Study Evaluating 13-valent Pneumococcal Conjugate Vaccine... | NCT00444457

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine... | NCT00444457 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
2	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
3	Experimental	Biological: 13-valent Pneumococcal Conjugate Vaccine
4	Active Comparator	Biological: 7vPnC

Name	Type	Description	Arm Group Labels	Other Names
13-valent Pneumococcal Conjugate Vaccine	Biological	0.5 mL of study vaccine administered IM at 2, 4, 6, and 12 months of age.	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series	Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.	1 Month after the infant series (7 Months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series	Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.	1 month after the infant series (7 months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series	Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.	1 month after the infant series (7 months of age)
Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series	Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Other Outcomes

Measure	Description	Time Frame
Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)	Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23584582	Derived	Payton T, Girgenti D, Frenck RW, Patterson S, Love J, Razmpour A, Sidhu MS, Emini EA, Gruber WC, Scott DA. Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States. Pediatr Infect Dis J. 2013 Aug;32(8):871-80. doi: 10.1097/INF.0b013e3182906499.
23104129

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Other		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Parent or legal guardian request		FG00018 subjects FG00129 subjects FG00234 subjects FG00314 subjects
Lost to Follow-up		FG00010 subjects FG00111 subjects FG0027 subjects FG0036 subjects
Protocol Violation		FG00016 subjects FG0018 subjects FG0026 subjects FG0033 subjects
Failed to return		FG0005 subjects FG0014 subjects FG0024 subjects FG0032 subjects
Investigator request		FG0004 subjects FG0013 subjects FG0023 subjects FG0032 subjects
Other		FG0000 subjects FG0012 subjects FG0024 subjects FG0030 subjects
Adverse Event		FG0001 subjects FG0012 subjects FG0022 subjects FG0030 subjects
Death		FG0000 subjects FG0011 subjects FG0021 subjects FG0031 subjects

After Infant Series

Type	Comment	Milestone Data
STARTED		FG000435 subjects FG001427 subjects FG002427 subjects FG003218 subjects
COMPLETED		FG000415 subjectsNot completed=Withdrawn after infant series FG001397 subjectsNot completed=Withdrawn after infant series FG002408 subjectsNot completed=Withdrawn after infant series FG003
NOT COMPLETED		FG00020 subjects FG00130 subjects FG00219 subjects FG00310 subjects

Type	Comment	Reasons
Other		FG0000 subjects FG0011 subjects FG0021 subjects FG003

Toddler Dose

Type	Comment	Milestone Data
STARTED		FG000415 subjectsVaccinated toddler dose FG001397 subjectsVaccinated toddler dose FG002408 subjectsVaccinated toddler dose FG003208 subjectsVaccinated toddler dose
COMPLETED		FG000408 subjects FG001391 subjects FG002404 subjects FG003200 subjects
NOT COMPLETED		FG0007 subjects FG0016 subjects FG0024 subjects FG0038 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0004 subjects FG0011 subjects FG0021 subjects FG003

Arm/Group Information

ID	Title	Description
BG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
BG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
BG002	13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
BG003	7vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

months

Title

Denominators

Categories

Title	Measurements
	BG0002.2± 0.3 BG0012.2± 0.3 BG0022.2± 0.3 BG003

Sex/Gender, Customized

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000230 BG001226 BG002

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

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Infant Series

Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations; (n)=number of participants with IgG antibody concentration to given serotype for the three 13vPnC lots, respectively.

Posted

Geometric Mean

95% Confidence Interval

GMC mcg/mL

1 Month after the infant series (7 Months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
OG002	13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Units	Counts
Participants	OG000435 OG001427 OG002427

Title

Denominators

Categories

Common serotypes - serotype 4 (n=411, 404, 398)

Title	Measurements
	OG0001.33(1.24 to 1.43) OG0011.34(1.25 to 1.44) OG0021.75(1.63 to 1.88)

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 OG001	Common serotypes - serotype 4					difference in log-transformed GM	-0.01			2-Sided	95	-0.11	0.09			2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	Yes	Non-Inferiority or Equivalence	The 3 lots were considered equivalent if the maximum difference between any 2 lots is less than 0.693 and greater than -0.693 using the equivalence testing procedure for 3 vaccine groups given by Wiens and Iglewicz, for all 13 serotypes.

Primary

Percentage of Participants Achieving Predefined Antibody Level ≥0.1 International Units Per Milliliter (IU/mL) for Tetanus Toxoid in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.1 IU/ mL along with the corresponding 95% CI for concomitant antigen tetanus toxoid are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

Evaluable immunogenicity population. Combined 13vPnC group includes participants who received pilot lot 1, pilot lot 2, or manufacturing lot; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the infant series (7 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Primary

Percentage of Participants Achieving Predefined Antibody Level ≥1:8 for Poliovirus in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥1:8 along with the corresponding 95% CI for concomitant antigen poliovirus type 1, type 2, and type 3 (Sabin strains 1, 2, 3) are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component; n)=number of participants with an antibody titer ≥ prespecified level for given concomitant vaccine antigen for combined 13vPnC and 7vPnC, respectively.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the infant series (7 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Primary

Percentage of Participants Achieving Predefined Antibody Level ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B in the Combined 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥10.0 mIU/ mL along with the corresponding 95% CI for concomitant antigen hepatitis B are presented. Exact 2-sided CI was based on the observed proportion of participants. Combined 13vPnC group includes participants randomized to pilot lot 1, pilot lot 2, or the manufacturing lot.

Evaluable immunogenicity population; N=number of participants analyzed with a determinate post-third dose IgG antibody concentration to the given concomitant vaccine component.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the infant series (7 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Secondary

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the infant series (7 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Secondary

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose

Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the toddler dose (13 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Secondary

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Combined 13vPnC Group 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold ≥1.00 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.

Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the combined 13vPnC lot.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the infant series (7 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Secondary

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.00 Mcg/mL in the Three 13vPnC Groups 1 Month After the Toddler Dose

Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.

Posted

Number

95% Confidence Interval

observed percentage of participants

1 month after the toddler dose (13 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Secondary

Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in the Three 13vPnC Groups 1 Month After the Toddler Dose

Antibody geometric mean concentration (GMC) as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Evaluable immunogenicity population; (n)=number of subjects with a determinate IgG antibody concentration to the given serotype for the three 13vPnC lots, respectively.

Posted

Geometric Mean

95% Confidence Interval

GMC mcg/mL

1 month after the toddler dose (13 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Other Pre-specified

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any local reactions; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.

Posted

Number

percentage of participants

Within 7 days after dose (2 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

Posted

Number

percentage of participants

Within 7 days after dose (4 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Local Reactions in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

Posted

Number

percentage of participants

Within 7 days after dose (6 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Local Reactions in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.

Posted

Number

percentage of participants

Within 7 days after dose (12 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.

Other Pre-specified

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 1 (2 Months of Age)

Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting any systemic events; (n)=number of participants reporting yes for at least 1 day or no for all days for the three 13vPnC groups and 7vPnC, respectively.

Posted

Number

percentage of participants

Within 7 days after dose (2 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 2 (4 Months of Age)

Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep, and hives [urticaria]) were reported using an electronic diary. Participants may be represented in more than 1 category.

Posted

Number

percentage of participants

Within 7 days after dose (4 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Systemic Events in the Three 13vPnC Groups and 7vPnC Group: Infant Series Dose 3 (6 Months of Age)

Posted

Number

percentage of participants

Within 7 days after dose (6 months of age)

ID	Title	Description
OG000	13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
OG001	13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).

Other Pre-specified

Percentage of Participants Reporting Systemic Events in the Combined 13vPnC Group and 7vPnC Group: Toddler Dose (12 Months of Age)

Posted

Number

percentage of participants

Within 7 days after dose (12 months of age)

ID	Title	Description
OG000	Combined 13vPnC	Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
OG001

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Infant Series 13vPnC (Pilot Lot 1)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373.	13	486	407	486
EG001	Infant Series 13vPnC (Pilot Lot 2)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364.	23	483	394	483
EG002	Infant Series 13vPnC (Manufacturing Lot)	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386.	17	483	402	483
EG003	Infant Series 7vPnC	Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198.	15	244	207	244
EG004	After the Infant Series Combined 13vPnC	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).	25	1,445	88	1,445
EG005	After the Infant Series 7vPnC	Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).	3	244	11	244
EG006	Toddler Dose Combined 13vPnC	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771.	9	1,210	771	1,210
EG007	Toddler Dose 7vPnC	Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age. Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128.	1	208	128	208
EG008	Post Toddler Dose 6-Month Follow-up Combined 13vPnC	Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).	21	1,443	37	1,443
EG009	Post Toddler Dose 6-Month Follow-up 7vPnC	Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).	7	244	9	244

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG0030 affected244 at risk EG0041 affected1,445 at risk EG0051 affected244 at risk EG0060 affected1,210 at risk EG0070 affected208 at risk EG0080 affected1,443 at risk EG0090 affected244 at risk
Cyanosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Pulmonary valve stenosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Dacryostenosis acquired	Eye disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Intussusception	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Sudden infant death syndrome	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Irritability	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Injection site rash	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Allergy to vaccine	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Food allergy	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected486 at risk EG0012 affected483 at risk EG0024 affected483 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected486 at risk EG0015 affected483 at risk EG0024 affected483 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Croup infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Abscess oral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Meningitis aseptic	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Meningitis enteroviral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Urosepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Eczema herpeticum	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Herpangina	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Impetigo	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Skin infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cellulitis pharyngeal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Rectal abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Viral rash	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Otitis media acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Near drowning	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Foreign body trauma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0023 affected483 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected486 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Apparent life threatening event	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0024 affected483 at risk EG0030 affected244 at risk EG0042 affected1,445 at risk EG0050 affected244 at risk EG0064 affected1,210 at risk EG0071 affected208 at risk EG0080 affected1,443 at risk EG0090 affected244 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cyanosis	Cardiac disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Plagiocephaly	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0009 affected486 at risk EG0016 affected483 at risk EG00211 affected483 at risk EG003
Dacryostenosis congenital	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0013 affected483 at risk EG0021 affected483 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Macrocephaly	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Pectus excavatum	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Ankyloglossia congenital	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Brachycephaly	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Hemihypertrophy	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hip dysplasia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Hypospadias	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Laryngomalacia	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Naevus flammeus	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Pulmonary valve stenosis congenital	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Skull malformation	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Von Willebrand's disease	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Congenital neavus	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tibial torsion	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0006 affected486 at risk EG0017 affected483 at risk EG0026 affected483 at risk EG003
Middle ear effusion	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0012 affected483 at risk EG0024 affected483 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
External ear inflammation	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tympanic membrane disorder	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Precocious puberty	Endocrine disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Conjunctivitis	Eye disorders	MedDRA	Non-systematic Assessment		EG00035 affected486 at risk EG00137 affected483 at risk EG00244 affected483 at risk EG003
Dacryostenosis acquired	Eye disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0013 affected483 at risk EG0022 affected483 at risk EG003
Eye discharge	Eye disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0015 affected483 at risk EG0022 affected483 at risk EG003
Strabismus	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Lacrimation increased	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0021 affected483 at risk EG003
Blepharitis	Eye disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Eye swelling	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Eyelid oedema	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Dark circles under eyes	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Eye irritation	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Heterophoria	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hypermetropia	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Pupillary reflex impaired	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Pupils unequal	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Scleral disorder	Eye disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG00044 affected486 at risk EG00134 affected483 at risk EG00256 affected483 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG00026 affected486 at risk EG00123 affected483 at risk EG00230 affected483 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG00015 affected486 at risk EG00131 affected483 at risk EG00217 affected483 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG00028 affected486 at risk EG00120 affected483 at risk EG00218 affected483 at risk EG003
Teething	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0005 affected486 at risk EG00111 affected483 at risk EG0029 affected483 at risk EG003
Infantile spitting up	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0015 affected483 at risk EG0025 affected483 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0016 affected483 at risk EG0023 affected483 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0010 affected483 at risk EG0025 affected483 at risk EG003
Stomach discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0023 affected483 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0021 affected483 at risk EG003
Abnormal faeces	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Infantile colic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Allergic colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Gingval cyst	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Gingval ulceration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Mouth cyst	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Retching	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Tongue discolouration	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Tongue geographic	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Vomiting projectile	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Anal skin tags	Gastrointestinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pyrexia	General disorders	MedDRA	Non-systematic Assessment		EG00043 affected486 at risk EG00149 affected483 at risk EG00240 affected483 at risk EG003
Irritability	General disorders	MedDRA	Non-systematic Assessment		EG00015 affected486 at risk EG00112 affected483 at risk EG0027 affected483 at risk EG003
Injection site erythema	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0014 affected483 at risk EG0021 affected483 at risk EG003
Injection site swelling	General disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Injection site induration	General disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Injection site pain	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Oedema peripheral	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Xerosis	General disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Injection site reaction	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Cyst	General disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Influenza like illness	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Injection site bruising	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Injection site dryness	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Injection site haemorrhage	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Injection site rash	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Injection site haematoma	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Injection site urticaria	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Developmental delay	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Localised oedema	General disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Milk allergy	Immune system disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0024 affected483 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Food allergy	Immune system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Allergy to vaccine	Immune system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG000194 affected486 at risk EG001187 affected483 at risk EG002204 affected483 at risk EG003
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment		EG000142 affected486 at risk EG001125 affected483 at risk EG002135 affected483 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00072 affected486 at risk EG00175 affected483 at risk EG00266 affected483 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00031 affected486 at risk EG00129 affected483 at risk EG00228 affected483 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00021 affected486 at risk EG00132 affected483 at risk EG00219 affected483 at risk EG003
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG00019 affected486 at risk EG00118 affected483 at risk EG00224 affected483 at risk EG003
Croup infectious	Infections and infestations	MedDRA	Non-systematic Assessment		EG00016 affected486 at risk EG00119 affected483 at risk EG00218 affected483 at risk EG003
Candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00021 affected486 at risk EG00114 affected483 at risk EG00210 affected483 at risk EG003
Sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00016 affected486 at risk EG00115 affected483 at risk EG00211 affected483 at risk EG003
Otitis media acute	Infections and infestations	MedDRA	Non-systematic Assessment		EG00014 affected486 at risk EG00114 affected483 at risk EG00215 affected483 at risk EG003
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00011 affected486 at risk EG00116 affected483 at risk EG00213 affected483 at risk EG003
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG00011 affected486 at risk EG00110 affected483 at risk EG00212 affected483 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0008 affected486 at risk EG0016 affected483 at risk EG0026 affected483 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0007 affected486 at risk EG0017 affected483 at risk EG00210 affected483 at risk EG003
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment		EG0009 affected486 at risk EG00112 affected483 at risk EG0024 affected483 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment		EG0008 affected486 at risk EG0016 affected483 at risk EG00212 affected483 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG00011 affected486 at risk EG00111 affected483 at risk EG0027 affected483 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment		EG00010 affected486 at risk EG0015 affected483 at risk EG0029 affected483 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0006 affected486 at risk EG0015 affected483 at risk EG00210 affected483 at risk EG003
Candida nappy rash	Infections and infestations	MedDRA	Non-systematic Assessment		EG0007 affected486 at risk EG0015 affected483 at risk EG0029 affected483 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0009 affected486 at risk EG0015 affected483 at risk EG0026 affected483 at risk EG003
Ear infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0005 affected486 at risk EG0015 affected483 at risk EG0027 affected483 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0013 affected483 at risk EG0024 affected483 at risk EG003
Viral skin infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0017 affected483 at risk EG0023 affected483 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0006 affected486 at risk EG0016 affected483 at risk EG0020 affected483 at risk EG003
Impetigo	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Skin candida	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0014 affected483 at risk EG0023 affected483 at risk EG003
Conjunctivitis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0023 affected483 at risk EG003
Herpangina	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Roseola	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0014 affected483 at risk EG0022 affected483 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Otitis externa	Infections and infestations	MedDRA	Non-systematic Assessment		EG0005 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dacryocystitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0013 affected483 at risk EG0021 affected483 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Conjunctivitis infective	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Eye infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Intertrigo candida	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Paronychia	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Varicella	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Body tinea	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Dermatophytosis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Fungal infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Gastritis viral	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Hordeolum	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Rash pustular	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Tinea capitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tinea infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Abscess oral	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Breast cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cellulitis of male external genital organ	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Eczema herpeticum	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Eczema infected	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Erysipelas	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Erythema infectiosum	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Folliculitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Furuncle	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Genital candidiasis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Parotitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Rotavirus infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Scarlet fever	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Staphylococcal skin infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Viraemia	Infections and infestations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Wound infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Coxsackie viral infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Viral rash	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hand-foot-and-mouth disease	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Acute tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Adenovirus infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Herpes virus infection	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Lyme disease	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0023 affected483 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0023 affected483 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Chemical burns of eye	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Corneal abrasion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Mouth injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Torus fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Vaccination complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cardiac murmur	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Weight decreased	Investigations	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Cardiac murmur functional	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Head circumference abnormal	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Weight increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
White blood cell count increased	Investigations	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Blood lead increased	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Body height below normal	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Liver function test abnormal	Investigations	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0012 affected483 at risk EG0025 affected483 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Weight gain poor	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Food intolerance	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Feeding disorder neonatal	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Cow's milk intolerance	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Oral intake reduced	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Overweight	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Underweight	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0012 affected483 at risk EG0024 affected483 at risk EG003
Head deformity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Muscle twiching	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Knee deformity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0014 affected483 at risk EG0020 affected483 at risk EG003
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Benign penile neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0012 affected483 at risk EG0020 affected483 at risk EG003
Hypertonia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Head titubation	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Hyporeflexia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hypotonia	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Lethargy	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Psychomotor hyperactivity	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Subdural effusion	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Cerebral cyst	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Speech disorder developmental	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Gross motor delay	Nervous system disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cephalhaematoma	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Neonatal disorder	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Umbilical granuloma	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Crying	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Agitation	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Breath holding	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Restlessness	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Screaming	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Tic	Psychiatric disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Urine odour abnormal	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Vesicoureteric reflux	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Renal tubular acidosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Vulval disorder	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Penile adhesion	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0024 affected483 at risk EG003
Balanitis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Breast cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Genital discomfort	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Gynaecomastia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Genital labial adhesions	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Genital rash	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Penile oedema	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG00059 affected486 at risk EG00152 affected483 at risk EG00251 affected483 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG00043 affected486 at risk EG00148 affected483 at risk EG00234 affected483 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG00021 affected486 at risk EG00125 affected483 at risk EG00218 affected483 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG00018 affected486 at risk EG00110 affected483 at risk EG00215 affected483 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG00011 affected486 at risk EG00111 affected483 at risk EG0028 affected483 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0003 affected486 at risk EG0013 affected483 at risk EG0022 affected483 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0013 affected483 at risk EG0024 affected483 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0011 affected483 at risk EG0022 affected483 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0012 affected483 at risk EG0023 affected483 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0022 affected483 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected483 at risk EG0013 affected483 at risk EG0020 affected483 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Tracheomalacia	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Rhinitis seasonal	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG00045 affected486 at risk EG00128 affected483 at risk EG00242 affected483 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG00034 affected486 at risk EG00113 affected483 at risk EG00230 affected483 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG00022 affected486 at risk EG00120 affected483 at risk EG00218 affected483 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG00012 affected486 at risk EG00112 affected483 at risk EG00211 affected483 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0009 affected486 at risk EG00112 affected483 at risk EG00215 affected483 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG00111 affected483 at risk EG0028 affected483 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0005 affected486 at risk EG0014 affected483 at risk EG0029 affected483 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0017 affected483 at risk EG0027 affected483 at risk EG003
Heat rash	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0013 affected483 at risk EG0028 affected483 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0013 affected483 at risk EG0028 affected483 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0004 affected486 at risk EG0013 affected483 at risk EG0025 affected483 at risk EG003
Dandruff	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0012 affected483 at risk EG0026 affected483 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0005 affected486 at risk EG0014 affected483 at risk EG0022 affected483 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0024 affected483 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Acne infantile	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Petechiae	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0002 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Acanthosis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Post inflammatory pigmentation change	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0021 affected483 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Cafe au lait spots	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dermographism	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Eczema infantile	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pityriasis alba	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Rash neonatal	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0011 affected483 at risk EG0020 affected483 at risk EG003
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0001 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Urticaria papular	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0021 affected483 at risk EG003
Keratosis pilaris	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Acrodermatitis	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Overfeeding of infant	Social circumstances	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0020 affected483 at risk EG003
Haematoma	Vascular disorders	MedDRA	Non-systematic Assessment		EG0000 affected486 at risk EG0010 affected483 at risk EG0022 affected483 at risk EG003
Tenderness (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.	EG000262 affected420 at risk EG001262 affected409 at risk EG002250 affected400 at risk EG003
Tenderness (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Tenderness (any)=present at site of vaccination.	EG000235 affected354 at risk EG001222 affected330 at risk EG002219 affected337 at risk EG003
Tenderness (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Tenderness (any)=present at site of vaccination.	EG000198 affected317 at risk EG001185 affected304 at risk EG002165 affected300 at risk EG003
Tenderness (significant)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.	EG00032 affected348 at risk EG00135 affected337 at risk EG00236 affected345 at risk EG003
Tenderness (significant)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement.	EG00026 affected269 at risk EG00117 affected231 at risk EG00232 affected262 at risk EG003
Tenderness (significant)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement.	EG00022 affected248 at risk EG00117 affected226 at risk EG00224 affected237 at risk EG003
Induration (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.	EG00059 affected356 at risk EG00168 affected347 at risk EG00268 affected352 at risk EG003
Induration (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Induration (any)=present at site of vaccination.	EG00071 affected291 at risk EG00156 affected248 at risk EG00280 affected279 at risk EG003
Induration (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Induration (any)=present at site of vaccination.	EG00071 affected263 at risk EG00159 affected250 at risk EG00275 affected262 at risk EG003
Induration (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.	EG00052 affected353 at risk EG00158 affected344 at risk EG00254 affected348 at risk EG003
Induration (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Induration (mild)=0.5 cm to 2.0 cm.	EG00065 affected288 at risk EG00154 affected246 at risk EG00274 affected276 at risk EG003
Induration (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Induration (mild)=0.5 cm to 2.0 cm.	EG00064 affected260 at risk EG00156 affected249 at risk EG00271 affected260 at risk EG003
Induration (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.	EG00012 affected338 at risk EG00119 affected328 at risk EG00217 affected340 at risk EG003
Induration (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Induration (moderate)=2.5 cm to 7.0 cm.	EG00011 affected270 at risk EG0013 affected224 at risk EG00212 affected255 at risk EG003
Induration (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Induration (moderate)=2.5 cm to 7.0 cm.	EG00010 affected242 at risk EG0019 affected221 at risk EG0029 affected229 at risk EG003
Induration (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.	EG0000 affected333 at risk EG0010 affected325 at risk EG0020 affected335 at risk EG003
Induration (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Induration (severe) >7.0 cm.	EG0000 affected263 at risk EG0010 affected221 at risk EG0021 affected250 at risk EG003
Induration (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Induration (severe) >7.0 cm.	EG0000 affected237 at risk EG0010 affected217 at risk EG0020 affected227 at risk EG003
Erythema (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.	EG00069 affected355 at risk EG00188 affected352 at risk EG00283 affected360 at risk EG003
Erythema (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Erythema (any)=present at site of vaccination.	EG00088 affected292 at risk EG00195 affected265 at risk EG00297 affected281 at risk EG003
Erythema (any)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Erythema (any)=present at site of vaccination.	EG000110 affected278 at risk EG00194 affected262 at risk EG002103 affected274 at risk EG003
Erythema (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.	EG00064 affected354 at risk EG00187 affected352 at risk EG00276 affected358 at risk EG003
Erythema (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Erythema (mild)=0.5 cm to 2.0 cm.	EG00082 affected289 at risk EG00191 affected263 at risk EG00293 affected279 at risk EG003
Erythema (mild)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Erythema (mild)=0.5 cm to 2.0 cm.	EG000102 affected275 at risk EG00188 affected260 at risk EG00299 affected272 at risk EG003
Erythema (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.	EG0007 affected334 at risk EG0012 affected326 at risk EG0028 affected337 at risk EG003
Erythema (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Erythema (moderate)=2.5 cm to 7.0 cm	EG0009 affected268 at risk EG0014 affected223 at risk EG0028 affected252 at risk EG003
Erythema (moderate)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Erythema (moderate)=2.5 cm to 7.0 cm.	EG00013 affected243 at risk EG0019 affected219 at risk EG00213 affected231 at risk EG003
Erythema (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.	EG0000 affected333 at risk EG0010 affected325 at risk EG0020 affected335 at risk EG003
Erythema (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 2; Erythema (severe) >7.0 cm.	EG0000 affected263 at risk EG0010 affected221 at risk EG0020 affected249 at risk EG003
Erythema (severe)	Skin and subcutaneous tissue disorders	Local reactions	Systematic Assessment	Infant Series Dose 3; Erythema (severe) >7.0 cm.	EG0000 affected237 at risk EG0010 affected217 at risk EG0020 affected227 at risk EG003
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.	EG00087 affected353 at risk EG00179 affected337 at risk EG00287 affected353 at risk EG003
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C.	EG00097 affected290 at risk EG00191 affected250 at risk EG002103 affected290 at risk EG003
Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever ≥ 38 degrees Celsius C but ≤ 39 degrees C	EG00070 affected266 at risk EG00168 affected246 at risk EG00280 affected252 at risk EG003
Fever > 39 degrees C but ≤ 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but ≤ 40 degrees C.	EG0002 affected328 at risk EG0011 affected319 at risk EG0023 affected333 at risk EG003
Fever > 39 degrees C but ≤ 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever > 39 degrees C but ≤ 40 degrees C.	EG0009 affected263 at risk EG0017 affected216 at risk EG0029 affected248 at risk EG003
Fever > 39 degrees C but ≤ 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever > 39 degrees C but ≤ 40 degrees C.	EG0006 affected237 at risk EG0018 affected219 at risk EG00213 affected231 at risk EG003
Fever > 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C.	EG0000 affected328 at risk EG0010 affected319 at risk EG0021 affected331 at risk EG003
Fever > 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever > 40 degrees C.	EG0001 affected259 at risk EG0010 affected214 at risk EG0020 affected245 at risk EG003
Fever > 40 degrees C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever > 40 degrees C.	EG0000 affected234 at risk EG0011 affected216 at risk EG0020 affected224 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Decreased appetite.	EG000199 affected393 at risk EG001177 affected385 at risk EG002193 affected386 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Decreased appetite.	EG000156 affected322 at risk EG001144 affected293 at risk EG002156 affected325 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Decreased appetite.	EG000131 affected286 at risk EG001131 affected273 at risk EG002145 affected286 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Irritability.	EG000373 affected435 at risk EG001364 affected432 at risk EG002386 affected433 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Irritability.	EG000326 affected377 at risk EG001320 affected370 at risk EG002318 affected376 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Irritability.	EG000280 affected352 at risk EG001273 affected339 at risk EG002287 affected347 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Increased sleep.	EG000304 affected425 at risk EG001303 affected417 at risk EG002279 affected402 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Increased sleep.	EG000215 affected332 at risk EG001217 affected318 at risk EG002231 affected343 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Increased sleep.	EG000160 affected289 at risk EG001170 affected289 at risk EG002171 affected286 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Decreased sleep.	EG000167 affected379 at risk EG001177 affected377 at risk EG002159 affected377 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Decreased sleep.	EG000159 affected324 at risk EG001142 affected291 at risk EG002136 affected305 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Decreased sleep.	EG000120 affected282 at risk EG001137 affected272 at risk EG002140 affected289 at risk EG003
Hives (Urticaria)	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Hives (Urticaria).	EG0002 affected333 at risk EG0013 affected328 at risk EG0022 affected335 at risk EG003
Hives (Urticaria)	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Hives (Urticaria).	EG0001 affected263 at risk EG0015 affected225 at risk EG0024 affected253 at risk EG003
Hives (Urticaria)	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Hives (Urticaria).	EG0004 affected239 at risk EG0012 affected218 at risk EG0024 affected229 at risk EG003

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 OG001	Tetanus toxoid: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.					Difference	-0.1			2-Sided	95	-3.3	3.0			Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Yes	Non-Inferiority or Equivalence	For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.

Title

Denominators

Categories

Poliovirus type 1 (n=183, 187)

Title	Measurements
	OG000100.0(98.0 to 100.0) OG001100.0(98.0 to 100.0)

Poliovirus type 2 (n=181, 186)

Title	Measurements
	OG00098.9(96.1 to 99.9) OG00199.5(97.1 to 100.0)

Poliovirus type 3 (n=182, 186)

Title	Measurements
	OG000100.0(98.0 to 100.0) OG00199.5(97.1 to 100.0)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Poliovirus type 1: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Difference	0.0	2-Sided	95	-2.1	2.0	Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Yes	Non-Inferiority or Equivalence	For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.
OG000 OG001	Poliovirus type 2: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Difference	-0.6	2-Sided	95	-3.4	2.0	Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Yes	Non-Inferiority or Equivalence	For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.
OG000 OG001	Poliovirus type 3: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Difference	0.5	2-Sided	95	-1.5	3.0	Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Yes	Non-Inferiority or Equivalence	For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.

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 OG001	Hepatitis B: Difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.					Difference	0.0			2-Sided	95	-2.4	2.2			Exact 2-sided CI for difference in proportions (combined 13vPnC, 7vPnC) expressed as a percentage.	Yes	Non-Inferiority or Equivalence	For each of the 5 concomitant antigens (tetanus toxoid, poliovirus Type 1, 2, and 3, and hepatitis b antibodies), non-inferiority was shown if the lower limit of the 2-sided 95% CI, computed using the Chan and Zhang procedure for the difference in proportions, is greater than -10%.

Title

Denominators

Categories

Common serotypes - serotype 4 (n=411, 404, 398)

Title	Measurements
	OG00097.6(95.6 to 98.8) OG00195.5(93.0 to 97.3) OG00298.5(96.7 to 99.4)

Common serotypes - serotype 6B (n=409, 401, 396)

Title	Measurements
	OG00094.9(92.3 to 96.8) OG00189.5(86.1 to 92.3) OG00294.4(91.7 to 96.5)

Common serotypes - serotype 9V (n=411, 403, 396)

Title	Measurements
	OG00095.4(92.9 to 97.2) OG00195.5(93.0 to 97.3) OG00296.5(94.1 to 98.1)

Common serotypes - serotype 14 (n=398, 387, 387)

Title	Measurements
	OG00099.2(97.8 to 99.8) OG00199.0(97.4 to 99.7) OG00298.2(96.3 to 99.3)

Common serotypes - serotype 18C (n=413, 401, 398)

Title	Measurements
	OG00097.8(95.9 to 99.0) OG00195.8(93.3 to 97.5) OG00298.0(96.1 to 99.1)

Common serotypes - serotype 19F (n=408, 399, 398)

Title	Measurements
	OG00097.8(95.9 to 99.0) OG00197.5(95.4 to 98.8) OG00299.2(97.8 to 99.8)

Common serotypes - serotype 23F (n=411, 402, 399)

Title	Measurements
	OG00091.2(88.1 to 93.8) OG00188.1(84.5 to 91.1) OG00287.2(83.5 to 90.3)

Additional serotypes - serotype 1 (n=411, 403,395)

Title	Measurements
	OG00097.8(95.9 to 99.0) OG00197.0(94.9 to 98.5) OG00298.5(96.7 to 99.4)

Additional serotypes - serotype 3 (n=406, 391,393)

Title	Measurements
	OG00068.5(63.7 to 73.0) OG00172.4(67.7 to 76.8) OG00279.1(74.8 to 83.0)

Additional serotypes - serotype 5 (n=412, 402,393)

Title	Measurements
	OG00094.2(91.5 to 96.2) OG00190.3(87.0 to 93.0) OG00294.4(91.6 to 96.5)

Additional serotypes - serotype 6A (n=413,402,398)

Title	Measurements
	OG00098.1(96.2 to 99.2) OG00195.5(93.0 to 97.3) OG00298.2(96.4 to 99.3)

Additional serotypes - serotype 7F (n=412,401,397)

Title	Measurements
	OG00099.8(98.7 to 100.0) OG00199.0(97.5 to 99.7) OG00299.7(98.6 to 100.0)

Additional serotype - serotype 19A (n=411,403,397)

Title	Measurements
	OG00098.1(96.2 to 99.2) OG00199.0(97.5 to 99.7) OG00298.7(97.1 to 99.6)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Common serotypes - serotype 4	Difference	2.0	2-Sided	95	-0.51	4.75	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 4	Difference	-0.9	2-Sided	95	-3.09	1.10	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 4	Difference	-2.9	2-Sided	95	-5.58	-0.58	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 6B	Difference	5.3	2-Sided	95	1.55	9.19	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 6B	Difference	0.4	2-Sided	95	-2.77	3.66	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 6B	Difference	-4.9	2-Sided	95	-8.82	-1.10	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 9V	Difference	-0.2	2-Sided	95	-3.13	2.83	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 9V	Difference	-1.1	2-Sided	95	-3.97	1.73	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 9V	Difference	-0.9	2-Sided	95	-3.81	1.88	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 14	Difference	0.3	2-Sided	95	-1.27	1.95	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 14	Difference	1.1	2-Sided	95	-0.60	3.01	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 14	Difference	0.8	2-Sided	95	-1.04	2.76	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 18C	Difference	2.1	2-Sided	95	-0.38	4.74	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 18C	Difference	-0.2	2-Sided	95	-2.33	1.99	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 18C	Difference	-2.2	2-Sided	95	-4.89	0.23	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 19F	Difference	0.3	2-Sided	95	-1.93	2.60	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 19F	Difference	-1.5	2-Sided	95	-3.46	0.28	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 19F	Difference	-1.8	2-Sided	95	-3.87	0.02	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Common serotypes - serotype 23F	Difference	3.2	2-Sided	95	-1.03	7.46	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Common serotypes - serotype 23F	Difference	4.0	2-Sided	95	-0.27	8.39	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Common serotypes - serotype 23F	Difference	0.8	2-Sided	95	-3.75	5.46	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 1	Difference	0.8	2-Sided	95	-1.48	3.18	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 1	Difference	-0.7	2-Sided	95	-2.78	1.34	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 1	Difference	-1.5	2-Sided	95	-3.77	0.67	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 3	Difference	-3.9	2-Sided	95	-10.27	2.45	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 3	Difference	-10.7	2-Sided	95	-16.80	-4.57	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 3	Difference	-6.8	2-Sided	95	-12.76	-0.74	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 5	Difference	3.9	2-Sided	95	0.15	7.69	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 5	Difference	-0.2	2-Sided	95	-3.52	3.09	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 5	Difference	-4.1	2-Sided	95	-7.92	-0.36	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 6A	Difference	2.5	2-Sided	95	0.12	5.23	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 6A	Difference	-0.2	2-Sided	95	-2.22	1.86	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 6A	Difference	-2.7	2-Sided	95	-5.39	-0.27	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 7F	Difference	0.8	2-Sided	95	-0.47	2.30	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 7F	Difference	0.0	2-Sided	95	-1.12	1.18	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 7F	Difference	-0.7	2-Sided	95	-2.30	0.52	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG001	Additional serotypes - serotype 19A	Difference	-1.0	2-Sided	95	-2.91	0.80	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG000 OG002	Additional serotypes - serotype 19A	Difference	-0.7	2-Sided	95	-2.69	1.19	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
OG001 OG002	Additional serotypes - serotype 19A	Difference	0.3	2-Sided	95	-1.40	2.04	Yes	Non-Inferiority or Equivalence	Exact, unconditional 2-sided 95% CI on the pairwise difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.

Title

Denominators

Categories

Common serotypes - serotype 4 (n=364, 342, 355)

Title	Measurements
	OG00099.2(97.6 to 99.8) OG00199.1(97.5 to 99.8) OG002100.0(99.0 to 100.0)

Common serotypes - serotype 6B (n=368,341,357)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG001100.0(98.9 to 100.0) OG002100.0(99.0 to 100.0)

Common serotypes - serotype 9V (n=368,342,357)

Title	Measurements
	OG00099.7(98.5 to 100.0) OG00199.7(98.4 to 100.0) OG00299.2(97.6 to 99.8)

Common serotypes - serotype 14 (n=366,344,358)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG00199.7(98.4 to 100.0) OG002100.0(99.0 to 100.0)

Common serotypes - serotype 18C (n=362,341,354)

Title	Measurements
	OG00098.9(97.2 to 99.7) OG00198.5(96.6 to 99.5) OG00299.4(98.0 to 99.9)

Common serotypes - serotype 19F (n=362,342,353)

Title	Measurements
	OG00098.3(96.4 to 99.4) OG00198.8(97.0 to 99.7) OG00299.4(98.0 to 99.9)

Common serotypes - serotype 23F (n=362,340,353)

Title	Measurements
	OG00099.4(98.0 to 99.9) OG00199.1(97.4 to 99.8) OG00298.3(96.3 to 99.4)

Additional serotypes - serotype 1 (n=367,344,357)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG00199.1(97.5 to 99.8) OG00299.2(97.6 to 99.8)

Additional serotypes - serotype 3 (n=366,343,356)

Title	Measurements
	OG00083.6(79.4 to 87.3) OG00180.8(76.2 to 84.8) OG00288.5(84.7 to 91.6)

Additional serotypes - serotype 5 (n=368,343,357)

Title	Measurements
	OG00099.7(98.5 to 100.0) OG00199.4(97.9 to 99.9) OG00299.7(98.4 to 100.0)

Additional serotypes - serotype 6A (n=366,342,355)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG001100.0(98.9 to 100.0) OG00299.7(98.4 to 100.0)

Additional serotypes - serotype 7F (n=366,343,358)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG00199.4(97.9 to 99.9) OG00299.4(98.0 to 99.9)

Additional serotype - serotype 19A (n=362,341,353)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG001100.0(98.9 to 100.0) OG002100.0(99.0 to 100.0)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Common serotypes - serotype 4	Difference	0.1	2-Sided	95	-1.61	1.81	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 4	Difference	-0.8	2-Sided	95	-2.39	0.23	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 4	Difference	-0.9	2-Sided	95	-2.54	0.20	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 6B	Difference	0.0	2-Sided	95	-1.02	1.11	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 6B	Difference	0.0	2-Sided	95	-1.03	1.04	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 6B	Difference	0.0	2-Sided	95	-1.13	1.06	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 9V	Difference	0.0	2-Sided	95	-1.25	1.37	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 9V	Difference	0.6	2-Sided	95	-0.76	2.18	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 9V	Difference	0.5	2-Sided	95	-0.87	2.18	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 14	Difference	0.3	2-Sided	95	-0.74	1.62	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 14	Difference	0.0	2-Sided	95	-1.03	1.04	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 14	Difference	-0.3	2-Sided	95	-1.61	0.76	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 18C	Difference	0.4	2-Sided	95	-1.52	2.39	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 18C	Difference	-0.5	2-Sided	95	-2.30	1.04	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 18C	Difference	-0.9	2-Sided	95	-2.87	0.74	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 19F	Difference	-0.5	2-Sided	95	-2.55	1.50	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 19F	Difference	-1.1	2-Sided	95	-3.06	0.57	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 19F	Difference	-0.6	2-Sided	95	-2.44	1.00	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 23F	Difference	0.3	2-Sided	95	-1.21	2.05	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 23F	Difference	1.1	2-Sided	95	-0.52	3.16	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 23F	Difference	0.8	2-Sided	95	-1.05	2.87	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 1	Difference	0.9	2-Sided	95	-0.17	2.53	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 1	Difference	0.8	2-Sided	95	-0.20	2.44	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 1	Difference	-0.0	2-Sided	95	-1.79	1.66	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 3	Difference	2.8	2-Sided	95	-2.85	8.55	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 3	Difference	-4.9	2-Sided	95	-9.99	0.21	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 3	Difference	-7.7	2-Sided	95	-13.14	-2.37	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 5	Difference	0.3	2-Sided	95	-1.00	1.84	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 5	Difference	0.0	2-Sided	95	-1.27	1.30	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 5	Difference	-0.3	2-Sided	95	-1.84	1.02	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 6A	Difference	0.0	2-Sided	95	-1.04	1.08	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 6A	Difference	0.3	2-Sided	95	-0.76	1.56	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 6A	Difference	0.3	2-Sided	95	-0.83	1.56	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 7F	Difference	0.6	2-Sided	95	-0.47	2.09	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 7F	Difference	0.6	2-Sided	95	-0.48	2.00	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 7F	Difference	-0.0	2-Sided	95	-1.59	1.49	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 19A	Difference	0.0	2-Sided	95	-1.04	1.09	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 19A	Difference	0.0	2-Sided	95	-1.05	1.04	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 19A	Difference	0.0	2-Sided	95	-1.09	1.07	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.

Title

Denominators

Categories

Common serotypes - serotype 4 (n=1213)

Title	Measurements
	OG00070.7(68.1 to 73.3)

Common serotypes - serotype 6B (n=1206)

Title	Measurements
	OG00078.9(76.4 to 81.1)

Common serotypes - serotype 9V (n=1210)

Title	Measurements
	OG00055.7(52.9 to 58.5)

Common serotypes - serotype 14 (n=1172)

Title	Measurements
	OG00095.2(93.8 to 96.4)

Common serotypes - serotype 18C (n=1212)

Title	Measurements
	OG00068.7(66.0 to 71.3)

Common serotypes - serotype 19F (n=1205)

Title	Measurements
	OG00085.4(83.3 to 87.3)

Common serotypes - serotype 23F (n=1212)

Title	Measurements
	OG00060.1(57.2 to 62.8)

Additional serotypes - serotype 1 (n=1209)

Title	Measurements
	OG00075.2(72.7 to 77.6)

Additional serotypes - serotype 3 (n=1190)

Title	Measurements
	OG00021.3(19.0 to 23.8)

Additional serotypes - serotype 5 (n=1207)

Title	Measurements
	OG00060.3(57.5 to 63.1)

Additional serotypes - serotype 6A (n=1213)

Title	Measurements
	OG00085.1(82.9 to 87.0)

Additional serotypes - serotype 7F (n=1210)

Title	Measurements
	OG00092.8(91.2 to 94.2)

Additional serotypes - serotype 19A (n=1211)

Title	Measurements
	OG00080.8(78.4 to 82.9)

Title

Denominators

Categories

Common serotypes - serotype 4 (n=364,342,355)

Title	Measurements
	OG00086.0(82.0 to 89.4) OG00187.4(83.4 to 90.7) OG00292.7(89.5 to 95.2)

Common serotypes - serotype 6B (n=368,341,357)

Title	Measurements
	OG00099.5(98.1 to 99.9) OG00199.1(97.5 to 99.8) OG00299.7(98.4 to 100.0)

Common serotypes - serotype 9V (n=368,342,357)

Title	Measurements
	OG00080.7(76.3 to 84.6) OG00184.5(80.2 to 88.2) OG00285.4(81.3 to 88.9)

Common serotypes - serotype 14 (n=366,344,358)

Title	Measurements
	OG00098.6(96.8 to 99.6) OG00198.8(97.0 to 99.7) OG00298.3(96.4 to 99.4)

Common serotypes - serotype 18C (n=362,341,354)

Title	Measurements
	OG00079.6(75.0 to 83.6) OG00185.0(80.8 to 88.7) OG00289.5(85.9 to 92.5)

Common serotypes - serotype 19F (n=362,342,353)

Title	Measurements
	OG00094.5(91.6 to 96.6) OG00195.3(92.5 to 97.3) OG00297.7(95.6 to 99.0)

Common serotypes - serotype 23F (n=362,340,353)

Title	Measurements
	OG00091.7(88.4 to 94.3) OG00191.2(87.6 to 94.0) OG00289.8(86.2 to 92.8)

Additional serotypes - serotype 1 (n=367,344,357)

Title	Measurements
	OG00091.8(88.5 to 94.4) OG00191.0(87.5 to 93.8) OG00294.4(91.5 to 96.5)

Additional serotypes - serotype 3 (n=366,343,356)

Title	Measurements
	OG00032.0(27.2 to 37.0) OG00130.3(25.5 to 35.5) OG00236.8(31.8 to 42.0)

Additional serotypes - serotype 5 (n=368,343,357)

Title	Measurements
	OG00094.0(91.1 to 96.2) OG00191.0(87.4 to 93.8) OG00293.6(90.5 to 95.9)

Additional serotypes - serotype 6A (n=366,342,355)

Title	Measurements
	OG00099.2(97.6 to 99.8) OG00198.2(96.2 to 99.4) OG00299.2(97.6 to 99.8)

Additional serotypes - serotype 7F (n=366,343,358)

Title	Measurements
	OG00098.1(96.1 to 99.2) OG00196.2(93.6 to 98.0) OG00298.6(96.8 to 99.5)

Additional serotype - serotype 19A (n=362,341,353)

Title	Measurements
	OG000100.0(99.0 to 100.0) OG00199.4(97.9 to 99.9) OG00299.7(98.4 to 100.0)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Common serotypes - serotype 4	Difference	-1.4	2-Sided	95	-6.52	3.63	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 4	Difference	-6.7	2-Sided	95	-11.30	-2.15	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 4	Difference	-5.2	2-Sided	95	-9.85	-0.79	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 6B	Difference	0.3	2-Sided	95	-1.19	2.07	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 6B	Difference	-0.3	2-Sided	95	-1.69	1.06	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 6B	Difference	-0.6	2-Sided	95	-2.27	0.75	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 9V	Difference	-3.8	2-Sided	95	-9.46	1.82	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 9V	Difference	-4.7	2-Sided	95	-10.24	0.76	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 9V	Difference	-0.9	2-Sided	95	-6.30	4.41	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 14	Difference	-0.2	2-Sided	95	-2.14	1.73	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 14	Difference	0.3	2-Sided	95	-1.69	2.39	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 14	Difference	0.5	2-Sided	95	-1.46	2.59	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 18C	Difference	-5.5	2-Sided	95	-11.17	0.20	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 18C	Difference	-10.0	2-Sided	95	-15.31	-4.70	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 18C	Difference	-4.5	2-Sided	95	-9.55	0.46	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 19F	Difference	-0.8	2-Sided	95	-4.23	2.52	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 19F	Difference	-3.3	2-Sided	95	-6.35	-0.40	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 19F	Difference	-2.4	2-Sided	95	-5.44	0.33	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Common serotypes - serotype 23F	Difference	0.5	2-Sided	95	-3.67	4.80	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Common serotypes - serotype 23F	Difference	1.9	2-Sided	95	-2.38	6.28	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Common serotypes - serotype 23F	Difference	1.4	2-Sided	95	-3.06	5.82	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 1	Difference	0.8	2-Sided	95	-3.34	5.08	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 1	Difference	-2.6	2-Sided	95	-6.39	1.18	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 1	Difference	-3.4	2-Sided	95	-7.45	0.46	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 3	Difference	1.6	2-Sided	95	-5.20	8.55	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 3	Difference	-4.8	2-Sided	95	-11.79	2.16	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 3	Difference	-6.5	2-Sided	95	-13.51	0.54	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 5	Difference	3.1	2-Sided	95	-0.84	7.13	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 5	Difference	0.5	2-Sided	95	-3.14	4.11	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 5	Difference	-2.6	2-Sided	95	-6.72	1.40	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 6A	Difference	0.9	2-Sided	95	-0.87	3.02	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 6A	Difference	0.0	2-Sided	95	-1.62	1.71	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 6A	Difference	-0.9	2-Sided	95	-3.00	0.92	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 7F	Difference	1.9	2-Sided	95	-0.62	4.67	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 7F	Difference	-0.5	2-Sided	95	-2.67	1.55	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 7F	Difference	-2.4	2-Sided	95	-5.11	-0.01	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG001	Additional serotypes - serotype 19A	Difference	0.6	2-Sided	95	-0.45	2.10	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG000 OG002	Additional serotypes - serotype 19A	Difference	0.3	2-Sided	95	-0.75	1.58	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.
OG001 OG002	Additional serotypes - serotype 19A	Difference	-0.3	2-Sided	95	-1.86	1.05	Exact unconditional 2-sided 95% CI on the pairwise difference in proportions; expressed as a percentage.	Yes	Non-Inferiority or Equivalence	The equivalence test of Wiens and Iglewicz used to evaluate consistency among the three 13vPnC lots.

Title

Denominators

Categories

Common serotypes - serotype 4 (n=364,342,355)

Title	Measurements
	OG0002.29(2.11 to 2.48) OG0012.25(2.07 to 2.44) OG0023.06(2.79 to 3.35)

Common serotypes - serotype 6B (n=368,341,357)

Title	Measurements
	OG00011.14(10.24 to 12.11) OG0019.33(8.55 to 10.19) OG0029.92(9.15 to 10.75)

Common serotypes - serotype 9V (n=368,342,357)

Title	Measurements
	OG0001.91(1.76 to 2.06) OG0011.95(1.80 to 2.10) OG0021.99(1.84 to 2.15)

Common serotypes - serotype 14 (n=366,344,358)

Title	Measurements
	OG0006.61(6.06 to 7.22) OG0017.05(6.42 to 7.74) OG0026.91(6.32 to 7.56)

Common serotypes - serotype 18C (n=362,341,354)

Title	Measurements
	OG0001.95(1.78 to 2.12) OG0012.20(2.01 to 2.41) OG0022.48(2.27 to 2.71)

Common serotypes - serotype 19F (n=362,342,353)

Title	Measurements
	OG0004.51(4.05 to 5.03) OG0014.67(4.23 to 5.14) OG0026.51(5.91 to 7.18)

Common serotypes - serotype 23F (n=362,340,353)

Title	Measurements
	OG0003.35(3.02 to 3.71) OG0013.46(3.14 to 3.82) OG0023.10(2.81 to 3.43)

Additional serotypes - serotype 1 (n=367,344,357)

Title	Measurements
	OG0002.75(2.53 to 2.99) OG0012.95(2.68 to 3.24) OG0023.01(2.75 to 3.30)

Additional serotypes - serotype 3 (n=366,343,356)

Title	Measurements
	OG0000.75(0.69 to 0.81) OG0010.71(0.65 to 0.77) OG0020.80(0.74 to 0.87)

Additional serotypes - serotype 5 (n=368,343,357)

Title	Measurements
	OG0003.11(2.87 to 3.37) OG0012.63(2.42 to 2.87) OG0022.80(2.60 to 3.02)

Additional serotypes - serotype 6A (n=366,342,355)

Title	Measurements
	OG0007.52(6.93 to 8.17) OG0016.97(6.41 to 7.59) OG0026.83(6.30 to 7.41)

Additional serotypes - serotype 7F (n=366,343,358)

Title	Measurements
	OG0004.35(4.01 to 4.72) OG0014.24(3.86 to 4.66) OG0024.58(4.21 to 4.98)

Additional serotype - serotype 19A (n=362,341,353)

Title	Measurements
	OG0008.41(7.73 to 9.14) OG0018.32(7.66 to 9.04) OG0028.60(7.91 to 9.36)

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Common serotypes - serotype 4	Difference in log-transformed GM	0.02	2-Sided	95	-0.10	0.13	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 4	Difference in log-transformed GM	-0.29	2-Sided	95	-0.41	-0.17	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 4	Difference in log-transformed GM	-0.31	2-Sided	95	-0.43	-0.19	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 6B	Difference in log-transformed GM	0.18	2-Sided	95	0.06	0.30	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 6B	Difference in log-transformed GM	0.12	2-Sided	95	-0.00	0.23	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 6B	Difference in log-transformed GM	-0.06	2-Sided	95	-0.18	0.06	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 9V	Difference in log-transformed GM	-0.02	2-Sided	95	-0.13	0.09	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 9V	Difference in log-transformed GM	-0.04	2-Sided	95	-0.15	0.07	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 9V	Difference in log-transformed GM	-0.02	2-Sided	95	-0.13	0.09	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 14	Difference in log-transformed GM	-0.06	2-Sided	95	-0.19	0.06	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 14	Difference in log-transformed GM	-0.04	2-Sided	95	-0.17	0.08	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 14	Difference in log-transformed GM	0.02	2-Sided	95	-0.11	0.15	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 18C	Difference in log-transformed GM	-0.12	2-Sided	95	-0.25	0.00	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 18C	Difference in log-transformed GM	-0.24	2-Sided	95	-0.37	-0.12	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 18C	Difference in log-transformed GM	-0.12	2-Sided	95	-0.25	0.01	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 19F	Difference in log-transformed GM	-0.03	2-Sided	95	-0.18	0.11	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 19F	Difference in log-transformed GM	-0.37	2-Sided	95	-0.51	-0.22	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 19F	Difference in log-transformed GM	-0.33	2-Sided	95	-0.47	-0.20	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Common serotypes - serotype 23F	Difference in log-transformed GM	-0.03	2-Sided	95	-0.17	0.11	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Common serotypes - serotype 23F	Difference in log-transformed GM	0.08	2-Sided	95	-0.07	0.22	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Common serotypes - serotype 23F	Difference in log-transformed GM	0.11	2-Sided	95	-0.03	0.25	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 1	Difference in log-transformed GM	-0.07	2-Sided	95	-0.20	0.06	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 1	Difference in log-transformed GM	-0.09	2-Sided	95	-0.21	0.03	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 1	Difference in log-transformed GM	-0.02	2-Sided	95	-0.15	0.11	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 3	Difference in log-transformed GM	0.06	2-Sided	95	-0.06	0.18	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 3	Difference in log-transformed GM	-0.07	2-Sided	95	-0.18	0.04	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 3	Difference in log-transformed GM	-0.13	2-Sided	95	-0.25	-0.01	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 5	Difference in log-transformed GM	0.17	2-Sided	95	0.05	0.28	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 5	Difference in log-transformed GM	0.10	2-Sided	95	-0.00	0.21	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 5	Difference in log-transformed GM	-0.06	2-Sided	95	-0.17	0.05	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 6A	Difference in log-transformed GM	0.08	2-Sided	95	-0.04	0.19	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 6A	Difference in log-transformed GM	0.10	2-Sided	95	-0.02	0.21	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 6A	Difference in log-transformed GM	0.02	2-Sided	95	-0.10	0.14	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 7F	Difference in log-transformed GM	0.03	2-Sided	95	-0.10	0.15	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 7F	Difference in log-transformed GM	-0.05	2-Sided	95	-0.17	0.07	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 7F	Difference in log-transformed GM	-0.08	2-Sided	95	-0.20	0.05	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG001	Additional serotypes - serotype 19A	Difference in log-transformed GM	0.01	2-Sided	95	-0.11	0.13	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG000 OG002	Additional serotypes - serotype 19A	Difference in log-transformed GM	-0.02	2-Sided	95	-0.14	0.10	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other
OG001 OG002	Additional serotypes - serotype 19A	Difference in log-transformed GM	-0.03	2-Sided	95	-0.15	0.08	2-sided 95% CI were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed using the Student t distribution.	No	Superiority or Other

Title

Denominators

Categories

Tenderness: Any (n=420, 409, 400, 212)

Title	Measurements
	OG00062.4 OG00164.1 OG00262.5 OG00367.0

Tenderness: Significant (n=348, 337, 345, 170)

Title	Measurements
	OG0009.2 OG00110.4 OG00210.4 OG003

Induration: Any (n=356, 347, 352, 176)

Title	Measurements
	OG00016.6 OG00119.6 OG00219.3 OG003

Induration: Mild (n=353, 344, 348, 173)

Title	Measurements
	OG00014.7 OG00116.9 OG00215.5 OG003

Induration: Moderate (n=338, 328, 340, 167)

Title	Measurements
	OG0003.6 OG0015.8 OG0025.0 OG003

Induration: Severe (n=333, 325, 335, 164)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0 OG003

Erythema: Any (n=355, 352, 360, 180)

Title	Measurements
	OG00019.4 OG00125.0 OG00223.1 OG003

Erythema: Mild (n=354, 352, 358, 180)

Title	Measurements
	OG00018.1 OG00124.7 OG00221.2 OG003

Erythema: Moderate (n=334, 326, 337, 164)

Title	Measurements
	OG0002.1 OG0010.6 OG0022.4 OG003

Erythema: Severe (n=333, 325, 335, 164)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0 OG003

Title

Denominators

Categories

Tenderness: Any (n=354, 330, 337, 176)

Title	Measurements
	OG00066.4 OG00167.3 OG00265.0 OG00364.8

Tenderness: Significant (n=269, 231, 262, 132)

Title	Measurements
	OG0009.7 OG0017.4 OG00212.2 OG003

Induration: Any (n=291, 248, 279, 141)

Title	Measurements
	OG00024.4 OG00122.6 OG00228.7 OG003

Induration: Mild (n=288, 246, 276, 141)

Title	Measurements
	OG00022.6 OG00122.0 OG00226.8 OG003

Induration: Moderate (n=270, 224, 255, 128)

Title	Measurements
	OG0004.1 OG0011.3 OG0024.7 OG003

Induration: Severe (n=263, 221, 250, 127)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.4 OG003

Erythema: Any (n=292, 265, 281, 153)

Title	Measurements
	OG00030.1 OG00135.8 OG00234.5 OG003

Erythema: Mild (n=289, 263, 279, 153)

Title	Measurements
	OG00028.4 OG00134.6 OG00233.3 OG003

Erythema: Moderate (n=268, 223, 252, 128)

Title	Measurements
	OG0003.4 OG0011.8 OG0023.2 OG003

Erythema: Severe (n=263, 221, 249, 127)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0 OG003

Title

Denominators

Categories

Tenderness: Any (n=317, 304, 300, 156)

Title	Measurements
	OG00062.5 OG00160.9 OG00255.0 OG00364.7

Tenderness: Significant (n=248, 226, 237, 118)

Title	Measurements
	OG0008.9 OG0017.5 OG00210.1 OG003

Induration: Any (n=263, 250, 262, 128)

Title	Measurements
	OG00027.0 OG00123.6 OG00228.6 OG003

Induration: Mild (n=260, 249, 260, 127)

Title	Measurements
	OG00024.6 OG00122.5 OG00227.3 OG003

Induration: Moderate (n=242, 221, 229, 114)

Title	Measurements
	OG0004.1 OG0014.1 OG0023.9 OG003

Induration: Severe (n=237, 217, 227, 111)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0 OG003

Erythema: Any (n=278, 262, 274, 137)

Title	Measurements
	OG00039.6 OG00135.9 OG00237.6 OG003

Erythema: Mild (n=275, 260, 272, 135)

Title	Measurements
	OG00037.1 OG00133.8 OG00236.4 OG003

Erythema: Moderate (n=243, 219, 231, 116)

Title	Measurements
	OG0005.3 OG0014.1 OG0025.6 OG003

Erythema: Severe (n=237, 217, 227, 111)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.0 OG003

Title

Denominators

Categories

Tenderness: Any (n=826, 131)

Title	Measurements
	OG00057.3 OG00163.4

Tenderness: Significant (n=630, 97)

Title	Measurements
	OG0006.7 OG0014.1

Induration: Any (n=698, 110)

Title	Measurements
	OG00031.5 OG00143.6

Induration: Mild (n=689, 107)

Title	Measurements
	OG00028.9 OG00141.1

Induration: Moderate (n=627, 101)

Title	Measurements
	OG0008.5 OG00117.8

Induration: Severe (n=603, 93)

Title	Measurements
	OG0000.0 OG0010.0

Erythema: Any (n=749, 121)

Title	Measurements
	OG00042.6 OG00152.9

Erythema: Mild (n=735, 116)

Title	Measurements
	OG00039.2 OG00150.0

Erythema: Moderate (n=631, 104)

Title	Measurements
	OG00010.6 OG00121.2

Erythema: Severe (n=603, 93)

Title	Measurements
	OG0000.0 OG0010.0

Title

Denominators

Categories

Fever ≥38 but ≤39 degrees C (n=353, 337, 353, 173)

Title	Measurements
	OG00024.6 OG00123.4 OG00224.6 OG00326.0

Fever >39 but ≤40 degrees C (n=328, 319, 333, 161)

Title	Measurements
	OG0000.6 OG0010.3 OG0020.9 OG003

Fever >40 degrees C (n=328, 319, 331, 160)

Title	Measurements
	OG0000.0 OG0010.0 OG0020.3 OG003

Decreased appetite (n=393, 385, 386, 200)

Title	Measurements
	OG00050.6 OG00146.0 OG00250.0 OG003

Irritability (n=435, 432, 433, 226)

Title	Measurements
	OG00085.7 OG00184.3 OG00289.1 OG003

Increased sleep (n=425, 417, 402, 212)

Title	Measurements
	OG00071.5 OG00172.7 OG00269.4 OG003

Decreased sleep (n=379, 377, 377, 194)

Title	Measurements
	OG00044.1 OG00146.9 OG00242.2 OG003

Hives [urticaria] (n=333, 328, 335, 164)

Title	Measurements
	OG0000.6 OG0010.9 OG0020.6 OG003

Title

Denominators

Categories

Fever ≥38 but ≤39 degrees C (n=290, 250, 290, 143)

Title	Measurements
	OG00033.4 OG00136.4 OG00235.5 OG00328.0

Fever >39 but ≤40 degrees C (n=263, 216, 248, 124)

Title	Measurements
	OG0003.4 OG0013.2 OG0023.6 OG003

Fever >40 degrees C (n=259, 214, 245, 124)

Title	Measurements
	OG0000.4 OG0010.0 OG0020.0 OG003

Decreased appetite (n=322, 293, 325, 164)

Title	Measurements
	OG00048.4 OG00149.1 OG00248.0 OG003

Irritability (n=377, 370, 376, 201)

Title	Measurements
	OG00086.5 OG00186.5 OG00284.6 OG003

Increased sleep (n=332, 318, 343, 177)

Title	Measurements
	OG00064.8 OG00168.2 OG00267.3 OG003

Decreased sleep (n=324, 291, 305, 159)

Title	Measurements
	OG00049.1 OG00148.8 OG00244.6 OG003

Hives [urticaria] (n=263, 225, 253, 127)

Title	Measurements
	OG0000.4 OG0012.2 OG0021.6 OG003

Title

Denominators

Categories

Fever ≥38 but ≤39 degrees C (n=266, 246, 252, 132)

Title	Measurements
	OG00026.3 OG00127.6 OG00231.7 OG00332.6

Fever >39 but ≤40 degrees C (n=237, 219, 231, 113)

Title	Measurements
	OG0002.5 OG0013.7 OG0025.6 OG003

Fever >40 degrees C (n=234, 216, 224, 111)

Title	Measurements
	OG0000.0 OG0010.5 OG0020.0 OG003

Decreased appetite (n=286, 273, 286, 144)

Title	Measurements
	OG00045.8 OG00148.0 OG00250.7 OG003

Irritability (n=352, 339, 347, 186)

Title	Measurements
	OG00079.5 OG00180.5 OG00282.7 OG003

Increased sleep (n=289, 289, 286, 138)

Title	Measurements
	OG00055.4 OG00158.8 OG00259.8 OG003

Decreased sleep (n=282, 272, 289, 147)

Title	Measurements
	OG00042.6 OG00150.4 OG00248.4 OG003

Hives [urticaria] (n=239, 218, 229, 112)

Title	Measurements
	OG0001.7 OG0010.9 OG0021.7 OG003

Title

Denominators

Categories

Fever ≥38 but ≤39 degrees C (n=667, 107)

Title	Measurements
	OG00028.8 OG00129.9

Fever >39 but ≤40 degrees C (n=592, 95)

Title	Measurements
	OG0004.4 OG0015.3

Fever >40 degrees C (n=586, 93)

Title	Measurements
	OG0001.0 OG0010.0

Decreased appetite (n=790, 115)

Title	Measurements
	OG00051.9 OG00150.4

Irritability (n=943, 160)

Title	Measurements
	OG00081.8 OG00180.0

Increased sleep (n=779, 126)

Title	Measurements
	OG00047.8 OG00147.6

Decreased sleep (n=770, 117)

Title	Measurements
	OG00046.9 OG00142.7

Hives [urticaria] (n=607, 96)

Title	Measurements
	OG0002.1 OG0015.2

Facility	Status	City	State	ZIP	Country	Contacts
		Benton	Arkansas	72019	United States