Trial Outcomes & Findings for Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine (NCT NCT00373958)
NCT ID: NCT00373958
Last Updated: 2013-02-21
Results Overview
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
666 participants
Primary outcome timeframe
One month after the 3-dose infant series (7 months of age)
Results posted on
2013-02-21
Participant Flow
Participants were recruited in the United States from September 2006 to January 2008.
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participant milestones
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
STARTED
|
334
|
332
|
|
Infant Series
Vaccinated Dose 1
|
332
|
331
|
|
Infant Series
Vaccinated Dose 2
|
309
|
305
|
|
Infant Series
Vaccinated Dose 3
|
298
|
300
|
|
Infant Series
COMPLETED
|
294
|
290
|
|
Infant Series
NOT COMPLETED
|
40
|
42
|
|
Toddler Dose
STARTED
|
294
|
290
|
|
Toddler Dose
Withdrawn After Infant Series
|
22
|
25
|
|
Toddler Dose
Vaccinated Toddler Dose
|
272
|
265
|
|
Toddler Dose
COMPLETED
|
264
|
252
|
|
Toddler Dose
NOT COMPLETED
|
30
|
38
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|
|
Infant Series
Withdrawal by Subject
|
13
|
15
|
|
Infant Series
Failed to return
|
8
|
13
|
|
Infant Series
Lost to Follow-up
|
6
|
5
|
|
Infant Series
Protocol Violation
|
3
|
7
|
|
Infant Series
Lost Kaiser coverage
|
4
|
0
|
|
Infant Series
Child relocated
|
1
|
0
|
|
Infant Series
Consent was not received
|
1
|
0
|
|
Infant Series
Adverse Event
|
3
|
1
|
|
Infant Series
Physician Decision
|
1
|
1
|
|
Toddler Dose
Lost to Follow-up
|
5
|
8
|
|
Toddler Dose
Withdrawal by Subject
|
2
|
2
|
|
Toddler Dose
Failed to return
|
1
|
2
|
|
Toddler Dose
Protocol Violation
|
0
|
1
|
|
Toddler Dose
Withdrawn after infant series
|
22
|
25
|
Baseline Characteristics
Study Comparing 13-valent Pneumococcal Conjugate Vaccine With 7-valent Pneumococcal Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
13vPnC
n=334 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=332 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
Total
n=666 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
2.1 months
STANDARD_DEVIATION 0.3 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
165 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after the 3-dose infant series (7 months of age)Population: Evaluable immunogenicity (per protocol) population consisting of 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 IgG antibody concentration to the given serotype.
Percentages of Participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35 μg/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.
Outcome measures
| Measure |
13vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 18C (n=252,252)
|
96.8 percentage of participants
Interval 93.8 to 98.6
|
98.4 percentage of participants
Interval 96.0 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 4 (n=252,251)
|
94.4 percentage of participants
Interval 90.9 to 96.9
|
98.0 percentage of participants
Interval 95.4 to 99.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 6B (n=252,250)
|
87.3 percentage of participants
Interval 82.5 to 91.1
|
92.8 percentage of participants
Interval 88.9 to 95.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 9V (n=252,252)
|
90.5 percentage of participants
Interval 86.2 to 93.8
|
98.4 percentage of participants
Interval 96.0 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 14 (n=251,252)
|
97.6 percentage of participants
Interval 94.9 to 99.1
|
97.2 percentage of participants
Interval 94.4 to 98.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 19F (n=252,251)
|
98.0 percentage of participants
Interval 95.4 to 99.4
|
97.6 percentage of participants
Interval 94.9 to 99.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Common Serotypes - Serotype 23F (n=252,252)
|
90.5 percentage of participants
Interval 86.2 to 93.8
|
94.0 percentage of participants
Interval 90.4 to 96.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 1 (n=252,248)
|
95.6 percentage of participants
Interval 92.3 to 97.8
|
1.6 percentage of participants
Interval 0.4 to 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 3 (n=249,241)
|
63.5 percentage of participants
Interval 57.1 to 69.4
|
4.6 percentage of participants
Interval 2.3 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 5 (n=252,197)
|
89.7 percentage of participants
Interval 85.2 to 93.1
|
31.0 percentage of participants
Interval 24.6 to 37.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 6A (n=252,240)
|
96.0 percentage of participants
Interval 92.8 to 98.1
|
42.5 percentage of participants
Interval 36.2 to 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 7F (n=252,248)
|
98.4 percentage of participants
Interval 96.0 to 99.6
|
2.8 percentage of participants
Interval 1.1 to 5.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥0.35 μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series
Additional Serotypes - Serotype 19A (n=251,238)
|
98.4 percentage of participants
Interval 96.0 to 99.6
|
86.6 percentage of participants
Interval 81.6 to 90.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 Month After the Toddler DosePopulation: Evaluable immunogenicity (per protocol) population of eligible participants, 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.
Antibody concentration/geometric mean concentration as measured by enzyme-linked immunosorbent assay (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.
Outcome measures
| Measure |
13vPnC
n=239 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=223 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 4 (n=235,223)
|
3.73 μg/mL
Interval 3.28 to 4.24
|
5.49 μg/mL
Interval 4.91 to 6.13
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 6B (n=234,223)
|
11.53 μg/mL
Interval 9.99 to 13.3
|
15.63 μg/mL
Interval 13.8 to 17.69
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 9V (n=234,223)
|
2.62 μg/mL
Interval 2.32 to 2.94
|
3.63 μg/mL
Interval 3.25 to 4.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 14 (n=235,223)
|
9.11 μg/mL
Interval 7.95 to 10.45
|
12.72 μg/mL
Interval 11.22 to 14.41
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 18C (n=236,223)
|
3.20 μg/mL
Interval 2.82 to 3.64
|
4.70 μg/mL
Interval 4.18 to 5.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 19F (n=235,223)
|
6.60 μg/mL
Interval 5.85 to 7.44
|
5.60 μg/mL
Interval 4.87 to 6.43
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Common Serotypes - Serotype 23F (n=234,222)
|
5.07 μg/mL
Interval 4.41 to 5.83
|
7.84 μg/mL
Interval 6.91 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 1 (n=235,223)
|
5.06 μg/mL
Interval 4.43 to 5.8
|
0.03 μg/mL
Interval 0.03 to 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 3 (n=232,223)
|
0.94 μg/mL
Interval 0.83 to 1.05
|
0.07 μg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 5 (n=235,223)
|
3.72 μg/mL
Interval 3.31 to 4.18
|
0.55 μg/mL
Interval 0.47 to 0.64
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 6A (n=235,223)
|
8.20 μg/mL
Interval 7.3 to 9.2
|
1.87 μg/mL
Interval 1.6 to 2.19
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 7F (n=235,223)
|
5.67 μg/mL
Interval 5.01 to 6.42
|
0.05 μg/mL
Interval 0.04 to 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose
Additional Serotypes - Serotype 19A (n=236,223)
|
8.55 μg/mL
Interval 7.64 to 9.56
|
3.54 μg/mL
Interval 3.15 to 3.98
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One Month After the Infant Series (7 months of age)Population: Evaluable immunogenicity (per protocol) population 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.
Predefined Antibody Levels for Haemophilus Influenzae Type b (\[Hib\] 0.15 µg/mL or 1.0 µg/mL), Diphtheria Toxoid (0.1 International Units \[IU\]/mL), and Pertussis antigens (Pertussis filamentous hemagglutinin \[FHA\] 40.5 Elisa Units \[EU\]/mL, Pertussis toxoid \[PT\] 16.5 EU/mL, Pertussis pertactin \[PRN\] 26 EU/mL).
Outcome measures
| Measure |
13vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hib 1.0 µg/mL (n=237,230)
|
77.6 Percentage of participants
Interval 71.8 to 82.8
|
78.3 Percentage of participants
Interval 72.4 to 83.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
PT [EU]/mL (n=239,240)
|
94.1 Percentage of participants
Interval 90.4 to 96.8
|
95.0 Percentage of participants
Interval 91.4 to 97.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
PRN [EU]/mL (n=239,240)
|
93.7 Percentage of participants
Interval 89.9 to 96.4
|
95.8 Percentage of participants
Interval 92.5 to 98.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Hib 0.15 µg/mL (n=237,230)
|
97.9 Percentage of participants
Interval 95.1 to 99.3
|
97.8 Percentage of participants
Interval 95.0 to 99.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
Diphtheria [IU]/mL (n=233,230)
|
95.7 Percentage of participants
Interval 92.2 to 97.9
|
96.1 Percentage of participants
Interval 92.7 to 98.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series
FHA [EU]/mL (n=239,240)
|
96.7 Percentage of participants
Interval 93.5 to 98.5
|
95.0 Percentage of participants
Interval 91.4 to 97.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days after each dosePopulation: Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.
Systemic events (any fever \[Fv\] ≥ 38 degrees Celsius \[C\], decreased (decr.) appetite, irritability, increased (incr.) sleep, decreased sleep, and hives \[urticaria\], use of antipyretic medication \[med\] to treat or prevent symptoms \[sx\]) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=332 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=331 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
n=309 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
n=305 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
n=298 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
n=300 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
n=272 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=265 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Fv >40°C (n=174,187,116,121,87,80,60,45)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.8 Percentage of participants
|
0.0 Percentage of participants
|
1.3 Percentage of participants
|
1.7 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Decr. appetite (n=228,238,177,174,147,136,116,110)
|
54.8 Percentage of participants
|
45.4 Percentage of participants
|
59.9 Percentage of participants
|
52.3 Percentage of participants
|
59.2 Percentage of participants
|
59.6 Percentage of participants
|
65.5 Percentage of participants
|
73.6 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Incr. sleep (n=268,270,203,200,164,149,115,109)
|
79.5 Percentage of participants
|
78.5 Percentage of participants
|
79.3 Percentage of participants
|
73.5 Percentage of participants
|
71.3 Percentage of participants
|
69.8 Percentage of participants
|
70.4 Percentage of participants
|
74.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Decr. sleep (n=221,236,169,172,154,134,113,95)
|
45.7 Percentage of participants
|
47.9 Percentage of participants
|
49.1 Percentage of participants
|
55.8 Percentage of participants
|
60.4 Percentage of participants
|
63.4 Percentage of participants
|
58.4 Percentage of participants
|
64.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Hives (urticaria) (n=178,188,118,120,89,79,62,47)
|
1.7 Percentage of participants
|
1.1 Percentage of participants
|
2.5 Percentage of participants
|
0.0 Percentage of participants
|
4.5 Percentage of participants
|
0.0 Percentage of participants
|
4.8 Percentage of participants
|
6.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Med-treat sx (n=257,266,221,221,203,187,162,138)
|
78.6 Percentage of participants
|
71.8 Percentage of participants
|
82.4 Percentage of participants
|
81.9 Percentage of participants
|
82.3 Percentage of participants
|
85.6 Percentage of participants
|
84.0 Percentage of participants
|
87.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Med-prevent sx (n=272,274,233,231,202,189,164,162)
|
75.0 Percentage of participants
|
74.8 Percentage of participants
|
86.7 Percentage of participants
|
83.5 Percentage of participants
|
81.2 Percentage of participants
|
84.1 Percentage of participants
|
88.4 Percentage of participants
|
90.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Fv≥38°C but ≤39°C(n=196,203,146,151,123,106,99,76
|
24.0 Percentage of participants
|
21.2 Percentage of participants
|
43.2 Percentage of participants
|
40.4 Percentage of participants
|
39.8 Percentage of participants
|
37.7 Percentage of participants
|
53.5 Percentage of participants
|
51.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Fv>39°C but ≤40°C(n=177,187,118,123,94,81,61,48)
|
2.8 Percentage of participants
|
0.0 Percentage of participants
|
2.5 Percentage of participants
|
4.9 Percentage of participants
|
8.5 Percentage of participants
|
2.5 Percentage of participants
|
6.6 Percentage of participants
|
12.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Systemic Events
Irritability (n=289,290,236,236,216,218,199,175)
|
89.6 Percentage of participants
|
85.9 Percentage of participants
|
89.8 Percentage of participants
|
91.5 Percentage of participants
|
88.4 Percentage of participants
|
92.2 Percentage of participants
|
92.0 Percentage of participants
|
93.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 7 days after each dosePopulation: Safety population who received the given vaccination. (n)= number of participants reporting yes for at least 1 day or no for all days.
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (\[Sig.\], present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (\[Mod.\], 2.5 to 7.0 cm); Severe (\[Sev.\], \> 7.0 cm). Participants may have been represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=332 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=331 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
n=309 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
n=305 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
n=298 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
n=300 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
n=272 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
n=265 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Tenderness-Any (n=264,270,200,216,178,173,149,147)
|
72.7 Percentage of participants
|
72.2 Percentage of participants
|
77.0 Percentage of participants
|
75.9 Percentage of participants
|
78.7 Percentage of participants
|
80.9 Percentage of participants
|
81.2 Percentage of participants
|
84.4 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Tenderness-Sig. (n=182,195,123,131,91,86,65,49)
|
13.7 Percentage of participants
|
9.2 Percentage of participants
|
10.6 Percentage of participants
|
11.5 Percentage of participants
|
8.8 Percentage of participants
|
9.3 Percentage of participants
|
15.4 Percentage of participants
|
12.2 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Swelling-Any (n=201,216,141,146,116,103,91,73)
|
27.4 Percentage of participants
|
23.6 Percentage of participants
|
31.2 Percentage of participants
|
29.5 Percentage of participants
|
37.9 Percentage of participants
|
36.9 Percentage of participants
|
44.0 Percentage of participants
|
50.7 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Swelling-Mild (n=199,212,141,142,113,103,90,71)
|
23.1 Percentage of participants
|
21.2 Percentage of participants
|
29.8 Percentage of participants
|
26.1 Percentage of participants
|
35.4 Percentage of participants
|
36.9 Percentage of participants
|
43.3 Percentage of participants
|
46.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Swelling-Mod. (n=176,193,118,126,91,82,68,49)
|
6.8 Percentage of participants
|
5.2 Percentage of participants
|
5.1 Percentage of participants
|
7.1 Percentage of participants
|
6.6 Percentage of participants
|
6.1 Percentage of participants
|
14.7 Percentage of participants
|
14.3 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Swelling-Sev. (n=172,187,116,120,87,79,59,44)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Redness-Any (n=202,223,155,164,131,118,103,87)
|
35.6 Percentage of participants
|
32.3 Percentage of participants
|
45.2 Percentage of participants
|
37.8 Percentage of participants
|
48.9 Percentage of participants
|
50.0 Percentage of participants
|
54.4 Percentage of participants
|
65.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Redness-Mild (n=200,220,155,162,128,117,102,85)
|
34.5 Percentage of participants
|
31.4 Percentage of participants
|
44.5 Percentage of participants
|
37.0 Percentage of participants
|
47.7 Percentage of participants
|
48.7 Percentage of participants
|
53.9 Percentage of participants
|
63.5 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Redness-Mod. (n=177,191,117,124,91,80,62,50)
|
4.5 Percentage of participants
|
2.6 Percentage of participants
|
1.7 Percentage of participants
|
3.2 Percentage of participants
|
5.5 Percentage of participants
|
5.0 Percentage of participants
|
8.1 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of Participants Reporting Pre-specified Local Reactions
Redness-Sev. (n=173,186,116,120,87,79,59,44)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: One month after toddler dose (13 to 16 months of age)Population: Evaluable immunogenicity (per protocol) population 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 posttoddler dose antibody concentration to the given concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=239 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=223 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Measles ≥1.10 I.V. (n=221,210)
|
96.4 percentage of participants
Interval 93.0 to 98.4
|
97.1 percentage of participants
Interval 93.9 to 98.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Mumps ≥1.10 I.V. (n=221,210)
|
76.5 percentage of participants
Interval 70.3 to 81.9
|
72.9 percentage of participants
Interval 66.3 to 78.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Rubella ≥15 IU/mL (n=209,204)
|
91.9 percentage of participants
Interval 87.3 to 95.2
|
90.7 percentage of participants
Interval 85.8 to 94.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Varicella ≥1.09 I.V. (n=221,210)
|
26.7 percentage of participants
Interval 21.0 to 33.0
|
21.9 percentage of participants
Interval 16.5 to 28.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Hib (PRP) 0.15 µg/mL (n=230,214)
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Vaccine Antigens Induced by Measles, Mumps, Rubella, Varicella (MMR-V) and Haemophilus Influenzae Type b (Hib)
Hib (PRP) 1.0 µg/mL (n=230,214)
|
90.4 percentage of participants
Interval 85.9 to 93.9
|
92.1 percentage of participants
Interval 87.6 to 95.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dosePopulation: The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=248 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=231 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Hib PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
|
6.84 µg/mL
Interval 5.85 to 7.99
|
7.30 µg/mL
Interval 6.21 to 8.59
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dosePopulation: The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Normalization was performed for unit of measure "index value" as Index Value of 1.00 = 10 mIU/mL.
Outcome measures
| Measure |
13vPnC
n=239 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=227 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Varicella
|
0.74 index value
Interval 0.69 to 0.79
|
0.73 index value
Interval 0.69 to 0.77
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Measles
|
1.98 index value
Interval 1.81 to 2.16
|
2.06 index value
Interval 1.9 to 2.23
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration of Measles, Mumps, and Varicella ELISA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
Mumps
|
1.32 index value
Interval 1.19 to 1.46
|
1.32 index value
Interval 1.2 to 1.45
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the toddler dosePopulation: The all-available toddler immunogenicity population included all subjects who had at least 1 valid and determinate assay result before (excluding postinfant) or after the toddler dose. N = number of participants with a determinate antibody concentration or index value for the specified concomitant antigen.
Outcome measures
| Measure |
13vPnC
n=227 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=221 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration of Rubella in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose
|
76.53 IU/mL
Interval 64.55 to 90.72
|
97.69 IU/mL
Interval 82.28 to 115.98
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: One month after infant series and one month after toddler dosePopulation: Evaluable immunogenicity (per protocol) population 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 OPA antibody titer to the given serotype.
Percentage of participants achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) 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.
Outcome measures
| Measure |
13vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
n=239 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
n=223 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 4 (n=92,92,88,92)
|
97.8 percentage of participants
Interval 92.4 to 99.7
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
98.9 percentage of participants
Interval 93.8 to 100.0
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 6B (n=94,94,92,95)
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 14 (n=94,94,92,96)
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 18C (n=94,94,91,96)
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
98.9 percentage of participants
Interval 94.0 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 19F (n=94,94,92,96)
|
90.4 percentage of participants
Interval 82.6 to 95.5
|
92.6 percentage of participants
Interval 85.3 to 97.0
|
96.7 percentage of participants
Interval 90.8 to 99.3
|
94.8 percentage of participants
Interval 88.3 to 98.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 23F (n=94,94,90,92)
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
98.9 percentage of participants
Interval 94.0 to 100.0
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 1 (n=92,92,89,92)
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
9.8 percentage of participants
Interval 4.6 to 17.8
|
98.9 percentage of participants
Interval 93.9 to 100.0
|
12.0 percentage of participants
Interval 6.1 to 20.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 3 (n=94,94,91,96)
|
96.8 percentage of participants
Interval 91.0 to 99.3
|
21.3 percentage of participants
Interval 13.5 to 30.9
|
97.8 percentage of participants
Interval 92.3 to 99.7
|
43.8 percentage of participants
Interval 33.6 to 54.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 5 (n=91,93,91,96)
|
92.3 percentage of participants
Interval 84.8 to 96.9
|
2.2 percentage of participants
Interval 0.3 to 7.6
|
98.9 percentage of participants
Interval 94.0 to 100.0
|
5.2 percentage of participants
Interval 1.7 to 11.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 6A (n=94,94,92,96)
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
77.7 percentage of participants
Interval 67.9 to 85.6
|
98.9 percentage of participants
Interval 94.1 to 100.0
|
94.8 percentage of participants
Interval 88.3 to 98.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 7F (n=94,89,91,92)
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
76.4 percentage of participants
Interval 66.2 to 84.8
|
100.0 percentage of participants
Interval 96.0 to 100.0
|
80.4 percentage of participants
Interval 70.9 to 88.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes-Serotype 19A (n=93,92,91,94)
|
91.4 percentage of participants
Interval 83.8 to 96.2
|
16.3 percentage of participants
Interval 9.4 to 25.5
|
97.8 percentage of participants
Interval 92.3 to 99.7
|
53.2 percentage of participants
Interval 42.6 to 63.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Functional Antibody Titer ≥1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 9V (n=93,94,90,94)
|
100.0 percentage of participants
Interval 96.1 to 100.0
|
98.9 percentage of participants
Interval 94.2 to 100.0
|
98.9 percentage of participants
Interval 94.0 to 100.0
|
100.0 percentage of participants
Interval 96.2 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: one month after the infant series and the toddler dosePopulation: Evaluable immunogenicity (per protocol) population of eligible subjects 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 titer for the specified serotype.
Geometric mean titer (GMT) as measured by opsonophagocytic activity assay (OPA) 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.
Outcome measures
| Measure |
13vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC
n=252 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC Dose 2
n=239 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
7vPnC Dose 2
n=223 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes -Serotype 4 (n=92,92,88,92)
|
359.32 titer
Interval 276.04 to 467.72
|
535.68 titer
Interval 421.13 to 681.37
|
1179.98 titer
Interval 847.34 to 1643.2
|
1492.46 titer
Interval 1114.4 to 1998.78
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 6B (n=94,94,92,95)
|
1054.65 titer
Interval 817.34 to 1360.87
|
1513.66 titer
Interval 1206.64 to 1898.81
|
3099.51 titer
Interval 2337.02 to 4110.79
|
4066.22 titer
Interval 3243.42 to 5097.76
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 9V (n=93,94,90,94)
|
4035.40 titer
Interval 2932.68 to 5552.75
|
3259.01 titer
Interval 2288.43 to 4641.25
|
11856.03 titer
Interval 8809.85 to 15955.49
|
18032.33 titer
Interval 14124.99 to 23020.53
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 14 (n=94,94,92,96)
|
1240.41 titer
Interval 934.93 to 1645.69
|
1480.55 titer
Interval 1133.4 to 1934.02
|
2002.23 titer
Interval 1452.54 to 2759.93
|
2365.87 titer
Interval 1870.56 to 2992.34
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 18C (n=94,94,91,96)
|
275.59 titer
Interval 210.33 to 361.1
|
375.64 titer
Interval 291.68 to 483.75
|
993.27 titer
Interval 754.08 to 1308.33
|
1722.16 titer
Interval 1326.59 to 2235.67
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 19F (n=94,94,92,96)
|
54.42 titer
Interval 40.2 to 73.65
|
44.92 titer
Interval 33.9 to 59.52
|
199.65 titer
Interval 144.22 to 276.38
|
167.20 titer
Interval 121.35 to 230.37
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 23F (n=94,94,90,92)
|
791.07 titer
Interval 604.96 to 1034.44
|
923.56 titer
Interval 708.59 to 1203.74
|
2723.25 titer
Interval 1960.67 to 3782.41
|
4981.68 titer
Interval 3885.71 to 6386.76
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 1 (n=92,92,89,92)
|
51.83 titer
Interval 38.84 to 69.16
|
4.41 titer
Interval 4.06 to 4.8
|
164.23 titer
Interval 113.83 to 236.93
|
5.01 titer
Interval 4.22 to 5.96
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 3 (n=94,94,91,96)
|
120.67 titer
Interval 92.38 to 157.62
|
6.70 titer
Interval 5.27 to 8.52
|
380.41 titer
Interval 300.19 to 482.08
|
11.81 titer
Interval 8.68 to 16.08
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 5 (n=91,93,91,96)
|
90.86 titer
Interval 67.1 to 123.02
|
4.15 titer
Interval 3.94 to 4.38
|
300.41 titer
Interval 229.39 to 393.4
|
4.69 titer
Interval 3.99 to 5.51
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 6A (n=94,94,92,96)
|
979.68 titer
Interval 783.04 to 1225.71
|
100.35 titer
Interval 66.22 to 152.08
|
2241.79 titer
Interval 1706.71 to 2944.63
|
538.54 titer
Interval 374.83 to 773.75
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 7F (n=94,89,91,92)
|
9493.77 titer
Interval 7339.13 to 12280.98
|
128.00 titer
Interval 79.55 to 205.97
|
11629.44 titer
Interval 9053.62 to 14938.11
|
267.84 titer
Interval 164.49 to 436.11
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series and the Toddler Dose
Additional Serotypes-Serotype 19A (n=93,92,91,94)
|
151.94 titer
Interval 105.16 to 219.52
|
6.53 titer
Interval 5.01 to 8.5
|
1024.00 titer
Interval 774.12 to 1354.54
|
28.65 titer
Interval 18.58 to 44.17
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Infant Series
Serious events: 17 serious events
Other events: 272 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 16 serious events
Other events: 263 other events
Deaths: 0 deaths
13vPnC Post Infant Series
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
7vPnC Post Infant Series
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
13vPnC Toddler Series
Serious events: 3 serious events
Other events: 183 other events
Deaths: 0 deaths
7vPnC Toddler Series
Serious events: 4 serious events
Other events: 163 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 9 serious events
Other events: 11 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=332 participants at risk
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
|
7vPnC Infant Series
n=331 participants at risk
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
|
13vPnC Post Infant Series
n=332 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
7vPnC Post Infant Series
n=330 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
13vPnC Toddler Series
n=267 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Series
n=258 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC 6-Month Follow-up
n=330 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
7vPnC 6-Month Follow-up
n=329 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Epilepsy
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Febrile convulsion
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchiolitis
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Congenital megacolon
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Constipation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Convulsion
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nephroblastoma
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pneumonia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pneumonia viral
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Postical paralysis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Pyrexia
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Selective IgA immunodeficiency
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Thromboycytopenia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Varicella
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
Other adverse events
| Measure |
13vPnC Infant Series
n=332 participants at risk
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
|
7vPnC Infant Series
n=331 participants at risk
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
|
13vPnC Post Infant Series
n=332 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
7vPnC Post Infant Series
n=330 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
13vPnC Toddler Series
n=267 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
7vPnC Toddler Series
n=258 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
|
13vPnC 6-Month Follow-up
n=330 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
7vPnC 6-Month Follow-up
n=329 participants at risk
Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Lice infestation
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Injury
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Investigations
Cardiac murmur
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Pectus excavatum
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Pilonidal cyst congenital
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Thalassaemia trait
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Sickle cell trait
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Haemoglobin C trait
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Congenital, familial and genetic disorders
Tibial torsion
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Ear and labyrinth disorders
Ear pain
|
1.5%
5/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Endocrine disorders
Precocious puberty
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Conjunctivitis
|
6.6%
22/332 • Adverse events were collected throughout the study.
|
7.3%
24/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
1.1%
3/267 • Adverse events were collected throughout the study.
|
2.3%
6/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Eye discharge
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Eye swelling
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Strabismus
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Dacryostenosis acquired
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Eyelid irritation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
35/332 • Adverse events were collected throughout the study.
|
9.4%
31/331 • Adverse events were collected throughout the study.
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
3.4%
9/267 • Adverse events were collected throughout the study.
|
3.1%
8/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
23/332 • Adverse events were collected throughout the study.
|
7.6%
25/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
1.1%
3/267 • Adverse events were collected throughout the study.
|
2.3%
6/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Constipation
|
4.8%
16/332 • Adverse events were collected throughout the study.
|
6.3%
21/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.3%
11/332 • Adverse events were collected throughout the study.
|
6.9%
23/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Teething
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
2.1%
7/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
1.1%
3/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Anal fissure
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Abdominal wall disorder
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Enamel anomaly
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
General disorders
Pyrexia
|
8.7%
29/332 • Adverse events were collected throughout the study.
|
6.3%
21/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
3.7%
10/267 • Adverse events were collected throughout the study.
|
3.9%
10/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Irritability
|
88.4%
191/216 • Adverse events were collected throughout the study.
|
92.2%
201/218 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site erythema
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site swelling
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site bruising
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site induration
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Xerosis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Developmental delay
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Hernia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Influenza like illness
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site pain
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site rash
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Injection site reaction
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Allergy to metals
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Food allergy
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Milk allergy
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Immune system disorders
Seasonal allergy
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
39.5%
131/332 • Adverse events were collected throughout the study.
|
39.6%
131/331 • Adverse events were collected throughout the study.
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
7.9%
21/267 • Adverse events were collected throughout the study.
|
9.3%
24/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Otitis media
|
28.3%
94/332 • Adverse events were collected throughout the study.
|
23.3%
77/331 • Adverse events were collected throughout the study.
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
1.2%
4/330 • Adverse events were collected throughout the study.
|
8.6%
23/267 • Adverse events were collected throughout the study.
|
8.9%
23/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchiolitis
|
15.7%
52/332 • Adverse events were collected throughout the study.
|
14.8%
49/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
1.6%
4/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
21/332 • Adverse events were collected throughout the study.
|
5.4%
18/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.4%
18/332 • Adverse events were collected throughout the study.
|
6.0%
20/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Otitis media acute
|
3.6%
12/332 • Adverse events were collected throughout the study.
|
6.6%
22/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
1.9%
5/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viral infection
|
3.9%
13/332 • Adverse events were collected throughout the study.
|
5.4%
18/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
1.9%
5/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Candidiasis
|
3.3%
11/332 • Adverse events were collected throughout the study.
|
4.8%
16/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
10/332 • Adverse events were collected throughout the study.
|
3.3%
11/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Sinusitis
|
3.6%
12/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Oral candidiasis
|
3.0%
10/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pharyngitis
|
2.1%
7/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
2.2%
6/267 • Adverse events were collected throughout the study.
|
1.6%
4/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Rhinitis
|
1.5%
5/332 • Adverse events were collected throughout the study.
|
2.4%
8/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Candida nappy rash
|
2.1%
7/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pneumonia
|
2.1%
7/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Croup infectious
|
1.5%
5/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
2.6%
7/267 • Adverse events were collected throughout the study.
|
2.3%
6/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.5%
5/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viral skin infection
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchitis
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Skin candida
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Ear infection
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Impetigo
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viral pharyngitis
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Body tinea
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Fungal skin infection
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Influenza
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Intertrigo candida
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Tinea capitis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchiectasis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Ear lobe infection
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Folliculitis
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Genital candidiasis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Breast cellulitis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Conjunctivitis infective
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Erythema infectiosum
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Fungal infection
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Gastritis viral
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Laryngitis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Paronychia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Roseola
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Viraemia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Infected insect bite
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Varicella
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Investigations
Cardiac murmur functional
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Investigations
Head circumference abnormal
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Investigations
Weight decreased
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Nose deformity
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Musculoskeletal and connective tissue disorders
Premature closure of cranial sutures
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign vaginal neoplasm
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Tremor
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Convulsion
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Hypersomnia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Hypertonia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Lethargy
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Somnolence
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Psychiatric disorders
Crying
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Psychiatric disorders
Insomnia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.30%
1/329 • Adverse events were collected throughout the study.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Psychiatric disorders
Staring
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Renal and urinary disorders
Crystalluria
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Penile blister
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Penis disorder
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
28/332 • Adverse events were collected throughout the study.
|
11.8%
39/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
3.4%
9/267 • Adverse events were collected throughout the study.
|
3.5%
9/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.8%
36/332 • Adverse events were collected throughout the study.
|
7.6%
25/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
16/332 • Adverse events were collected throughout the study.
|
5.1%
17/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
1.9%
5/267 • Adverse events were collected throughout the study.
|
1.6%
4/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
11/332 • Adverse events were collected throughout the study.
|
4.2%
14/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
1.8%
6/332 • Adverse events were collected throughout the study.
|
2.7%
9/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.2%
4/332 • Adverse events were collected throughout the study.
|
1.8%
6/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.91%
3/330 • Adverse events were collected throughout the study.
|
1.1%
3/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
1.2%
4/331 • Adverse events were collected throughout the study.
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.91%
3/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.61%
2/330 • Adverse events were collected throughout the study.
|
1.2%
4/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.3%
31/332 • Adverse events were collected throughout the study.
|
9.4%
31/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
1.2%
4/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
1.2%
3/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.61%
2/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
6.3%
21/332 • Adverse events were collected throughout the study.
|
3.9%
13/331 • Adverse events were collected throughout the study.
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
2.2%
6/267 • Adverse events were collected throughout the study.
|
2.3%
6/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
2.1%
7/332 • Adverse events were collected throughout the study.
|
5.1%
17/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.4%
8/332 • Adverse events were collected throughout the study.
|
3.9%
13/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
1.1%
3/267 • Adverse events were collected throughout the study.
|
3.5%
9/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.1%
7/332 • Adverse events were collected throughout the study.
|
3.6%
12/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.30%
1/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.8%
6/332 • Adverse events were collected throughout the study.
|
2.1%
7/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
1.5%
5/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.90%
3/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.91%
3/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.60%
2/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.75%
2/267 • Adverse events were collected throughout the study.
|
0.78%
2/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.60%
2/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Cafe au lait spots
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Pityriasis alba
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.37%
1/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Rash rubelliform
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.39%
1/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Social circumstances
Exposure to communicable disease
|
0.30%
1/332 • Adverse events were collected throughout the study.
|
0.00%
0/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.30%
1/331 • Adverse events were collected throughout the study.
|
0.00%
0/332 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/267 • Adverse events were collected throughout the study.
|
0.00%
0/258 • Adverse events were collected throughout the study.
|
0.00%
0/330 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
78.7%
140/178 • Adverse events were collected throughout the study.
|
80.9%
140/173 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
8.8%
8/91 • Adverse events were collected throughout the study.
|
9.3%
8/86 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
37.9%
44/116 • Adverse events were collected throughout the study.
|
36.9%
38/103 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
35.4%
40/113 • Adverse events were collected throughout the study.
|
36.9%
38/103 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
6.6%
6/91 • Adverse events were collected throughout the study.
|
6.1%
5/82 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/87 • Adverse events were collected throughout the study.
|
0.00%
0/79 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
48.9%
64/131 • Adverse events were collected throughout the study.
|
50.0%
59/118 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
47.7%
61/128 • Adverse events were collected throughout the study.
|
48.7%
57/117 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
5.5%
5/91 • Adverse events were collected throughout the study.
|
5.0%
4/80 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/87 • Adverse events were collected throughout the study.
|
0.00%
0/79 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Fever ≥38°C but ≤39°C
|
39.8%
49/123 • Adverse events were collected throughout the study.
|
37.7%
40/106 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
0.00%
0/329 • Adverse events were collected throughout the study.
|
|
General disorders
Fever >39°C but ≤40°C
|
8.5%
8/94 • Adverse events were collected throughout the study.
|
2.5%
2/81 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
Skin and subcutaneous tissue disorders
Fever >39°C but ≤40°C
|
2.5%
3/118 • Adverse events were collected throughout the study.
|
4.9%
6/123 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Fever >40°C
|
0.00%
0/87 • Adverse events were collected throughout the study.
|
1.2%
1/80 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Decreased appetite
|
59.2%
87/147 • Adverse events were collected throughout the study.
|
59.6%
81/136 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Increased sleep
|
71.3%
117/164 • Adverse events were collected throughout the study.
|
69.8%
104/149 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Decreased sleep
|
60.4%
93/154 • Adverse events were collected throughout the study.
|
63.4%
85/134 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
|
General disorders
Hives (urticaria)
|
4.5%
4/89 • Adverse events were collected throughout the study.
|
0.00%
0/79 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
—
0/0 • Adverse events were collected throughout the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER