Study to Evaluate a 13-valent Pneumococcal Conjugate Vacc... | NCT00368966

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

Name	Type	Description	Arm Group Labels	Other Names
13-valent Pneumococcal Conjugate Vaccine	Biological		1
7-valent Pneumococcal Conjugate Vaccine

Measure	Description	Time Frame
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series	Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.	One month after 2-doses of the infant series (5 months of age)
Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series		One month after 2-doses of the infant series (5 months of age)
Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series		One month after 2-doses of the infant series (5 months of age)
Percentage of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.	During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director
Trial Manager	For Spain, infomed@wyeth.com	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
23965217	Derived	Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
21704105

ID	Title	Description
FG000	13vPnC	Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.

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

Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or >=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.

Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Posted

Mar 2010

Number

95% Confidence Interval

Percentage of Participants

One month after 2-doses of the infant series (5 months of age)

ID	Title	Description
OG000	13vPnC	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
OG001	7vPnC	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

Units	Counts
Participants	OG000297 OG001284

Title

Denominators

Categories

Meningococcal C ≥ 1:8

Title	Measurements
	OG00098.3(96.1 to 99.5) OG00198.9(96.9 to 99.8)

Diptheria ≥ 0.10 IU/mL

Title	Measurements
	OG000

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	For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥ 1:8 threshold was calculated					Difference	-0.6				95	-2.9	1.6				Yes	Non-Inferiority or Equivalence	Non-inferiority for concomitant antigens was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%.

Primary

Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

titer

One month after 2-doses of the infant series (5 months of age)

ID	Title	Description
OG000	13vPnC	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
OG001	7vPnC	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

Primary

Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

IU/mL

One month after 2-doses of the infant series (5 months of age)

ID	Title	Description
OG000	13vPnC	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
OG001	7vPnC	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

Primary

Percentage of Participants Reporting Pre-Specified Local Reactions

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

The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Posted

Mar 2010

Number

percentage of participants

During the 4-day period after each dose

ID	Title	Description
OG000	13vPnC Dose 1	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
OG001	7vPnC Dose 1	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
OG002	13vPnC Dose 2	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).

Primary

Percentage of Participants Reporting Pre-Specified Systemic Events

Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.

The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.

Posted

Mar 2010

Number

percentage of participants

During the 4-day period after each dose

ID	Title	Description
OG000	13vPnC Dose 1	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
OG001	7vPnC Dose 1	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
OG002	13vPnC Dose 2	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).

Primary

Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (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.

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

μg/mL

One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series Dose 2	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
OG001	13vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).

Primary

Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.

Posted

Mar 2010

Number

95% Confidence Interval

percentage of participants

One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG001	7vPnC After Infant Series	Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG002	13vPnC After the Toddler Dose

Primary

Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

titer

One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG001	7vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG002	13vPnC After the Toddler Dose	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
OG003	7vPnC Afte the Toddler Dose

Primary

Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

IU/mL

One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG001	7vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG002	13vPnC After the Toddler Dose	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
OG003	7vPnC Afte the Toddler Dose

Primary

Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose

GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.

Posted

Mar 2010

Geometric Mean

95% Confidence Interval

EU/mL

One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG001	7vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
OG002	13vPnC After the Toddler Dose	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).

Primary

Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose

Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (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.

Posted

Mar 2010

Number

95% Confidence Interval

Percentage of Participants

One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)

ID	Title	Description
OG000	13vPnC After Infant Series Dose 2	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
OG001	13vPnC After Infant Series Dose 3	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Agitation	Psychiatric disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG0030 affected300 at risk EG0040 affected291 at risk EG0050 affected284 at risk EG0060 affected312 at risk EG0070 affected299 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Arthritis bacterial	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Bronchiolitis	Infections and infestations		Non-systematic Assessment		EG0006 affected314 at risk EG0016 affected300 at risk EG0020 affected314 at risk EG003
Bronchitis	Infections and infestations		Non-systematic Assessment		EG0002 affected314 at risk EG0011 affected300 at risk EG0021 affected314 at risk EG003
Bronchopneumonia	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Congenital nystagmus	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Cytomegalovirus infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Dehydration	Metabolism and nutrition disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Diarrhoea	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Epstein-Barr virus infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Febrile convulsion	Nervous system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0021 affected314 at risk EG003
Femur fracture	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Fontanelle bulging	Nervous system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Gastroenteritis	Gastrointestinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Gastroenteritis rotavirus	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0022 affected314 at risk EG003
Gastroenteritis salmonella	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Hypotonia	Nervous system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Infected cyst	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Lobar pneumonia	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Meningitis viral	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Oral disorder	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Partial seizures	Nervous system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Pharyngotonsillitis	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Pneumonia	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Pyrexia	General disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations		Non-systematic Assessment		EG0004 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Respiratory tract infection	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Rotavirus infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Scaphocephaly	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Skull fracture	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Sudden infant death syndrome	General disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Thermal burn	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Tuberculosis	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Upper respiratory tract infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Urinary tract infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0014 affected300 at risk EG0021 affected314 at risk EG003
Viral infection	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Vomiting	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Induration (Moderate)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (moderate)	EG00012 affected247 at risk EG0014 affected248 at risk EG00216 affected136 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hip dysplasia	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG0030 affected300 at risk EG0040 affected291 at risk EG0050 affected284 at risk EG0060 affected312 at risk EG0070 affected299 at risk
Atrial septal defect	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Double ureter	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Hydrocele	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Hypospadias	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Strabismus congenital	Congenital, familial and genetic disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Ear pain	Ear and labyrinth disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Otorrhoea	Ear and labyrinth disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Conjunctivitis	Eye disorders		Non-systematic Assessment		EG00010 affected314 at risk EG00110 affected300 at risk EG0020 affected314 at risk EG003
Dacryostenosis acquired	Eye disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Conjuctivitis allergic	Eye disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Coeliac disease	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Diarrhoea	Gastrointestinal disorders		Non-systematic Assessment		EG00011 affected314 at risk EG0015 affected300 at risk EG0021 affected314 at risk EG003
Vomiting	Gastrointestinal disorders		Non-systematic Assessment		EG0007 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Constipation	Gastrointestinal disorders		Non-systematic Assessment		EG0002 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders		Non-systematic Assessment		EG0003 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Gastrointestinal inflammation	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Abdominal pain	Gastrointestinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Stomatitis	Gastrointestinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Pyrexia	General disorders		Non-systematic Assessment		EG00020 affected314 at risk EG00116 affected300 at risk EG0020 affected314 at risk EG003
Irritability	General disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Cyst	General disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Hypothermia	General disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Influenza like illness	General disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Injection site reaction	General disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Injection site swelling	General disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Milk allergy	Immune system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0012 affected300 at risk EG0021 affected314 at risk EG003
Food allergy	Immune system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0022 affected314 at risk EG003
Upper respiratory tract infection	Infections and infestations		Non-systematic Assessment		EG00053 affected314 at risk EG00147 affected300 at risk EG0020 affected314 at risk EG003
Bronchiolitis	Infections and infestations		Non-systematic Assessment		EG00032 affected314 at risk EG00135 affected300 at risk EG0020 affected314 at risk EG003
Bronchitis	Infections and infestations		Non-systematic Assessment		EG00025 affected314 at risk EG00123 affected300 at risk EG0020 affected314 at risk EG003
Bronchopneumonia	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0021 affected314 at risk EG003
Candidiasis	Infections and infestations		Non-systematic Assessment		EG0002 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Cystitis	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Conjunctivitis bacterial	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Coxsackie viral infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Ear infection	Infections and infestations		Non-systematic Assessment		EG0008 affected314 at risk EG0016 affected300 at risk EG0020 affected314 at risk EG003
Nasopharyngitis	Infections and infestations		Non-systematic Assessment		EG00023 affected314 at risk EG00133 affected300 at risk EG0020 affected314 at risk EG003
Gastroenteritis	Infections and infestations		Non-systematic Assessment		EG00019 affected314 at risk EG00122 affected300 at risk EG0020 affected314 at risk EG003
Rhinitis	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Varicella	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Tuberculosis	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Pharyngitis	Infections and infestations		Non-systematic Assessment		EG0005 affected314 at risk EG0017 affected300 at risk EG0020 affected314 at risk EG003
Respiratory tract infection	Infections and infestations		Non-systematic Assessment		EG0009 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Otitis media	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0016 affected300 at risk EG0020 affected314 at risk EG003
Tonsillitis	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0013 affected300 at risk EG0020 affected314 at risk EG003
Otitis media acute	Infections and infestations		Non-systematic Assessment		EG0004 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Laryngitis	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0013 affected300 at risk EG0020 affected314 at risk EG003
Pneumonia	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Acute tonsillitis	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Viral infection	Infections and infestations		Non-systematic Assessment		EG0002 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Dacryocystitis	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Urinary tract infection	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Gastroenteritis rotavirus	Infections and infestations		Non-systematic Assessment		EG0002 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Oral candidiasis	Infections and infestations		Non-systematic Assessment		EG0003 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Viral skin infection	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Influenza	Infections and infestations		Non-systematic Assessment		EG0002 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Lower respiratory tract infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Acarodermatitis	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Fungal infection	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Herpangina	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Impetigo	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Respiratory syncytial virus bronchiolitis	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Skin candida	Infections and infestations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Tracheitis	Infections and infestations		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Head injury	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Overdose	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0006 affected314 at risk EG0019 affected300 at risk EG0020 affected314 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0002 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Rash	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0013 affected300 at risk EG0020 affected314 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0013 affected300 at risk EG0020 affected314 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0007 affected314 at risk EG0014 affected300 at risk EG0020 affected314 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0021 affected314 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0012 affected300 at risk EG0020 affected314 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Penis disorder	Reproductive system and breast disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Testicular retraction	Reproductive system and breast disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Genital rash	Reproductive system and breast disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Febrile convulsion	Nervous system disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Weight decreased	Investigations		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Torticollis	Musculoskeletal and connective tissue disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Agitation	Psychiatric disorders		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Insomnia	Psychiatric disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Restlessness	Psychiatric disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0010 affected300 at risk EG0020 affected314 at risk EG003
Pyelocaliectasis	Renal and urinary disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0011 affected300 at risk EG0020 affected314 at risk EG003
Exposure to communicable disease	Social circumstances		Non-systematic Assessment		EG0000 affected314 at risk EG0011 affected300 at risk EG0020 affected314 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.	EG000136 affected275 at risk EG001117 affected270 at risk EG0020 affected0 at risk EG003
Tenderness (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Tenderness (any)	EG000103 affected227 at risk EG001108 affected232 at risk EG0020 affected0 at risk EG003
Tenderness (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Non-systematic Assessment	Infant Series Dose 3; Tenderness (any)	EG000104 affected217 at risk EG00190 affected215 at risk EG0020 affected0 at risk EG003
Tenderness (Significant)	Skin and subcutaneous tissue disorders	Local Reactions	Non-systematic Assessment	Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.	EG0007 affected247 at risk EG0017 affected250 at risk EG0020 affected0 at risk EG003
Tenderness (Significant)	Skin and subcutaneous tissue disorders	Local Reactions	Non-systematic Assessment	Infant Series Dose 2; Tenderness (significant)	EG0008 affected192 at risk EG0018 affected203 at risk EG0020 affected0 at risk EG003
Tenderness (Significant)	Skin and subcutaneous tissue disorders	Local Reactions	Non-systematic Assessment	Infant Series Dose 3; Tenderness (significant)	EG00011 affected181 at risk EG0010 affected171 at risk EG0020 affected0 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.	EG00048 affected252 at risk EG00136 affected254 at risk EG0020 affected0 at risk EG003
Induration (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (any)	EG00058 affected206 at risk EG00149 affected212 at risk EG0020 affected0 at risk EG003
Induration (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (any)	EG00056 affected203 at risk EG00153 affected188 at risk EG0020 affected0 at risk EG003
Induration (Mild)	Skin and subcutaneous tissue disorders	Local Reactions	Non-systematic Assessment	Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.	EG00041 affected251 at risk EG00136 affected254 at risk EG0020 affected0 at risk EG003
Induration (Mild)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (mild)	EG00053 affected206 at risk EG00143 affected212 at risk EG0020 affected0 at risk EG003
Induration (Mild)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Induration (mild)	EG00053 affected201 at risk EG00148 affected186 at risk EG0020 affected0 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 affected247 at risk EG0014 affected248 at risk EG0020 affected0 at risk EG003
Induration (Moderate)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Induration (moderate)	EG00011 affected191 at risk EG0019 affected201 at risk EG0020 affected0 at risk EG003
Induration (Moderate)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (moderate)	EG00010 affected180 at risk EG0017 affected173 at risk EG0020 affected0 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 affected246 at risk EG0010 affected247 at risk EG0020 affected0 at risk EG003
Induration (Severe)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Induration (severe)	EG0000 affected191 at risk EG0010 affected201 at risk EG0020 affected0 at risk EG003
Induration (Severe)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Induration (severe)	EG0000 affected176 at risk EG0010 affected171 at risk EG0020 affected0 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.	EG00056 affected255 at risk EG00148 affected251 at risk EG0020 affected0 at risk EG003
Erythema (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Erythema (any)	EG00072 affected211 at risk EG00167 affected217 at risk EG0020 affected0 at risk EG003
Erythema (Any)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Erythema (any)	EG00063 affected203 at risk EG00169 affected198 at risk EG0020 affected0 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.	EG00051 affected254 at risk EG00146 affected251 at risk EG0020 affected0 at risk EG003
Erythema (Mild)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Erythema (mild)	EG00068 affected210 at risk EG00165 affected215 at risk EG0020 affected0 at risk EG003
Erythema (Mild)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Erythema (mild)	EG00059 affected203 at risk EG00165 affected195 at risk EG0020 affected0 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.	EG0006 affected247 at risk EG0013 affected247 at risk EG0020 affected0 at risk EG003
Erythema (Moderate)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Erythema (moderate)	EG0006 affected192 at risk EG0015 affected203 at risk EG0020 affected0 at risk EG003
Erythema (Moderate)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Erythema (moderate)	EG0008 affected177 at risk EG0019 affected175 at risk EG0020 affected0 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 affected246 at risk EG0010 affected247 at risk EG0020 affected0 at risk EG003
Erythema (Severe)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 2; Erythema (severe)	EG0000 affected191 at risk EG0010 affected201 at risk EG0020 affected0 at risk EG003
Erythema (Severe)	Skin and subcutaneous tissue disorders	Local Reactions	Systematic Assessment	Infant Series Dose 3; Erythema (severe)	EG0000 affected176 at risk EG0010 affected171 at risk EG0020 affected0 at risk EG003
Fever ≥38°C but ≤39°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C	EG00080 affected262 at risk EG00162 affected253 at risk EG0020 affected0 at risk EG003
Fever ≥38°C but ≤39°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C	EG00086 affected213 at risk EG00193 affected223 at risk EG0020 affected0 at risk EG003
Fever ≥38°C but ≤39°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C	EG00068 affected198 at risk EG00175 affected196 at risk EG0020 affected0 at risk EG003
Fever >39°C but ≤40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever >39 degrees C but ≤40 degrees C	EG0002 affected249 at risk EG0012 affected247 at risk EG0020 affected0 at risk EG003
Fever >39°C but ≤40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever >39 degrees C but ≤40 degrees C	EG0005 affected194 at risk EG0015 affected204 at risk EG0020 affected0 at risk EG003
Fever >39°C but ≤40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever >39 degrees C but ≤40 degrees C	EG00010 affected177 at risk EG0019 affected174 at risk EG0020 affected0 at risk EG003
Fever >40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Fever >40 degrees C	EG0000 affected249 at risk EG0010 affected247 at risk EG0020 affected0 at risk EG003
Fever >40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Fever >40 degrees C	EG0000 affected192 at risk EG0010 affected201 at risk EG0020 affected0 at risk EG003
Fever >40°C	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Fever >40 degrees C	EG0000 affected176 at risk EG0010 affected171 at risk EG0020 affected0 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Decreased appetite	EG000107 affected269 at risk EG00195 affected258 at risk EG0020 affected0 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Decreased appetite	EG000102 affected226 at risk EG001102 affected229 at risk EG0020 affected0 at risk EG003
Decreased appetite	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Decreased appetite	EG000103 affected219 at risk EG00187 affected204 at risk EG0020 affected0 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Irritability	EG000142 affected276 at risk EG001114 affected267 at risk EG0020 affected0 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Irritability	EG000151 affected234 at risk EG001150 affected244 at risk EG0020 affected0 at risk EG003
Irritability	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Irritability	EG000131 affected229 at risk EG001130 affected221 at risk EG0020 affected0 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Increased sleep	EG000146 affected273 at risk EG001138 affected269 at risk EG0020 affected0 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Increased sleep	EG000102 affected218 at risk EG00192 affected221 at risk EG0020 affected0 at risk EG003
Increased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Increased sleep	EG00069 affected206 at risk EG00170 affected203 at risk EG0020 affected0 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 1 and Toddler Dose; Decreased sleep	EG00091 affected263 at risk EG00163 affected255 at risk EG0020 affected0 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 2; Decreased sleep	EG00079 affected218 at risk EG00166 affected223 at risk EG0020 affected0 at risk EG003
Decreased sleep	General disorders	Systemic Events	Systematic Assessment	Infant Series Dose 3; Decreased sleep	EG00062 affected205 at risk EG00149 affected190 at risk EG0020 affected0 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders		Non-systematic Assessment		EG0001 affected314 at risk EG0011 affected300 at risk EG0021 affected314 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		A Coruña	A Coruna	15006	Spain

ID	Title	Description
BG000	13vPnC	Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
BG001	7vPnC	Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
BG002	Total	Total of all reporting groups

ID	Term
D022242	Pneumococcal Vaccines
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D017778	Vaccines, Combined

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	13vPnC Infant Series	Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.	16	314	151	314
EG001	7vPnC Infant Series	Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.	16	300	156	300
EG002	13vPnC Post-Infant Series	Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.	16	314	7	314
EG003	7vPnC Post-Infant Series	Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.	16	300	10	300
EG004	13vPnC Toddler Series	Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.	3	291	124	291
EG005	7vPnC Toddler Series	Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.	1	284	110	284
EG006	13vPnC 6-Month Follow-up	Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.	3	312	3	312
EG007	7vPnC 6-Month Follow-up	Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.	6	299	2	299