110
- ParticipantsBG0120
- ParticipantsBG0130
- ParticipantsBG0140
- ParticipantsBG0150
- ParticipantsBG0160
- ParticipantsBG0170
- ParticipantsBG018812

Title	Measurements
	BG0000 BG0010 BG0020 BG003

Not specified

- ParticipantsBG000198
- ParticipantsBG001198
- ParticipantsBG002199
- ParticipantsBG00371
- ParticipantsBG00472
- ParticipantsBG00574
- ParticipantsBG0060
- ParticipantsBG0070
- ParticipantsBG0080
- ParticipantsBG0090
- ParticipantsBG0100
- ParticipantsBG0110
- ParticipantsBG0120
- ParticipantsBG0130
- ParticipantsBG0140
- ParticipantsBG0150
- ParticipantsBG0160
- ParticipantsBG0170
- ParticipantsBG018812

Title	Measurements
	BG0000 BG0011 BG0021 BG003

White - Arabic/North African Heritage

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0020
- ParticipantsBG0030
- ParticipantsBG0040
- ParticipantsBG0050
- ParticipantsBG00664
- ParticipantsBG00760
- ParticipantsBG00863
- ParticipantsBG00963
- ParticipantsBG01063
- ParticipantsBG01163
- ParticipantsBG01263
- ParticipantsBG01365
- ParticipantsBG01462
- ParticipantsBG01567
- ParticipantsBG01668
- ParticipantsBG01767
- ParticipantsBG018768

Title	Measurements
	BG0060 BG0070 BG0080 BG009

Not specified

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0020
- ParticipantsBG0030
- ParticipantsBG0040
- ParticipantsBG0050
- ParticipantsBG00664
- ParticipantsBG00760
- ParticipantsBG00863
- ParticipantsBG00963
- ParticipantsBG01063
- ParticipantsBG01163
- ParticipantsBG01263
- ParticipantsBG01365
- ParticipantsBG01462
- ParticipantsBG01567
- ParticipantsBG01668
- ParticipantsBG01767
- ParticipantsBG018768

Title	Measurements
	BG0060 BG0070 BG0080 BG009

Title

Denominators

Categories

Anti-1

- ParticipantsOG000144
- ParticipantsOG001155
- ParticipantsOG002161
- ParticipantsOG00354
- ParticipantsOG00451
- ParticipantsOG00555

Title	Measurements
	OG0001.82(1.59 to 2.09) OG0011.71(1.49 to 1.95) OG0021.9(1.67 to 2.17) OG003

Anti-4

- ParticipantsOG000146
- ParticipantsOG001155
- ParticipantsOG002159
- ParticipantsOG00355

Anti-5

- ParticipantsOG000143
- ParticipantsOG001154
- ParticipantsOG002157
- ParticipantsOG00353

Anti-6B

- ParticipantsOG000144
- ParticipantsOG001155
- ParticipantsOG002157
- ParticipantsOG00353

Anti-7F

- ParticipantsOG000154
- ParticipantsOG001157
- ParticipantsOG002164
- ParticipantsOG00355

Anti-9V

- ParticipantsOG000145
- ParticipantsOG001153
- ParticipantsOG002157
- ParticipantsOG00353

Anti-14

- ParticipantsOG000144
- ParticipantsOG001154
- ParticipantsOG002155
- ParticipantsOG00353

Anti-18C

- ParticipantsOG000144
- ParticipantsOG001154
- ParticipantsOG002157
- ParticipantsOG00353

Anti-19F

- ParticipantsOG000145
- ParticipantsOG001154
- ParticipantsOG002158
- ParticipantsOG00353

Anti-23F

- ParticipantsOG000148
- ParticipantsOG001158
- ParticipantsOG002162
- ParticipantsOG00354

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 1.	GMC ratio	0.96	2-Sided	99.8	0.71	1.29	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 4.	GMC ratio	1.02	2-Sided	99.8	0.77	1.35	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 5.	GMC ratio	1.06	2-Sided	99.8	0.8	1.41	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.	GMC ratio	1.12	2-Sided	99.8	0.72	1.74	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.	GMC ratio	1.04	2-Sided	99.8	0.79	1.35	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.	GMC ratio	0.96	2-Sided	99.8	0.7	1.31	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 14.	GMC ratio	1	2-Sided	99.8	0.71	1.4	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.	GMC ratio	0.89	2-Sided	99.8	0.6	1.31	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.	GMC ratio	1.23	2-Sided	99.8	0.87	1.75	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.	GMC ratio	0.97	2-Sided	99.8	0.66	1.44	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 1.	GMC ratio	0.9	2-Sided	99.8	0.67	1.21	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 4.	GMC ratio	1	2-Sided	99.8	0.76	1.32	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 5.	GMC ratio	0.86	2-Sided	99.8	0.66	1.14	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 6B.	GMC ratio	1.28	2-Sided	99.8	0.83	1.97	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 7F.	GMC ratio	1.02	2-Sided	99.8	0.8	1.31	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 9V.	GMC ratio	0.92	2-Sided	99.8	0.69	1.22	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 14.	GMC ratio	0.95	2-Sided	99.8	0.68	1.32	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 18C.	GMC ratio	0.88	2-Sided	99.8	0.6	1.27	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 19F.	GMC ratio	1.02	2-Sided	99.8	0.72	1.44	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-pneumococcal serotype 23F.	GMC ratio	0.86	2-Sided	99.8	0.58	1.27	Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for at least one of the 10 vaccine pneumococcal serotypes.

Title

Denominators

Categories

Title	Measurements
	OG0001461.3(1267.4 to 1684.8) OG0011353.1(1191.3 to 1537) OG0021557.7(1355.4 to 1790.3) OG0031109.6(876.9 to 1404.1) OG0041348.6(1048.2 to 1734.9) OG0051667.9(1401.9 to 1984.4)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (IIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.					GMC ratio	0.94			2-Sided	99.8	0.69	1.28					Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (IIBU over NIBU) was below (<) 1 for protein D.
OG001 OG002	At one month after primary immunization, ELISA Geometric Mean Concentration (GMC) ratios (DIBU over NIBU) were calculated for anti-Protein D (anti-PD) antibody.					GMC ratio	0.87			2-Sided	99.8	0.64	1.17					Non-Inferiority	A statistically significant decrease in GMC was established if the UL of the two-sided 99.8% CI (adjusted one-sided alpha = 0.11364%) for the GMC ratios (DIBU over NIBU) was below (<) 1 for protein D.

Title

Denominators

Categories

Anti-6A

- ParticipantsOG000147
- ParticipantsOG001152
- ParticipantsOG002157
- ParticipantsOG00353
- ParticipantsOG00450
- ParticipantsOG00553

Title	Measurements
	OG0000.17(0.14 to 0.21) OG0010.18(0.15 to 0.23) OG0020.15(0.12 to 0.19) OG003

Anti-19A

- ParticipantsOG000145
- ParticipantsOG001152
- ParticipantsOG002157
- ParticipantsOG00353

Title

Denominators

Categories

Any Pain, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370
- ParticipantsOG00471
- ParticipantsOG00574

Title	Measurements
	OG00044 OG00148 OG00278 OG003

Grade 3 Pain, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Redness, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Redness, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Swelling, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Swelling, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Pain, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Pain, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Redness, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Redness, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Swelling, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Swelling, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Pain, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Pain, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Redness, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Redness, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Swelling, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Swelling, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Pain, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Pain, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Redness, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Redness, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Swelling, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Swelling, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Title

Denominators

Categories

Any Pain

Title	Measurements
	OG00025 OG00122 OG00215 OG00322 OG00416 OG00525 OG00628 OG00732 OG00828 OG00923 OG01024 OG01124

Grade 3 Pain

Title	Measurements
	OG0000 OG0013 OG0020 OG003

Any Redness

Title	Measurements
	OG00027 OG00125 OG00217 OG003

Grade 3 Redness

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Any Swelling

Title	Measurements
	OG00016 OG00116 OG0029 OG003

Grade 3 Swelling

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Any Drowsiness, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370
- ParticipantsOG00471
- ParticipantsOG00574

Title	Measurements
	OG00071 OG00178 OG002101 OG003

Grade 3 Drowsiness, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Drowsiness, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Irritability, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Irritability, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Irritability, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Loss appetite, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Loss appetite, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Loss appetite, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Fever, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Fever, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Fever, Dose 1

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Drowsiness, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Drowsiness, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Related Drowsiness, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Irritability, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Irritability, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Related Irritability, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Loss appetite, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Loss appetite, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Related Loss appetite, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Fever, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Grade 3 Fever, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Related Fever, Dose 2

- ParticipantsOG000195
- ParticipantsOG001197
- ParticipantsOG002197
- ParticipantsOG00369

Any Drowsiness, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Drowsiness, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Related Drowsiness, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Irritability, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Irritability, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Related Irritability, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Loss appetite, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Loss appetite, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Related Loss appetite, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Fever, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Grade 3 Fever, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Related Fever, Dose 3

- ParticipantsOG000194
- ParticipantsOG001195
- ParticipantsOG002194
- ParticipantsOG00369

Any Drowsiness, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Drowsiness, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Drowsiness, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Irritability, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Irritability, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Irritability, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Loss appetite, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Loss appetite, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Loss appetite, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Any Fever, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Grade 3 Fever, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Related Fever, Across doses

- ParticipantsOG000197
- ParticipantsOG001197
- ParticipantsOG002199
- ParticipantsOG00370

Title

Denominators

Categories

Any Drowsiness

Title	Measurements
	OG00018 OG00118 OG00217 OG00319 OG0049 OG00521 OG00622 OG00724 OG00824 OG00912 OG01016 OG01119

Grade 3 Drowsiness

Title	Measurements
	OG0001 OG0011 OG0020 OG003

Related Drowsiness

Title	Measurements
	OG00015 OG00113 OG00213 OG003

Any Irritability

Title	Measurements
	OG00033 OG00127 OG00223 OG003

Grade 3 Irritability

Title	Measurements
	OG0001 OG0013 OG0021 OG003

Related Irritability

Title	Measurements
	OG00022 OG00118 OG00213 OG003

Any Loss of appetite

Title	Measurements
	OG00014 OG00116 OG0029 OG003

Grade 3 Loss of appetite

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Related Loss of appetite

Title	Measurements
	OG00011 OG00111 OG0024 OG003

Any Fever

Title	Measurements
	OG00022 OG00121 OG00215 OG003

Grade 3 Fever

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Related Fever

Title	Measurements
	OG00020 OG00117 OG00212 OG003

Title

Denominators

Categories

Anti-1, M9

- ParticipantsOG00046
- ParticipantsOG00144
- ParticipantsOG00240
- ParticipantsOG00347
- ParticipantsOG00444
- ParticipantsOG00544
- ParticipantsOG00646
- ParticipantsOG00744
- ParticipantsOG00845
- ParticipantsOG00948
- ParticipantsOG01041
- ParticipantsOG01144

Title	Measurements
	OG0000.41(0.31 to 0.54) OG0010.36(0.28 to 0.46) OG0020.27(0.22 to 0.34) OG003

Anti-1, M10

- ParticipantsOG00049
- ParticipantsOG00146
- ParticipantsOG00236
- ParticipantsOG00344

Anti-4, M9

- ParticipantsOG00047
- ParticipantsOG00145
- ParticipantsOG00240
- ParticipantsOG00347

Anti-4, M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00236
- ParticipantsOG00345

Anti-5, M9

- ParticipantsOG00046
- ParticipantsOG00144
- ParticipantsOG00241
- ParticipantsOG00347

Anti-5, M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00236
- ParticipantsOG00344

Anti-6B, M9

- ParticipantsOG00049
- ParticipantsOG00145
- ParticipantsOG00241
- ParticipantsOG00348

Anti-6B M10

- ParticipantsOG00049
- ParticipantsOG00145
- ParticipantsOG00236
- ParticipantsOG00345

Anti-7F, M9

- ParticipantsOG00047
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00347

Anti-7F M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00236
- ParticipantsOG00344

Anti-9V, M9

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00242
- ParticipantsOG00347

Anti-9V M10

- ParticipantsOG00049
- ParticipantsOG00146
- ParticipantsOG00236
- ParticipantsOG00345

Anti-14, M9

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00241
- ParticipantsOG00347

Anti-14 M10

- ParticipantsOG00049
- ParticipantsOG00146
- ParticipantsOG00238
- ParticipantsOG00345

Anti-18C M9

- ParticipantsOG00050
- ParticipantsOG00144
- ParticipantsOG00241
- ParticipantsOG00347

Anti-18C M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00238
- ParticipantsOG00344

Anti-19F M9

- ParticipantsOG00046
- ParticipantsOG00144
- ParticipantsOG00240
- ParticipantsOG00346

Anti-19F M10

- ParticipantsOG00049
- ParticipantsOG00145
- ParticipantsOG00236
- ParticipantsOG00345

Anti-23F M9

- ParticipantsOG00048
- ParticipantsOG00143
- ParticipantsOG00241
- ParticipantsOG00347

Anti-23F M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00235
- ParticipantsOG00344

Anti-6A, M9

- ParticipantsOG00046
- ParticipantsOG00143
- ParticipantsOG00242
- ParticipantsOG00347

Anti-6A M10

- ParticipantsOG00049
- ParticipantsOG00146
- ParticipantsOG00236
- ParticipantsOG00345

Anti-19A M9

- ParticipantsOG00047
- ParticipantsOG00144
- ParticipantsOG00241
- ParticipantsOG00346

Anti-19A M10

- ParticipantsOG00049
- ParticipantsOG00145
- ParticipantsOG00235
- ParticipantsOG00344

Title

Denominators

Categories

OPSONO-1

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00221
- ParticipantsOG0039
- ParticipantsOG00412
- ParticipantsOG0058

Title	Measurements
	OG00069.4(26.5 to 182) OG00167.9(28.9 to 159.6) OG00275.9(32.5 to 177) OG003

OPSONO-4

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00221
- ParticipantsOG0039

OPSONO-5

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00221
- ParticipantsOG0039

OPSONO-6B

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00219
- ParticipantsOG0039

OPSONO-7F

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00218
- ParticipantsOG0039

OPSONO-9V

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00217
- ParticipantsOG0039

OPSONO-14

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00221
- ParticipantsOG0039

OPSONO-18C

- ParticipantsOG00019
- ParticipantsOG00115
- ParticipantsOG00218
- ParticipantsOG0037

OPSONO-19F

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00218
- ParticipantsOG0039

OPSONO-23F

- ParticipantsOG00020
- ParticipantsOG00116
- ParticipantsOG00220
- ParticipantsOG0039

OPSONO-6A

- ParticipantsOG00020
- ParticipantsOG00114
- ParticipantsOG00218
- ParticipantsOG0039

OPSONO-19A

- ParticipantsOG00014
- ParticipantsOG00113
- ParticipantsOG00211
- ParticipantsOG0036

Title

Denominators

Categories

OPSONO-1, M9

- ParticipantsOG0006
- ParticipantsOG0016
- ParticipantsOG0023
- ParticipantsOG0033
- ParticipantsOG0048
- ParticipantsOG0058
- ParticipantsOG0067
- ParticipantsOG0074
- ParticipantsOG0084
- ParticipantsOG0099
- ParticipantsOG01010
- ParticipantsOG0118

Title	Measurements
	OG0005.8(2.2 to 15.3) OG0014(4 to 4) OG0024(4 to 4) OG003

OPSONO-1, M10

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-4, M9

- ParticipantsOG0004
- ParticipantsOG0014
- ParticipantsOG0022
- ParticipantsOG0031

OPSONO-4, M10

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-5, M9

- ParticipantsOG0006
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0033

OPSONO-5, M10

- ParticipantsOG0004
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-6B, M9

- ParticipantsOG0003
- ParticipantsOG0014
- ParticipantsOG0023
- ParticipantsOG0032

OPSONO-6B, M10

- ParticipantsOG0004
- ParticipantsOG0013
- ParticipantsOG0023
- ParticipantsOG0034

OPSONO-7F, M9

- ParticipantsOG0004
- ParticipantsOG0016
- ParticipantsOG0023
- ParticipantsOG0033

OPSONO-7F, M10

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0035

OPSONO-9V, M9

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0033

OPSONO-9V, M10

- ParticipantsOG0005
- ParticipantsOG0014
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-14, M9

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG0022
- ParticipantsOG0032

OPSONO-14, M10

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-18C, M9

- ParticipantsOG0004
- ParticipantsOG0015
- ParticipantsOG0022
- ParticipantsOG0032

OPSONO-18C, M10

- ParticipantsOG0005
- ParticipantsOG0014
- ParticipantsOG0023
- ParticipantsOG0035

OPSONO-19F, M9

- ParticipantsOG0006
- ParticipantsOG0016
- ParticipantsOG0023
- ParticipantsOG0033

OPSONO-19F, M10

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0035

OPSONO-23F, M9

- ParticipantsOG0005
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0032

OPSONO-23F, M10

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-6A, M9

- ParticipantsOG0004
- ParticipantsOG0015
- ParticipantsOG0023
- ParticipantsOG0033

OPSONO-6A, M10

- ParticipantsOG0005
- ParticipantsOG0016
- ParticipantsOG0024
- ParticipantsOG0035

OPSONO-19A, M9

- ParticipantsOG0003
- ParticipantsOG0014
- ParticipantsOG0022
- ParticipantsOG0032

OPSONO-19A, M10

- ParticipantsOG0002
- ParticipantsOG0012
- ParticipantsOG0022
- ParticipantsOG0033

Title

Denominators

Categories

Anti-PD, M9

- ParticipantsOG00049
- ParticipantsOG00144
- ParticipantsOG00243
- ParticipantsOG00348
- ParticipantsOG00447
- ParticipantsOG00545
- ParticipantsOG00647
- ParticipantsOG00745
- ParticipantsOG00846
- ParticipantsOG00950
- ParticipantsOG01046
- ParticipantsOG01148

Title	Measurements
	OG000661.6(517.8 to 845.4) OG001660.4(501.1 to 870.4) OG002588.3(431.8 to 801.5) OG003

Anti-PD M10

- ParticipantsOG00049
- ParticipantsOG00145
- ParticipantsOG00241
- ParticipantsOG00346

Title

Denominators

Categories

Anti-D

- ParticipantsOG000137
- ParticipantsOG001150
- ParticipantsOG002153
- ParticipantsOG00350
- ParticipantsOG00449
- ParticipantsOG00553

Title	Measurements
	OG0003.326(2.97 to 3.725) OG0012.938(2.651 to 3.257) OG0023.132(2.801 to 3.503) OG003

Anti-T

- ParticipantsOG000137
- ParticipantsOG001150
- ParticipantsOG002153
- ParticipantsOG00349

Title

Denominators

Categories

Anti-D, M9

- ParticipantsOG00045
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00346
- ParticipantsOG00444
- ParticipantsOG00543
- ParticipantsOG00643
- ParticipantsOG00741
- ParticipantsOG00843
- ParticipantsOG00946
- ParticipantsOG01041
- ParticipantsOG01144

Title	Measurements
	OG0000.736(0.556 to 0.975) OG0010.593(0.476 to 0.739) OG0020.616(0.499 to 0.762) OG003

Anti-D, M10

- ParticipantsOG00048
- ParticipantsOG00144
- ParticipantsOG00234
- ParticipantsOG00344

Anti-T, M9

- ParticipantsOG00044
- ParticipantsOG00140
- ParticipantsOG00239
- ParticipantsOG00346

Anti-T, M10

- ParticipantsOG00048
- ParticipantsOG00144
- ParticipantsOG00234
- ParticipantsOG00344

Title

Denominators

Categories

Anti-PT

- ParticipantsOG000133
- ParticipantsOG001145
- ParticipantsOG002147
- ParticipantsOG00347
- ParticipantsOG00445
- ParticipantsOG00553

Title	Measurements
	OG00059.1(53.7 to 65.1) OG00164.2(58.7 to 70.2) OG00265(59.6 to 71) OG003

Anti-FHA

- ParticipantsOG000131
- ParticipantsOG001143
- ParticipantsOG002142
- ParticipantsOG00347

Anti-PRN

- ParticipantsOG000138
- ParticipantsOG001149
- ParticipantsOG002155
- ParticipantsOG00347

Title

Denominators

Categories

Anti-PT, M9

- ParticipantsOG00044
- ParticipantsOG00140
- ParticipantsOG00237
- ParticipantsOG00344
- ParticipantsOG00443
- ParticipantsOG00543
- ParticipantsOG00643
- ParticipantsOG00739
- ParticipantsOG00843
- ParticipantsOG00945
- ParticipantsOG01038
- ParticipantsOG01144

Title	Measurements
	OG00013.3(10.8 to 16.3) OG00112.8(11 to 14.9) OG00210.5(8.2 to 13.3) OG003

Anti-PT, M10

- ParticipantsOG00048
- ParticipantsOG00144
- ParticipantsOG00234
- ParticipantsOG00344

Anti-FHA, M9

- ParticipantsOG00044
- ParticipantsOG00140
- ParticipantsOG00237
- ParticipantsOG00344

Anti-FHA, M10

- ParticipantsOG00048
- ParticipantsOG00144
- ParticipantsOG00234
- ParticipantsOG00344

Anti-PRN, M9

- ParticipantsOG00047
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00346

Anti-PRN, M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00234
- ParticipantsOG00344

Title

Denominators

Categories

Title	Measurements
	OG000911.85(719.55 to 1155.56) OG0011139.1(902.93 to 1437.04) OG0021245.07(998.97 to 1551.8) OG003934.65(580.7 to 1504.32) OG004674.25(373.26 to 1217.95) OG0051027.79(719.24 to 1468.7)

Title

Denominators

Categories

Anti-HBs, M9

- ParticipantsOG00034
- ParticipantsOG00135
- ParticipantsOG00230
- ParticipantsOG00334
- ParticipantsOG00435
- ParticipantsOG00535
- ParticipantsOG00634
- ParticipantsOG00730
- ParticipantsOG00836
- ParticipantsOG00933
- ParticipantsOG01033
- ParticipantsOG01133

Title	Measurements
	OG000197.46(125.7 to 310.18) OG001210.32(125.47 to 352.56) OG002164.33(98.38 to 274.49) OG003

Anti-HBs, M10

- ParticipantsOG00043
- ParticipantsOG00139
- ParticipantsOG00229
- ParticipantsOG00341

Title

Denominators

Categories

Anti-PRP, M9

- ParticipantsOG00046
- ParticipantsOG00141
- ParticipantsOG00240
- ParticipantsOG00346
- ParticipantsOG00444
- ParticipantsOG00544
- ParticipantsOG00645
- ParticipantsOG00743
- ParticipantsOG00844
- ParticipantsOG00946
- ParticipantsOG01042
- ParticipantsOG01144

Title	Measurements
	OG0000.878(0.609 to 1.266) OG0010.684(0.48 to 0.974) OG0020.678(0.436 to 1.055) OG003

Anti-PRP, M10

- ParticipantsOG00048
- ParticipantsOG00145
- ParticipantsOG00234
- ParticipantsOG00344

Title

Denominators

Categories

Anti-Polio 1

- ParticipantsOG00024
- ParticipantsOG00124
- ParticipantsOG00224
- ParticipantsOG00311
- ParticipantsOG0044
- ParticipantsOG0058

Title	Measurements
	OG000283.4(175.5 to 457.6) OG001252.5(156.9 to 406.2) OG002337(204.2 to 556.2) OG003

Anti-Polio 2

- ParticipantsOG00021
- ParticipantsOG00124
- ParticipantsOG00224
- ParticipantsOG00311

Anti-Polio 3

- ParticipantsOG00020
- ParticipantsOG00123
- ParticipantsOG00221
- ParticipantsOG00310

Title

Denominators

Categories

Anti-Polio 1, M9

- ParticipantsOG0005
- ParticipantsOG0017
- ParticipantsOG0026
- ParticipantsOG0038
- ParticipantsOG0048
- ParticipantsOG0054
- ParticipantsOG0066
- ParticipantsOG0074
- ParticipantsOG0087
- ParticipantsOG0094
- ParticipantsOG0104
- ParticipantsOG0114

Title	Measurements
	OG00056(15.7 to 200.2) OG00185.9(26.7 to 276.4) OG00280.9(18.7 to 349.8) OG003

Anti-Polio 1, M10

- ParticipantsOG0007
- ParticipantsOG0014
- ParticipantsOG0024
- ParticipantsOG0036

Anti-Polio 2, M9

- ParticipantsOG0006
- ParticipantsOG0017
- ParticipantsOG0025
- ParticipantsOG0038

Anti-Polio 2, M10

- ParticipantsOG0007
- ParticipantsOG0014
- ParticipantsOG0025
- ParticipantsOG0037

Anti-Polio 3, M9

- ParticipantsOG0006
- ParticipantsOG0017
- ParticipantsOG0025
- ParticipantsOG0038

Anti-Polio 3, M10

- ParticipantsOG0008
- ParticipantsOG0014
- ParticipantsOG0024
- ParticipantsOG0036

Title	Measurements
	OG0002.87(2.1 to 3.91) OG0012.23(1.57 to 3.17) OG0022.39(1.68 to 3.41) OG0032.69(1.99 to 3.63) OG0042.44(1.78 to 3.33) OG0051.87(1.36 to 2.57) OG0062.84(2.02 to 3.99) OG0073.04(2.38 to 3.88) OG0082.84(2.1 to 3.85) OG0091.76(1.29 to 2.38) OG0102.14(1.59 to 2.89) OG0112.84(2.06 to 3.89)

Title	Measurements
	OG0000.71(0.55 to 0.92) OG0010.63(0.5 to 0.8) OG0020.55(0.44 to 0.69) OG0030.63(0.47 to 0.85) OG0040.72(0.55 to 0.95) OG0050.64(0.49 to 0.83) OG0060.72(0.55 to 0.93) OG0070.73(0.55 to 0.98) OG0080.62(0.47 to 0.82) OG0090.52(0.39 to 0.68) OG0100.6(0.48 to 0.76) OG0110.84(0.64 to 1.11)

Title	Measurements
	OG0004.09(3.2 to 5.22) OG0013.65(2.76 to 4.84) OG0023.22(2.36 to 4.39) OG0034.05(2.99 to 5.5) OG0043.63(2.84 to 4.62) OG0053.41(2.46 to 4.71) OG0064.04(3.05 to 5.36) OG0074.08(3.11 to 5.36) OG0084.07(3.09 to 5.35) OG0093.27(2.51 to 4.25) OG0103.31(2.66 to 4.12) OG0114.28(3.23 to 5.68)

Title	Measurements
	OG0000.98(0.74 to 1.29) OG0010.83(0.66 to 1.05) OG0020.76(0.59 to 0.98) OG0030.78(0.61 to 1) OG0040.76(0.58 to 0.99) OG0050.7(0.57 to 0.86) OG0060.83(0.66 to 1.05) OG0070.84(0.67 to 1.04) OG0080.96(0.76 to 1.23) OG0090.59(0.45 to 0.77) OG0100.72(0.57 to 0.91) OG0110.85(0.62 to 1.17)

Title	Measurements
	OG0004.5(3.45 to 5.88) OG0013.9(2.95 to 5.16) OG0024.11(2.91 to 5.81) OG0033.42(2.62 to 4.46) OG0043.33(2.56 to 4.33) OG0053.37(2.46 to 4.6) OG0064.21(3.03 to 5.86) OG0073.92(3.06 to 5.01) OG0084.48(3.48 to 5.77) OG0092.62(1.92 to 3.57) OG0103.58(2.74 to 4.69) OG0114.33(3.26 to 5.76)

Title	Measurements
	OG0000.63(0.48 to 0.82) OG0010.44(0.31 to 0.61) OG0020.54(0.4 to 0.72) OG0030.55(0.4 to 0.77) OG0040.62(0.48 to 0.8) OG0050.6(0.45 to 0.8) OG0060.56(0.42 to 0.75) OG0070.58(0.43 to 0.78) OG0080.67(0.51 to 0.87) OG0090.43(0.33 to 0.56) OG0100.43(0.33 to 0.57) OG0110.61(0.49 to 0.76)

Title	Measurements
	OG0002.75(2.16 to 3.48) OG0011.97(1.41 to 2.74) OG0022.43(1.85 to 3.19) OG0032.13(1.64 to 2.76) OG0042.18(1.69 to 2.81) OG0051.52(0.98 to 2.34) OG0062.16(1.47 to 3.18) OG0072.32(1.6 to 3.36) OG0082.51(1.96 to 3.22) OG0091.74(1.23 to 2.45) OG0101.84(1.36 to 2.49) OG0112.29(1.79 to 2.91)

Title	Measurements
	OG0001.33(1.07 to 1.64) OG0010.96(0.75 to 1.23) OG0020.89(0.74 to 1.07) OG0031.08(0.8 to 1.46) OG0041.1(0.9 to 1.35) OG0051.09(0.89 to 1.34) OG0061.07(0.89 to 1.29) OG0071.31(1.02 to 1.67) OG0081.11(0.83 to 1.49) OG0090.84(0.67 to 1.06) OG0100.98(0.79 to 1.22) OG0110.97(0.76 to 1.24)

Title	Measurements
	OG0005.75(4.59 to 7.21) OG0014.2(3.33 to 5.31) OG0024.2(3.24 to 5.46) OG0034.96(3.77 to 6.54) OG0044.36(3.35 to 5.66) OG0053.93(3.04 to 5.08) OG0065.43(4.13 to 7.14) OG0075.55(4.38 to 7.04) OG0084.93(3.64 to 6.69) OG0093.89(2.98 to 5.1) OG0104.63(3.56 to 6.04) OG0114.52(3.31 to 6.16)

Title	Measurements
	OG0001.07(0.82 to 1.39) OG0010.83(0.67 to 1.02) OG0020.83(0.67 to 1.03) OG0031.03(0.79 to 1.36) OG0041.03(0.81 to 1.3) OG0050.93(0.76 to 1.14) OG0061.09(0.83 to 1.44) OG0070.92(0.76 to 1.12) OG0081.09(0.82 to 1.46) OG0090.74(0.58 to 0.95) OG0100.93(0.76 to 1.14) OG0110.97(0.73 to 1.28)

Title	Measurements
	OG0004.46(3.35 to 5.93) OG0013.3(2.47 to 4.41) OG0023.94(2.8 to 5.54) OG0033.47(2.76 to 4.36) OG0043.16(2.39 to 4.17) OG0053.07(2.32 to 4.07) OG0064.07(3 to 5.52) OG0073.88(3.09 to 4.87) OG0084.05(3.18 to 5.15) OG0093.11(2.36 to 4.09) OG0103.49(2.68 to 4.56) OG0113.9(2.86 to 5.3)

Title	Measurements
	OG0001.76(1.23 to 2.51) OG0011.74(1.25 to 2.41) OG0021.06(0.71 to 1.57) OG0031.31(0.99 to 1.74) OG0041.7(1.18 to 2.44) OG0051.73(1.29 to 2.33) OG0061.6(1.06 to 2.39) OG0071.93(1.47 to 2.53) OG0081.95(1.28 to 2.95) OG0091.18(0.85 to 1.64) OG0101.53(1.08 to 2.16) OG0111.86(1.38 to 2.52)

Title	Measurements
	OG0006.02(4.47 to 8.12) OG0015.62(3.99 to 7.92) OG0025.16(3.61 to 7.36) OG0034.54(3.45 to 5.98) OG0045.08(3.8 to 6.8) OG0054.61(3.37 to 6.3) OG0066.03(4.18 to 8.7) OG0076.56(5.06 to 8.51) OG0086.3(4.45 to 8.92) OG0094.72(3.56 to 6.27) OG0105.52(4.13 to 7.38) OG0115.62(4.23 to 7.48)

Title	Measurements
	OG0001.13(0.88 to 1.47) OG0011.03(0.81 to 1.32) OG0020.96(0.73 to 1.26) OG0031.08(0.82 to 1.41) OG0041.1(0.86 to 1.39) OG0051.03(0.8 to 1.31) OG0061.12(0.87 to 1.43) OG0071.39(1.08 to 1.79) OG0081.23(0.93 to 1.63) OG0090.91(0.67 to 1.23) OG0101.14(0.92 to 1.41) OG0111.31(1.01 to 1.69)

Title	Measurements
	OG0009.35(7.13 to 12.25) OG0018.06(5.93 to 10.96) OG0027.78(5.53 to 10.93) OG0038.23(6.37 to 10.65) OG0047.16(5.41 to 9.46) OG0057.1(5.33 to 9.46) OG0067.15(5.13 to 9.96) OG00711.29(7.96 to 16) OG0088.68(6.41 to 11.75) OG0096.18(4.65 to 8.2) OG0108.66(6.76 to 11.09) OG0118.17(5.8 to 11.52)

Title	Measurements
	OG0001.94(1.46 to 2.57) OG0011.66(1.28 to 2.17) OG0021.72(1.23 to 2.39) OG0031.58(1.14 to 2.19) OG0041.54(1.09 to 2.19) OG0051.38(1.09 to 1.75) OG0061.25(0.96 to 1.63) OG0071.7(1.27 to 2.26) OG0081.9(1.38 to 2.62) OG0091.56(1.14 to 2.13) OG0101.51(1.15 to 2) OG0111.72(1.31 to 2.27)

Title	Measurements
	OG0006.9(4.89 to 9.72) OG0016.64(5.17 to 8.54) OG0026.91(4.88 to 9.77) OG0035.35(3.84 to 7.47) OG0045.27(3.64 to 7.64) OG0055.57(4.14 to 7.51) OG0065.24(3.66 to 7.49) OG0077.26(5.28 to 9.97) OG0087.34(5.55 to 9.73) OG0095.94(4.43 to 7.97) OG0105.54(3.88 to 7.93) OG0116.66(4.92 to 9.01)

Title	Measurements
	OG0000.65(0.45 to 0.94) OG0010.64(0.52 to 0.79) OG0020.41(0.28 to 0.58) OG0030.55(0.39 to 0.77) OG0040.5(0.34 to 0.72) OG0050.65(0.5 to 0.84) OG0060.61(0.45 to 0.81) OG0070.69(0.51 to 0.92) OG0080.58(0.43 to 0.79) OG0090.47(0.34 to 0.65) OG0100.43(0.3 to 0.62) OG0110.52(0.37 to 0.74)

Title	Measurements
	OG0003.72(2.6 to 5.33) OG0013.08(2.25 to 4.21) OG0022.59(1.63 to 4.11) OG0032.93(2.05 to 4.19) OG0042.16(1.4 to 3.33) OG0052.74(2.06 to 3.65) OG0063.12(2.17 to 4.48) OG0073.17(2.34 to 4.31) OG0083.33(2.36 to 4.7) OG0092.5(1.76 to 3.56) OG0102.53(1.74 to 3.68) OG0113.15(2.31 to 4.3)

Title	Measurements
	OG0000.31(0.21 to 0.46) OG0010.18(0.12 to 0.27) OG0020.25(0.17 to 0.37) OG0030.26(0.18 to 0.39) OG0040.32(0.23 to 0.43) OG0050.32(0.21 to 0.49) OG0060.26(0.17 to 0.4) OG0070.28(0.19 to 0.43) OG0080.34(0.24 to 0.49) OG0090.19(0.13 to 0.27) OG0100.22(0.16 to 0.31) OG0110.24(0.17 to 0.35)

Title	Measurements
	OG0001.36(0.93 to 1.97) OG0010.86(0.56 to 1.34) OG0021.14(0.72 to 1.79) OG0030.89(0.57 to 1.39) OG0041.09(0.78 to 1.54) OG0050.74(0.49 to 1.12) OG0061.03(0.61 to 1.74) OG0070.99(0.66 to 1.48) OG0081.4(0.97 to 2.01) OG0090.81(0.53 to 1.23) OG0100.87(0.59 to 1.29) OG0110.98(0.67 to 1.43)

Title	Measurements
	OG0000.28(0.19 to 0.42) OG0010.23(0.16 to 0.32) OG0020.22(0.15 to 0.32) OG0030.24(0.16 to 0.36) OG0040.2(0.14 to 0.3) OG0050.24(0.17 to 0.33) OG0060.15(0.11 to 0.2) OG0070.2(0.14 to 0.3) OG0080.28(0.19 to 0.4) OG0090.21(0.15 to 0.3) OG0100.19(0.13 to 0.28) OG0110.24(0.16 to 0.36)

Title	Measurements
	OG0001.11(0.67 to 1.83) OG0011.1(0.78 to 1.56) OG0021.05(0.66 to 1.69) OG0030.75(0.48 to 1.15) OG0040.66(0.4 to 1.1) OG0050.95(0.61 to 1.48) OG0060.67(0.43 to 1.04) OG0070.93(0.58 to 1.47) OG0080.97(0.61 to 1.53) OG0090.74(0.49 to 1.1) OG0100.63(0.37 to 1.09) OG0111.11(0.71 to 1.74)

Title	Measurements
	OG000346.2(96.8 to 1237.9) OG001296.3(31 to 2828.6) OG002316.4(96.8 to 1034.8) OG003158(10.2 to 2438.7) OG004248(67.5 to 911.1) OG005344.4(105.7 to 1122.1) OG006388.2(134.4 to 1121.8) OG007546.2(75.4 to 3956.8) OG008627(37 to 10621.6) OG009120.6(10.8 to 1346.5) OG010736.3(184.7 to 2934.6) OG011887.6(226.3 to 3481.1)

Title	Measurements
	OG00034(0.7 to 1751.4) OG00180.2(3.1 to 2046.3) OG0024(4 to 4) OG0039(9 to 9) OG004407.6(178.5 to 930.7) OG00574.2(10.1 to 546.3) OG00698.1(13.7 to 703) OG00752.4(4 to 681.7) OG00815.2(2.9 to 80.3) OG00925.9(3 to 227) OG01056.3(7.2 to 442) OG011161.8(14.5 to 1807.7)

Title	Measurements
	OG000928.1(309.6 to 2781.8) OG001865.8(48.5 to 15451.2) OG0022213.4(438.4 to 11174.3) OG0032096.7(828.7 to 5304.9) OG0041037.5(310.2 to 3469.2) OG0051096.7(266.3 to 4516.1) OG0061953.4(972.9 to 3922.2) OG0071149.8(209.9 to 6297.3) OG0081414.1(738.6 to 2707.3) OG009548.3(15 to 20011.5) OG0101885.9(1047.9 to 3394) OG011854.4(51.9 to 14066.3)

Title	Measurements
	OG00012.9(4.6 to 36.3) OG0019.2(3.2 to 26.5) OG0028.2(0.4 to 185) OG00319(0.5 to 699.8) OG00417.5(4 to 76) OG00510.8(2.8 to 41.7) OG0067.6(2.6 to 21.8) OG00712.7(1.4 to 114.2) OG0089.8(3.7 to 26) OG0095.7(3.3 to 10.1) OG0107.4(4.5 to 12.3) OG01122.2(6.4 to 77)

Title	Measurements
	OG000131.8(77.7 to 223.6) OG00193.3(15.5 to 562.2) OG002241.7(19.1 to 3061.6) OG00379(7.6 to 826.1) OG004114.1(17.2 to 758.5) OG005165.8(75.4 to 364.8) OG00699.5(36.2 to 273.8) OG007128.9(16.8 to 989.4) OG008184.6(20.4 to 1671.3) OG00942.2(6.3 to 283) OG010125.3(43.6 to 360.3) OG011149.7(27.8 to 806)

Title	Measurements
	OG00096.1(0.1 to 90019.7) OG001237.2(86.5 to 650.7) OG00284.3(0.1 to 63745.1) OG00313.3(0 to 54806323) OG004289.4(9.8 to 8513.4) OG005208.9(12.9 to 3385.1) OG00616.4(1.2 to 229.5) OG00713.7(0 to 86126942) OG008182.5(18.9 to 1765.4) OG009127.7(6.1 to 2672.4) OG010105.6(22.7 to 492.5) OG011239(239 to 239)

Title	Measurements
	OG000745.6(129.8 to 4282.1) OG001606.2(42 to 8748.2) OG002769.1(98.3 to 6016.6) OG003694.2(296.4 to 1626.1) OG004553.1(61.9 to 4943.5) OG0051021.6(405.4 to 2574.3) OG006237.6(50.1 to 1127.3) OG007173.1(2 to 14809) OG0081047.8(203.5 to 5394.1) OG009431.5(26.4 to 7055.2) OG010904.3(416.8 to 1961.9) OG011376.5(92.7 to 1529.8)

Title	Measurements
	OG0002076(972 to 4433.7) OG0011777.3(826.6 to 3821.5) OG0021762.5(499.8 to 6215) OG0031729.9(44.7 to 66995.8) OG0045343.2(1372.2 to 20805) OG0053522.8(1918.3 to 6469.5) OG0062563(1240.6 to 5295.2) OG0071152(421.9 to 3145.6) OG0081263.5(941.3 to 1696) OG0091290.9(705 to 2363.9) OG0102256.2(1405.5 to 3622) OG0111744.7(1196.4 to 2544.2)

Title	Measurements
	OG00016259.9(3902.8 to 67742.7) OG0014591.4(1411.4 to 14936.5) OG00212162.6(776.4 to 190521.8) OG00311741(6560.1 to 21013.7) OG0049941.8(8127.1 to 12161.8) OG0055744.5(1641 to 20109.7) OG00614362.4(7145.2 to 28869.5) OG0073565.8(921.7 to 13795.9) OG0085829.1(2843 to 11951.8) OG00911414.1(394.1 to 330587.3) OG01021670(6757.9 to 69487.8) OG0117567.3(2674.9 to 21408.2)

Title	Measurements
	OG000830(289.3 to 2381) OG0011283.8(523.1 to 3150.9) OG002649.4(55.7 to 7568.6) OG0031302.7(463.1 to 3664.3) OG0041423.6(322.4 to 6284.8) OG0051081.9(332.8 to 3517.5) OG0061075.2(296.2 to 3903.4) OG007282.1(31.3 to 2546.4) OG0081571.3(115.1 to 21457.3) OG009567.4(200.7 to 1604.5) OG010480.9(277.4 to 833.4) OG011738.7(380.4 to 1434.4)

Title	Measurements
	OG0004969(1397.5 to 17668) OG0017041.7(275.3 to 180111.2) OG0024756.1(1023.5 to 22100.8) OG0034190.8(2825.5 to 6215.9) OG0043772.9(80.6 to 176558.2) OG0054970.9(936.8 to 26377) OG0064218.9(1894.6 to 9394.3) OG0072919.8(474 to 17985) OG0088601.7(382.8 to 193287.2) OG009856.6(128.2 to 5724.3) OG0107262.2(2971.8 to 17746.7) OG0111340.1(362 to 4961.2)

Title	Measurements
	OG000149.2(9.9 to 2241.1) OG001255.1(16.7 to 3888.7) OG00247.2(0 to 99999.9) OG003737.1(1.4 to 400658.5) OG004791.7(200.6 to 3124.5) OG005539.2(251.1 to 1157.8) OG006295(23.9 to 3647.4) OG007255.9(99.2 to 660.2) OG008382.6(115.3 to 1269.1) OG00998.3(15.8 to 613) OG010260.7(132.9 to 511.3) OG011195.4(12.5 to 3045.4)

Title	Measurements
	OG0001592.9(687.7 to 3689.5) OG001671.4(14.8 to 30474.3) OG0024426.6(692.4 to 28298.7) OG0031507.6(358 to 6348.6) OG0042002(134.3 to 29839.5) OG0051312.4(226.7 to 7597.8) OG0061498.1(672.9 to 3335.6) OG007935.3(301.9 to 2897.7) OG0083817(1256.3 to 11596.8) OG009557.5(17.8 to 17418.8) OG0102288(761.1 to 6878.7) OG011587.5(42.6 to 8103.2)

Title	Measurements
	OG0007.2(1.1 to 45.6) OG0017.2(1.4 to 35.9) OG0024(4 to 4) OG00311.5(0 to 7631549) OG00421.9(2.3 to 205.5) OG00510.9(3.2 to 37.4) OG00631.9(5.9 to 174) OG0079.4(3.4 to 25.9) OG0085.5(2 to 14.8) OG0096.5(3.1 to 13.6) OG01019.1(6.5 to 56.3) OG01114(2.7 to 71.5)

Title	Measurements
	OG000912.9(365.4 to 2280.6) OG001207.3(2.1 to 20168.5) OG0022394.7(2.7 to 2123879) OG003397.3(71.5 to 2207.5) OG004650.6(82.6 to 5122.3) OG005298.1(14.4 to 6180.8) OG006428.6(155.3 to 1183.2) OG007707.9(6.7 to 74589.3) OG008481.3(128.3 to 1804.6) OG009149.9(2.8 to 8106) OG010888.9(225.5 to 3502.9) OG011242.7(24.7 to 2382.5)

Title	Measurements
	OG00063(10.7 to 370.1) OG00132.1(4.2 to 247.3) OG00288.5(0.7 to 11624.3) OG0039.7(0.2 to 438) OG00417.7(1.4 to 226.2) OG00567.8(19 to 242.3) OG00615(5.7 to 39.2) OG00724.2(5.9 to 98.4) OG00853.2(7.7 to 365.3) OG00911(5 to 24.3) OG01042.3(16.4 to 109.6) OG01148.4(12.9 to 181.2)

Title	Measurements
	OG0001112.9(289.7 to 4274.9) OG001330.5(32.2 to 3390.7) OG0022575.2(120.5 to 55029.6) OG003637.1(262.3 to 1547.9) OG0041040.7(12 to 90618.7) OG0051575(246.7 to 10054.3) OG006572.7(332.3 to 986.9) OG007273.9(0 to 2588316) OG008250.6(70.4 to 892.1) OG009163.3(8.6 to 3091.2) OG0101215.3(222.2 to 6647.8) OG011511(59.2 to 4412.4)

Title	Measurements
	OG00027.9(1 to 771.2) OG001132.4(2.3 to 7484.5) OG00222.2(0 to 35490.8) OG00329.7(0 to 99999.9) OG004134(2.2 to 8194.2) OG005396.6(19.4 to 8113.1) OG006499.7(54.2 to 4605.6) OG00730.5(0 to 190610.3) OG00815.6(1.1 to 212.9) OG00989.4(4.8 to 1668.6) OG010274.5(30.2 to 2491.4) OG01137.7(0.8 to 1716.9)

Title	Measurements
	OG000581(14.5 to 23210.4) OG0012381.5(861.8 to 6581) OG0022792.9(391 to 19949.8) OG0032977.7(687.2 to 12903.5) OG0042096.1(823.2 to 5337.4) OG0053530.1(1606.2 to 7758.5) OG0064249.1(2398 to 7529.2) OG0073682.7(1187 to 11426) OG0081464.1(437.9 to 4895.2) OG009297(2 to 44387.7) OG0101436.2(114.1 to 18085.7) OG011875.2(92.2 to 8311)

Title	Measurements
	OG00039.8(0.6 to 2715.5) OG00145.1(2.8 to 721.4) OG00213.4(0.1 to 2451) OG003239.5(21.3 to 2696.8) OG004224.8(41.3 to 1222.9) OG00599(12.8 to 765.5) OG00623.3(3 to 180.7) OG00734.1(1.5 to 760.2) OG00858.3(1.3 to 2537.6) OG00946.7(5.1 to 428.4) OG01084(11.2 to 631.4) OG01124.5(4.1 to 148.1)

Title	Measurements
	OG000183.7(7.3 to 4625.8) OG001125.4(14 to 1123.6) OG002318.4(160.1 to 632.9) OG003581.1(220.5 to 1531.4) OG00474.5(0.1 to 40934.6) OG005169.2(2.9 to 9717.7) OG00698.1(21 to 458.5) OG007106.9(6.5 to 1749.7) OG008120(0.1 to 185061.8) OG009154(8.4 to 2814.5) OG010159.1(9.9 to 2554.8) OG01178.5(10.4 to 592.3)

Title	Measurements
	OG000363.7(0 to 5716540) OG0014(4 to 4) OG00221.2(0 to 99999.9) OG00328(0.4 to 1990.5) OG00429.8(0 to 169123.8) OG005325.4(1.9 to 56037.4) OG006125.7(25.1 to 627.8) OG007253(253 to 253) OG00812.8(0 to 33779569) OG00944.3(0.2 to 11784.5) OG010416.5(108.9 to 1593) OG011541.6(22 to 13332.7)

Title	Measurements
	OG0002069(1639.7 to 2610.8) OG0011980.1(1484.1 to 2641.8) OG0021907.5(1330.9 to 2733.9) OG0031888.7(1349.3 to 2643.6) OG0041664.8(1283 to 2160.2) OG0051540.7(1108.6 to 2141.2) OG0062319.7(1701.9 to 3161.8) OG0071953.1(1541.5 to 2474.5) OG0082285.5(1724.1 to 3029.7) OG0091482.7(1077.1 to 2040.9) OG0101517.3(1134.5 to 2029.2) OG0112082.5(1634.9 to 2652.5)

Title	Measurements
	OG0007.492(5.932 to 9.463) OG0015.257(4.033 to 6.853) OG0027.57(5.512 to 10.396) OG0035.926(4.752 to 7.39) OG0045.831(4.642 to 7.324) OG0056.486(4.778 to 8.805) OG0067.059(5.455 to 9.136) OG0077.226(5.872 to 8.892) OG0088.206(6.869 to 9.802) OG0097.238(5.322 to 9.845) OG0106.477(5.069 to 8.277) OG0116.749(4.931 to 9.237)

Title	Measurements
	OG0000.838(0.661 to 1.062) OG0010.735(0.573 to 0.944) OG0020.66(0.519 to 0.839) OG0030.681(0.538 to 0.862) OG0040.868(0.668 to 1.13) OG0050.692(0.531 to 0.901) OG0060.843(0.661 to 1.076) OG0070.883(0.686 to 1.136) OG0080.858(0.671 to 1.097) OG0090.666(0.523 to 0.849) OG0100.698(0.538 to 0.907) OG0110.9(0.707 to 1.146)

Title	Measurements
	OG0008.03(6.347 to 10.159) OG0016.887(5.372 to 8.829) OG0027.283(5.179 to 10.243) OG0037.092(5.734 to 8.772) OG0047.269(5.916 to 8.932) OG0056.522(4.886 to 8.707) OG0067.095(5.32 to 9.461) OG00710.8(8.799 to 13.254) OG0089.045(7.659 to 10.681) OG0096.491(4.93 to 8.546) OG0107.431(5.672 to 9.736) OG0117.423(5.625 to 9.796)

Title	Measurements
	OG00073.8(58.9 to 92.5) OG00164.4(50.4 to 82.3) OG00256.6(39.9 to 80.5) OG00372.3(57.7 to 90.6) OG00475.5(59.4 to 95.9) OG00574.8(56.9 to 98.2) OG00663.4(48 to 83.6) OG00774.9(60 to 93.4) OG00897.6(82.5 to 115.5) OG00959.4(46.8 to 75.2) OG01066.8(50.6 to 88.3) OG01157(42.2 to 77.1)

Title	Measurements
	OG00046.1(36.7 to 57.9) OG00142.6(34.5 to 52.6) OG00242.6(33.3 to 54.5) OG00353.8(40.2 to 72.2) OG00459.3(44.1 to 79.8) OG00557.7(41.7 to 79.9) OG00657.9(42.5 to 78.8) OG00745.7(36.3 to 57.6) OG00859.1(46.4 to 75.1) OG00950.8(42.1 to 61.3) OG01048.5(39.7 to 59.3) OG01152.9(39.1 to 71.7)

Title	Measurements
	OG000308.8(247.1 to 385.9) OG001252.7(195.1 to 327.4) OG002327.2(240.9 to 444.4) OG003359.8(289.2 to 447.6) OG004322.9(252.2 to 413.4) OG005332.7(250.9 to 441.2) OG006312.3(238.7 to 408.8) OG007338.6(270.3 to 424.3) OG008442.8(370.6 to 529) OG009321(246.5 to 417.9) OG010332.9(258.2 to 429.3) OG011294.2(224.3 to 385.9)

Title	Measurements
	OG00015.7(11.8 to 21.1) OG00116(12.9 to 19.9) OG00218.3(13.8 to 24.4) OG00322.4(16.5 to 30.5) OG00425.1(18.5 to 34) OG00516(11.6 to 22.1) OG00619.4(13.5 to 27.9) OG00718.8(14.1 to 24.9) OG00827.3(20.9 to 35.7) OG00920.1(14.7 to 27.6) OG01019.7(14.6 to 26.7) OG01120.3(14.3 to 29)

Title	Measurements
	OG000218.6(162.4 to 294.3) OG001173.5(131 to 229.8) OG002225.9(145.9 to 349.8) OG003262.9(196.5 to 351.7) OG004246.2(182.5 to 332) OG005184.3(122.6 to 277.1) OG006226.7(162.6 to 316.1) OG007255.7(189.9 to 344.3) OG008330.4(263.9 to 413.7) OG009205.1(148.5 to 283.5) OG010214.2(151.8 to 302.3) OG011213.6(151.2 to 301.8)

Title	Measurements
	OG0001949.42(1220.13 to 3114.61) OG0011898.54(1147.47 to 3141.21) OG0021970.6(1017.24 to 3817.44) OG0031685.87(1012.93 to 2805.87) OG0042492.42(1638.97 to 3790.27) OG0052107.75(1257.97 to 3531.56) OG0061851.22(1033.84 to 3314.85) OG0072579.59(1575.91 to 4222.52) OG0083244.33(2235.34 to 4708.75) OG0092078.63(1261.91 to 3423.92) OG0102003.09(1040.72 to 3855.37) OG0112218.23(1219.17 to 4035.97)

Title	Measurements
	OG00021.964(15.76 to 30.61) OG00117.484(11.592 to 26.37) OG00221.277(12.268 to 36.901) OG00320.28(13.96 to 29.462) OG00418.987(13.365 to 26.973) OG00517.544(11.966 to 25.722) OG00620.659(14.948 to 28.55) OG00733.45(23.717 to 47.176) OG00822.083(14.795 to 32.961) OG00916.682(11.367 to 24.481) OG01021.602(14.406 to 32.392) OG01123.277(16.047 to 33.765)

Title	Measurements
	OG0001378.2(682.4 to 2783.4) OG001790.7(75.3 to 8304.9) OG002429.9(35.6 to 5190.7) OG0031824.5(831.6 to 4003) OG004388(60.4 to 2494.6) OG005543.9(79.4 to 3726.3) OG0061217.7(327.7 to 4525.4) OG0074(4 to 4) OG0081075.9(546.1 to 2119.8) OG0091290.1(455.8 to 3651.2) OG0101448.1(148.5 to 14125.5) OG011861.1(74.6 to 9935)

Title	Measurements
	OG000120.8(27 to 540.4) OG00160.8(17.8 to 207) OG00248.3(16.3 to 143.4) OG003292.1(61.3 to 1391.9) OG00441.7(19.6 to 88.5) OG0058(0 to 53461.2) OG006134.8(54.1 to 336.1) OG007119.6(25.8 to 553.9) OG008156.1(65.7 to 371) OG00929.7(10.5 to 83.9) OG010139.6(106 to 183.9) OG011168.9(73.8 to 386.4)

Title	Measurements
	OG0001949(844.4 to 4498.6) OG0011217.7(101.3 to 14638.5) OG002548.7(41.2 to 7308) OG0032151.9(715.2 to 6474.4) OG004512.5(131.8 to 1993.2) OG005542.4(41.7 to 7057.5) OG0061217.7(195.5 to 7583) OG007434.1(0 to 999999) OG0081393.4(731.1 to 2655.7) OG0092047.9(1068.3 to 3925.7) OG0101625.4(270.8 to 9756.8) OG0111116.6(126.6 to 9848.8)

Title	Measurements
	OG00072(18.9 to 273.5) OG00186(33.8 to 218.9) OG002127.8(30.6 to 534.2) OG003205.4(52.5 to 804.1) OG00445.3(14.2 to 144.4) OG00545.2(19.1 to 106.8) OG00670(31.6 to 155.4) OG007139.6(30.5 to 638.7) OG008128(75.8 to 216.3) OG00996.5(12.3 to 758.1) OG010108.1(62.5 to 186.8) OG01169.7(2.2 to 2175.5)

Title	Measurements
	OG000861(363.5 to 2039.4) OG0011724.5(66.3 to 44854.5) OG002359.5(8.4 to 15474.7) OG0033649.1(1721.5 to 7735.1) OG004588.1(44 to 7860.3) OG0051152.5(123.7 to 10737.5) OG006558.3(140.6 to 2216.3) OG007724.1(0 to 999999) OG0082233.3(1122.1 to 4445) OG0092195(889 to 5419.4) OG0101625.4(436.4 to 6054.1) OG0112048(2048 to 2048)

ID	Term
D013290	Streptococcal Infections
D005334	Fever
D011008	Pneumococcal Infections

ID	Term
C541235	diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine
D007052	Ibuprofen
D000082	Acetaminophen