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Trial Outcomes & Findings for Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants (NCT NCT00366899)

NCT ID: NCT00366899

Last Updated: 2013-02-22

Results Overview

Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

605 participants

Primary outcome timeframe

During the 4-day period after each dose

Results posted on

2013-02-22

Participant Flow

Participants were recruited in Italy from October 2006 to March 2007.

Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period. One subject was prerandomized and counted twice.

Participant milestones

Participant milestones
Measure
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
Infant Series
STARTED
303
303
Infant Series
Vaccinated Dose 1
302
302
Infant Series
Vaccinated Dose 2
296
293
Infant Series
COMPLETED
294
291
Infant Series
NOT COMPLETED
9
12
After Infant Series
STARTED
294
291
After Infant Series
COMPLETED
287
282
After Infant Series
NOT COMPLETED
7
9
Toddler Dose
STARTED
287
282
Toddler Dose
COMPLETED
285
281
Toddler Dose
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
13vPnC
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
7vPnC
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
Infant Series
Withdrawal by Subject
4
7
Infant Series
Protocol Violation
2
1
Infant Series
Failed to return
1
1
Infant Series
Lost to Follow-up
0
2
Infant Series
Adverse Event
0
1
Infant Series
Physician Decision
1
0
Infant Series
Randomized but not consented
1
0
After Infant Series
Lost to Follow-up
4
3
After Infant Series
Withdrawal by Subject
1
4
After Infant Series
Adverse Event
1
2
After Infant Series
Protocol Violation
1
0
Toddler Dose
Withdrawal by Subject
1
1
Toddler Dose
Protocol Violation
1
0

Baseline Characteristics

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
13vPnC
n=303 Participants
Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
7vPnC
n=303 Participants
Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
Total
n=606 Participants
Total of all reporting groups
Age Continuous
2.9 months
STANDARD_DEVIATION 0.3 • n=5 Participants
2.9 months
STANDARD_DEVIATION 0.3 • n=7 Participants
2.9 months
STANDARD_DEVIATION 0.3 • n=5 Participants
Gender
Female
138 participants
n=5 Participants
133 participants
n=7 Participants
271 participants
n=5 Participants
Gender
Male
164 participants
n=5 Participants
170 participants
n=7 Participants
334 participants
n=5 Participants

PRIMARY outcome

Timeframe: During the 4-day period after each dose

Population: 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 (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 (2.5 to 7.0 cm); Severe (\>7.0 cm). Participants may be represented in more than 1 category.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=302 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=296 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=293 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
n=294 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
n=291 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Moderate (n=222,231,200,195,160,156)
2.7 Percentage of Participants
3.0 Percentage of Participants
5.5 Percentage of Participants
3.6 Percentage of Participants
7.5 Percentage of Participants
10.9 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Severe (n=243,255,197,194,159,152)
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
Tenderness - Any (n=234,243,214,215,199,188)
32.1 Percentage of Participants
30.0 Percentage of Participants
30.4 Percentage of Participants
36.7 Percentage of Participants
47.2 Percentage of Participants
44.1 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Tenderness-Significant (n=224,231,199,199,164,153)
2.7 Percentage of Participants
3.5 Percentage of Participants
4.5 Percentage of Participants
5.0 Percentage of Participants
8.5 Percentage of Participants
5.9 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Any (n=232,240,207,209,175,165)
19.0 Percentage of Participants
19.6 Percentage of Participants
24.6 Percentage of Participants
28.7 Percentage of Participants
28.6 Percentage of Participants
27.3 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Mild (n=232,240,207,208,174,161)
17.7 Percentage of Participants
18.3 Percentage of Participants
21.7 Percentage of Participants
26.4 Percentage of Participants
26.4 Percentage of Participants
21.7 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Moderate (n=223,229,198,195,160,157)
3.6 Percentage of Participants
3.1 Percentage of Participants
5.6 Percentage of Participants
5.1 Percentage of Participants
7.5 Percentage of Participants
10.2 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Swelling - Severe (n=222,229,197,194,159,152)
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=233,245,213,212,178,174)
25.8 Percentage of Participants
26.5 Percentage of Participants
31.5 Percentage of Participants
34.4 Percentage of Participants
36.5 Percentage of Participants
36.2 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Local Reactions
Redness - Mild (n=233,244,211,211,178,172)
24.0 Percentage of Participants
24.6 Percentage of Participants
28.4 Percentage of Participants
32.2 Percentage of Participants
32.6 Percentage of Participants
30.8 Percentage of Participants

PRIMARY outcome

Timeframe: During the 4-day period after each dose

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

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=302 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=302 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=296 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=293 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
n=294 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
n=291 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197)
41.7 Percentage of Participants
38.6 Percentage of Participants
55.5 Percentage of Participants
60.6 Percentage of Participants
63.7 Percentage of Participants
52.3 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >39°C but ≤40°C (n=224,233,204,201,167,160)
3.6 Percentage of Participants
4.7 Percentage of Participants
6.9 Percentage of Participants
7.0 Percentage of Participants
9.6 Percentage of Participants
12.5 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Fever >40°C (n=222,230,198,195,160,152)
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
0.7 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased appetite (n=246,248,220,218,198,197)
35.4 Percentage of Participants
34.3 Percentage of Participants
47.3 Percentage of Participants
45.4 Percentage of Participants
52.0 Percentage of Participants
57.4 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Irritability (n=258,259,245,243,221,227)
72.9 Percentage of Participants
63.7 Percentage of Participants
75.5 Percentage of Participants
75.3 Percentage of Participants
74.7 Percentage of Participants
74.9 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Increased sleep (n=269,276,226,232,195,196)
65.8 Percentage of Participants
64.5 Percentage of Participants
57.1 Percentage of Participants
56.5 Percentage of Participants
53.8 Percentage of Participants
54.6 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Decreased sleep (n=244,242,222,213,180,171)
39.3 Percentage of Participants
36.4 Percentage of Participants
40.1 Percentage of Participants
41.8 Percentage of Participants
35.6 Percentage of Participants
35.7 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-treat symptoms (n=244,245,219,109,192,190)
34.8 Percentage of Participants
30.6 Percentage of Participants
43.4 Percentage of Participants
47.8 Percentage of Participants
53.1 Percentage of Participants
43.7 Percentage of Participants
Percentage of Participants Reporting Pre-Specified Systemic Events
Meds-prevent symptoms (n=230,238,208,208,172,169)
12.6 Percentage of Participants
18.1 Percentage of Participants
20.2 Percentage of Participants
24.5 Percentage of Participants
27.9 Percentage of Participants
24.3 Percentage of Participants

PRIMARY outcome

Timeframe: One month after the infant series (6 months of age) and after the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate postinfant antibody concentration/titer for the given concomitant antigen.

Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=279 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=254 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=261 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertussis, PT ≥5 EU/mL (n=250,272,235,219)
99.6 percentage of participants
Interval 97.8 to 100.0
100.0 percentage of participants
Interval 98.7 to 100.0
100.0 percentage of participants
Interval 98.4 to 100.0
100.0 percentage of participants
Interval 98.3 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Hepatitis B ≥ 10.0 mIU/mL
93.8 percentage of participants
Interval 90.2 to 96.3
93.1 percentage of participants
Interval 89.5 to 95.8
98.40 percentage of participants
Interval 96.0 to 99.6
98.80 percentage of participants
Interval 96.6 to 99.8
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertussis, FHA ≥5 EU/mL (n=243,272,229,214)
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 98.7 to 100.0
100.0 percentage of participants
Interval 98.4 to 100.0
100.0 percentage of participants
Interval 98.3 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214)
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 98.7 to 100.0
100.0 percentage of participants
Interval 98.4 to 100.0
100.0 percentage of participants
Interval 98.3 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Haemophilus Influenzae type b 0.15 μg/ml
87.0 percentage of participants
Interval 82.0 to 91.1
90.3 percentage of participants
Interval 86.1 to 93.5
99.6 percentage of participants
Interval 97.7 to 100.0
98.2 percentage of participants
Interval 95.4 to 99.5
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Haemophilus Influenzae type b 1.0 μg/ml
49.9 percentage of participants
Interval 42.7 to 56.0
48.7 percentage of participants
Interval 42.6 to 54.9
96.2 percentage of participants
Interval 92.9 to 98.2
92.2 percentage of participants
Interval 87.8 to 95.4
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Diptheria 0.01 IU/mL (n=207,240,164,190)
100.0 percentage of participants
Interval 98.2 to 100.0
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 97.8 to 100.0
100.0 percentage of participants
Interval 98.1 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Diptheria 0.1 IU/mL (n=207,240,164,190)
92.8 percentage of participants
Interval 88.3 to 95.9
96.3 percentage of participants
Interval 93.0 to 98.3
100.0 percentage of participants
Interval 97.8 to 100.0
100.0 percentage of participants
Interval 98.1 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Tetanus 0.1 IU/mL (n=155,214,125,96)
94.2 percentage of participants
Interval 89.3 to 97.3
92.5 percentage of participants
Interval 88.1 to 95.7
97.6 percentage of participants
Interval 93.1 to 99.5
93.8 percentage of participants
Interval 86.9 to 97.7
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Polio, Type 1 ≥1:8
99.5 percentage of participants
Interval 97.3 to 100.0
99.6 percentage of participants
Interval 97.9 to 100.0
100.0 percentage of participants
Interval 97.9 to 100.0
100.0 percentage of participants
Interval 98.0 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Polio, Type 2 ≥1:8
95.6 percentage of participants
Interval 91.8 to 98.0
96.6 percentage of participants
Interval 93.6 to 98.4
100.0 percentage of participants
Interval 97.6 to 100.0
100.0 percentage of participants
Interval 97.9 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertactin ≥5 EU/mL (n=248,270,234,217)
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 98.6 to 100.0
100.0 percentage of participants
Interval 98.4 to 100.0
100.0 percentage of participants
Interval 98.3 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Polio, Type 3 ≥1:8
99.5 percentage of participants
Interval 97.3 to 100.0
98.9 percentage of participants
Interval 96.7 to 99.8
100.0 percentage of participants
Interval 97.6 to 100.0
100.0 percentage of participants
Interval 97.9 to 100.0
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL
95.2 percentage of participants
Interval 91.8 to 97.5
95.2 percentage of participants
Interval 92.0 to 97.4
92.8 percentage of participants
Interval 88.7 to 95.7
95.4 percentage of participants
Interval 91.8 to 97.8
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL
94.7 percentage of participants
Interval 91.0 to 97.1
95.6 percentage of participants
Interval 92.4 to 97.7
95.2 percentage of participants
Interval 91.6 to 97.6
95.3 percentage of participants
Interval 91.6 to 97.7
—
—
Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose
Pertactin (Infant ≥40; Toddler ≥106) EU/mL
91.9 percentage of participants
Interval 87.8 to 95.0
95.2 percentage of participants
Interval 91.9 to 97.4
94.9 percentage of participants
Interval 91.2 to 97.3
95.4 percentage of participants
Interval 91.7 to 97.8
—
—

PRIMARY outcome

Timeframe: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.

GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=279 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=254 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=261 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Pertussis FHA
102.87 EU/mL
Interval 94.35 to 112.16
105.17 EU/mL
Interval 97.25 to 113.73
463.23 EU/mL
Interval 425.19 to 504.67
456.55 EU/mL
Interval 415.06 to 502.18
—
—
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Pertussis PT
50.01 EU/mL
Interval 45.82 to 54.58
48.44 EU/mL
Interval 44.71 to 52.49
60.89 EU/mL
Interval 55.61 to 66.67
64.53 EU/mL
Interval 59.13 to 70.42
—
—
Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Pertussis PRN
167.76 EU/mL
Interval 149.54 to 188.18
166.19 EU/mL
Interval 150.28 to 183.78
339.30 EU/mL
Interval 309.16 to 372.38
361.70 EU/mL
Interval 328.59 to 398.14
—
—

PRIMARY outcome

Timeframe: One month after the infant series (6 months of age) and the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.

GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=273 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=276 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=252 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=255 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose
260.46 mIU/mL
Interval 214.47 to 316.31
272.67 mIU/mL
Interval 220.83 to 336.68
1655.30 mIU/mL
Interval 1343.3 to 2039.77
2284.95 mIU/mL
Interval 1878.82 to 2778.88
—
—

PRIMARY outcome

Timeframe: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.

GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=231 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=267 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=235 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=218 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
0.99 μg/mL
Interval 0.8 to 1.21
1.00 μg/mL
Interval 0.83 to 1.2
9.09 μg/mL
Interval 7.8 to 10.6
8.85 μg/mL
Interval 7.37 to 10.62
—
—

PRIMARY outcome

Timeframe: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.

GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=279 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=254 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=261 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Diptheria (n=207,240,164,190)
0.52 IU/mL
Interval 0.46 to 0.6
0.67 IU/mL
Interval 0.59 to 0.76
2.77 IU/mL
Interval 2.45 to 3.13
3.71 IU/mL
Interval 3.28 to 4.2
—
—
Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Tetanus (n=155,214,125,96)
0.53 IU/mL
Interval 0.45 to 0.63
0.63 IU/mL
Interval 0.53 to 0.74
2.62 IU/mL
Interval 2.12 to 3.25
2.09 IU/mL
Interval 1.56 to 2.81
—
—

PRIMARY outcome

Timeframe: one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Population: Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration/titer for the specified concomitant antigen.

GMC of Polio as measured using a polio in vitro plaque neutralization.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=275 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=279 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
n=254 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
n=261 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Polio Type 1 (n=207,262,156,179)
180.72 Titers
Interval 154.31 to 211.64
207.17 Titers
Interval 178.64 to 240.25
924.52 Titers
Interval 782.71 to 1092.03
1348.04 Titers
Interval 1163.56 to 1561.77
—
—
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Polio Type 2 (n=205,262,153,175)
123.74 Titers
Interval 102.68 to 149.13
130.39 Titers
Interval 109.96 to 154.63
1141.62 Titers
Interval 958.68 to 1359.47
1340.51 Titers
Interval 1147.88 to 1565.48
—
—
Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose
Polio Type 3 (n=205,262,153,178)
397.32 Titers
Interval 327.0 to 482.76
452.14 Titers
Interval 382.57 to 534.35
1567.64 Titers
Interval 1289.72 to 1905.45
2421.31 Titers
Interval 2072.82 to 2828.39
—
—

PRIMARY outcome

Timeframe: one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Population: The evaluable pneumococcal 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 (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

Outcome measures
Measure
13vPnC Dose 1
n=265 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=265 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 4
96.6 percentage of participants
Interval 93.6 to 98.4
66.9 percentage of participants
Interval 60.6 to 72.9
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 6B
58.4 percentage of participants
Interval 52.2 to 64.4
76.3 percentage of participants
Interval 70.3 to 81.6
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 9V
94.7 percentage of participants
Interval 91.2 to 97.1
70.5 percentage of participants
Interval 64.2 to 76.2
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 14
94.2 percentage of participants
Interval 90.6 to 96.7
94.4 percentage of participants
Interval 90.6 to 97.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 18C
92.4 percentage of participants
Interval 88.5 to 95.3
53.0 percentage of participants
Interval 46.4 to 59.5
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 19F
95.1 percentage of participants
Interval 91.7 to 97.3
92.4 percentage of participants
Interval 88.2 to 95.4
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Common Serotypes - Serotype 23F
68.6 percentage of participants
Interval 62.6 to 74.1
32.3 percentage of participants
Interval 26.4 to 38.7
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 1
96.6 percentage of participants
Interval 93.6 to 98.4
83.4 percentage of participants
Interval 78.0 to 87.9
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 3
92.8 percentage of participants
Interval 89.0 to 95.6
30.8 percentage of participants
Interval 24.9 to 37.1
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 5
91.6 percentage of participants
Interval 87.5 to 94.6
87.3 percentage of participants
Interval 82.4 to 91.3
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 6A
86.5 percentage of participants
Interval 81.8 to 90.4
86.4 percentage of participants
Interval 81.4 to 90.5
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 7F
98.5 percentage of participants
Interval 96.2 to 99.6
90.7 percentage of participants
Interval 86.3 to 94.1
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose
Additional Serotypes - Serotype 19A
98.5 percentage of participants
Interval 96.1 to 99.6
96.2 percentage of participants
Interval 92.9 to 98.2
—
—
—
—

PRIMARY outcome

Timeframe: One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Population: Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.

Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=265 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=265 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 4
2.38 μg/mL
Interval 2.11 to 2.67
0.53 μg/mL
Interval 0.48 to 0.59
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 6B
0.41 μg/mL
Interval 0.36 to 0.47
0.61 μg/mL
Interval 0.54 to 0.69
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 9V
1.68 μg/mL
Interval 1.51 to 1.86
0.48 μg/mL
Interval 0.43 to 0.52
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 14
2.84 μg/mL
Interval 2.44 to 3.31
2.03 μg/mL
Interval 1.79 to 2.3
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 18C
1.72 μg/mL
Interval 1.54 to 1.93
0.35 μg/mL
Interval 0.32 to 0.39
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 19F
3.42 μg/mL
Interval 2.95 to 3.97
0.94 μg/mL
Interval 0.83 to 1.06
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Common Serotypes - Serotype 23F
0.61 μg/mL
Interval 0.53 to 0.71
0.26 μg/mL
Interval 0.23 to 0.29
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 1
2.30 μg/mL
Interval 2.03 to 2.6
0.68 μg/mL
Interval 0.61 to 0.75
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 3
1.15 μg/mL
Interval 1.04 to 1.28
0.25 μg/mL
Interval 0.22 to 0.27
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 5
1.27 μg/mL
Interval 1.14 to 1.41
0.88 μg/mL
Interval 0.8 to 0.97
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 6A
1.17 μg/mL
Interval 1.02 to 1.33
0.81 μg/mL
Interval 0.72 to 0.92
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 7F
2.06 μg/mL
Interval 1.88 to 2.26
0.76 μg/mL
Interval 0.7 to 0.82
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose
Additional Serotypes - Serotype 19F
2.87 μg/mL
Interval 2.55 to 3.24
1.20 μg/mL
Interval 1.06 to 1.35
—
—
—
—

SECONDARY outcome

Timeframe: One month after the toddler dose (12 months of age)

Population: Evaluable pneumococcal immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate IgG antibody concentration to the given serotype.

Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=246 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=249 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 4 (n=244,245)
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 98.5 to 100.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 6B (n=243,243)
100.0 percentage of participants
Interval 98.5 to 100.0
100.0 percentage of participants
Interval 98.5 to 100.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 9V (n=235,248)
100.0 percentage of participants
Interval 98.4 to 100.0
100.0 percentage of participants
Interval 98.5 to 100.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 14 (n=237,240)
99.6 percentage of participants
Interval 97.7 to 100.0
99.6 percentage of participants
Interval 97.7 to 100.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 18C (n=245,245)
99.2 percentage of participants
Interval 97.1 to 99.9
99.6 percentage of participants
Interval 97.8 to 100.0
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 19F (n=243,245)
98.8 percentage of participants
Interval 96.4 to 99.7
98.4 percentage of participants
Interval 95.9 to 99.6
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 23F (n=240,243)
99.2 percentage of participants
Interval 97.0 to 99.9
98.8 percentage of participants
Interval 96.4 to 99.7
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 1 (n=244,240)
99.6 percentage of participants
Interval 97.7 to 100.0
3.3 percentage of participants
Interval 1.4 to 6.5
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 3 (n=245,218)
93.9 percentage of participants
Interval 90.1 to 96.5
6.7 percentage of participants
Interval 3.9 to 10.6
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 5 (n=245,243)
100.0 percentage of participants
Interval 98.5 to 100.0
70.2 percentage of participants
Interval 63.6 to 76.2
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=243,243)
99.6 percentage of participants
Interval 97.7 to 100.0
86.4 percentage of participants
Interval 81.5 to 90.5
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 7F (n=242,243)
99.6 percentage of participants
Interval 97.7 to 100.0
4.9 percentage of participants
Interval 2.6 to 8.5
—
—
—
—
Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19A (n=241,241)
100.0 percentage of participants
Interval 98.5 to 100.0
99.6 percentage of participants
Interval 97.7 to 100.0
—
—
—
—

SECONDARY outcome

Timeframe: One month after toddler dose (12 months of age)

Population: Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate antibody concentration for the specified serotype.

Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=246 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=249 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 4 (n=244,245)
4.77 μg/mL
Interval 4.29 to 5.3
7.08 μg/mL
Interval 6.41 to 7.83
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 6B (n=243,243)
10.00 μg/mL
Interval 8.79 to 11.38
10.39 μg/mL
Interval 9.14 to 11.82
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 9V (n=235,248)
3.02 μg/mL
Interval 2.74 to 3.32
4.10 μg/mL
Interval 3.72 to 4.51
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 14 (n=237,240)
10.30 μg/mL
Interval 9.26 to 11.47
11.99 μg/mL
Interval 10.77 to 13.35
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 18C (n=245,247)
2.83 μg/mL
Interval 2.55 to 3.14
4.26 μg/mL
Interval 3.85 to 4.7
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 19F (n=243,245)
9.01 μg/mL
Interval 7.84 to 10.36
8.06 μg/mL
Interval 7.06 to 9.21
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Common Serotypes - Serotype 23F (n=244,245)
3.43 μg/mL
Interval 3.02 to 3.88
4.87 μg/mL
Interval 4.3 to 5.51
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 1 (n=244,240)
5.76 μg/mL
Interval 5.12 to 6.47
0.03 μg/mL
Interval 0.03 to 0.04
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 3 (n=245,240)
1.22 μg/mL
Interval 1.09 to 1.35
0.07 μg/mL
Interval 0.06 to 0.08
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 5 (n=245,218)
3.59 μg/mL
Interval 3.25 to 3.96
0.56 μg/mL
Interval 0.49 to 0.64
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 6A (n=243,243)
6.78 μg/mL
Interval 6.04 to 7.61
1.42 μg/mL
Interval 1.21 to 1.66
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 7F (n=242,243)
4.31 μg/mL
Interval 3.94 to 4.72
0.04 μg/mL
Interval 0.04 to 0.05
—
—
—
—
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Additional Serotypes - Serotype 19F (n=241,241)
9.81 μg/mL
Interval 8.82 to 10.92
4.24 μg/mL
Interval 3.85 to 4.67
—
—
—
—

OTHER_PRE_SPECIFIED outcome

Timeframe: one month after infant series dose 2 and after the toddler dose

Population: OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group

Percentage of subjects achieving functional antibody titer ≥1:8 as measured by opsonophagocytic activity assay (OPA) along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. (This is not a geometric mean comparison as suggested by the table row heading).

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=100 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=100 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 4
100.0 % Achieving OPA Titer ≥1:8
Interval 96.3 to 100.0
100.0 % Achieving OPA Titer ≥1:8
Interval 95.8 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 6B
90.0 % Achieving OPA Titer ≥1:8
Interval 82.4 to 95.1
99.0 % Achieving OPA Titer ≥1:8
Interval 94.3 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 9V
100.0 % Achieving OPA Titer ≥1:8
Interval 96.3 to 100.0
100.0 % Achieving OPA Titer ≥1:8
Interval 96.1 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 14
100.0 % Achieving OPA Titer ≥1:8
Interval 96.3 to 100.0
100.0 % Achieving OPA Titer ≥1:8
Interval 96.2 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 18C
97.0 % Achieving OPA Titer ≥1:8
Interval 91.4 to 99.4
100.0 % Achieving OPA Titer ≥1:8
Interval 96.3 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 19F
96.0 % Achieving OPA Titer ≥1:8
Interval 90.1 to 98.9
97.9 % Achieving OPA Titer ≥1:8
Interval 92.7 to 99.7
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 23F
97.0 % Achieving OPA Titer ≥1:8
Interval 91.4 to 99.4
100.0 % Achieving OPA Titer ≥1:8
Interval 96.3 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 1
94.8 % Achieving OPA Titer ≥1:8
Interval 88.3 to 98.3
100.0 % Achieving OPA Titer ≥1:8
Interval 96.2 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 3
99.0 % Achieving OPA Titer ≥1:8
Interval 94.6 to 100.0
100.0 % Achieving OPA Titer ≥1:8
Interval 96.2 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 5
96.0 % Achieving OPA Titer ≥1:8
Interval 90.0 to 98.9
100.0 % Achieving OPA Titer ≥1:8
Interval 96.1 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 6A
95.9 % Achieving OPA Titer ≥1:8
Interval 89.9 to 98.9
100.0 % Achieving OPA Titer ≥1:8
Interval 96.2 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 7F
100.0 % Achieving OPA Titer ≥1:8
Interval 96.4 to 100.0
100.0 % Achieving OPA Titer ≥1:8
Interval 96.2 to 100.0
—
—
—
—
Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 19A
95.6 % Achieving OPA Titer ≥1:8
Interval 89.0 to 98.8
100.0 % Achieving OPA Titer ≥1:8
Interval 96.0 to 100.0
—
—
—
—

OTHER_PRE_SPECIFIED outcome

Timeframe: one month after infant series dose 2 and after the toddler dose

Population: OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group

Antibody functionality/geometric mean titer (GMT) as measured by opsonophagocytic activity assay(OPA) for7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.

Outcome measures

Outcome measures
Measure
13vPnC Dose 1
n=100 Participants
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
7vPnC Dose 1
n=100 Participants
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
13vPnC Dose 2
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
7vPnC Dose 2
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
13vPnC Toddler Dose
Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
7vPnC Toddler Dose
Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 4
526.69 Titers
Interval 431.88 to 642.32
1276.21 Titers
Interval 1025.09 to 1588.85
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 6B
191.34 Titers
Interval 133.35 to 274.55
2383.31 Titers
Interval 1850.47 to 3069.57
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 9V
3585.80 Titers
Interval 2787.34 to 4612.99
16384.00 Titers
Interval 13066.97 to 20543.06
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 14
1882.96 Titers
Interval 1446.51 to 2451.1
1903.89 Titers
Interval 1580.9 to 2292.88
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 18C
294.48 Titers
Interval 221.8 to 390.98
1324.41 Titers
Interval 1063.57 to 1649.22
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 19F
222.86 Titers
Interval 170.46 to 291.37
391.97 Titers
Interval 296.34 to 518.46
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Common Serotypes - Serotype 23F
487.51 Titers
Interval 356.25 to 667.13
3679.67 Titers
Interval 2971.61 to 4556.44
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 1
62.63 Titers
Interval 47.59 to 82.41
294.07 Titers
Interval 226.88 to 381.15
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 3
176.07 Titers
Interval 144.89 to 213.96
504.66 Titers
Interval 435.71 to 584.53
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 5
127.11 Titers
Interval 99.36 to 162.6
333.24 Titers
Interval 274.24 to 404.94
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 6A
541.81 Titers
Interval 392.09 to 748.68
2217.29 Titers
Interval 1821.95 to 2698.42
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 7F
5914.33 Titers
Interval 4710.83 to 7425.3
14886.35 Titers
Interval 12560.25 to 17643.22
—
—
—
—
Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Additional Serotypes - Serotype 19F
157.59 Titers
Interval 118.91 to 208.84
1415.08 Titers
Interval 1140.56 to 1755.66
—
—
—
—

Adverse Events

13vPnC Infant Series

Serious events: 6 serious events
Other events: 188 other events
Deaths: 0 deaths

7vPnC Infant Series

Serious events: 10 serious events
Other events: 183 other events
Deaths: 0 deaths

13vPnC Post-Infant Series

Serious events: 8 serious events
Other events: 96 other events
Deaths: 0 deaths

7vPnC Post-Infant Series

Serious events: 11 serious events
Other events: 90 other events
Deaths: 0 deaths

13vPnC Toddler Series

Serious events: 3 serious events
Other events: 165 other events
Deaths: 0 deaths

7vPnC Toddler Series

Serious events: 1 serious events
Other events: 170 other events
Deaths: 0 deaths

13vPnC 6-Month Follow-up

Serious events: 9 serious events
Other events: 1 other events
Deaths: 0 deaths

7vPnC 6-Month Follow-up

Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
13vPnC Infant Series
n=303 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
7vPnC Infant Series
n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
13vPnC Post-Infant Series
n=294 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
7vPnC Post-Infant Series
n=291 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
13vPnC Toddler Series
n=287 participants at risk
Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
7vPnC Toddler Series
n=282 participants at risk
Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
13vPnC 6-Month Follow-up
n=290 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
7vPnC 6-Month Follow-up
n=288 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
Gastrointestinal disorders
Anal fissure
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Cardiac disorders
Atrioventricular block complete
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Infections and infestations
Bronchiolitis
0.66%
2/303
0.99%
3/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Infections and infestations
Bronchitis
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.35%
1/288
Infections and infestations
Bronchopneumonia
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.69%
2/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Cellulitis orbital
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Gastrointestinal disorders
Constipation
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Psychiatric disorders
Crying
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Psychiatric disorders
Decreased activity
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Metabolism and nutrition disorders
Dehydration
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Nervous system disorders
Depressed level of consciousness
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Diarrhoea
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Ear infection
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Epstein-Barr virus infection
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Nervous system disorders
Febrile convulsion
0.00%
0/303
0.00%
0/303
0.68%
2/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.69%
2/290
0.35%
1/288
Infections and infestations
Gastroenteritis
0.33%
1/303
0.33%
1/303
1.0%
3/294
0.69%
2/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
1.4%
4/288
Infections and infestations
Gastroenteritis adenovirus
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Gastroenteritis rotavirus
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Injury, poisoning and procedural complications
Head injury
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Nervous system disorders
Hypokinesia
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Nervous system disorders
Infantile spasms
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Kawasaki's disease
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Laryngospasm
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Nervous system disorders
Meningism
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Blood and lymphatic system disorders
Microcytic anaemia
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Nervous system disorders
Nystagmus
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Otits media
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Parainfluenzae virus infection
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Congenital, familial and genetic disorders
Pelizaeus-Merzbacher disease
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Pharyngitis
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Infections and infestations
Pharyngotonsillitis
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.35%
1/288
Infections and infestations
Pneumonia
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
General disorders
Pyrexia
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Nervous system disorders
Syncope vasovagal
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Injury, poisoning and procedural complications
Tibia fracture
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Infections and infestations
Upper respiratory tract infection
0.33%
1/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Infections and infestations
Viral infection
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.35%
1/288
Gastrointestinal disorders
Vomiting
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.70%
2/287
0.00%
0/282
0.34%
1/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288

Other adverse events

Other adverse events
Measure
13vPnC Infant Series
n=303 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
7vPnC Infant Series
n=303 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
13vPnC Post-Infant Series
n=294 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
7vPnC Post-Infant Series
n=291 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
13vPnC Toddler Series
n=287 participants at risk
Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
7vPnC Toddler Series
n=282 participants at risk
Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
13vPnC 6-Month Follow-up
n=290 participants at risk
Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
7vPnC 6-Month Follow-up
n=288 participants at risk
Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
Skin and subcutaneous tissue disorders
Tenderness (Any)
30.4%
65/214
36.7%
79/215
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Tenderness (Significant)
4.5%
9/199
5.0%
10/199
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Induration (Any)
24.6%
51/207
28.7%
60/209
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Induration (Mild)
21.7%
45/207
26.4%
55/208
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Induration (Moderate)
5.6%
11/198
5.1%
10/195
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Induration (Severe)
0.00%
0/197
0.00%
0/194
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Erythema (Any)
31.5%
67/213
34.4%
73/212
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Erythema (Mild)
28.4%
60/211
32.2%
68/211
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Erythema (Moderate)
5.5%
11/200
3.6%
7/195
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Erythema (Severe)
0.00%
0/197
0.00%
0/194
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Fever ≥38°C but ≤39°C
55.5%
126/227
60.6%
137/226
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Fever >39°C but ≤40°C
6.9%
14/204
7.0%
14/201
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Fever >40°C
0.00%
0/198
0.00%
0/195
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Decreased appetite
47.3%
104/220
45.4%
99/218
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Irritability
0.00%
0/303
0.66%
2/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
General disorders
Increased sleep
57.1%
129/226
56.5%
131/232
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
General disorders
Decreased sleep
40.1%
89/222
41.8%
89/213
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
—
0/0
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.99%
3/303
1.7%
5/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Cardiac disorders
Extrasystoles
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Ear and labyrinth disorders
Ear pain
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Endocrine disorders
Thyroid cyst
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Eye disorders
Conjunctivitis
0.00%
0/303
1.3%
4/303
0.34%
1/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Diarrhoea
1.7%
5/303
4.0%
12/303
0.68%
2/294
100.0%
5/5
2.8%
8/287
1.1%
3/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Vomiting
0.33%
1/303
1.7%
5/303
0.34%
1/294
1.0%
3/291
1.4%
4/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.33%
1/303
0.66%
2/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Abdominal pain
0.00%
0/303
0.66%
2/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Constipation
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.71%
2/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Flatulence
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Frequent bowel movements
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Gingival pain
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Haematochezia
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Infantile colic
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Perianal erythema
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Stomatitis
0.00%
0/303
0.00%
0/303
0.34%
1/294
1.0%
3/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Nausea
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Gastrointestinal disorders
Regurgitation
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
General disorders
Pyrexia
7.9%
24/303
7.6%
23/303
11.2%
33/294
11.7%
34/291
8.7%
25/287
5.7%
16/282
0.00%
0/290
0.00%
0/288
General disorders
Injection site swelling
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Hepatobiliary disorders
Hepatomegaly
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Upper respiratory tract infection
4.3%
13/303
3.3%
10/303
2.7%
8/294
4.1%
12/291
1.4%
4/287
2.5%
7/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Rhinitis
3.6%
11/303
3.3%
10/303
2.0%
6/294
1.4%
4/291
3.1%
9/287
1.8%
5/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Bronchiolitis
2.6%
8/303
3.0%
9/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Pharyngitis
2.6%
8/303
2.0%
6/303
5.4%
16/294
2.4%
7/291
0.70%
2/287
3.9%
11/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Bronchitis
2.0%
6/303
1.7%
5/303
1.4%
4/294
2.7%
8/291
1.0%
3/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Nasopharyngitis
1.3%
4/303
2.0%
6/303
0.00%
0/294
1.0%
3/291
0.35%
1/287
0.71%
2/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Gastroenteritis
1.3%
4/303
1.3%
4/303
1.4%
4/294
1.7%
5/291
1.7%
5/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Exanthema subitum
1.3%
4/303
0.99%
3/303
5.4%
16/294
7.6%
22/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Ear infection
1.3%
4/303
0.66%
2/303
2.4%
7/294
2.4%
7/291
2.1%
6/287
2.5%
7/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Influenza
0.33%
1/303
1.7%
5/303
0.34%
1/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Varicella
0.33%
1/303
0.99%
3/303
2.7%
8/294
1.7%
5/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Urinary tract infection
0.33%
1/303
0.66%
2/303
1.0%
3/294
1.7%
5/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Oral candidiasis
0.33%
1/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Otitis media
0.00%
0/303
0.66%
2/303
0.34%
1/294
0.34%
1/291
0.70%
2/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Sinusitis
0.33%
1/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Tracheitis
0.00%
0/303
0.66%
2/303
0.34%
1/294
0.34%
1/291
0.35%
1/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Viral skin infection
0.66%
2/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Fungal skin infection
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Impetigo
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Laryngitis
0.00%
0/303
0.33%
1/303
0.68%
2/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Otitis media acute
0.00%
0/303
0.33%
1/303
0.34%
1/294
0.00%
0/291
1.0%
3/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Pharyngotonsillitis
0.00%
0/303
0.33%
1/303
1.0%
3/294
0.00%
0/291
0.35%
1/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Tonsillitis
0.00%
0/303
0.33%
1/303
0.68%
2/294
0.34%
1/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Respiratory tract infection
0.00%
0/303
0.00%
0/303
0.00%
0/294
1.0%
3/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Enteritis infectious
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.69%
2/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Erythema infectiosum
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Hand-foot-and-mouth disease
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.69%
2/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Acute tonsillitis
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Bronchopneumonia
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Cystitis
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Gastroenteritis viral
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Lower respiratory tract infection
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Roseola
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Infections and infestations
Herpes simplex
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Injury, poisoning and procedural complications
Limb injury
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Metabolism and nutrition disorders
Decreased appetite
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Metabolism and nutrition disorders
Anorexia
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Nervous system disorders
Nystagmus
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Psychiatric disorders
Sleep disorder
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Renal and urinary disorders
Urinary tract pain
0.33%
1/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Reproductive system and breast disorders
Genital rash
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Cough
5.9%
18/303
5.9%
18/303
2.7%
8/294
2.4%
7/291
2.8%
8/287
2.5%
7/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.66%
2/303
0.99%
3/303
0.00%
0/294
0.34%
1/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Asthma
0.99%
3/303
0.00%
0/303
1.0%
3/294
0.34%
1/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.66%
2/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Rhonchi
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/303
0.00%
0/303
0.34%
1/294
0.34%
1/291
0.35%
1/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/303
0.33%
1/303
0.34%
1/294
0.00%
0/291
0.00%
0/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Rash
0.33%
1/303
0.00%
0/303
0.34%
1/294
0.69%
2/291
0.70%
2/287
0.35%
1/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Skin fissures
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/303
0.33%
1/303
0.00%
0/294
0.00%
0/291
0.00%
0/287
0.00%
0/282
0.00%
0/290
0.00%
0/288
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/303
0.00%
0/303
0.00%
0/294
0.69%
2/291
100.0%
1/1
0.00%
0/282
0.00%
0/290
0.00%
0/288

Additional Information

U. S. Contact Center

Wyeth

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