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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00384059
Collaborator
(none)
286
Enrollment
11
Locations
2
Arms
24
Duration (Months)
26
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Biological: 7vPnC
  • Biological: Pediacel
  • Biological: NeisVac-C
  • Biological: Menitorix
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
286 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

13-valent pneumococcal vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age

Biological: Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

Biological: NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age

Biological: Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Active Comparator: 2

7-valent pneumococcal vaccine

Biological: 7vPnC
Single 0.5 mL dose given at 2, 3, 4 and 12 months of age

Biological: Pediacel
concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age

Biological: NeisVac-C
concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age

Biological: Menitorix
concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age

Outcome Measures

Primary Outcome Measures

  1. 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. [One month after infant series dose 2 (5 months of age)]

    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.

  2. 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)]

  3. 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)]

  4. 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)]

  5. 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 [one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)]

    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.

  6. Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. [one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)]

    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.

Secondary Outcome Measures

  1. 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)]

  2. 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. [one month after toddler dose (13 months of age)]

  3. 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)]

  4. 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)]

Other Outcome Measures

  1. Percentage of Participants Reporting Pre-Specified Local Reactions [During the 4-day period after each dose]

    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.

  2. Percentage of Participants Reporting Pre-Specified Systemic Events [During the 4-day period after each dose]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
42 Days to 98 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Aged 2 months (42 to 98 days) at the time of enrollment.

  2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.

  3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.

  4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.

  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.

  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.

  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

  6. Known or suspected immune deficiency or suppression.

  7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.

  8. Major known congenital malformation or serious chronic disorder.

  9. 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.

  10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).

  11. Participation in another investigational trial. Participation in purely observational studies was acceptable.

  12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Atherstone United Kingdom CV9 1EU
2 Bangor United Kingdom BT19 1NB
3 Bristol United Kingdom BS2 8AE
4 Co Antrim United Kingdom BT41 3AE
5 Coventry United Kingdom CV6 4DD
6 Ely United Kingdom CB7 4HF
7 London United Kingdom SW17 ORE
8 Oxford United Kingdom OX3 9DU
9 Plymouth United Kingdom PL5 3JB
10 Southampton United Kingdom SO16 6YD
11 Weston-Super-Mare United Kingdom BS22 6AJ

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
  • Principal Investigator: Trial Manager, For UK/Great Britian, ukmedinfo@wyeth.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384059
Other Study ID Numbers:
  • 6096A1-007
First Posted:
Oct 4, 2006
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013
Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details Participants were recruited in the United Kingdom (UK) from October 2006 to June 2007.
Pre-assignment Detail Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Period Title: Infant Series
STARTED 141 145
Vaccinated Dose 1 139 139
Vaccinated Dose 2 136 135
COMPLETED 135 132
NOT COMPLETED 6 13
Period Title: Infant Series
STARTED 135 132
COMPLETED 131 122
NOT COMPLETED 4 10
Period Title: Infant Series
STARTED 131 122
COMPLETED 130 120
NOT COMPLETED 1 2

Baseline Characteristics

Arm/Group Title 13vPnC 7vPnC Total
Arm/Group Description 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). 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). Total of all reporting groups
Overall Participants 120 118 238
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]
2.1
(0.3)
2.1
(0.2)
2.1
(0.3)
Sex: Female, Male (Count of Participants)
Female
55
45.8%
57
48.3%
112
47.1%
Male
65
54.2%
61
51.7%
126
52.9%

Outcome Measures

1. Primary Outcome
Title 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.
Description 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.
Time Frame One month after infant series dose 2 (5 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 120 118
Meningococcal C ≥ 1:8 titer (n=120,118)
99.2
82.7%
99.2
84.1%
Hib (PRP) ≥ 0.15 μg/mL (n=114,102)
96.5
80.4%
98.0
83.1%
Hib (PRP) ≥ 1.0 μg/mL (n=114,102)
85.1
70.9%
89.2
75.6%
Pertussis PT ≥ 5 EU/mL (n=119,112)
100.0
83.3%
100.0
84.7%
Pertussis PT ≥ 17 EU/mL (n=119,112)
96.6
80.5%
95.5
80.9%
Pertussis FHA ≥ 5 EU/mL (n=119,113)
100.0
83.3%
100.0
84.7%
Pertussis FHA ≥ 7.82 EU/mL (n=119,113)
100.0
83.3%
100.0
84.7%
Pertussis FHA ≥ 20 EU/mL (n=119,113)
94.1
78.4%
95.6
81%
Pertussis PRN ≥ 5 EU/mL (n=119,113)
100.0
83.3%
100.0
84.7%
Pertussis PRN ≥ 15 EU/mL (n=119,113)
92.4
77%
95.6
81%
Pertussis FIM ≥ 2.2 EU/mL (n=119,113)
100.0
83.3%
97.3
82.5%
Pertussis FIM ≥ 5 EU/mL (n=119,113)
97.5
81.3%
96.5
81.8%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.8 to 3.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -1.5
Confidence Interval () 95%
-7.1 to 3.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -4.1
Confidence Interval () 95%
-13.4 to 5.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.2 to 3.3
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PT the difference in percentage between the two groups (13vPnC - 7vPnC) at 17 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 1.1
Confidence Interval () 95%
-4.5 to 7.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.2 to 3.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 7.82 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.2 to 3.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FHA the difference in percentage between the two groups (13vPnC - 7vPnC) at 20 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -1.5
Confidence Interval () 95%
-7.9 to 4.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.2 to 3.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PRN the difference in percentage between the two groups (13vPnC - 7vPnC) at 15 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -3.1
Confidence Interval () 95%
-10.0 to 3.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 2.2 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval () 95%
-0.5 to 7.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FIM the difference in percentage between the two groups (13vPnC - 7vPnC) at 5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 1.0
Confidence Interval () 95%
-4.1 to 6.5
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title 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.
Description
Time Frame one month after the toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC Before Toddler Dose 7vPnC Before Toddler Dose 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description 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. 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. Participants received Menitorix at the 12-month visit. Participants received Menitorix at the 12-month visit.
Measure Participants 102 93 109 98
Number (95% Confidence Interval) [Percentage of Participants]
44.1
36.8%
49.5
41.9%
91.7
38.5%
91.8
NaN
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -5.3
Confidence Interval () 95%
-19.7 to 8.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC After Toddler Dose, 7vPnC After Toddler Dose
Comments For Meningococcal C the difference in percentage between the two groups (13vPnC - 7vPnC) at 1:8 titer was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.1
Confidence Interval () 95%
-8.0 to 8.1
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title 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.
Description
Time Frame one month after toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 105 96
Hib (PRP) ≥0.15 μg/mL
100.0
83.3%
100.0
84.7%
Hib (PRP)≥1.0 μg/mL
99.0
82.5%
100.0
84.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 µg/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-3.5 to 3.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 µg/mL threshold was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -1.0
Confidence Interval () 95%
-5.3 to 2.8
Parameter Dispersion Type:
Value:
Estimation Comments
4. Primary Outcome
Title 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
Description
Time Frame one month after infant series dose 2 (5 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 120 118
Geometric Mean (95% Confidence Interval) [titer]
306.20
345.42
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.89
Confidence Interval () 95%
0.68 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
5. Primary Outcome
Title 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
Description
Time Frame one month after infant series dose 2 (5 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 114 102
Geometric Mean (95% Confidence Interval) [μg/mL]
3.40
4.44
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.77
Confidence Interval () 95%
0.54 to 1.08
Parameter Dispersion Type:
Value:
Estimation Comments
6. Primary Outcome
Title 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
Description
Time Frame one month after infant series dose 2 (5 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 120 118
Pertussis FHA (n=119,113)
54.74
55.99
Pertussis PT (n=119,112)
66.26
67.05
Pertussis PRN (n=119,113)
61.33
61.07
Pertussis FIM (n=119,113)
21.72
21.77
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.98
Confidence Interval () 95%
0.82 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.99
Confidence Interval () 95%
0.83 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.00
Confidence Interval () 95%
0.80 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Pertussis FIM the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments 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).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.00
Confidence Interval () 95%
0.81 to 1.23
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
Title Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose.
Description
Time Frame one month after toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 105 96
Geometric Mean (95% Confidence Interval) [μg/mL]
22.22
19.75
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.13
Confidence Interval () 95%
0.83 to 1.53
Parameter Dispersion Type:
Value:
Estimation Comments
8. Primary Outcome
Title 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
Description 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.
Time Frame one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After Infant Series Dose 2 13vPnC Before Toddler Dose 13vPnC After Toddler Dose
Arm/Group Description 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. 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. Participants received Menitorix at the 12-month visit.
Measure Participants 120 120 110
Common Serotypes - Serotype 4 (n=107,89,102)
95.3
79.4%
24.7
20.9%
99.0
41.6%
Common Serotypes - Serotype 6B (n=107,86,102)
40.2
33.5%
74.4
63.1%
98.0
41.2%
Common Serotypes - Serotype 9V (n=104,91,101)
85.6
71.3%
44.0
37.3%
98.0
41.2%
Common Serotypes - Serotype 14 (n=107,88,101)
92.5
77.1%
92.0
78%
100.0
42%
Common Serotypes - Serotype 18C (n=111,91,105)
92.8
77.3%
13.2
11.2%
97.1
40.8%
Common Serotypes - Serotype 19F (n=109,91,104)
93.6
78%
67.0
56.8%
98.1
41.2%
Common Serotypes - Serotype 23F (n=111,89,104)
66.7
55.6%
37.1
31.4%
98.1
41.2%
Additional Serotypes - Serotype 1 (n=107,88,101)
97.2
81%
50.0
42.4%
100.0
42%
Additional Serotypes - Serotype 3 (n=107,87,102)
86.0
71.7%
12.6
10.7%
88.2
37.1%
Additional Serotypes - Serotype 5 (n=103,88,101)
89.3
74.4%
78.4
66.4%
100.0
42%
Additional Serotypes - Serotype 6A (n=106,86,99)
79.2
66%
79.1
67%
98.0
41.2%
Additional Serotypes - Serotype 7F (n=107,91,100)
94.4
78.7%
71.4
60.5%
100.0
42%
Additional Serotypes - Serotype 19A (n=110,91,103)
92.7
77.3%
86.8
73.6%
100.0
42%
9. Primary Outcome
Title Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose.
Description 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.
Time Frame one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After Infant Series Dose 2 13vPnC Before Toddler Dose 13vPnC After Toddler Dose
Arm/Group Description 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. 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. 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.
Measure Participants 120 120 110
Common Serotypes - Serotype 4 (n=107,87,87)
1.37
0.21
3.52
Common Serotypes - Serotype 6B (n=107,85,85)
0.26
0.77
7.67
Common Serotypes - Serotype 9V (n=104,88,88)
0.87
0.29
2.46
Common Serotypes - Serotype 14 (n=107,87,87)
1.83
1.34
11.32
Common Serotypes - Serotype 18C (n=111,91,91)
1.37
0.20
2.14
Common Serotypes - Serotype 19F (n=109,90,90)
2.38
0.60
7.25
Common Serotypes - Serotype 23F (n=111,88,88)
0.53
0.24
3.13
Additional Serotypes - Serotype 1 (n=107,85,85)
1.69
0.39
5.60
Additional Serotypes - Serotype 3 (n=107,85,85)
0.63
0.14
0.98
Additional Serotypes - Serotype 5 (n=103,86,86)
0.95
0.59
3.68
Additional Serotypes - Serotype 6A (n=106,83,83)
0.86
0.81
6.31
Additional Serotypes - Serotype 7F (n=107,87,87)
2.14
0.56
4.06
Additional Serotypes - Serotype 19A (n=110,89,89)
1.90
1.01
11.33
10. Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Description 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.
Time Frame During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Toddler Dose 7vPnC Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
Measure Participants 139 139 136 135 131 122
Tenderness-Any (n=123,127,114,96,87,71)
44.7
37.3%
43.3
36.7%
42.1
17.7%
40.6
NaN
44.8
NaN
50.7
NaN
Tenderness-Significant (n=116,122,97,89,77,58)
1.7
1.4%
6.6
5.6%
4.1
1.7%
4.5
NaN
3.9
NaN
3.4
NaN
Swelling-Any (n=121,126,106,93,83,68)
24.8
20.7%
29.4
24.9%
30.2
12.7%
34.4
NaN
30.1
NaN
39.7
NaN
Swelling-Mild (n=120,125,105,93,82,66)
21.7
18.1%
27.2
23.1%
28.6
12%
29.0
NaN
28.0
NaN
34.8
NaN
Swelling-Moderate (n=118,121,98,88,77,60)
6.8
5.7%
6.6
5.6%
8.2
3.4%
6.8
NaN
3.9
NaN
11.7
NaN
Swelling-Severe (n=115,119,96,88,76,57)
0.0
0%
0.0
0%
1.0
0.4%
0.0
NaN
0.0
NaN
0.0
NaN
Redness-Any (n=122,126,107,99,85,73)
22.1
18.4%
39.7
33.6%
39.3
16.5%
40.4
NaN
38.8
NaN
53.4
NaN
Redness-Mild (n=122,126,106,99,83,71)
21.3
17.8%
39.7
33.6%
37.7
15.8%
37.4
NaN
33.7
NaN
49.3
NaN
Redness-Moderate (n=116,119,98,88,78,61)
1.7
1.4%
0.0
0%
4.1
1.7%
3.4
NaN
12.8
NaN
16.4
NaN
Redness-Severe (n=115,119,97,88,76,57)
0.0
0%
0.0
0%
2.1
0.9%
0.0
NaN
0.0
NaN
0.0
NaN
11. Other Pre-specified Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events
Description 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.
Time Frame During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Toddler Dose 7vPnC Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
Measure Participants 139 139 136 135 131 122
Fever ≥38°C but ≤39°C (n=116,119,96,88,78,61)
6.0
5%
3.4
2.9%
3.1
1.3%
4.5
NaN
7.7
NaN
16.4
NaN
Fever >39°C but ≤40°C (n=115,119,95,88,76,58)
0.9
0.8%
0.0
0%
0.0
0%
0.0
NaN
0.0
NaN
5.2
NaN
Fever >40°C (n=115,119,96,88,76,57)
0.0
0%
0.0
0%
2.1
0.9%
0.0
NaN
0.0
NaN
0.0
NaN
Decreased appetite (n=120,129,104,98,92,68)
39.2
32.7%
34.1
28.9%
35.6
15%
37.8
NaN
39.1
NaN
44.1
NaN
Irritability (n=128,135,117,119,97,80)
76.6
63.8%
74.1
62.8%
71.8
30.2%
80.7
NaN
74.2
NaN
76.3
NaN
Increased sleep (n=129,129,114,109,88,71)
69.8
58.2%
66.7
56.5%
51.8
21.8%
56.9
NaN
38.6
NaN
40.8
NaN
Decreased sleep (n=119,124,98,100,81,67)
32.8
27.3%
33.9
28.7%
35.7
15%
38.0
NaN
32.1
NaN
44.8
NaN
Meds to treat symptoms (n=123,128,108,110,85,72)
43.9
36.6%
40.6
34.4%
50.9
21.4%
54.5
NaN
49.4
NaN
58.3
NaN
Meds to prevent symptoms (n=122,124,117,103,92,77)
49.2
41%
40.3
34.2%
48.7
20.5%
50.5
NaN
52.2
NaN
67.5
NaN
12. Secondary Outcome
Title Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Description
Time Frame one month after toddler dose (13 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description 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). 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).
Measure Participants 109 98
Geometric Mean (95% Confidence Interval) [titer]
656.11
771.67
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Meningococcal C the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ration
Estimated Value 0.85
Confidence Interval () 95%
0.48 to 1.49
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title 13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Arm/Group Description 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. 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. 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. 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. 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). 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). 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). 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).
All Cause Mortality
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/139 (0.7%) 3/139 (2.2%) 5/139 (3.6%) 2/139 (1.4%) 1/131 (0.8%) 2/122 (1.6%) 2/138 (1.4%) 0/139 (0%)
Gastrointestinal disorders
Gastrooesophaegeal reflux 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Vomiting 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 1/138 (0.7%) 0/139 (0%)
Infections and infestations
Bronchiolitis 1/139 (0.7%) 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 1/131 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Cellulitis 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Gastroenteritis 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Lower respiratory tract infection 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Mastoiditis 0/139 (0%) 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Pneumonia 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Injury, poisoning and procedural complications
Fall 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Head injury 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Tongue injury 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Nervous system disorders
Febrile convulsion 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 1/138 (0.7%) 0/139 (0%)
Hemiplegia 0/139 (0%) 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Psychiatric disorders
Breath holding 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Respiratory, thoracic and mediastinal disorders
Wheezing 0/139 (0%) 0/139 (0%) 1/139 (0.7%) 0/139 (0%) 0/131 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Other (Not Including Serious) Adverse Events
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 111/138 (80.4%) 105/139 (75.5%) 9/138 (6.5%) 8/139 (5.8%) 72/130 (55.4%) 61/122 (50%) 1/138 (0.7%) 1/139 (0.7%)
Blood and lymphatic system disorders
Lymphadenopathy 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Cardiac disorders
Cyanosis 2/138 (1.4%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Congenital, familial and genetic disorders
Dacryostenosis congenital 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Lymphangioma 0/138 (0%) 0/139 (0%) 1/138 (0.7%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Ear and labyrinth disorders
Cerumen impaction 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Tympanic membrane perforation 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Eye disorders
Conjunctivitis 7/138 (5.1%) 13/139 (9.4%) 0/138 (0%) 0/139 (0%) 3/130 (2.3%) 4/122 (3.3%) 0/138 (0%) 0/139 (0%)
Eye discharge 5/138 (3.6%) 3/139 (2.2%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Ocular hyperaemia 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Astigmatism 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dacryostenosis acquired 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Hypermetropia 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Gastrointestinal disorders
Diarrhoea 24/138 (17.4%) 17/139 (12.2%) 0/138 (0%) 0/139 (0%) 12/130 (9.2%) 13/122 (10.7%) 0/138 (0%) 0/139 (0%)
Vomiting 19/138 (13.8%) 11/139 (7.9%) 0/138 (0%) 0/139 (0%) 12/130 (9.2%) 13/122 (10.7%) 0/138 (0%) 0/139 (0%)
Teething 11/138 (8%) 9/139 (6.5%) 0/138 (0%) 0/139 (0%) 4/130 (3.1%) 3/122 (2.5%) 0/138 (0%) 0/139 (0%)
Gastrooesophageal reflux disease 5/138 (3.6%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Constipation 1/138 (0.7%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Infantile spitting up 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Stomach discomfort 2/138 (1.4%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Abdominal discomfort 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Abdominal pain 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Flatulence 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Frequent bowel movements 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Reflux oesophagitis 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
General disorders
Pyrexia 9/138 (6.5%) 7/139 (5%) 0/138 (0%) 0/139 (0%) 5/130 (3.8%) 6/122 (4.9%) 0/138 (0%) 0/139 (0%)
Injection site erythema 1/138 (0.7%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Feeling hot 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Injection site bruising 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Injection site induration 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Injection site swelling 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Irritability 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Malaise 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Vessel puncture site haematoma 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Gait disturbance 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 1/138 (0.7%) 0/139 (0%)
Fever ≥38°C but ≤39°C 7/116 (6%) 4/119 (3.4%) 0/0 (NaN) 0/0 (NaN) 6/78 (7.7%) 10/61 (16.4%) 0/0 (NaN) 0/0 (NaN)
Fever ≥38°C but ≤39°C 3/96 (3.1%) 4/88 (4.5%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Fever >39°C but ≤40°C 1/115 (0.9%) 0/119 (0%) 0/0 (NaN) 0/0 (NaN) 0/76 (0%) 3/58 (5.2%) 0/0 (NaN) 0/0 (NaN)
Fever >39°C but ≤40°C 0/95 (0%) 0/88 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Fever >40°C 0/115 (0%) 0/119 (0%) 0/0 (NaN) 0/0 (NaN) 0/76 (0%) 0/57 (0%) 0/0 (NaN) 0/0 (NaN)
Fever >40°C 2/96 (2.1%) 0/88 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Decreased appetite 47/120 (39.2%) 44/129 (34.1%) 0/0 (NaN) 0/0 (NaN) 36/92 (39.1%) 30/68 (44.1%) 0/0 (NaN) 0/0 (NaN)
Decreased appetite 37/104 (35.6%) 37/98 (37.8%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Irritability 98/128 (76.6%) 100/135 (74.1%) 0/0 (NaN) 0/0 (NaN) 72/97 (74.2%) 61/80 (76.3%) 0/0 (NaN) 0/0 (NaN)
Irritability 84/117 (71.8%) 96/119 (80.7%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Increased sleep 90/129 (69.8%) 86/129 (66.7%) 0/0 (NaN) 0/0 (NaN) 34/88 (38.6%) 29/71 (40.8%) 0/0 (NaN) 0/0 (NaN)
Increased sleep 59/114 (51.8%) 62/109 (56.9%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Decreased sleep 39/119 (32.8%) 42/124 (33.9%) 0/0 (NaN) 0/0 (NaN) 26/81 (32.1%) 30/67 (44.8%) 0/0 (NaN) 0/0 (NaN)
Decreased sleep 35/98 (35.7%) 38/100 (38%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Immune system disorders
Food allergy 0/138 (0%) 0/139 (0%) 1/138 (0.7%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Drug hypersensitivity 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Infections and infestations
Rhinitis 32/138 (23.2%) 26/139 (18.7%) 1/138 (0.7%) 0/139 (0%) 11/130 (8.5%) 10/122 (8.2%) 0/138 (0%) 0/139 (0%)
Upper respiratory tract infection 16/138 (11.6%) 19/139 (13.7%) 0/138 (0%) 1/139 (0.7%) 4/130 (3.1%) 4/122 (3.3%) 0/138 (0%) 0/139 (0%)
Nasopharyngitis 15/138 (10.9%) 14/139 (10.1%) 0/138 (0%) 1/139 (0.7%) 9/130 (6.9%) 8/122 (6.6%) 0/138 (0%) 0/139 (0%)
Lower respiratory tract infection 7/138 (5.1%) 4/139 (2.9%) 0/138 (0%) 0/139 (0%) 8/130 (6.2%) 2/122 (1.6%) 0/138 (0%) 0/139 (0%)
Varicella 2/138 (1.4%) 8/139 (5.8%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Gastroenteritis 5/138 (3.6%) 4/139 (2.9%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Oral candidiasis 5/138 (3.6%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Viral infection 4/138 (2.9%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 2/130 (1.5%) 2/122 (1.6%) 0/138 (0%) 0/139 (0%)
Herpes zoster 2/138 (1.4%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Injection site infection 1/138 (0.7%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Viral skin infection 2/138 (1.4%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Bronchiolitis 0/138 (0%) 2/139 (1.4%) 0/138 (0%) 1/139 (0.7%) 1/130 (0.8%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Ear infection 0/138 (0%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 5/130 (3.8%) 3/122 (2.5%) 0/138 (0%) 0/139 (0%)
Eczema infected 2/138 (1.4%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Otitis media 1/138 (0.7%) 1/139 (0.7%) 1/138 (0.7%) 1/139 (0.7%) 1/130 (0.8%) 2/122 (1.6%) 0/138 (0%) 0/139 (0%)
Candidiasis 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dermatitis infected 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Impetigo 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 2/130 (1.5%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Respiratory tract infection 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Skin candida 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Tonsillitis 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Viral upper respiratory tract infection 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Rubella 0/138 (0%) 0/139 (0%) 1/138 (0.7%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Gastroenteritis viral 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 2/122 (1.6%) 0/138 (0%) 0/139 (0%)
Bronchitis 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Eye infection 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Pharyngitis 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Skin infection 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Injury, poisoning and procedural complications
Contusion 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Head injury 2/138 (1.4%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Traumatic haematoma 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Radius fracture 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Investigations
Physical examination abnormal 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Cardiac murmur 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Metabolism and nutrition disorders
Decreased appetite 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Anorexia 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Increased appetite 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Weight gain poor 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Lactose intolerance 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Nervous system disorders
High-pitched crying 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Somnolence 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Hypertonia 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Lethargy 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Agitation 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Restlessness 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Psychiatric disorders
Crying 2/138 (1.4%) 4/139 (2.9%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Insomnia 1/138 (0.7%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Staring 0/138 (0%) 0/139 (0%) 1/138 (0.7%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 29/138 (21%) 16/139 (11.5%) 1/138 (0.7%) 0/139 (0%) 10/130 (7.7%) 10/122 (8.2%) 0/138 (0%) 0/139 (0%)
Rhinorrhoea 1/138 (0.7%) 7/139 (5%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Wheezing 1/138 (0.7%) 2/139 (1.4%) 1/138 (0.7%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Nasal congestion 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Sneezing 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dysphonia 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dyspnoea 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Grunting 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Asthma 0/138 (0%) 0/139 (0%) 0/138 (0%) 3/139 (2.2%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 1/139 (0.7%)
Pharyngolaryngeal pain 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Skin and subcutaneous tissue disorders
Eczema 11/138 (8%) 5/139 (3.6%) 1/138 (0.7%) 2/139 (1.4%) 1/130 (0.8%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Rash 3/138 (2.2%) 5/139 (3.6%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 1/122 (0.8%) 0/138 (0%) 0/139 (0%)
Dermatitis diaper 2/138 (1.4%) 5/139 (3.6%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dry skin 2/138 (1.4%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Eczema infantile 1/138 (0.7%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Erythema 0/138 (0%) 2/139 (1.4%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Urticaria 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dermatitis contact 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Heat rash 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Rash erythematous 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Rash papular 0/138 (0%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Seborrhoeic dermatitis 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Skin discolouration 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Umbilical erythema 1/138 (0.7%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dermatitis atopic 0/138 (0%) 0/139 (0%) 1/138 (0.7%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Dermatitis allergic 0/138 (0%) 0/139 (0%) 0/138 (0%) 0/139 (0%) 1/130 (0.8%) 0/122 (0%) 0/138 (0%) 0/139 (0%)
Tenderness (Any) 55/123 (44.7%) 55/127 (43.3%) 0/0 (NaN) 0/0 (NaN) 39/87 (44.8%) 36/71 (50.7%) 0/0 (NaN) 0/0 (NaN)
Tenderness (Any) 48/114 (42.1%) 39/96 (40.6%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Tenderness (Significant) 2/116 (1.7%) 8/122 (6.6%) 0/0 (NaN) 0/0 (NaN) 3/77 (3.9%) 2/58 (3.4%) 0/0 (NaN) 0/0 (NaN)
Tenderness (Significant) 4/97 (4.1%) 4/89 (4.5%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Any) 30/121 (24.8%) 37/126 (29.4%) 0/0 (NaN) 0/0 (NaN) 25/83 (30.1%) 27/68 (39.7%) 0/0 (NaN) 0/0 (NaN)
Induration (Any) 32/106 (30.2%) 32/93 (34.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Mild) 26/120 (21.7%) 34/125 (27.2%) 0/0 (NaN) 0/0 (NaN) 23/82 (28%) 23/66 (34.8%) 0/0 (NaN) 0/0 (NaN)
Induration (Mild) 30/105 (28.6%) 27/93 (29%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Moderate) 8/118 (6.8%) 8/121 (6.6%) 0/0 (NaN) 0/0 (NaN) 3/77 (3.9%) 7/60 (11.7%) 0/0 (NaN) 0/0 (NaN)
Induration (Moderate) 8/98 (8.2%) 6/88 (6.8%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Severe) 0/115 (0%) 0/119 (0%) 0/0 (NaN) 0/0 (NaN) 0/76 (0%) 0/57 (0%) 0/0 (NaN) 0/0 (NaN)
Induration (Severe) 1/96 (1%) 0/88 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Any) 27/122 (22.1%) 50/126 (39.7%) 0/0 (NaN) 0/0 (NaN) 33/85 (38.8%) 39/73 (53.4%) 0/0 (NaN) 0/0 (NaN)
Erythema (Any) 42/107 (39.3%) 40/99 (40.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Mild) 26/122 (21.3%) 50/126 (39.7%) 0/0 (NaN) 0/0 (NaN) 28/83 (33.7%) 35/71 (49.3%) 0/0 (NaN) 0/0 (NaN)
Erythema (Mild) 40/106 (37.7%) 37/99 (37.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Moderate) 2/116 (1.7%) 0/119 (0%) 0/0 (NaN) 0/0 (NaN) 10/78 (12.8%) 10/61 (16.4%) 0/0 (NaN) 0/0 (NaN)
Erythema (Moderate) 4/98 (4.1%) 3/88 (3.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Severe) 0/115 (0%) 0/119 (0%) 0/0 (NaN) 0/0 (NaN) 0/76 (0%) 0/57 (0%) 0/0 (NaN) 0/0 (NaN)
Erythema (Severe) 2/97 (2.1%) 0/88 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Vascular disorders
Flushing 1/138 (0.7%) 1/139 (0.7%) 0/138 (0%) 0/139 (0%) 0/130 (0%) 0/122 (0%) 0/138 (0%) 0/139 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00384059
Other Study ID Numbers:
  • 6096A1-007
First Posted:
Oct 4, 2006
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013