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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00366899
Collaborator
(none)
605
Enrollment
13
Locations
2
Arms
21
Duration (Months)
46.5
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.

Condition or Disease Intervention/Treatment Phase
  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: 7 valent pneumococcal conjugate vaccine
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
605 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 3, Randomized, Active-Controlled, Double-blind Trial Evaluating the Safety,Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Paediatric Vaccinations in Italy
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
Active Comparator: 2

7-valent pneumococcal conjugate vaccine

Biological: 7 valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.

Outcome Measures

Primary Outcome Measures

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

    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.

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

    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.

  3. 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 [One month after the infant series (6 months of age) and after the toddler dose (12 months of age)]

    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.

  4. 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 [one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]

    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)

  5. 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 [One month after the infant series (6 months of age) and the toddler dose (12 months of age)]

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

  6. 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 [one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]

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

  7. 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 [one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]

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

  8. 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 [one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)]

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

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

    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.

  10. 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 [One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)]

    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.

Secondary Outcome Measures

  1. Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose [One month after the toddler dose (12 months of age)]

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

  2. Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose [One month after toddler dose (12 months of age)]

    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.

Other Outcome Measures

  1. Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose [one month after infant series dose 2 and after the toddler dose]

    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).

  2. Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose [one month after infant series dose 2 and after the toddler dose]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Days to 105 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

  1. Aged 3 months (75 to 105 days) at time of enrollment.

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

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

  4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.

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

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.

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

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

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

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

  6. Known or suspected immune deficiency or suppression.

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

  8. Major known congenital malformation or serious chronic disorder.

  9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.

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

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

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Napoli Campania Italy 80122
2 Napoli Campania Italy 80139
3 Bologna Emilia Romagna Italy 40138
4 Roma Lazio Italy 00100
5 Roma Lazio Italy 00165
6 Genova Liguria Italy 16132
7 Milan Lombardia Italy 20122
8 Novara Piemonte Italy 28100
9 Taranto Puglia Italy 74100
10 Sassari Sardegna Italy 07100
11 Ragusa Sicilia Italy 97100
12 Palermo Sicillia Italy 90100
13 Firenze Toscana Italy 50132

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
  • Principal Investigator: Trial Manager, For Italy, descresg@wyeth.com

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00366899
Other Study ID Numbers:
  • 6096A1-500
First Posted:
Aug 21, 2006
Last Update Posted:
Feb 22, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Vaccine
Infants
Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details Participants were recruited in Italy from October 2006 to March 2007.
Pre-assignment Detail Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period. One subject was prerandomized and counted twice.
Arm/Group Title 13vPnC 7vPnC
Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with 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). 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).
Period Title: Infant Series
STARTED 303 303
Vaccinated Dose 1 302 302
Vaccinated Dose 2 296 293
COMPLETED 294 291
NOT COMPLETED 9 12
Period Title: Infant Series
STARTED 294 291
COMPLETED 287 282
NOT COMPLETED 7 9
Period Title: Infant Series
STARTED 287 282
COMPLETED 285 281
NOT COMPLETED 2 1

Baseline Characteristics

Arm/Group Title 13vPnC 7vPnC Total
Arm/Group Description Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with 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). 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 of all reporting groups
Overall Participants 303 303 606
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]
2.9
(0.3)
2.9
(0.3)
2.9
(0.3)
Gender (participants) [Number]
Female
138
45.5%
133
43.9%
271
44.7%
Male
164
54.1%
170
56.1%
334
55.1%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Description 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.
Time Frame During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Toddler Dose 7vPnC Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Measure Participants 302 302 296 293 294 291
Tenderness - Any (n=234,243,214,215,199,188)
32.1
10.6%
30.0
9.9%
30.4
5%
36.7
NaN
47.2
NaN
44.1
NaN
Tenderness-Significant (n=224,231,199,199,164,153)
2.7
0.9%
3.5
1.2%
4.5
0.7%
5.0
NaN
8.5
NaN
5.9
NaN
Swelling - Any (n=232,240,207,209,175,165)
19.0
6.3%
19.6
6.5%
24.6
4.1%
28.7
NaN
28.6
NaN
27.3
NaN
Swelling - Mild (n=232,240,207,208,174,161)
17.7
5.8%
18.3
6%
21.7
3.6%
26.4
NaN
26.4
NaN
21.7
NaN
Swelling - Moderate (n=223,229,198,195,160,157)
3.6
1.2%
3.1
1%
5.6
0.9%
5.1
NaN
7.5
NaN
10.2
NaN
Swelling - Severe (n=222,229,197,194,159,152)
0.0
0%
0.0
0%
0.0
0%
0.0
NaN
0.0
NaN
0.0
NaN
Redness - Any (n=233,245,213,212,178,174)
25.8
8.5%
26.5
8.7%
31.5
5.2%
34.4
NaN
36.5
NaN
36.2
NaN
Redness - Mild (n=233,244,211,211,178,172)
24.0
7.9%
24.6
8.1%
28.4
4.7%
32.2
NaN
32.6
NaN
30.8
NaN
Redness - Moderate (n=222,231,200,195,160,156)
2.7
0.9%
3.0
1%
5.5
0.9%
3.6
NaN
7.5
NaN
10.9
NaN
Redness - Severe (n=243,255,197,194,159,152)
0.0
0%
0.0
0%
0.0
0%
0.0
NaN
0.0
NaN
0.0
NaN
2. Primary Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events
Description 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.
Time Frame During the 4-day period after each dose

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC Dose 1 7vPnC Dose 1 13vPnC Dose 2 7vPnC Dose 2 13vPnC Toddler Dose 7vPnC Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
Measure Participants 302 302 296 293 294 291
Fever ≥38°C but ≤39°C (n=247,246,227,226,204,197)
41.7
13.8%
38.6
12.7%
55.5
9.2%
60.6
NaN
63.7
NaN
52.3
NaN
Fever >39°C but ≤40°C (n=224,233,204,201,167,160)
3.6
1.2%
4.7
1.6%
6.9
1.1%
7.0
NaN
9.6
NaN
12.5
NaN
Fever >40°C (n=222,230,198,195,160,152)
0.0
0%
0.0
0%
0.0
0%
0.0
NaN
0.0
NaN
0.7
NaN
Decreased appetite (n=246,248,220,218,198,197)
35.4
11.7%
34.3
11.3%
47.3
7.8%
45.4
NaN
52.0
NaN
57.4
NaN
Irritability (n=258,259,245,243,221,227)
72.9
24.1%
63.7
21%
75.5
12.5%
75.3
NaN
74.7
NaN
74.9
NaN
Increased sleep (n=269,276,226,232,195,196)
65.8
21.7%
64.5
21.3%
57.1
9.4%
56.5
NaN
53.8
NaN
54.6
NaN
Decreased sleep (n=244,242,222,213,180,171)
39.3
13%
36.4
12%
40.1
6.6%
41.8
NaN
35.6
NaN
35.7
NaN
Meds-treat symptoms (n=244,245,219,109,192,190)
34.8
11.5%
30.6
10.1%
43.4
7.2%
47.8
NaN
53.1
NaN
43.7
NaN
Meds-prevent symptoms (n=230,238,208,208,172,169)
12.6
4.2%
18.1
6%
20.2
3.3%
24.5
NaN
27.9
NaN
24.3
NaN
3. Primary Outcome
Title 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
Description 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.
Time Frame One month after the infant series (6 months of age) and after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 275 279 254 261
Pertussis, PT ≥5 EU/mL (n=250,272,235,219)
99.6
32.9%
100.0
33%
100.0
16.5%
100.0
NaN
Pertussis, FHA ≥5 EU/mL (n=243,272,229,214)
100.0
33%
100.0
33%
100.0
16.5%
100.0
NaN
Pertussis, FHA ≥7.82 EU/mL (n=243,272,229,214)
100.0
33%
100.0
33%
100.0
16.5%
100.0
NaN
Pertactin ≥5 EU/mL (n=248,270,234,217)
100.0
33%
100.0
33%
100.0
16.5%
100.0
NaN
Hepatitis B ≥ 10.0 mIU/mL
93.8
31%
93.1
30.7%
98.40
16.2%
98.80
NaN
Haemophilus Influenzae type b 0.15 μg/ml
87.0
28.7%
90.3
29.8%
99.6
16.4%
98.2
NaN
Haemophilus Influenzae type b 1.0 μg/ml
49.9
16.5%
48.7
16.1%
96.2
15.9%
92.2
NaN
Diptheria 0.01 IU/mL (n=207,240,164,190)
100.0
33%
100.0
33%
100.0
16.5%
100.0
NaN
Diptheria 0.1 IU/mL (n=207,240,164,190)
92.8
30.6%
96.3
31.8%
100.0
16.5%
100.0
NaN
Tetanus 0.1 IU/mL (n=155,214,125,96)
94.2
31.1%
92.5
30.5%
97.6
16.1%
93.8
NaN
Polio, Type 1 ≥1:8
99.5
32.8%
99.6
32.9%
100.0
16.5%
100.0
NaN
Polio, Type 2 ≥1:8
95.6
31.6%
96.6
31.9%
100.0
16.5%
100.0
NaN
Polio, Type 3 ≥1:8
99.5
32.8%
98.9
32.6%
100.0
16.5%
100.0
NaN
Pertussis, PT (infant ≥16; Toddler ≥21) EU/mL
95.2
31.4%
95.2
31.4%
92.8
15.3%
95.4
NaN
Pertussis, FHA (Infant ≥31; Toddler ≥162) EU/mL
94.7
31.3%
95.6
31.6%
95.2
15.7%
95.3
NaN
Pertactin (Infant ≥40; Toddler ≥106) EU/mL
91.9
30.3%
95.2
31.4%
94.9
15.7%
95.4
NaN
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval () 95%
-2.2 to 1.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥16 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-4.0 to 3.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis FHA the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥31 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.90
Confidence Interval () 95%
-5.0 to 2.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.5 to 1.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertactin the difference in percentages between the two groups ( 13vPnC - 7vPnC) at ≥40 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -3.2
Confidence Interval () 95%
-7.8 to 1.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.7
Confidence Interval () 95%
-3.6 to 5.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -3.2
Confidence Interval () 95%
-9.1 to 2.4
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Haemophilus influenzae type b the difference in percentages between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.7
Confidence Interval () 95%
-8.2 to 9.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Diptheria the difference in percentages between the two groups ( 13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.8 to 1.6
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Diptheria the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -3.5
Confidence Interval () 95%
-8.3 to 0.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Tetanus the difference in percentage between the two groups ( 13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 1.7
Confidence Interval () 95%
-3.9 to 7.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.1
Confidence Interval () 95%
-2.3 to 1.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 2 the difference in percentage between the two groups ( 13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -1.0
Confidence Interval () 95%
-5.0 to 2.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 3 the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.7
Confidence Interval () 95%
-1.6 to 2.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis PT the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥21 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -2.7
Confidence Interval () 95%
-7.3 to 1.8
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥7.82 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis FHA the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥162 EU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.1
Confidence Interval () 95%
-4.3 to 4.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥5 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-1.6 to 1.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertactin the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥106 EU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.5
Confidence Interval () 95%
-4.7 to 3.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For hepatitis B the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥10.0 mIU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value -0.4
Confidence Interval () 95%
-3.0 to 2.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 0.15 μg/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 1.4
Confidence Interval () 95%
-0.8 to 4.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Haemophilus influenzae type b the difference in percentage between the two groups (13vPnC - 7vPnC) at 1.0 μg/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 4.0
Confidence Interval () 95%
-0.4 to 8.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.01 IU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-2.3 to 2.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Diphtheria the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-2.3 to 2.0
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Tetanus the difference in percentages between the two groups (13vPnC - 7vPnC) at 0.1 IU/mL threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 3.8
Confidence Interval () 95%
-1.7 to 10.9
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 1 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-2.4 to 2.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 2 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-2.4 to 2.1
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 3 the difference in percentage between the two groups (13vPnC - 7vPnC) at ≥1:8 threshold was calculated.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lowest limit of the 2-sided 95% CI for the difference between the two groups was > -10%.
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval () 95%
-2.4 to 2.1
Parameter Dispersion Type:
Value:
Estimation Comments
4. Primary Outcome
Title 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
Description 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)
Time Frame one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 275 279 254 261
Pertussis FHA
102.87
105.17
463.23
456.55
Pertussis PT
50.01
48.44
60.89
64.53
Pertussis PRN
167.76
166.19
339.30
361.70
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.98
Confidence Interval () 95%
0.87 to 1.10
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.03
Confidence Interval () 95%
0.92 to 1.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.01
Confidence Interval () 95%
0.87 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis FHA the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.01
Confidence Interval () 95%
0.89 to 1.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis PT the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.94
Confidence Interval () 95%
0.83 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Pertussis PRN the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.94
Confidence Interval () 95%
0.82 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
5. Other Pre-specified Outcome
Title Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Description 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).
Time Frame one month after infant series dose 2 and after the toddler dose

Outcome Measure Data

Analysis Population Description
OPAs were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
Arm/Group Title 13vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose
Arm/Group Description Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 100 100
Common Serotypes - Serotype 4
100.0
100.0
Common Serotypes - Serotype 6B
90.0
99.0
Common Serotypes - Serotype 9V
100.0
100.0
Common Serotypes - Serotype 14
100.0
100.0
Common Serotypes - Serotype 18C
97.0
100.0
Common Serotypes - Serotype 19F
96.0
97.9
Common Serotypes - Serotype 23F
97.0
100.0
Additional Serotypes - Serotype 1
94.8
100.0
Additional Serotypes - Serotype 3
99.0
100.0
Additional Serotypes - Serotype 5
96.0
100.0
Additional Serotypes - Serotype 6A
95.9
100.0
Additional Serotypes - Serotype 7F
100.0
100.0
Additional Serotypes - Serotype 19A
95.6
100.0
6. Other Pre-specified Outcome
Title Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose
Description 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.
Time Frame one month after infant series dose 2 and after the toddler dose

Outcome Measure Data

Analysis Population Description
OPAS were done in a subset of approximately 100 subjects (range 90-100 per serotype) in the 13vPnC group
Arm/Group Title 13vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose
Arm/Group Description Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 100 100
Common Serotypes - Serotype 4
526.69
1276.21
Common Serotypes - Serotype 6B
191.34
2383.31
Common Serotypes - Serotype 9V
3585.80
16384.00
Common Serotypes - Serotype 14
1882.96
1903.89
Common Serotypes - Serotype 18C
294.48
1324.41
Common Serotypes - Serotype 19F
222.86
391.97
Common Serotypes - Serotype 23F
487.51
3679.67
Additional Serotypes - Serotype 1
62.63
294.07
Additional Serotypes - Serotype 3
176.07
504.66
Additional Serotypes - Serotype 5
127.11
333.24
Additional Serotypes - Serotype 6A
541.81
2217.29
Additional Serotypes - Serotype 7F
5914.33
14886.35
Additional Serotypes - Serotype 19F
157.59
1415.08
7. Primary Outcome
Title 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
Description GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.
Time Frame One month after the infant series (6 months of age) and the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 273 276 252 255
Number (95% Confidence Interval) [mIU/mL]
260.46
272.67
1655.30
2284.95
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Hepatitis b the geometric mean concentration (GMC) ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the geometric mean concentration (GMC)/geometric mean titer (GMT) ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.96
Confidence Interval () 95%
0.72 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Hepatitis b the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.72
Confidence Interval () 95%
0.54 to 0.96
Parameter Dispersion Type:
Value:
Estimation Comments
8. Primary Outcome
Title 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
Description GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).
Time Frame one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable immunogenicity (per protocol) population had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 231 267 235 218
Geometric Mean (95% Confidence Interval) [μg/mL]
0.99
1.00
9.09
8.85
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments or Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.99
Confidence Interval () 95%
0.75 to 1.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Haemophilus influenzae type b the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.03
Confidence Interval () 95%
0.81 to 1.30
Parameter Dispersion Type:
Value:
Estimation Comments
9. Primary Outcome
Title 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
Description GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).
Time Frame one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 275 279 254 261
Diptheria (n=207,240,164,190)
0.52
0.67
2.77
3.71
Tetanus (n=155,214,125,96)
0.53
0.63
2.62
2.09
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.78
Confidence Interval () 95%
0.65 to 0.94
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.85
Confidence Interval () 95%
0.67 to 1.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For diphtheria toxoid the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.75
Confidence Interval () 95%
0.63 to 0.89
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Tetanus the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.25
Confidence Interval () 95%
0.88 to 1.79
Parameter Dispersion Type:
Value:
Estimation Comments
10. Primary Outcome
Title 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
Description GMC of Polio as measured using a polio in vitro plaque neutralization.
Time Frame one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After 2-Dose Infant Series 7vPnC After 2-Dose Infant Series 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 275 279 254 261
Polio Type 1 (n=207,262,156,179)
180.72
207.17
924.52
1348.04
Polio Type 2 (n=205,262,153,175)
123.74
130.39
1141.62
1340.51
Polio Type 3 (n=205,262,153,178)
397.32
452.14
1567.64
2421.31
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.87
Confidence Interval () 95%
0.70 to 1.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.95
Confidence Interval () 95%
0.74 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 1, 7vPnC Dose 1
Comments For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.88
Confidence Interval () 95%
0.68 to 1.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 1 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.69
Confidence Interval () 95%
0.55 to 0.86
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 2 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.85
Confidence Interval () 95%
0.68 to 1.07
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC Dose 2, 7vPnC Dose 2
Comments For Polio Type 3 the GMC ratio (13vPnC/7vPnC) was calculated
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority for concomitant antigens was declared if the lower bound of the 2-sided, 95% CI for the GMC/GMT ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion).
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.65
Confidence Interval () 95%
0.51 to 0.83
Parameter Dispersion Type:
Value:
Estimation Comments
11. Primary Outcome
Title 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
Description 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.
Time Frame one month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After 2-Dose Infant Series 13vPnC Before Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 265 265
Common Serotypes - Serotype 4
96.6
31.9%
66.9
22.1%
Common Serotypes - Serotype 6B
58.4
19.3%
76.3
25.2%
Common Serotypes - Serotype 9V
94.7
31.3%
70.5
23.3%
Common Serotypes - Serotype 14
94.2
31.1%
94.4
31.2%
Common Serotypes - Serotype 18C
92.4
30.5%
53.0
17.5%
Common Serotypes - Serotype 19F
95.1
31.4%
92.4
30.5%
Common Serotypes - Serotype 23F
68.6
22.6%
32.3
10.7%
Additional Serotypes - Serotype 1
96.6
31.9%
83.4
27.5%
Additional Serotypes - Serotype 3
92.8
30.6%
30.8
10.2%
Additional Serotypes - Serotype 5
91.6
30.2%
87.3
28.8%
Additional Serotypes - Serotype 6A
86.5
28.5%
86.4
28.5%
Additional Serotypes - Serotype 7F
98.5
32.5%
90.7
29.9%
Additional Serotypes - Serotype 19A
98.5
32.5%
96.2
31.7%
12. Primary Outcome
Title 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
Description 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.
Time Frame One month after infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Outcome Measure Data

Analysis Population Description
Evaluable pneumococcal immunogenicity (per protocol) had valid and determinate assay results, and had no other major protocol violations.
Arm/Group Title 13vPnC After 2-Dose Infant Series 13vPnC Before Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 265 265
Common Serotypes - Serotype 4
2.38
0.53
Common Serotypes - Serotype 6B
0.41
0.61
Common Serotypes - Serotype 9V
1.68
0.48
Common Serotypes - Serotype 14
2.84
2.03
Common Serotypes - Serotype 18C
1.72
0.35
Common Serotypes - Serotype 19F
3.42
0.94
Common Serotypes - Serotype 23F
0.61
0.26
Additional Serotypes - Serotype 1
2.30
0.68
Additional Serotypes - Serotype 3
1.15
0.25
Additional Serotypes - Serotype 5
1.27
0.88
Additional Serotypes - Serotype 6A
1.17
0.81
Additional Serotypes - Serotype 7F
2.06
0.76
Additional Serotypes - Serotype 19F
2.87
1.20
13. Secondary Outcome
Title Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose
Description Percentages of Participants achieving WHO predefined antibody threshold ≥0.35μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame One month after the toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
Measure Participants 246 249
Common Serotypes - Serotype 4 (n=244,245)
100.0
33%
100.0
33%
Common Serotypes - Serotype 6B (n=243,243)
100.0
33%
100.0
33%
Common Serotypes - Serotype 9V (n=235,248)
100.0
33%
100.0
33%
Common Serotypes - Serotype 14 (n=237,240)
99.6
32.9%
99.6
32.9%
Common Serotypes - Serotype 18C (n=245,245)
99.2
32.7%
99.6
32.9%
Common Serotypes - Serotype 19F (n=243,245)
98.8
32.6%
98.4
32.5%
Common Serotypes - Serotype 23F (n=240,243)
99.2
32.7%
98.8
32.6%
Additional Serotypes - Serotype 1 (n=244,240)
99.6
32.9%
3.3
1.1%
Additional Serotypes - Serotype 3 (n=245,218)
93.9
31%
6.7
2.2%
Additional Serotypes - Serotype 5 (n=245,243)
100.0
33%
70.2
23.2%
Additional Serotypes - Serotype 6A (n=243,243)
99.6
32.9%
86.4
28.5%
Additional Serotypes - Serotype 7F (n=242,243)
99.6
32.9%
4.9
1.6%
Additional Serotypes - Serotype 19A (n=241,241)
100.0
33%
99.6
32.9%
14. Secondary Outcome
Title Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose
Description 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.
Time Frame One month after toddler dose (12 months of age)

Outcome Measure Data

Analysis Population Description
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.
Arm/Group Title 13vPnC After Toddler Dose 7vPnC After Toddler Dose
Arm/Group Description Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose). Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
Measure Participants 246 249
Common Serotypes - Serotype 4 (n=244,245)
4.77
7.08
Common Serotypes - Serotype 6B (n=243,243)
10.00
10.39
Common Serotypes - Serotype 9V (n=235,248)
3.02
4.10
Common Serotypes - Serotype 14 (n=237,240)
10.30
11.99
Common Serotypes - Serotype 18C (n=245,247)
2.83
4.26
Common Serotypes - Serotype 19F (n=243,245)
9.01
8.06
Common Serotypes - Serotype 23F (n=244,245)
3.43
4.87
Additional Serotypes - Serotype 1 (n=244,240)
5.76
0.03
Additional Serotypes - Serotype 3 (n=245,240)
1.22
0.07
Additional Serotypes - Serotype 5 (n=245,218)
3.59
0.56
Additional Serotypes - Serotype 6A (n=243,243)
6.78
1.42
Additional Serotypes - Serotype 7F (n=242,243)
4.31
0.04
Additional Serotypes - Serotype 19F (n=241,241)
9.81
4.24

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title 13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Arm/Group Description Participants received one single 0.5mL 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. 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. 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. 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. 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. 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. 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. 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.
All Cause Mortality
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/303 (2%) 10/303 (3.3%) 8/294 (2.7%) 11/291 (3.8%) 3/287 (1%) 1/282 (0.4%) 9/290 (3.1%) 11/288 (3.8%)
Blood and lymphatic system disorders
Microcytic anaemia 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Cardiac disorders
Atrioventricular block complete 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Congenital, familial and genetic disorders
Pelizaeus-Merzbacher disease 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Gastrointestinal disorders
Anal fissure 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Constipation 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Diarrhoea 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Gastroesophageal reflux disease 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Vomiting 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 2/287 (0.7%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
General disorders
Pyrexia 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Infections and infestations
Bronchiolitis 2/303 (0.7%) 3/303 (1%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Bronchitis 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 1/288 (0.3%)
Bronchopneumonia 0/303 (0%) 0/303 (0%) 0/294 (0%) 2/291 (0.7%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Cellulitis orbital 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Ear infection 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Epstein-Barr virus infection 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Gastroenteritis 1/303 (0.3%) 1/303 (0.3%) 3/294 (1%) 2/291 (0.7%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 4/288 (1.4%)
Gastroenteritis adenovirus 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Gastroenteritis rotavirus 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Kawasaki's disease 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Otits media 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Parainfluenzae virus infection 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Pharyngitis 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Pharyngotonsillitis 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 1/288 (0.3%)
Pneumonia 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Upper respiratory tract infection 1/303 (0.3%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Viral infection 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Injury, poisoning and procedural complications
Head injury 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Tibia fracture 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Metabolism and nutrition disorders
Dehydration 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 1/288 (0.3%)
Failure to thrive 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Musculoskeletal and connective tissue disorders
Muscle spasms 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Nervous system disorders
Depressed level of consciousness 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Febrile convulsion 0/303 (0%) 0/303 (0%) 2/294 (0.7%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 2/290 (0.7%) 1/288 (0.3%)
Hypokinesia 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Infantile spasms 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Meningism 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Nystagmus 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Syncope vasovagal 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Psychiatric disorders
Crying 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Decreased activity 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Bronchospasm 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Cough 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Dyspnoea 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Laryngospasm 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Pneumonia aspiration 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Wheezing 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Other (Not Including Serious) Adverse Events
13vPnC Infant Series 7vPnC Infant Series 13vPnC Post-Infant Series 7vPnC Post-Infant Series 13vPnC Toddler Series 7vPnC Toddler Series 13vPnC 6-Month Follow-up 7vPnC 6-Month Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 188/303 (62%) 183/303 (60.4%) 96/294 (32.7%) 90/291 (30.9%) 165/287 (57.5%) 170/282 (60.3%) 1/290 (0.3%) 0/288 (0%)
Cardiac disorders
Extrasystoles 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Ear and labyrinth disorders
Ear pain 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Endocrine disorders
Thyroid cyst 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Eye disorders
Conjunctivitis 0/303 (0%) 4/303 (1.3%) 1/294 (0.3%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Gastrointestinal disorders
Diarrhoea 5/303 (1.7%) 12/303 (4%) 2/294 (0.7%) 5/5 (100%) 8/287 (2.8%) 3/282 (1.1%) 0/290 (0%) 0/288 (0%)
Vomiting 1/303 (0.3%) 5/303 (1.7%) 1/294 (0.3%) 3/291 (1%) 4/287 (1.4%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Gastrooesophageal reflux disease 1/303 (0.3%) 2/303 (0.7%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Abdominal pain 0/303 (0%) 2/303 (0.7%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Constipation 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 2/282 (0.7%) 0/290 (0%) 0/288 (0%)
Flatulence 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Frequent bowel movements 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Gingival pain 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Haematochezia 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Infantile colic 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Perianal erythema 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Stomatitis 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 3/291 (1%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Nausea 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Regurgitation 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
General disorders
Fever ≥38°C but ≤39°C 103/247 (41.7%) 95/246 (38.6%) 0/0 (NaN) 0/0 (NaN) 130/204 (63.7%) 103/197 (52.3%) 0/0 (NaN) 0/0 (NaN)
Fever ≥38°C but ≤39°C 126/227 (55.5%) 137/226 (60.6%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Fever >39°C but ≤40°C 8/224 (3.6%) 11/233 (4.7%) 0/0 (NaN) 0/0 (NaN) 16/167 (9.6%) 20/160 (12.5%) 0/0 (NaN) 0/0 (NaN)
Fever >39°C but ≤40°C 14/204 (6.9%) 14/201 (7%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Fever >40°C 0/222 (0%) 0/230 (0%) 0/0 (NaN) 0/0 (NaN) 0/160 (0%) 1/152 (0.7%) 0/0 (NaN) 0/0 (NaN)
Fever >40°C 0/198 (0%) 0/195 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Decreased appetite 87/246 (35.4%) 85/248 (34.3%) 0/0 (NaN) 0/0 (NaN) 103/198 (52%) 113/197 (57.4%) 0/0 (NaN) 0/0 (NaN)
Decreased appetite 104/220 (47.3%) 99/218 (45.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Irritability 188/258 (72.9%) 165/259 (63.7%) 0/0 (NaN) 0/0 (NaN) 165/221 (74.7%) 170/227 (74.9%) 0/0 (NaN) 0/0 (NaN)
Irritability 185/245 (75.5%) 183/243 (75.3%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Increased sleep 177/269 (65.8%) 178/276 (64.5%) 0/0 (NaN) 0/0 (NaN) 105/195 (53.8%) 107/196 (54.6%) 0/0 (NaN) 0/0 (NaN)
Increased sleep 129/226 (57.1%) 131/232 (56.5%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Decreased sleep 96/244 (39.3%) 88/242 (36.4%) 0/0 (NaN) 0/0 (NaN) 64/180 (35.6%) 61/171 (35.7%) 0/0 (NaN) 0/0 (NaN)
Decreased sleep 89/222 (40.1%) 89/213 (41.8%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Pyrexia 24/303 (7.9%) 23/303 (7.6%) 33/294 (11.2%) 34/291 (11.7%) 25/287 (8.7%) 16/282 (5.7%) 0/290 (0%) 0/288 (0%)
Irritability 0/303 (0%) 2/303 (0.7%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Injection site swelling 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Hepatobiliary disorders
Hepatomegaly 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Infections and infestations
Upper respiratory tract infection 13/303 (4.3%) 10/303 (3.3%) 8/294 (2.7%) 12/291 (4.1%) 4/287 (1.4%) 7/282 (2.5%) 0/290 (0%) 0/288 (0%)
Rhinitis 11/303 (3.6%) 10/303 (3.3%) 6/294 (2%) 4/291 (1.4%) 9/287 (3.1%) 5/282 (1.8%) 0/290 (0%) 0/288 (0%)
Bronchiolitis 8/303 (2.6%) 9/303 (3%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Pharyngitis 8/303 (2.6%) 6/303 (2%) 16/294 (5.4%) 7/291 (2.4%) 2/287 (0.7%) 11/282 (3.9%) 0/290 (0%) 0/288 (0%)
Bronchitis 6/303 (2%) 5/303 (1.7%) 4/294 (1.4%) 8/291 (2.7%) 3/287 (1%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Nasopharyngitis 4/303 (1.3%) 6/303 (2%) 0/294 (0%) 3/291 (1%) 1/287 (0.3%) 2/282 (0.7%) 0/290 (0%) 0/288 (0%)
Gastroenteritis 4/303 (1.3%) 4/303 (1.3%) 4/294 (1.4%) 5/291 (1.7%) 5/287 (1.7%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Exanthema subitum 4/303 (1.3%) 3/303 (1%) 16/294 (5.4%) 22/291 (7.6%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Ear infection 4/303 (1.3%) 2/303 (0.7%) 7/294 (2.4%) 7/291 (2.4%) 6/287 (2.1%) 7/282 (2.5%) 0/290 (0%) 0/288 (0%)
Influenza 1/303 (0.3%) 5/303 (1.7%) 1/294 (0.3%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Varicella 1/303 (0.3%) 3/303 (1%) 8/294 (2.7%) 5/291 (1.7%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Urinary tract infection 1/303 (0.3%) 2/303 (0.7%) 3/294 (1%) 5/291 (1.7%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Oral candidiasis 1/303 (0.3%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Otitis media 0/303 (0%) 2/303 (0.7%) 1/294 (0.3%) 1/291 (0.3%) 2/287 (0.7%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Sinusitis 1/303 (0.3%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Tracheitis 0/303 (0%) 2/303 (0.7%) 1/294 (0.3%) 1/291 (0.3%) 1/287 (0.3%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Viral skin infection 2/303 (0.7%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Fungal skin infection 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Impetigo 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Laryngitis 0/303 (0%) 1/303 (0.3%) 2/294 (0.7%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Otitis media acute 0/303 (0%) 1/303 (0.3%) 1/294 (0.3%) 0/291 (0%) 3/287 (1%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Pharyngotonsillitis 0/303 (0%) 1/303 (0.3%) 3/294 (1%) 0/291 (0%) 1/287 (0.3%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Tonsillitis 0/303 (0%) 1/303 (0.3%) 2/294 (0.7%) 1/291 (0.3%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Respiratory tract infection 0/303 (0%) 0/303 (0%) 0/294 (0%) 3/291 (1%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Enteritis infectious 0/303 (0%) 0/303 (0%) 0/294 (0%) 2/291 (0.7%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Erythema infectiosum 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Hand-foot-and-mouth disease 0/303 (0%) 0/303 (0%) 0/294 (0%) 2/291 (0.7%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Acute tonsillitis 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Bronchopneumonia 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Cystitis 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Gastroenteritis viral 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Lower respiratory tract infection 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Roseola 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Herpes simplex 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Injury, poisoning and procedural complications
Limb injury 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Metabolism and nutrition disorders
Decreased appetite 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Anorexia 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Musculoskeletal and connective tissue disorders
Muscle spasms 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Nervous system disorders
Nystagmus 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Psychiatric disorders
Sleep disorder 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Renal and urinary disorders
Urinary tract pain 1/303 (0.3%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Reproductive system and breast disorders
Genital rash 0/303 (0%) 0/303 (0%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 18/303 (5.9%) 18/303 (5.9%) 8/294 (2.7%) 7/291 (2.4%) 8/287 (2.8%) 7/282 (2.5%) 0/290 (0%) 0/288 (0%)
Bronchospasm 2/303 (0.7%) 3/303 (1%) 0/294 (0%) 1/291 (0.3%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Asthma 3/303 (1%) 0/303 (0%) 3/294 (1%) 1/291 (0.3%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Rhinorrhoea 2/303 (0.7%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Rhonchi 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Wheezing 0/303 (0%) 0/303 (0%) 1/294 (0.3%) 1/291 (0.3%) 1/287 (0.3%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Pharyngolaryngeal pain 0/303 (0%) 0/303 (0%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Skin and subcutaneous tissue disorders
Tenderness (Any) 75/234 (32.1%) 73/243 (30%) 0/0 (NaN) 0/0 (NaN) 94/199 (47.2%) 83/188 (44.1%) 0/0 (NaN) 0/0 (NaN)
Tenderness (Any) 65/214 (30.4%) 79/215 (36.7%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Tenderness (Significant) 6/224 (2.7%) 8/231 (3.5%) 0/0 (NaN) 0/0 (NaN) 14/164 (8.5%) 9/153 (5.9%) 0/0 (NaN) 0/0 (NaN)
Tenderness (Significant) 9/199 (4.5%) 10/199 (5%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Any) 44/232 (19%) 47/240 (19.6%) 0/0 (NaN) 0/0 (NaN) 50/175 (28.6%) 45/165 (27.3%) 0/0 (NaN) 0/0 (NaN)
Induration (Any) 51/207 (24.6%) 60/209 (28.7%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Mild) 41/232 (17.7%) 44/240 (18.3%) 0/0 (NaN) 0/0 (NaN) 46/174 (26.4%) 35/161 (21.7%) 0/0 (NaN) 0/0 (NaN)
Induration (Mild) 45/207 (21.7%) 55/208 (26.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Moderate) 8/223 (3.6%) 7/229 (3.1%) 0/0 (NaN) 0/0 (NaN) 12/160 (7.5%) 16/157 (10.2%) 0/0 (NaN) 0/0 (NaN)
Induration (Moderate) 11/198 (5.6%) 10/195 (5.1%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Induration (Severe) 0/222 (0%) 0/229 (0%) 0/0 (NaN) 0/0 (NaN) 0/159 (0%) 0/152 (0%) 0/0 (NaN) 0/0 (NaN)
Induration (Severe) 0/197 (0%) 0/194 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Any) 60/233 (25.8%) 65/245 (26.5%) 0/0 (NaN) 0/0 (NaN) 65/178 (36.5%) 63/174 (36.2%) 0/0 (NaN) 0/0 (NaN)
Erythema (Any) 67/213 (31.5%) 73/212 (34.4%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Mild) 56/233 (24%) 60/244 (24.6%) 0/0 (NaN) 0/0 (NaN) 58/178 (32.6%) 53/172 (30.8%) 0/0 (NaN) 0/0 (NaN)
Erythema (Mild) 60/211 (28.4%) 68/211 (32.2%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Moderate) 6/222 (2.7%) 7/231 (3%) 0/0 (NaN) 0/0 (NaN) 12/160 (7.5%) 17/156 (10.9%) 0/0 (NaN) 0/0 (NaN)
Erythema (Moderate) 11/200 (5.5%) 7/195 (3.6%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Erythema (Severe) 0/222 (0%) 0/229 (0%) 0/0 (NaN) 0/0 (NaN) 0/159 (0%) 0/152 (0%) 0/0 (NaN) 0/0 (NaN)
Erythema (Severe) 0/197 (0%) 0/194 (0%) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
Dermatitis atopic 3/303 (1%) 5/303 (1.7%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 1/290 (0.3%) 0/288 (0%)
Dermatitis atopic 3/303 (1%) 5/303 (1.7%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Dermatitis 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Eczema 0/303 (0%) 1/303 (0.3%) 1/294 (0.3%) 0/291 (0%) 0/287 (0%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Rash 1/303 (0.3%) 0/303 (0%) 1/294 (0.3%) 2/291 (0.7%) 2/287 (0.7%) 1/282 (0.4%) 0/290 (0%) 0/288 (0%)
Skin fissures 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Skin lesion 0/303 (0%) 1/303 (0.3%) 0/294 (0%) 0/291 (0%) 0/287 (0%) 0/282 (0%) 0/290 (0%) 0/288 (0%)
Urticaria 0/303 (0%) 0/303 (0%) 0/294 (0%) 2/291 (0.7%) 1/1 (100%) 0/282 (0%) 0/290 (0%) 0/288 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.

Results Point of Contact

Name/Title U. S. Contact Center
Organization Wyeth
Phone
Email clintrialresults@wyeth.com
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00366899
Other Study ID Numbers:
  • 6096A1-500
First Posted:
Aug 21, 2006
Last Update Posted:
Feb 22, 2013
Last Verified:
Jan 1, 2013