Trial Outcomes & Findings for Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. (NCT NCT00368966)
NCT ID: NCT00368966
Last Updated: 2012-08-16
Results Overview
Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
619 participants
Primary outcome timeframe
One month after 2-doses of the infant series (5 months of age)
Results posted on
2012-08-16
Participant Flow
Participants were recruited in Spain from October 2006 to December 2006.
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 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
|
7vPnC
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
|
|---|---|---|
|
Infant Series
STARTED
|
315
|
304
|
|
Infant Series
Vaccinated Dose 1
|
314
|
302
|
|
Infant Series
Vaccinated Dose 2
|
307
|
298
|
|
Infant Series
Vaccinated Dose 3
|
301
|
296
|
|
Infant Series
COMPLETED
|
299
|
294
|
|
Infant Series
NOT COMPLETED
|
16
|
10
|
|
After Infant
STARTED
|
299
|
294
|
|
After Infant
COMPLETED
|
293
|
289
|
|
After Infant
NOT COMPLETED
|
6
|
5
|
|
Toddler Dose
STARTED
|
293
|
289
|
|
Toddler Dose
COMPLETED
|
292
|
286
|
|
Toddler Dose
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
13vPnC
Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
|
7vPnC
Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
|
|---|---|---|
|
Infant Series
Withdrawal by Subject
|
11
|
6
|
|
Infant Series
Protocol Violation
|
2
|
1
|
|
Infant Series
Lost to Follow-up
|
2
|
0
|
|
Infant Series
Randomization error
|
0
|
1
|
|
Infant Series
Failed to meet eligibility criteria
|
0
|
1
|
|
Infant Series
Adverse Event
|
0
|
1
|
|
Infant Series
Failed to return
|
1
|
0
|
|
After Infant
Failed to return
|
3
|
1
|
|
After Infant
Adverse Event
|
1
|
2
|
|
After Infant
Withdrawal by Subject
|
1
|
1
|
|
After Infant
Death
|
1
|
0
|
|
After Infant
Lost to Follow-up
|
0
|
1
|
|
Toddler Dose
Withdrawal by Subject
|
1
|
1
|
|
Toddler Dose
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Baseline characteristics by cohort
| Measure |
13vPnC
n=315 Participants
Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
|
7vPnC
n=304 Participants
Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
|
Total
n=619 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
2.1 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.1 months
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month after 2-doses of the infant series (5 months of age)Population: Evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentage of participants achieving predefined antibody threshold levels; greater than or equal to (≥) 1:8 for meningococcal C SBA titer and ≥ 0.10 or \>=0.01 International Units Per Milliliter (IU/mL) for diphtheria along with the corresponding 95% Confidence Interval (CI) are presented.
Outcome measures
| Measure |
13vPnC
n=297 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=284 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Meningococcal C ≥ 1:8
|
98.3 Percentage of Participants
Interval 96.1 to 99.5
|
98.9 Percentage of Participants
Interval 96.9 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Diptheria ≥ 0.10 IU/mL
|
95.9 Percentage of Participants
Interval 93.0 to 97.9
|
94.7 Percentage of Participants
Interval 91.4 to 97.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Meningococcal C Serum Bactericidal Assay (SBA) Titer of ≥ 1:8, and a Predefined Antibody Level for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
Diptheria ≥ 0.01 IU/mL
|
100.0 Percentage of Participants
Interval 98.8 to 100.0
|
100.0 Percentage of Participants
Interval 98.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 2-doses of the infant series (5 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC
n=297 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=284 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Meningococcal C in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
|
191.22 titer
Interval 167.72 to 218.02
|
266.19 titer
Interval 234.86 to 301.71
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after 2-doses of the infant series (5 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC
n=296 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=284 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) for Diphtheria in 13vPnC Group Relative to 7vPnC Group After 2-doses of the Infant Series
|
0.51 IU/mL
Interval 0.47 to 0.57
|
0.63 IU/mL
Interval 0.57 to 0.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 4-day period after each dosePopulation: The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=314 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=300 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=306 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=298 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
n=301 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
n=295 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
n=289 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Any (n=275,270,227,232,217,215,193,170)
|
49.5 percentage of participants
|
43.3 percentage of participants
|
45.4 percentage of participants
|
46.6 percentage of participants
|
47.9 percentage of participants
|
41.9 percentage of participants
|
64.2 percentage of participants
|
64.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Sig (n=247,250,192,203,181,171,136,118
|
2.8 percentage of participants
|
2.8 percentage of participants
|
4.2 percentage of participants
|
3.9 percentage of participants
|
6.1 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Any (n=252,254,206,212,203,181,153,140)
|
19.0 percentage of participants
|
14.2 percentage of participants
|
28.2 percentage of participants
|
23.1 percentage of participants
|
27.6 percentage of participants
|
28.2 percentage of participants
|
33.3 percentage of participants
|
30.7 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mild (n=251,254,206,212,201,186,151,132)
|
16.3 percentage of participants
|
14.2 percentage of participants
|
25.7 percentage of participants
|
20.3 percentage of participants
|
26.4 percentage of participants
|
25.8 percentage of participants
|
31.1 percentage of participants
|
24.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Mod (n=247,248,191,201,180,173,136,124)
|
4.9 percentage of participants
|
1.6 percentage of participants
|
5.8 percentage of participants
|
4.5 percentage of participants
|
5.6 percentage of participants
|
4.0 percentage of participants
|
11.8 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling-Severe(n=246,247,191,201,176,171,131,113)
|
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=255,251,211,217,203,198,159,146)
|
22.0 percentage of participants
|
19.1 percentage of participants
|
34.1 percentage of participants
|
30.9 percentage of participants
|
31.0 percentage of participants
|
34.8 percentage of participants
|
40.9 percentage of participants
|
41.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mild (n=254,251,210,215,203,195,157,141)
|
20.1 percentage of participants
|
18.3 percentage of participants
|
32.4 percentage of participants
|
30.2 percentage of participants
|
29.1 percentage of participants
|
33.3 percentage of participants
|
35.0 percentage of participants
|
37.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Mod (n=247,247,192,203,177,175,137,120)
|
2.4 percentage of participants
|
1.2 percentage of participants
|
3.1 percentage of participants
|
2.5 percentage of participants
|
4.5 percentage of participants
|
5.1 percentage of participants
|
13.1 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness-Severe (n=246,247,191,201,176,171,131,113)
|
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
|
PRIMARY outcome
Timeframe: During the 4-day period after each dosePopulation: The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Systemic events (fever \[Fv\] ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased \[Decr\] appetite, irritability, increased \[Incr\] sleep, decreased sleep, hives, use of medication \[Med\] to treat symptoms \[sx\], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Outcome measures
| Measure |
13vPnC
n=314 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=300 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=306 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=298 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
n=301 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
n=295 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
n=289 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv≥38°C, ≤39°C (n=262,253,213,223,198,196,162,145)
|
30.5 percentage of participants
|
24.5 percentage of participants
|
40.4 percentage of participants
|
41.7 percentage of participants
|
34.3 percentage of participants
|
38.3 percentage of participants
|
38.9 percentage of participants
|
44.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv>39°C, ≤40°C (n=249,247,194,204,177,174,135,118)
|
0.8 percentage of participants
|
0.8 percentage of participants
|
2.6 percentage of participants
|
2.5 percentage of participants
|
5.6 percentage of participants
|
5.2 percentage of participants
|
8.1 percentage of participants
|
6.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Fv >40°C (n=249,247,192,201,176,171,132,113)
|
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
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr appetite (n=269,258,226,229,219,204,174,147)
|
39.8 percentage of participants
|
36.8 percentage of participants
|
45.1 percentage of participants
|
44.5 percentage of participants
|
47.0 percentage of participants
|
42.6 percentage of participants
|
53.4 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=276,267,234,244,229,221,183,170)
|
51.4 percentage of participants
|
42.7 percentage of participants
|
64.5 percentage of participants
|
61.5 percentage of participants
|
57.2 percentage of participants
|
58.8 percentage of participants
|
61.7 percentage of participants
|
61.8 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Incr sleep (n=273,269,218,221,206,203,160,145)
|
53.5 percentage of participants
|
51.3 percentage of participants
|
46.8 percentage of participants
|
41.6 percentage of participants
|
33.5 percentage of participants
|
34.5 percentage of participants
|
39.4 percentage of participants
|
35.2 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Decr sleep (n=263,255,218,223,205,190,151,129)
|
34.6 percentage of participants
|
24.7 percentage of participants
|
36.2 percentage of participants
|
29.6 percentage of participants
|
30.2 percentage of participants
|
25.8 percentage of participants
|
27.2 percentage of participants
|
27.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med-treat sx (n=267,256,232,243,216,209,176,163)
|
50.6 percentage of participants
|
46.9 percentage of participants
|
60.3 percentage of participants
|
61.3 percentage of participants
|
55.6 percentage of participants
|
55.5 percentage of participants
|
59.7 percentage of participants
|
60.1 percentage of participants
|
|
Percentage of Participants Reporting Pre-Specified Systemic Events
Med-prevent sx (n=269,258,231,237,222,211,178,159)
|
49.1 percentage of participants
|
47.7 percentage of participants
|
58.4 percentage of participants
|
58.6 percentage of participants
|
56.3 percentage of participants
|
53.6 percentage of participants
|
59.6 percentage of participants
|
61.6 percentage of participants
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes which are present in both 7vPnC and 13vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC
n=297 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 4 (n=269,269,241)
|
1.89 μg/mL
Interval 1.7 to 2.1
|
2.33 μg/mL
Interval 2.11 to 2.57
|
4.97 μg/mL
Interval 4.42 to 5.58
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 6B (n=267,267,228)
|
0.42 μg/mL
Interval 0.37 to 0.47
|
3.88 μg/mL
Interval 3.41 to 4.41
|
11.88 μg/mL
Interval 10.57 to 13.35
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 9V (n=273,273,241)
|
1.49 μg/mL
Interval 1.34 to 1.66
|
1.71 μg/mL
Interval 1.56 to 1.86
|
3.44 μg/mL
Interval 3.12 to 3.8
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 14 (n=270,270,230)
|
3.84 μg/mL
Interval 3.37 to 4.37
|
6.17 μg/mL
Interval 5.45 to 6.98
|
11.37 μg/mL
Interval 10.17 to 12.71
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 18C (n=267,267,239)
|
1.58 μg/mL
Interval 1.4 to 1.78
|
2.29 μg/mL
Interval 2.08 to 2.52
|
3.96 μg/mL
Interval 3.55 to 4.43
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 19F (n=270,270,231)
|
2.85 μg/mL
Interval 2.53 to 3.21
|
2.64 μg/mL
Interval 2.42 to 2.89
|
8.04 μg/mL
Interval 7.07 to 9.14
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 23F (n=260,260,233)
|
0.54 μg/mL
Interval 0.47 to 0.62
|
2.15 μg/mL
Interval 1.89 to 2.45
|
5.07 μg/mL
Interval 4.5 to 5.71
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 1 (n=268,268,235)
|
1.90 μg/mL
Interval 1.7 to 2.13
|
3.04 μg/mL
Interval 2.73 to 3.38
|
4.79 μg/mL
Interval 4.21 to 5.45
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 3 (n=267,267,243)
|
0.79 μg/mL
Interval 0.72 to 0.87
|
0.97 μg/mL
Interval 0.87 to 1.08
|
1.07 μg/mL
Interval 0.95 to 1.2
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 5 (n=261,261,234)
|
0.99 μg/mL
Interval 0.9 to 1.1
|
1.93 μg/mL
Interval 1.74 to 2.13
|
3.90 μg/mL
Interval 3.53 to 4.31
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 6A (n=269,269,235)
|
1.10 μg/mL
Interval 0.97 to 1.25
|
3.16 μg/mL
Interval 2.82 to 3.53
|
7.07 μg/mL
Interval 6.35 to 7.87
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 7F (n=268,268,242)
|
1.85 μg/mL
Interval 1.69 to 2.02
|
4.03 μg/mL
Interval 3.7 to 4.4
|
5.78 μg/mL
Interval 5.13 to 6.53
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 19A (n=267,267,226)
|
2.36 μg/mL
Interval 2.1 to 2.66
|
3.07 μg/mL
Interval 2.79 to 3.37
|
11.64 μg/mL
Interval 10.43 to 13.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentage of participants achieving predefined antibody threshold levels with the corresponding 95% CI for each concomitant antigen (pertussis antigens including Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), and Pertactin (PRN); diphtheria; tetanus; and poliovirus types 1, 2, and 3) are presented.
Outcome measures
| Measure |
13vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=286 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=270 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, PT ≥ 5.0 EU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.6 percentage of participants
Interval 98.0 to 100.0
|
99.6 percentage of participants
Interval 97.9 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, PT (Infant ≥ 20; Toddler ≥ 11) EU/mL
|
93.2 percentage of participants
Interval 89.7 to 95.8
|
95.1 percentage of participants
Interval 91.9 to 97.3
|
94.9 percentage of participants
Interval 91.6 to 97.2
|
96.3 percentage of participants
Interval 93.3 to 98.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, FHA ≥ 5.0 EU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, FHA ≥ 7.82 EU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, FHA (Infant ≥ 64; Toddler ≥ 99) EU/mL
|
93.9 percentage of participants
Interval 90.5 to 96.3
|
95.1 percentage of participants
Interval 91.9 to 97.3
|
94.5 percentage of participants
Interval 91.1 to 96.9
|
95.1 percentage of participants
Interval 91.8 to 97.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, PRN ≥ 5 EU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis, PRN (Infant ≥ 39; Toddler ≥ 69) EU/mL
|
94.5 percentage of participants
Interval 91.3 to 96.8
|
95.1 percentage of participants
Interval 91.9 to 97.3
|
93.5 percentage of participants
Interval 89.9 to 96.1
|
95.2 percentage of participants
Interval 91.9 to 97.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Diptheria ≥ 0.10 IU/mL
|
99.3 percentage of participants
Interval 97.5 to 99.9
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.2 percentage of participants
Interval 97.2 to 99.9
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Diptheria ≥ 0.01 IU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
100.0 percentage of participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tetanus ≥ 0.10 IU/mL
|
98.6 percentage of participants
Interval 96.3 to 99.6
|
98.2 percentage of participants
Interval 95.8 to 99.4
|
98.6 percentage of participants
Interval 95.9 to 99.7
|
97.8 percentage of participants
Interval 94.9 to 99.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tetanus ≥ 0.01 IU/mL
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.3 to 100.0
|
100.0 percentage of participants
Interval 98.4 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus, Type 1 ≥ 1:8
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus, Type 2 ≥ 1:8
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.3 percentage of participants
Interval 97.5 to 99.9
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
99.6 percentage of participants
Interval 97.8 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Predefined Antibody Levels for Pertussis, Diphtheria, Tetanus, and Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus, Type 3 ≥ 1:8
|
100.0 percentage of participants
Interval 98.7 to 100.0
|
99.6 percentage of participants
Interval 98.0 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
100.0 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=286 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=270 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus Type 1
|
436.98 titer
Interval 378.21 to 504.88
|
436.15 titer
Interval 378.17 to 503.02
|
1057.40 titer
Interval 939.06 to 1190.7
|
1286.70 titer
Interval 1131.0 to 1463.8
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus Type 2
|
266.34 titer
Interval 227.84 to 311.36
|
281.85 titer
Interval 240.04 to 330.94
|
1032.30 titer
Interval 912.96 to 1167.1
|
1141.10 titer
Interval 992.96 to 1311.4
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Poliovirus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Poliovirus Type 3
|
897.67 titer
Interval 766.3 to 1051.6
|
943.95 titer
Interval 806.71 to 1104.5
|
2571.10 titer
Interval 2249.4 to 2938.9
|
2410.80 titer
Interval 2106.7 to 2758.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Outcome measures
| Measure |
13vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=286 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=270 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Diphtheria
|
1.19 IU/mL
Interval 1.08 to 1.3
|
1.40 IU/mL
Interval 1.28 to 1.53
|
3.00 IU/mL
Interval 2.65 to 3.4
|
3.51 IU/mL
Interval 3.08 to 3.99
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Tetanus
|
0.90 IU/mL
Interval 0.8 to 1.01
|
0.87 IU/mL
Interval 0.79 to 0.97
|
1.63 IU/mL
Interval 1.38 to 1.91
|
1.45 IU/mL
Interval 1.24 to 1.69
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the 3-dose infant series (7 months of age) and the toddler dose (16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
GMCs with the corresponding 95% CI for each concomitant antigen pertussis antigens (PT, FHA, PRN, and FIM) as measured by EU/mL are presented.
Outcome measures
| Measure |
13vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=286 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
n=270 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis PT
|
51.51 EU/mL
Interval 47.94 to 55.34
|
50.13 EU/mL
Interval 46.8 to 53.7
|
36.13 EU/mL
Interval 32.84 to 39.74
|
36.01 EU/mL
Interval 32.94 to 39.37
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis FHA
|
179.04 EU/mL
Interval 165.34 to 193.87
|
166.77 EU/mL
Interval 155.2 to 179.2
|
347.96 EU/mL
Interval 316.46 to 382.59
|
345.89 EU/mL
Interval 315.14 to 379.65
|
—
|
—
|
—
|
—
|
|
Geometric Mean Antibody Concentrations (GMC) for Pertussis in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and the Toddler Dose
Pertussis PRN
|
141.39 EU/mL
Interval 129.66 to 154.17
|
135.06 EU/mL
Interval 123.56 to 147.63
|
232.96 EU/mL
Interval 211.42 to 256.69
|
261.58 EU/mL
Interval 237.29 to 288.36
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)Population: The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes, present in both 13vPnC and 7vPnC (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Outcome measures
| Measure |
13vPnC
n=297 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC
n=293 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
13vPnC Dose 2
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
|
13vPnC Dose 3
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
7vPnC Dose 3
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
|
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 4
|
96.7 Percentage of Participants
Interval 93.7 to 98.5
|
98.9 Percentage of Participants
Interval 96.8 to 99.8
|
99.2 Percentage of Participants
Interval 97.0 to 99.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 6B
|
57.3 Percentage of Participants
Interval 51.1 to 63.3
|
98.5 Percentage of Participants
Interval 96.2 to 99.6
|
99.6 Percentage of Participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 9V
|
91.9 Percentage of Participants
Interval 88.1 to 94.9
|
99.3 Percentage of Participants
Interval 97.4 to 99.9
|
100.0 Percentage of Participants
Interval 98.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 14
|
98.5 Percentage of Participants
Interval 96.3 to 99.6
|
97.4 Percentage of Participants
Interval 94.7 to 99.0
|
100.0 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 18C
|
91.8 Percentage of Participants
Interval 87.8 to 94.8
|
98.1 Percentage of Participants
Interval 95.7 to 99.4
|
99.6 Percentage of Participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 19F
|
97.8 Percentage of Participants
Interval 95.2 to 99.2
|
99.3 Percentage of Participants
Interval 97.3 to 99.9
|
99.6 Percentage of Participants
Interval 97.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Common Serotype - Serotype 23F
|
68.1 Percentage of Participants
Interval 62.0 to 73.7
|
94.6 Percentage of Participants
Interval 91.1 to 97.0
|
99.1 Percentage of Participants
Interval 96.9 to 99.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 1
|
96.3 Percentage of Participants
Interval 93.2 to 98.2
|
99.3 Percentage of Participants
Interval 97.3 to 99.9
|
98.7 Percentage of Participants
Interval 96.3 to 99.7
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 3
|
88.0 Percentage of Participants
Interval 83.5 to 91.7
|
90.3 Percentage of Participants
Interval 86.1 to 93.5
|
92.2 Percentage of Participants
Interval 88.1 to 95.2
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 5
|
87.4 Percentage of Participants
Interval 82.7 to 91.1
|
97.3 Percentage of Participants
Interval 94.6 to 98.9
|
99.1 Percentage of Participants
Interval 96.9 to 99.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 6A
|
84.4 Percentage of Participants
Interval 79.5 to 88.5
|
97.4 Percentage of Participants
Interval 94.7 to 98.9
|
99.1 Percentage of Participants
Interval 97.0 to 99.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 7F
|
98.5 Percentage of Participants
Interval 96.2 to 99.6
|
100.0 Percentage of Participants
Interval 98.6 to 100.0
|
98.8 Percentage of Participants
Interval 96.4 to 99.7
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Antibody Level ≥ 0.35 Microgram Per Milliliter (μg/mL) in 13vPnC Group After the Second Dose and After the Third Dose of a 3-Dose Infant Series and After the Toddler Dose
Additional Serotype - Serotype 19A
|
98.1 Percentage of Participants
Interval 95.7 to 99.4
|
99.6 Percentage of Participants
Interval 97.9 to 100.0
|
100.0 Percentage of Participants
Interval 98.4 to 100.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
13vPnC Infant Series
Serious events: 16 serious events
Other events: 151 other events
Deaths: 0 deaths
7vPnC Infant Series
Serious events: 16 serious events
Other events: 156 other events
Deaths: 0 deaths
13vPnC Post-Infant Series
Serious events: 16 serious events
Other events: 7 other events
Deaths: 0 deaths
7vPnC Post-Infant Series
Serious events: 16 serious events
Other events: 10 other events
Deaths: 0 deaths
13vPnC Toddler Series
Serious events: 3 serious events
Other events: 124 other events
Deaths: 0 deaths
7vPnC Toddler Series
Serious events: 1 serious events
Other events: 110 other events
Deaths: 0 deaths
13vPnC 6-Month Follow-up
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
7vPnC 6-Month Follow-up
Serious events: 6 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
13vPnC Infant Series
n=314 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
|
7vPnC Infant Series
n=300 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
|
13vPnC Post-Infant Series
n=314 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
|
7vPnC Post-Infant Series
n=300 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
|
13vPnC Toddler Series
n=291 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
|
7vPnC Toddler Series
n=284 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
|
13vPnC 6-Month Follow-up
n=312 participants at risk
Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
|
7vPnC 6-Month Follow-up
n=299 participants at risk
Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Agitation
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Bronchiolitis
|
1.9%
6/314
|
2.0%
6/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Bronchitis
|
0.64%
2/314
|
0.33%
1/300
|
0.32%
1/314
|
0.67%
2/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Infections and infestations
Bronchopneumonia
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Congenital, familial and genetic disorders
Congenital nystagmus
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.32%
1/312
|
0.00%
0/299
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/314
|
0.33%
1/300
|
0.32%
1/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.67%
2/299
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Nervous system disorders
Fontanelle bulging
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.32%
1/314
|
0.67%
2/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.64%
2/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Gastroenteritis rotavirus
|
0.00%
0/314
|
0.00%
0/300
|
0.64%
2/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Gastrointestinal disorders
Gastroenteritis salmonella
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Infected cyst
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Pneumonia
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
General disorders
Pyrexia
|
0.32%
1/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.3%
4/314
|
0.33%
1/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Scaphocephaly
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Sudden infant death syndrome
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/314
|
1.3%
4/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Viral infection
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
4.9%
12/247
|
1.6%
4/248
|
11.8%
16/136
|
12.9%
16/124
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
Other adverse events
| Measure |
13vPnC Infant Series
n=314 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
|
7vPnC Infant Series
n=300 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
|
13vPnC Post-Infant Series
n=314 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
|
7vPnC Post-Infant Series
n=300 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
|
13vPnC Toddler Series
n=291 participants at risk
Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
|
7vPnC Toddler Series
n=284 participants at risk
Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
|
13vPnC 6-Month Follow-up
n=312 participants at risk
Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
|
7vPnC 6-Month Follow-up
n=299 participants at risk
Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
|
|---|---|---|---|---|---|---|---|---|
|
Congenital, familial and genetic disorders
Hip dysplasia
|
0.00%
0/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Double ureter
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Hypospadias
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Congenital, familial and genetic disorders
Strabismus congenital
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Eye disorders
Conjunctivitis
|
3.2%
10/314
|
3.3%
10/300
|
0.00%
0/314
|
0.33%
1/300
|
3.1%
9/291
|
1.1%
3/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Eye disorders
Conjuctivitis allergic
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
11/314
|
1.7%
5/300
|
0.32%
1/314
|
0.00%
0/300
|
1.7%
5/291
|
1.4%
4/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
7/314
|
1.3%
4/300
|
0.00%
0/314
|
0.00%
0/300
|
1.7%
5/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Constipation
|
0.64%
2/314
|
1.3%
4/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.96%
3/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Pyrexia
|
6.4%
20/314
|
5.3%
16/300
|
0.00%
0/314
|
0.00%
0/300
|
2.7%
8/291
|
1.4%
4/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Irritability
|
57.2%
131/229
|
58.8%
130/221
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Cyst
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Hypothermia
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Influenza like illness
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Injection site reaction
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
General disorders
Injection site swelling
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Immune system disorders
Milk allergy
|
0.00%
0/314
|
0.67%
2/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.32%
1/312
|
0.00%
0/299
|
|
Immune system disorders
Food allergy
|
0.00%
0/314
|
0.00%
0/300
|
0.64%
2/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.32%
1/312
|
0.33%
1/299
|
|
Infections and infestations
Upper respiratory tract infection
|
16.9%
53/314
|
15.7%
47/300
|
0.00%
0/314
|
0.00%
0/300
|
5.2%
15/291
|
4.2%
12/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Bronchiolitis
|
10.2%
32/314
|
11.7%
35/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.70%
2/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Bronchitis
|
8.0%
25/314
|
7.7%
23/300
|
0.00%
0/314
|
0.67%
2/300
|
3.8%
11/291
|
5.6%
16/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/314
|
0.33%
1/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Candidiasis
|
0.64%
2/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Cystitis
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Ear infection
|
2.5%
8/314
|
2.0%
6/300
|
0.00%
0/314
|
0.33%
1/300
|
0.34%
1/291
|
1.1%
3/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
23/314
|
11.0%
33/300
|
0.00%
0/314
|
0.33%
1/300
|
3.4%
10/291
|
3.2%
9/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Gastroenteritis
|
6.1%
19/314
|
7.3%
22/300
|
0.00%
0/314
|
0.00%
0/300
|
5.5%
16/291
|
5.3%
15/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Rhinitis
|
0.96%
3/314
|
1.3%
4/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Varicella
|
0.96%
3/314
|
0.33%
1/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.33%
1/299
|
|
Infections and infestations
Pharyngitis
|
1.6%
5/314
|
2.3%
7/300
|
0.00%
0/314
|
0.00%
0/300
|
2.1%
6/291
|
2.1%
6/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Respiratory tract infection
|
2.9%
9/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
1.7%
5/291
|
1.4%
4/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Otitis media
|
0.96%
3/314
|
2.0%
6/300
|
0.00%
0/314
|
0.00%
0/300
|
1.4%
4/291
|
1.8%
5/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Tonsillitis
|
0.96%
3/314
|
1.0%
3/300
|
0.00%
0/314
|
0.00%
0/300
|
0.69%
2/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Otitis media acute
|
1.3%
4/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
1.1%
3/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Laryngitis
|
0.32%
1/314
|
1.0%
3/300
|
0.00%
0/314
|
0.00%
0/300
|
0.69%
2/291
|
1.1%
3/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Pneumonia
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
1.0%
3/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.69%
2/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Viral infection
|
0.64%
2/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Dacryocystitis
|
0.96%
3/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Urinary tract infection
|
0.96%
3/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.64%
2/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Oral candidiasis
|
0.96%
3/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Viral skin infection
|
0.32%
1/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Influenza
|
0.64%
2/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Acarodermatitis
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Fungal infection
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Herpangina
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Impetigo
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Skin candida
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Infections and infestations
Tracheitis
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Injury, poisoning and procedural complications
Head injury
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Injury, poisoning and procedural complications
Overdose
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.9%
6/314
|
3.0%
9/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.32%
1/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.64%
2/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
1/314
|
1.3%
4/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.32%
1/314
|
1.3%
4/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/314
|
1.0%
3/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/314
|
1.0%
3/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
7/314
|
1.3%
4/300
|
0.00%
0/314
|
0.00%
0/300
|
1.0%
3/291
|
0.70%
2/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.32%
1/314
|
0.00%
0/300
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/314
|
0.67%
2/300
|
0.00%
0/314
|
0.00%
0/300
|
0.34%
1/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Investigations
Weight decreased
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Psychiatric disorders
Agitation
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Psychiatric disorders
Insomnia
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Psychiatric disorders
Restlessness
|
0.32%
1/314
|
0.00%
0/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.32%
1/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Social circumstances
Exposure to communicable disease
|
0.00%
0/314
|
0.33%
1/300
|
0.00%
0/314
|
0.00%
0/300
|
0.00%
0/291
|
0.00%
0/284
|
0.00%
0/312
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Tenderness (Any)
|
47.9%
104/217
|
41.9%
90/215
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Tenderness (Significant)
|
6.1%
11/181
|
0.00%
0/171
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Any)
|
27.6%
56/203
|
28.2%
53/188
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Mild)
|
26.4%
53/201
|
25.8%
48/186
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Moderate)
|
5.6%
10/180
|
4.0%
7/173
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Induration (Severe)
|
0.00%
0/176
|
0.00%
0/171
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Any)
|
31.0%
63/203
|
34.8%
69/198
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Mild)
|
29.1%
59/203
|
33.3%
65/195
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Moderate)
|
4.5%
8/177
|
5.1%
9/175
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Skin and subcutaneous tissue disorders
Erythema (Severe)
|
0.00%
0/176
|
0.00%
0/171
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever ≥38°C but ≤39°C
|
34.3%
68/198
|
38.3%
75/196
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >39°C but ≤40°C
|
5.6%
10/177
|
5.2%
9/174
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Fever >40°C
|
0.00%
0/176
|
0.00%
0/171
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased appetite
|
47.0%
103/219
|
42.6%
87/204
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Increased sleep
|
33.5%
69/206
|
34.5%
70/203
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
General disorders
Decreased sleep
|
30.2%
62/205
|
25.8%
49/190
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.32%
1/314
|
0.33%
1/300
|
0.32%
1/314
|
0.33%
1/300
|
1.0%
3/291
|
0.35%
1/284
|
0.00%
0/312
|
0.00%
0/299
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER