Study to Evaluate a 13-valent Pneumococcal Conjugate Vacc... | NCT00384059 | Trialant
NCT00384059
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Status
Completed
Last Update Posted
Jan 24, 2013Estimated
Enrollment
286Actual
Phase
Phase 3
Conditions
Vaccines, Pneumococcal
Interventions
13-valent Pneumococcal Conjugate Vaccine
7vPnC
Pediacel
NeisVac-C
Menitorix
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00384059
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
6096A1-007
Secondary IDs
Not provided
Brief Title
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title
A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom
Acronym
Not provided
Organization
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2006
Primary Completion Date
Oct 2008Actual
Completion Date
Oct 2008Actual
First Submitted Date
Oct 2, 2006
First Submission Date that Met QC Criteria
Oct 2, 2006
First Posted Date
Oct 4, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 26, 2010
Results First Submitted that Met QC Criteria
Jul 6, 2012
Results First Posted Date
Aug 15, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 26, 2009
Certification/Extension First Submitted that Passed QC Review
Jul 31, 2009
Certification/Extension First Posted Date
Oct 1, 2009Estimated
Last Update Submitted Date
Jan 22, 2013
Last Update Posted Date
Jan 24, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wyeth is now a wholly owned subsidiary of PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.
One month after infant series dose 2 (5 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
one month after infant series dose 2 (5 months of age)
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
one month after infant series dose 2 (5 months of age)
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/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.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
one month after the toddler dose (13 months of age)
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Other Outcomes
Measure
Description
Time Frame
Percentage of Participants Reporting Pre-Specified Local Reactions
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.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Aged 2 months (42 to 98 days) at the time of enrollment.
Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion Criteria:
Previous vaccination with licensed or investigational pneumococcal vaccine.
Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
A previous anaphylactic reaction to any vaccine or vaccine-related component.
Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Known or suspected immune deficiency or suppression.
History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
Major known congenital malformation or serious chronic disorder.
Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy.
Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
Participation in another investigational trial. Participation in purely observational studies was acceptable.
Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
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.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Recruitment Details
Participants were recruited in the United Kingdom (UK) from October 2006 to June 2007.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age
2
Pediacel
Biological
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age
1
2
NeisVac-C
Biological
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age
1
2
Menitorix
Biological
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
1
2
one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Antibody concentration/geometric mean concentration (GMC) as measured by ELISA 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 with corresponding 2-sided 95% CI.
one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)
one month after toddler dose (13 months of age)
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
one month after toddler dose (13 months of age)
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
one month after toddler dose (13 months of age)
During the 4-day period after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.
During the 4-day period after each dose
Bangor
BT19 1NB
United Kingdom
Bristol
BS2 8AE
United Kingdom
Co Antrim
BT41 3AE
United Kingdom
Coventry
CV6 4DD
United Kingdom
Ely
CB7 4HF
United Kingdom
London
SW17 ORE
United Kingdom
Oxford
OX3 9DU
United Kingdom
Plymouth
PL5 3JB
United Kingdom
Southampton
SO16 6YD
United Kingdom
Weston-super-Mare
BS22 6AJ
United Kingdom
Derived
Snape MD, Klinger CL, Daniels ED, John TM, Layton H, Rollinson L, Pestridge S, Dymond S, Galiza E, Tansey S, Scott DA, Baker SA, Jones TR, Yu LM, Gruber WC, Emini EA, Faust SN, Finn A, Heath PT, Pollard AJ. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr Infect Dis J. 2010 Dec;29(12):e80-90. doi: 10.1097/inf.0b013e3181faa6be.
FG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
FG000141 subjects
FG001145 subjects
Vaccinated Dose 1
FG000139 subjects
FG001139 subjects
Vaccinated Dose 2
FG000136 subjects
FG001135 subjects
COMPLETED
FG000135 subjects
FG001132 subjects
NOT COMPLETED
FG0006 subjects
FG00113 subjects
Type
Comment
Reasons
Not consented
FG0002 subjects
FG0016 subjects
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
After Infant Series
Type
Comment
Milestone Data
STARTED
FG000135 subjects
FG001132 subjects
COMPLETED
FG000131 subjects
FG001122 subjects
NOT COMPLETED
FG0004 subjects
FG00110 subjects
Type
Comment
Reasons
Protocol Violation
FG0002 subjects
FG0013 subjects
Withdrawal by Subject
FG0002 subjects
FG001
Toddler Dose
Type
Comment
Milestone Data
STARTED
FG000131 subjects
FG001122 subjects
COMPLETED
FG000130 subjects
FG001120 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0011 subjects
Failed to return
FG0000 subjects
FG001
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
BG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000120
BG001118
BG002238
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
BG0002.1± 0.3
BG0012.1± 0.2
BG0022.1± 0.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00055
BG00157
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
Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series.
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥1:8 and predefined antibody threshold levels with the corresponding 95% CI for concomitant antigens polyribosylribitol phosphate (PRP) in haemophilus influenzae type b [Hib](≥0.15 μg/mL or ≥ 1.0 μg/mL), pertussis toxoid [PT], filamentous haemagglutinin, pertactin [FHA], and pertactin (PRN) (≥5 Elisa Units EU/mL) and fimbrial agglutinogens [FIM] (≥2.2 EU/mL) are presented.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant series antibody concentration to the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of participants
One month after infant series dose 2 (5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Units
Counts
Participants
OG000120
OG001118
Title
Denominators
Categories
Meningococcal C ≥ 1:8 titer (n=120,118)
Title
Measurements
OG00099.2(95.4 to 100.0)
OG00199.2(95.4 to 100.0)
Hib (PRP) ≥ 0.15 μg/mL (n=114,102)
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 titer was calculated
Difference
0.0
95
-3.8
3.9
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
Secondary
Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of Participants
one month after the toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
OG001
7vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
OG002
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
OG003
Secondary
Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate posttoddler dose antibody concentration to the given concomitant antigen.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of Participants
one month after toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Primary
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Geometric Mean
95% Confidence Interval
titer
one month after infant series dose 2 (5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Primary
Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Geometric Mean
95% Confidence Interval
μg/mL
one month after infant series dose 2 (5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Primary
Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
EU/mL
one month after infant series dose 2 (5 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Secondary
Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
Evaluable immunogenicity (per protocol) population of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (N) = number of participants with a determinate antibody concentration/titer to the specific concomitant antigen.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
one month after toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Primary
Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose
Percentages of participants achieving WHO predefined antibody threshold ≥0.35μg/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.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate igG antibody concentration to the given serotype.
Posted
Mar 2010
Number
95% Confidence Interval
Percentage of Participants
one month after infant series dose 2 (5 months of age), before and after toddler dose (12 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 NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
OG001
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
Primary
Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Antibody concentration/geometric mean concentration (GMC) as measured by ELISA 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 with corresponding 2-sided 95% CI.
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.
Posted
Mar 2010
Geometric Mean
95% Confidence Interval
μg/mL
one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 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 NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
OG001
13vPnC Before Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Local Reactions
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.
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 NeisVac-C and Pediacel at 2 months of age.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
Other Pre-specified
Percentage of Participants Reporting Pre-Specified Systemic Events
Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds) to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary; percentage of participants with each event was evaluated.
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 NeisVac-C and Pediacel at 2 months of age.
OG001
7vPnC Dose 1
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
OG002
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
Secondary
Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations;(N)= number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.
Posted
Geometric Mean
95% Confidence Interval
titer
one month after toddler dose (13 months of age)
ID
Title
Description
OG000
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
OG001
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
13vPnC Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
1
139
111
138
EG001
7vPnC Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
3
139
105
139
EG002
13vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
5
139
9
138
EG003
7vPnC Post-Infant Series
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
2
139
8
139
EG004
13vPnC Toddler Series
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
1
131
72
130
EG005
7vPnC Toddler Series
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
2
122
61
122
EG006
13vPnC 6-Month Follow-up
Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
2
138
1
138
EG007
7vPnC 6-Month Follow-up
Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
0
139
1
139
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Breath holding
Psychiatric disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0011 affected139 at risk
EG0020 affected139 at risk
EG0030 affected139 at risk
EG0040 affected131 at risk
EG0050 affected122 at risk
EG0060 affected138 at risk
EG0070 affected139 at risk
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0001 affected139 at risk
EG0010 affected139 at risk
EG0021 affected139 at risk
EG003
Cellulitis
Infections and infestations
Non-systematic Assessment
EG0000 affected139 at risk
EG0011 affected139 at risk
EG0020 affected139 at risk
EG003
Fall
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Febrile convulsion
Nervous system disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0021 affected139 at risk
EG003
Gastrooesophaegeal reflux
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0011 affected139 at risk
EG0020 affected139 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0021 affected139 at risk
EG003
Hemiplegia
Nervous system disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected139 at risk
EG0011 affected139 at risk
EG0020 affected139 at risk
EG003
Mastoiditis
Infections and infestations
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Pneumonia
Infections and infestations
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Tongue injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0021 affected139 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0020 affected139 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected139 at risk
EG0010 affected139 at risk
EG0021 affected139 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG0030 affected139 at risk
EG0040 affected130 at risk
EG0050 affected122 at risk
EG0060 affected138 at risk
EG0070 affected139 at risk
Cyanosis
Cardiac disorders
Non-systematic Assessment
EG0002 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Dacryostenosis congenital
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Lymphangioma
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0021 affected138 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Conjunctivitis
Eye disorders
Non-systematic Assessment
EG0007 affected138 at risk
EG00113 affected139 at risk
EG0020 affected138 at risk
EG003
Eye discharge
Eye disorders
Non-systematic Assessment
EG0005 affected138 at risk
EG0013 affected139 at risk
EG0020 affected138 at risk
EG003
Ocular hyperaemia
Eye disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Astigmatism
Eye disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Dacryostenosis acquired
Eye disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Hypermetropia
Eye disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Non-systematic Assessment
EG00024 affected138 at risk
EG00117 affected139 at risk
EG0020 affected138 at risk
EG003
Vomiting
Gastrointestinal disorders
Non-systematic Assessment
EG00019 affected138 at risk
EG00111 affected139 at risk
EG0020 affected138 at risk
EG003
Teething
Gastrointestinal disorders
Non-systematic Assessment
EG00011 affected138 at risk
EG0019 affected139 at risk
EG0020 affected138 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Non-systematic Assessment
EG0005 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Constipation
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Infantile spitting up
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
Non-systematic Assessment
EG0002 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Flatulence
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Reflux oesophagitis
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Pyrexia
General disorders
Non-systematic Assessment
EG0009 affected138 at risk
EG0017 affected139 at risk
EG0020 affected138 at risk
EG003
Injection site erythema
General disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Feeling hot
General disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Injection site bruising
General disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Injection site induration
General disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Injection site swelling
General disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Irritability
General disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Malaise
General disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Vessel puncture site haematoma
General disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Gait disturbance
General disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Food allergy
Immune system disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0021 affected138 at risk
EG003
Drug hypersensitivity
Immune system disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Rhinitis
Infections and infestations
Non-systematic Assessment
EG00032 affected138 at risk
EG00126 affected139 at risk
EG0021 affected138 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG00016 affected138 at risk
EG00119 affected139 at risk
EG0020 affected138 at risk
EG003
Nasopharyngitis
Infections and infestations
Non-systematic Assessment
EG00015 affected138 at risk
EG00114 affected139 at risk
EG0020 affected138 at risk
EG003
Lower respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0007 affected138 at risk
EG0014 affected139 at risk
EG0020 affected138 at risk
EG003
Varicella
Infections and infestations
Non-systematic Assessment
EG0002 affected138 at risk
EG0018 affected139 at risk
EG0020 affected138 at risk
EG003
Gastroenteritis
Infections and infestations
Non-systematic Assessment
EG0005 affected138 at risk
EG0014 affected139 at risk
EG0020 affected138 at risk
EG003
Oral candidiasis
Infections and infestations
Non-systematic Assessment
EG0005 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Viral infection
Infections and infestations
Non-systematic Assessment
EG0004 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Herpes zoster
Infections and infestations
Non-systematic Assessment
EG0002 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Injection site infection
Infections and infestations
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Viral skin infection
Infections and infestations
Non-systematic Assessment
EG0002 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Bronchiolitis
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Ear infection
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Eczema infected
Infections and infestations
Non-systematic Assessment
EG0002 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Otitis media
Infections and infestations
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0021 affected138 at risk
EG003
Candidiasis
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Dermatitis infected
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Impetigo
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Skin candida
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Tonsillitis
Infections and infestations
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Rubella
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0021 affected138 at risk
EG003
Gastroenteritis viral
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Bronchitis
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Eye infection
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Pharyngitis
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Skin infection
Infections and infestations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Head injury
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0002 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Physical examination abnormal
Investigations
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Cardiac murmur
Investigations
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Anorexia
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Weight gain poor
Metabolism and nutrition disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Lactose intolerance
Metabolism and nutrition disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
High-pitched crying
Nervous system disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Somnolence
Nervous system disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Hypertonia
Nervous system disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Lethargy
Nervous system disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Crying
Psychiatric disorders
Non-systematic Assessment
EG0002 affected138 at risk
EG0014 affected139 at risk
EG0020 affected138 at risk
EG003
Insomnia
Psychiatric disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Agitation
Nervous system disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Restlessness
Nervous system disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Staring
Psychiatric disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0021 affected138 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00029 affected138 at risk
EG00116 affected139 at risk
EG0021 affected138 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0017 affected139 at risk
EG0020 affected138 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0021 affected138 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Grunting
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG00011 affected138 at risk
EG0015 affected139 at risk
EG0021 affected138 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected138 at risk
EG0015 affected139 at risk
EG0020 affected138 at risk
EG003
Dermatitis diaper
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0002 affected138 at risk
EG0015 affected139 at risk
EG0020 affected138 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0002 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Eczema infantile
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0012 affected139 at risk
EG0020 affected138 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Heat rash
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Umbilical erythema
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0021 affected138 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected138 at risk
EG0010 affected139 at risk
EG0020 affected138 at risk
EG003
Flushing
Vascular disorders
Non-systematic Assessment
EG0001 affected138 at risk
EG0011 affected139 at risk
EG0020 affected138 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.
EG00055 affected123 at risk
EG00155 affected127 at risk
EG0020 affected0 at risk
EG003
Tenderness (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (any)
EG00048 affected114 at risk
EG00139 affected96 at risk
EG0020 affected0 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.
EG0002 affected116 at risk
EG0018 affected122 at risk
EG0020 affected0 at risk
EG003
Tenderness (Significant)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Tenderness (significant)
EG0004 affected97 at risk
EG0014 affected89 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.
EG00030 affected121 at risk
EG00137 affected126 at risk
EG0020 affected0 at risk
EG003
Induration (Any)
Skin and subcutaneous tissue disorders
Local reactions
Systematic Assessment
Infant Series Dose 2; Induration (Any)
EG00032 affected106 at risk
EG00132 affected93 at risk
EG0020 affected0 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.
EG00026 affected120 at risk
EG00134 affected125 at risk
EG0020 affected0 at risk
EG003
Induration (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (Mild)
EG00030 affected105 at risk
EG00127 affected93 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.
EG0008 affected118 at risk
EG0018 affected121 at risk
EG0020 affected0 at risk
EG003
Induration (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (moderate)
EG0008 affected98 at risk
EG0016 affected88 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 affected115 at risk
EG0010 affected119 at risk
EG0020 affected0 at risk
EG003
Induration (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Induration (severe)
EG0001 affected96 at risk
EG0010 affected88 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.
EG00027 affected122 at risk
EG00150 affected126 at risk
EG0020 affected0 at risk
EG003
Erythema (Any)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (any)
EG00042 affected107 at risk
EG00140 affected99 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.
EG00026 affected122 at risk
EG00150 affected126 at risk
EG0020 affected0 at risk
EG003
Erythema (Mild)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (mild)
EG00040 affected106 at risk
EG00137 affected99 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.
EG0002 affected116 at risk
EG0010 affected119 at risk
EG0020 affected0 at risk
EG003
Erythema (Moderate)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (moderate)
EG0004 affected98 at risk
EG0013 affected88 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 affected115 at risk
EG0010 affected119 at risk
EG0020 affected0 at risk
EG003
Erythema (Severe)
Skin and subcutaneous tissue disorders
Local Reactions
Systematic Assessment
Infant Series Dose 2; Erythema (severe)
EG0002 affected97 at risk
EG0010 affected88 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
EG0007 affected116 at risk
EG0014 affected119 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
EG0003 affected96 at risk
EG0014 affected88 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
EG0001 affected115 at risk
EG0010 affected119 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
EG0000 affected95 at risk
EG0010 affected88 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 affected115 at risk
EG0010 affected119 at risk
EG0020 affected0 at risk
EG003
Fever >40°C
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Fever >40 degrees C
EG0002 affected96 at risk
EG0010 affected88 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased appetite
EG00047 affected120 at risk
EG00144 affected129 at risk
EG0020 affected0 at risk
EG003
Decreased appetite
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased appetite
EG00037 affected104 at risk
EG00137 affected98 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Irritability
EG00098 affected128 at risk
EG001100 affected135 at risk
EG0020 affected0 at risk
EG003
Irritability
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Irritability
EG00084 affected117 at risk
EG00196 affected119 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Increased sleep
EG00090 affected129 at risk
EG00186 affected129 at risk
EG0020 affected0 at risk
EG003
Increased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Increased sleep
EG00059 affected114 at risk
EG00162 affected109 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 1 and Toddler Dose; Decreased sleep
EG00039 affected119 at risk
EG00142 affected124 at risk
EG0020 affected0 at risk
EG003
Decreased sleep
General disorders
Systemic Events
Systematic Assessment
Infant Series Dose 2; Decreased sleep
EG00035 affected98 at risk
EG00138 affected100 at risk
EG0020 affected0 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
C541234
diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
Failed to Return
FG0000 subjects
FG0012 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
1 subjects
112
Male
BG00065
BG00161
BG002126
96.5
(91.3 to 99.0)
OG00198.0(93.1 to 99.8)
Hib (PRP) ≥ 1.0 μg/mL (n=114,102)
Title
Measurements
OG00085.1(77.2 to 91.1)
OG00189.2(81.5 to 94.5)
Pertussis PT ≥ 5 EU/mL (n=119,112)
Title
Measurements
OG000100.0(96.9 to 100.0)
OG001100.0(96.8 to 100.0)
Pertussis PT ≥ 17 EU/mL (n=119,112)
Title
Measurements
OG00096.6(91.6 to 99.1)
OG00195.5(89.9 to 98.5)
Pertussis FHA ≥ 5 EU/mL (n=119,113)
Title
Measurements
OG000100.0(96.9 to 100.0)
OG001100.0(96.8 to 100.0)
Pertussis FHA ≥ 7.82 EU/mL (n=119,113)
Title
Measurements
OG000100.0(96.9 to 100.0)
OG001100.0(96.8 to 100.0)
Pertussis FHA ≥ 20 EU/mL (n=119,113)
Title
Measurements
OG00094.1(88.3 to 97.6)
OG00195.6(90.0 to 98.5)
Pertussis PRN ≥ 5 EU/mL (n=119,113)
Title
Measurements
OG000100.0(96.9 to 100.0)
OG001100.0(96.8 to 100.0)
Pertussis PRN ≥ 15 EU/mL (n=119,113)
Title
Measurements
OG00092.4(86.1 to 96.5)
OG00195.6(90.0 to 98.5)
Pertussis FIM ≥ 2.2 EU/mL (n=119,113)
Title
Measurements
OG000100.0(96.9 to 100.0)
OG00197.3(92.4 to 99.4)
Pertussis FIM ≥ 5 EU/mL (n=119,113)
Title
Measurements
OG00097.5(92.8 to 99.5)
OG00196.5(91.2 to 99.0)
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Difference
-1.5
95
-7.1
3.7
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Difference
-4.1
95
-13.4
5.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Difference
0.0
95
-3.2
3.3
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated
Difference
1.1
95
-4.5
7.1
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Difference
0.0
95
-3.2
3.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated
Difference
0.0
95
-3.2
3.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated
Difference
-1.5
95
-7.9
4.8
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Difference
0.0
95
-3.2
3.2
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated
Difference
-3.1
95
-10.0
3.4
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated
Difference
2.7
95
-0.5
7.6
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
OG000
OG001
For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Difference
1.0
95
-4.1
6.5
Yes
Non-Inferiority or Equivalence
Non-inferiority for concomitant antigens was declared if the lower limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%.
7vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
Units
Counts
Participants
OG000102
OG00193
OG002109
OG00398
Title
Denominators
Categories
Title
Measurements
OG00044.1(34.3 to 54.3)
OG00149.5(38.9 to 60.0)
OG00291.7(84.9 to 96.2)
OG00391.8(84.5 to 96.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated
Difference
-5.3
95
-19.7
8.8
No
Superiority or Other
OG002
OG003
For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated
Difference
-0.1
95
-8.0
8.1
No
Superiority or Other
Units
Counts
Participants
OG000105
OG00196
Title
Denominators
Categories
Hib (PRP) ≥0.15 μg/mL
Title
Measurements
OG000100.0(96.5 to 100.0)
OG001100.0(96.2 to 100.0)
Hib (PRP)≥1.0 μg/mL
Title
Measurements
OG00099.0(94.8 to 100.0)
OG001100.0(96.2 to 100.0)
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 Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Difference
0.0
95
-3.5
3.8
No
Superiority or Other
OG000
OG001
For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Difference
-1.0
95
-5.3
2.8
No
Superiority or Other
Units
Counts
Participants
OG000120
OG001118
Title
Denominators
Categories
Title
Measurements
OG000306.20(251.21 to 373.22)
OG001345.42(287.91 to 414.41)
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 GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.89
95
0.68
1.16
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Units
Counts
Participants
OG000114
OG001102
Title
Denominators
Categories
Title
Measurements
OG0003.40(2.65 to 4.37)
OG0014.44(3.50 to 5.63)
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 Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.77
95
0.54
1.08
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Units
Counts
Participants
OG000120
OG001118
Title
Denominators
Categories
Pertussis FHA (n=119,113)
Title
Measurements
OG00054.74(48.25 to 373.22)
OG00155.99(49.55 to 414.41)
Pertussis PT (n=119,112)
Title
Measurements
OG00066.26(59.20 to 74.16)
OG00167.05(58.75 to 76.52)
Pertussis PRN (n=119,113)
Title
Measurements
OG00061.33(51.78 to 72.65)
OG00161.07(52.31 to 71.30)
Pertussis FIM (n=119,113)
Title
Measurements
OG00021.72(18.89 to 24.98)
OG00121.77(18.54 to 25.56)
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 Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.98
95
0.82
1.16
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
0.99
95
0.83
1.17
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.00
95
0.80
1.26
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
OG000
OG001
For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.00
95
0.81
1.23
Yes
Non-Inferiority or Equivalence
Non-inferiority for the concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Units
Counts
Participants
OG000105
OG00196
Title
Denominators
Categories
Title
Measurements
OG00022.22(17.66 to 27.96)
OG00119.75(16.05 to 24.30)
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 Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Ratio
1.13
95
0.83
1.53
No
Superiority or Other
OG002
13vPnC After Toddler Dose
Participants received Menitorix at the 12-month visit.
Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
Units
Counts
Participants
OG000120
OG001120
OG002110
Title
Denominators
Categories
Common Serotypes - Serotype 4 (n=107,87,87)
Title
Measurements
OG0001.37(1.16 to 1.62)
OG0010.21(0.17 to 0.24)
OG0023.52(2.91 to 4.26)
Common Serotypes - Serotype 6B (n=107,85,85)
Title
Measurements
OG0000.26(0.21 to 0.33)
OG0010.77(0.60 to 0.99)
OG0027.67(5.88 to 10.01)
Common Serotypes - Serotype 9V (n=104,88,88)
Title
Measurements
OG0000.87(0.72 to 1.05)
OG0010.29(0.24 to 0.36)
OG0022.46(2.03 to 2.99)
Common Serotypes - Serotype 14 (n=107,87,87)
Title
Measurements
OG0001.83(1.47 to 2.27)
OG0011.34(1.09 to 1.66)
OG00211.32(9.27 to 13.83)
Common Serotypes - Serotype 18C (n=111,91,91)
Title
Measurements
OG0001.37(1.14 to 1.64)
OG0010.20(0.17 to 0.23)
OG0022.14(1.82 to 2.53)
Common Serotypes - Serotype 19F (n=109,90,90)
Title
Measurements
OG0002.38(1.88 to 3.01)
OG0010.60(0.46 to 0.79)
OG0027.25(5.65 to 9.31)
Common Serotypes - Serotype 23F (n=111,88,88)
Title
Measurements
OG0000.53(0.42 to 0.67)
OG0010.24(0.19 to 0.32)
OG0023.13(2.59 to 3.78)
Additional Serotypes - Serotype 1 (n=107,85,85)
Title
Measurements
OG0001.69(1.41 to 2.04)
OG0010.39(0.33 to 0.46)
OG0025.60(4.60 to 6.82)
Additional Serotypes - Serotype 3 (n=107,85,85)
Title
Measurements
OG0000.63(0.56 to 0.71)
OG0010.14(0.10 to 0.18)
OG0020.98(0.78 to 1.22)
Additional Serotypes - Serotype 5 (n=103,86,86)
Title
Measurements
OG0000.95(0.79 to 1.14)
OG0010.59(0.49 to 0.72)
OG0023.68(3.04 to 4.45)
Additional Serotypes - Serotype 6A (n=106,83,83)
Title
Measurements
OG0000.86(0.68 to 1.07)
OG0010.81(0.64 to 1.03)
OG0026.31(5.06 to 7.87)
Additional Serotypes - Serotype 7F (n=107,87,87)
Title
Measurements
OG0002.14(1.75 to 2.62)
OG0010.56(0.48 to 0.66)
OG0024.06(3.42 to 4.83)
Additional Serotypes - Serotype 19A (n=110,89,89)
Title
Measurements
OG0001.90(1.54 to 2.34)
OG0011.01(0.77 to 1.32)
OG00211.33(9.29 to 13.83)
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
OG004
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
OG005
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
Units
Counts
Participants
OG000139
OG001139
OG002136
OG003135
OG004131
OG005122
Title
Denominators
Categories
Tenderness-Any (n=123,127,114,96,87,71)
Title
Measurements
OG00044.7
OG00143.3
OG00242.1
OG00340.6
OG00444.8
OG00550.7
Tenderness-Significant (n=116,122,97,89,77,58)
Title
Measurements
OG0001.7
OG0016.6
OG0024.1
OG003
Swelling-Any (n=121,126,106,93,83,68)
Title
Measurements
OG00024.8
OG00129.4
OG00230.2
OG003
Swelling-Mild (n=120,125,105,93,82,66)
Title
Measurements
OG00021.7
OG00127.2
OG00228.6
OG003
Swelling-Moderate (n=118,121,98,88,77,60)
Title
Measurements
OG0006.8
OG0016.6
OG0028.2
OG003
Swelling-Severe (n=115,119,96,88,76,57)
Title
Measurements
OG0000.0
OG0010.0
OG0021.0
OG003
Redness-Any (n=122,126,107,99,85,73)
Title
Measurements
OG00022.1
OG00139.7
OG00239.3
OG003
Redness-Mild (n=122,126,106,99,83,71)
Title
Measurements
OG00021.3
OG00139.7
OG00237.7
OG003
Redness-Moderate (n=116,119,98,88,78,61)
Title
Measurements
OG0001.7
OG0010.0
OG0024.1
OG003
Redness-Severe (n=115,119,97,88,76,57)
Title
Measurements
OG0000.0
OG0010.0
OG0022.1
OG003
OG003
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
OG004
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
OG005
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
Units
Counts
Participants
OG000139
OG001139
OG002136
OG003135
OG004131
OG005122
Title
Denominators
Categories
Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61)
Title
Measurements
OG0006.0
OG0013.4
OG0023.1
OG0034.5
OG0047.7
OG00516.4
Fever >39°C but ≤40°C (n=115,119,95,88,76,58)
Title
Measurements
OG0000.9
OG0010.0
OG0020.0
OG003
Fever >40°C (n=115,119,96,88,76,57)
Title
Measurements
OG0000.0
OG0010.0
OG0022.1
OG003
Decreased appetite (n=120,129,104,98,92,68)
Title
Measurements
OG00039.2
OG00134.1
OG00235.6
OG003
Irritability (n=128,135,117,119,97,80)
Title
Measurements
OG00076.6
OG00174.1
OG00271.8
OG003
Increased sleep (n=129,129,114,109,88,71)
Title
Measurements
OG00069.8
OG00166.7
OG00251.8
OG003
Decreased sleep (n=119,124,98,100,81,67)
Title
Measurements
OG00032.8
OG00133.9
OG00235.7
OG003
Meds to treat symptoms (n=123,128,108,110,85,72)
Title
Measurements
OG00043.9
OG00140.6
OG00250.9
OG003
Meds to prevent symptoms (n=122,124,117,103,92,77)
Title
Measurements
OG00049.2
OG00140.3
OG00248.7
OG003
Units
Counts
Participants
OG000109
OG00198
Title
Denominators
Categories
Title
Measurements
OG000656.11(445.46 to 966.38)
OG001771.67(509.98 to 1167.64)
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 GMC ratio (13vPnC/7vPnC) was calculated