Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00474539
Collaborator
(none)
449
27
2
20
16.6
0.8
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 Spain.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
449 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 a Meningococcal C-Tetanus Toxoid Conjugate Vaccine and Other Routine Pediatric Vaccinations in Spain
Study Start Date
:
Jul 1, 2007
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Biological: 13-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age
|
| Active Comparator: 2
|
Biological: 7-valent pneumococcal conjugate vaccine
1 dose at 2,4,6 and 15 months of age
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series [One month after infant series dose (at 5 months of age)]
Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented.
- Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose [One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age)]
- Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose [One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]
Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL).
- Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose [One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]
- Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
- Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose [One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age)]
GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed.
Secondary Outcome Measures
- Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [One month after toddler dose (at 16 months of age)]
Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented.
Other Outcome Measures
- 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 (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category.
- Percentage of Participants Reporting Pre-Specified Systemic Events [During the 4-day period after each dose]
Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category.
Eligibility Criteria
Criteria
Ages Eligible for Study:
42 Days
to 98 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy 2-month-old infants
-
Available for the entire study period
Exclusion criteria:
-
Previous vaccination with any vaccine before the start of the study
-
Known contraindication to vaccination
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Almeria | Spain | 4007 | ||
| 2 | Almeria | Spain | 4009 | ||
| 3 | Almeria | Spain | 4120 | ||
| 4 | Barcelona | Spain | 8195 | ||
| 5 | Barcelona | Spain | 8930 | ||
| 6 | Coruna | Spain | 15270 | ||
| 7 | Coruna | Spain | 15405 | ||
| 8 | Madrid | Spain | 28041 | ||
| 9 | Madrid | Spain | 28900 | ||
| 10 | Madrid | Spain | 28922 | ||
| 11 | Madrid | Spain | 28942 | ||
| 12 | Malaga | Spain | 29015 | ||
| 13 | Malaga | Spain | 29200 | ||
| 14 | Ourense | Spain | 32005 | ||
| 15 | Pamplona | Spain | 31008 | ||
| 16 | Santiago de Compostela | Spain | 15706 | ||
| 17 | Seville | Spain | 41013 | ||
| 18 | Valencia | Spain | 46008 | ||
| 19 | Valencia | Spain | 46011 | ||
| 20 | Valencia | Spain | 46021 | ||
| 21 | Valencia | Spain | 46022 | ||
| 22 | Valencia | Spain | 46023 | ||
| 23 | Valencia | Spain | 46024 | ||
| 24 | Valencia | Spain | 46183 | ||
| 25 | Valencia | Spain | 46200 | ||
| 26 | Valencia | Spain | 46930 | ||
| 27 | Vigo | Spain | 36204 |
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 Spain: infomed@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:
NCT00474539
Other Study ID Numbers:
- 6096A1-3007
First Posted:
May 17, 2007
Last Update Posted:
Mar 5, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited in Spain from 4 July 2007 to 23 July 2007. |
|---|---|
| Pre-assignment Detail | Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period. |
| Arm/Group Title | 13vPnC | 7vPnC |
|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. |
| Period Title: Infant Series | ||
| STARTED | 223 | 226 |
| Vaccinated Dose 1 | 218 | 226 |
| Vaccinated Dose 2 | 217 | 222 |
| Vaccinated Dose 3 | 214 | 221 |
| COMPLETED | 213 | 220 |
| NOT COMPLETED | 10 | 6 |
| Period Title: Infant Series | ||
| STARTED | 213 | 220 |
| COMPLETED | 209 | 220 |
| NOT COMPLETED | 4 | 0 |
| Period Title: Infant Series | ||
| STARTED | 209 | 220 |
| COMPLETED | 208 | 220 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | 13vPnC | 7vPnC | Total |
|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | Total of all reporting groups |
| Overall Participants | 219 | 225 | 444 |
| Age (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
2.1
(0.4)
|
2.0
(0.4)
|
2.1
(0.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
104
47.5%
|
116
51.6%
|
220
49.5%
|
| Male |
115
52.5%
|
109
48.4%
|
224
50.5%
|
Outcome Measures
| Title | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series |
|---|---|
| Description | Percentage of participants achieving a meningococcal C SBA serum antibody titer greater than or equal to (≥) 1:8 along with the corresponding 95% confidence interval (CI) are presented. |
| Time Frame | One month after infant series dose (at 5 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given concomitant vaccine component. |
| Arm/Group Title | 13vPnC After Infant Series Dose 2 | 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2). | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2). |
| Measure Participants | 206 | 218 |
| Number (95% Confidence Interval) [percentage of participants] |
98.5
45%
|
99.1
44%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at >=1:8 titer was calculated | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) greater than (>) -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -0.5 | |
| Confidence Interval |
() 95% -3.3 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 (Sig)(present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (Sev) (>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 Dose 3 | 7vPnC Dose 3 | 13vPnC Toddler Dose | 7vPnC Toddler Dose |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. |
| Measure Participants | 218 | 226 | 217 | 222 | 214 | 221 | 209 | 220 |
| Tenderness-Any (n=199,205,182,180,170,175,164,172) |
21.1
9.6%
|
18.5
8.2%
|
21.4
4.8%
|
16.1
NaN
|
10.6
NaN
|
14.3
NaN
|
28.7
NaN
|
26.7
NaN
|
| Tenderness-Sig (n=199,200,177,177,167,169,154,160) |
3.0
1.4%
|
4.0
1.8%
|
1.1
0.2%
|
4.0
NaN
|
1.2
NaN
|
1.2
NaN
|
2.6
NaN
|
3.8
NaN
|
| Swelling-Any (n=196,200,182,177,171,170,169,168) |
13.3
6.1%
|
14.5
6.4%
|
22.0
5%
|
14.7
NaN
|
23.4
NaN
|
20.0
NaN
|
26.6
NaN
|
18.5
NaN
|
| Swelling-Mild (n=196,200,182,177,171,170,166,168) |
12.2
5.6%
|
13.0
5.8%
|
20.3
4.6%
|
13.0
NaN
|
20.5
NaN
|
17.1
NaN
|
22.9
NaN
|
16.0
NaN
|
| Swelling-Mod (n=196,196,177,175,166,168,156,163) |
2.6
1.2%
|
2.0
0.9%
|
2.3
0.5%
|
2.3
NaN
|
6.6
NaN
|
6.0
NaN
|
9.0
NaN
|
5.5
NaN
|
| Swelling-Sev (n=196,196,177,175,166,168,152,156) |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Redness-Any (n=197,199,181,180,172,172,170,169) |
15.2
6.9%
|
15.1
6.7%
|
23.8
5.4%
|
20.0
NaN
|
26.7
NaN
|
22.7
NaN
|
30.0
NaN
|
23.1
NaN
|
| Redness-Mild (n=197,198,180,180,172,171,167,165) |
14.7
6.7%
|
14.1
6.3%
|
22.2
5%
|
19.4
NaN
|
24.4
NaN
|
21.1
NaN
|
28.1
NaN
|
21.2
NaN
|
| Redness-Mod (n=196,197,178,175,166,169,157,163) |
0.5
0.2%
|
1.0
0.4%
|
2.2
0.5%
|
1.1
NaN
|
3.6
NaN
|
3.6
NaN
|
9.6
NaN
|
6.7
NaN
|
| Redness-Sev (n=196,196,177,175,166,168,152,156) |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
NaN
|
0.6
NaN
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
| Title | Percentage of Participants Reporting Pre-Specified Systemic Events |
|---|---|
| Description | Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (Decr) appetite, irritability, increased (Incr) sleep, decreased sleep, hives, use of medication (Meds) to treat symptoms (Sx), and use of medication to prevent symptoms were reported using an electronic diary. Participants may be represented in more than 1 category. |
| 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 Dose 3 | 7vPnC Dose 3 | 13vPnC Toddler Dose | 7vPnC Toddler Dose |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. |
| Measure Participants | 218 | 226 | 217 | 222 | 214 | 221 | 209 | 220 |
| Fv ≥38°C, ≤39°C(n=201,204,181,189,172,176,156,169) |
22.9
10.5%
|
19.6
8.7%
|
32.6
7.3%
|
41.8
NaN
|
20.9
NaN
|
29.0
NaN
|
31.4
NaN
|
34.3
NaN
|
| Fv >39°C, ≤40°C(n=196,196,177,176,166,168,154,156) |
1.0
0.5%
|
0.5
0.2%
|
1.7
0.4%
|
1.1
NaN
|
3.6
NaN
|
3.0
NaN
|
4.5
NaN
|
2.6
NaN
|
| Fv >40°C (n=196,197,177,175,166,168,152,156) |
0.0
0%
|
0.5
0.2%
|
0.0
0%
|
0.0
NaN
|
0.0
NaN
|
0.0
NaN
|
0.7
NaN
|
0.0
NaN
|
| Decr appetite (n=204,207,189,191,178,178,163,178) |
31.4
14.3%
|
35.7
15.9%
|
46.6
10.5%
|
44.0
NaN
|
37.1
NaN
|
36.0
NaN
|
31.9
NaN
|
41.0
NaN
|
| Irritability (n=202,211,192,190,179,188,171,179) |
46.5
21.2%
|
49.8
22.1%
|
57.3
12.9%
|
60.0
NaN
|
43.0
NaN
|
39.4
NaN
|
41.5
NaN
|
53.6
NaN
|
| Incr sleep (n=204,206,189,187,175,174,162,165) |
38.7
17.7%
|
39.3
17.5%
|
39.2
8.8%
|
36.4
NaN
|
21.1
NaN
|
27.0
NaN
|
16.7
NaN
|
24.8
NaN
|
| Decr sleep (n=196,204,183,187,175,178,162,166) |
19.4
8.9%
|
27.5
12.2%
|
27.3
6.1%
|
27.8
NaN
|
22.9
NaN
|
25.3
NaN
|
19.8
NaN
|
18.7
NaN
|
| Meds-treat sx (n=205,209,193,197,175,189,165,177) |
41.0
18.7%
|
44.5
19.8%
|
54.4
12.3%
|
57.9
NaN
|
39.4
NaN
|
42.9
NaN
|
50.3
NaN
|
46.9
NaN
|
| Meds-prevent sx(n=201,210,194,196,177,185,168,177) |
41.3
18.9%
|
45.7
20.3%
|
47.9
10.8%
|
49.5
NaN
|
44.6
NaN
|
40.5
NaN
|
43.5
NaN
|
41.8
NaN
|
| Title | Geometric Mean Titers (GMT) for Meningococcal C Antibodies in as Measured by Serum Bactericidal Assay (SBA) 13vPnC Group Relative to 7vPnC Group After the 2-dose NeisVac-C Infant Series and the Toddler Dose |
|---|---|
| Description | |
| Time Frame | One month after infant series dose 2 (at 5 months of age) and one month after toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The evaluable 2-dose 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 Infant Series Dose 2 | 7vPnC After Infant Series Dose 2 | 13vPnC After Toddler Dose | 7vPnC After Toddler Dose |
|---|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2). | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. |
| Measure Participants | 206 | 218 | 164 | 172 |
| Geometric Mean (95% Confidence Interval) [titer] |
654.55
|
757.04
|
2573.06
|
2098.12
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the 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 | 0.86 | |
| Confidence Interval |
() 95% 0.69 to 1.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC Dose 2, 7vPnC Dose 2 |
|---|---|---|
| Comments | For Meningococcal C the GMT ratio (13vPnC/7vPnC) was calculated | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority for or immune response induced by NeisVac-C was declared if the lower bound of the 2-sided, 95% CI for the 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 | 1.23 | |
| Confidence Interval |
() 95% 0.97 to 1.55 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving Predefined Antibody Levels for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose |
|---|---|
| Description | Predefined antibody levels for Diphtheria (0.01 or 0.1 International units [IU]/mL) and Tetanus (0.01 or 0.1 [IU]/mL). |
| Time Frame | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The evaluable 3-dose 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 Infant Series Dose 3 | 7vPnC After Infant Series Dose 3 | 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 the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). |
| Measure Participants | 197 | 212 | 164 | 172 |
| Diphtheria ≥0.10 IU/mL |
98.5
45%
|
99.1
44%
|
100.0
22.5%
|
100.0
NaN
|
| Diphtheria ≥0.01 IU/mL |
100.0
45.7%
|
100.0
44.4%
|
100.0
22.5%
|
100.0
NaN
|
| Tetanus ≥0.10 IU/mL |
96.6
44.1%
|
96.7
43%
|
100.0
22.5%
|
100.0
NaN
|
| Tetanus ≥0.01 IU/mL |
100.0
45.7%
|
100.0
44.4%
|
100.0
22.5%
|
100.0
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -0.6 | |
| Confidence Interval |
() 95% -3.5 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For diphtheria the difference in percentage 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -1.9 to 1.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -0.2 | |
| Confidence Interval |
() 95% -4.4 to 4.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For tetanus the difference in percentage 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -2.1 to 2.0 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC Dose 2, 7vPnC Dose 2 |
|---|---|---|
| Comments | For diphtheria the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -2.2 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC Dose 2, 7vPnC Dose 2 |
|---|---|---|
| Comments | For diphtheria the difference in percentage 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -2.2 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC Dose 2, 7vPnC Dose 2 |
|---|---|---|
| Comments | For tetanus the difference in percentage between the two groups (13vPnC - 7vPnC) at >=0.10 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -2.3 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC Dose 2, 7vPnC Dose 2 |
|---|---|---|
| Comments | For tetanus the difference in percentage 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 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.0 | |
| Confidence Interval |
() 95% -2.3 to 2.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Geometric Mean Antibody Concentrations (GMC) for Diphtheria and Tetanus in 13vPnC Group Relative to 7vPnC Group After the 3-dose Infant Series and After the Toddler Dose |
|---|---|
| Description | |
| Time Frame | One month after infant series dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The evaluable 3-dose 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 Infant Series Dose 3 | 7vPnC After Infant Series Dose 3 | 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 the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). | SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). |
| Measure Participants | 197 | 212 | 164 | 172 |
| Diphtheria |
0.79
|
0.92
|
3.00
|
3.23
|
| Tetanus |
1.10
|
1.20
|
3.29
|
3.28
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series 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 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 | 0.86 | |
| Confidence Interval |
() 95% 0.72 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series 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 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 | 0.91 | |
| Confidence Interval |
() 95% 0.74 to 1.12 |
|
| 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 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 | 0.93 | |
| Confidence Interval |
() 95% 0.78 to 1.10 |
|
| 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 ratio (13vPnC group/7vPnC group) was >0.5 (2-fold criterion). | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.00 | |
| Confidence Interval |
() 95% 0.81 to 1.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Achieving Antibody Level ≥ 0.35μg/mL in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose |
|---|---|
| Description | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. |
| Time Frame | One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. |
| Arm/Group Title | 13vPnC After Infant Series Dose 2 | 13vPnC After Infant Series Dose 3 | 13vPnC After Toddler Dose |
|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2). | Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). |
| Measure Participants | 206 | 197 | 212 |
| Common Serotypes - Serotype 4 |
92.5
42.2%
|
98.5
43.8%
|
100.0
22.5%
|
| Common Serotypes - Serotype 6B |
27.9
12.7%
|
94.9
42.2%
|
100.0
22.5%
|
| Common Serotypes - Serotype 9V |
89.9
41.1%
|
97.0
43.1%
|
99.3
22.4%
|
| Common Serotypes - Serotype 14 |
91.0
41.6%
|
97.0
43.1%
|
99.4
22.4%
|
| Common Serotypes - Serotype 18C |
88.9
40.6%
|
99.0
44%
|
98.8
22.3%
|
| Common Serotypes - Serotype 19F |
100.0
45.7%
|
99.0
44%
|
98.7
22.2%
|
| Common Serotypes - Serotype 23F |
55.8
25.5%
|
93.0
41.3%
|
98.1
22.1%
|
| Additional Serotypes - Serotype 1 |
96.0
43.8%
|
98.5
43.8%
|
98.8
22.3%
|
| Additional Serotypes - Serotype 3 |
73.8
33.7%
|
86.2
38.3%
|
93.6
21.1%
|
| Additional Serotypes - Serotype 5 |
86.4
39.5%
|
96.0
42.7%
|
100.0
22.5%
|
| Additional Serotypes - Serotype 6A |
80.8
36.9%
|
99.0
44%
|
99.4
22.4%
|
| Additional Serotypes - Serotype 7F |
94.5
43.2%
|
100.0
44.4%
|
99.4
22.4%
|
| Additional Serotypes - Serotype 19A |
92.9
42.4%
|
99.5
44.2%
|
100.0
22.5%
|
| Title | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group After the Second and the Third Dose of a 3-Dose Infant Series and After the Toddler Dose |
|---|---|
| Description | GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMCs (13vPnC) were calculated for each pneumococcal serotype and timepoint, and 2-sided, 95% CI were constructed. |
| Time Frame | One month after infant series dose 2 (at 5 months of age) and dose 3 (at 7 months of age) and one month after the toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. |
| Arm/Group Title | 13vPnC After Infant Series Dose 2 | 13vPnC After Infant Series Dose 3 | 13vPnC After Toddler Dose |
|---|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2). | Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). |
| Measure Participants | 206 | 197 | 212 |
| Common Serotypes - Serotype 4 |
1.55
|
2.32
|
3.88
|
| Common Serotypes - Serotype 6B |
0.21
|
2.59
|
12.25
|
| Common Serotypes - Serotype 9V |
1.15
|
1.51
|
2.67
|
| Common Serotypes - Serotype 14 |
1.94
|
4.51
|
9.82
|
| Common Serotypes - Serotype 18C |
1.30
|
1.86
|
2.29
|
| Common Serotypes - Serotype 19F |
2.98
|
2.46
|
6.11
|
| Common Serotypes - Serotype 23F |
0.40
|
1.67
|
3.96
|
| Additional Serotypes - Serotype 1 |
1.87
|
2.95
|
4.60
|
| Additional Serotypes - Serotype 3 |
0.54
|
0.85
|
1.04
|
| Additional Serotypes - Serotype 5 |
0.88
|
1.83
|
3.69
|
| Additional Serotypes - Serotype 6A |
0.81
|
3.08
|
7.71
|
| Additional Serotypes - Serotype 7F |
1.51
|
3.41
|
5.66
|
| Additional Serotypes - Serotype 19A |
1.52
|
2.50
|
10.21
|
| Title | Percentage of Participants Achieving a Serum Bactericidal Assay (SBA) Titer ≥ 1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
|---|---|
| Description | Percentage of participants achieving a meningococcal C SBA serum antibody titer ≥ 1:8 along with the corresponding 95% confidence interval (CI) are presented. |
| Time Frame | One month after toddler dose (at 16 months of age) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Evaluable immunogenicity (per protocol) population consisting of eligible participants who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n)= number of participants with a determinate IgG antibody concentration to the given concomitant vaccine component. |
| Arm/Group Title | 13vPnC After Toddler Dose | 7vPnC After Toddler Dose |
|---|---|---|
| Arm/Group Description | Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. | Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit. |
| Measure Participants | 164 | 172 |
| Number (95% Confidence Interval) [percentage of participants] |
100.0
45.7%
|
99.4
44.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 13vPnC After Infant Series Dose 2, 7vPnC After Infant Series Dose 2 |
|---|---|---|
| Comments | For Meningococcal C the difference in percentages between the two groups (13vPnC - 7vPnC) at ≥ 1:8 titer was calculated. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority for immune response induced by NeisVac-C was declared if the lowest limit of 2-sided 95% CI for the difference between the 2 groups (13vPnC - 7vPnC) > -10%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.6 | |
| Confidence Interval |
() 95% -1.7 to 3.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | 13vPnC Infant Series | 7vPnC Infant Series | 13vPnC Post-Infant Series | 7vPnC Post-Infant Series | 13vPnC Toddler Series | 7vPnC Toddler Series | 13vPnC 6-Month Follow-up | 7vPnC 6-Month Follow-up | ||||||||
| Arm/Group Description | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3. | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3. | Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose. | Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose. | Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose. | Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit | Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. 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 | 6/218 (2.8%) | 8/226 (3.5%) | 9/218 (4.1%) | 6/226 (2.7%) | 1/218 (0.5%) | 0/226 (0%) | 4/218 (1.8%) | 9/226 (4%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Aphthous stomatitis | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Coleliac disease | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Diarrhoea | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Gastrooesophageal reflux disease | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Inguinal hernia | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Intussusception | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| General disorders | ||||||||||||||||
| Pyrexia | 1/218 (0.5%) | 1/226 (0.4%) | 1/218 (0.5%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Bacteriuria | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Bronchiolitis | 1/218 (0.5%) | 2/226 (0.9%) | 2/218 (0.9%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Bronchitis | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Enterocolitis viral | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Escherichia urinary tract infection | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Gastroenteritis | 1/218 (0.5%) | 1/226 (0.4%) | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 2/226 (0.9%) | ||||||||
| Gastroenteritis rotavirus | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Influenza | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | ||||||||
| Orchitis | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Otitis media | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Pharyngotonsillitis | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Pneumonia | 1/218 (0.5%) | 0/226 (0%) | 1/218 (0.5%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 2/218 (0.9%) | 0/226 (0%) | ||||||||
| Pyelonephritis | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Respiratory syncytial virus bronchiolitis | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 1/226 (0.4%) | ||||||||
| Tonsillitis | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Urinary tract infection | 1/218 (0.5%) | 1/226 (0.4%) | 1/218 (0.5%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Viral infection | 0/218 (0%) | 1/226 (0.4%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Femur fracture | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Joint dislocation | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Metabolic acidosis | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Convulsion | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Febrile convulsion | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Asthma | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | ||||||||
| Bronchospams | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 1/218 (0.5%) | 0/226 (0%) | ||||||||
| Increased bronchial secretion | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 1/226 (0.4%) | ||||||||
| Wheezing | 1/218 (0.5%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (0%) | 0/218 (0%) | 0/226 (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 | 204/218 (93.6%) | 211/225 (93.8%) | 6/218 (2.8%) | 13/225 (5.8%) | 171/209 (81.8%) | 179/218 (82.1%) | 4/218 (1.8%) | 2/224 (0.9%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Lymphadenitis | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||
| Phimosis | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Thalassaemia beta | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 1/218 (0.5%) | 0/224 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Ear pain | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| Conjunctivitis | 3/218 (1.4%) | 11/225 (4.9%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Conjunctivitis allergic | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Dacryostenosis acquired | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Diarrhoea | 8/218 (3.7%) | 9/225 (4%) | 0/218 (0%) | 1/225 (0.4%) | 2/209 (1%) | 3/218 (1.4%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Vomiting | 3/218 (1.4%) | 4/225 (1.8%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Gastrointestinal inflammation | 3/218 (1.4%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Constipation | 0/218 (0%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Enteritis | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Abnormal faeces | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Infantile colic | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Aphthous stomatitis | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Stomatitis | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Pyrexia | 6/218 (2.8%) | 9/225 (4%) | 0/218 (0%) | 0/225 (0%) | 5/209 (2.4%) | 2/218 (0.9%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Irritability | 2/218 (0.9%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Developmental delay | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Fever ≥38°C but ≤39°C | 201/218 (92.2%) | 204/225 (90.7%) | 0/0 (NaN) | 0/0 (NaN) | 156/209 (74.6%) | 169/218 (77.5%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever ≥38°C but ≤39°C | 181/218 (83%) | 189/225 (84%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever ≥38°C but ≤39°C | 172/218 (78.9%) | 176/225 (78.2%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >39°C but ≤40°C | 196/218 (89.9%) | 196/225 (87.1%) | 0/0 (NaN) | 0/0 (NaN) | 154/209 (73.7%) | 156/218 (71.6%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >39°C but ≤40°C | 177/218 (81.2%) | 176/225 (78.2%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >39°C but ≤40°C | 166/218 (76.1%) | 168/225 (74.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >40°C | 196/218 (89.9%) | 197/225 (87.6%) | 0/0 (NaN) | 0/0 (NaN) | 152/209 (72.7%) | 156/218 (71.6%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >40°C | 177/218 (81.2%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Fever >40°C | 166/218 (76.1%) | 168/225 (74.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased appetite | 204/218 (93.6%) | 207/225 (92%) | 0/0 (NaN) | 0/0 (NaN) | 163/209 (78%) | 178/218 (81.7%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased appetite | 189/218 (86.7%) | 191/225 (84.9%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased appetite | 178/218 (81.7%) | 178/225 (79.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Irritability | 202/218 (92.7%) | 211/225 (93.8%) | 0/0 (NaN) | 0/0 (NaN) | 171/209 (81.8%) | 179/218 (82.1%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Irritability | 192/218 (88.1%) | 190/225 (84.4%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Irritability | 179/218 (82.1%) | 188/225 (83.6%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Increased sleep | 204/218 (93.6%) | 206/225 (91.6%) | 0/0 (NaN) | 0/0 (NaN) | 162/209 (77.5%) | 165/218 (75.7%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Increased sleep | 189/218 (86.7%) | 187/225 (83.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Increased sleep | 175/218 (80.3%) | 174/225 (77.3%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased sleep | 196/218 (89.9%) | 204/225 (90.7%) | 0/0 (NaN) | 0/0 (NaN) | 162/209 (77.5%) | 166/218 (76.1%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased sleep | 183/218 (83.9%) | 187/225 (83.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Decreased sleep | 175/218 (80.3%) | 178/225 (79.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Immune system disorders | ||||||||||||||||
| Milk allergy | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Food allergy | 0/218 (0%) | 0/225 (0%) | 1/218 (0.5%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 1/218 (0.5%) | 1/224 (0.4%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Nasopharyngitis | 21/218 (9.6%) | 27/225 (12%) | 0/218 (0%) | 1/225 (0.4%) | 9/209 (4.3%) | 6/218 (2.8%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Upper respiratory tract infection | 23/218 (10.6%) | 24/225 (10.7%) | 1/218 (0.5%) | 2/225 (0.9%) | 5/209 (2.4%) | 4/218 (1.8%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Gastroenteritis | 19/218 (8.7%) | 15/225 (6.7%) | 0/218 (0%) | 0/225 (0%) | 7/209 (3.3%) | 3/218 (1.4%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Bronchiolitis | 12/218 (5.5%) | 17/225 (7.6%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Respiratory tract infection | 9/218 (4.1%) | 14/225 (6.2%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Bronchitis | 9/218 (4.1%) | 13/225 (5.8%) | 0/218 (0%) | 1/225 (0.4%) | 1/209 (0.5%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Laryngitis | 5/218 (2.3%) | 8/225 (3.6%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Otitis media | 3/218 (1.4%) | 8/225 (3.6%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Rhinitis | 4/218 (1.8%) | 7/225 (3.1%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Ear infection | 5/218 (2.3%) | 5/225 (2.2%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 5/218 (2.3%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Pharyngitis | 4/218 (1.8%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 5/209 (2.4%) | 3/218 (1.4%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Tonsillitis | 2/218 (0.9%) | 3/225 (1.3%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 4/218 (1.8%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Viral infection | 1/218 (0.5%) | 4/225 (1.8%) | 0/218 (0%) | 0/225 (0%) | 2/209 (1%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Candidiasis | 1/218 (0.5%) | 3/225 (1.3%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Otitis media acute | 1/218 (0.5%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 2/209 (1%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Varicella | 1/218 (0.5%) | 2/225 (0.9%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Oral candidiasis | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Urinary tract infection | 2/218 (0.9%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Bronchopneumonia | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Campylobacter gastroenteritis | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Campylobacter intestinal infection | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Croup infectious | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Escherichia urinary tract infection | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Exanthema subitum | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Gastroenteritis rotavirus | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Gastrointestinal infection | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Herpangina | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 1/218 (0.5%) | 0/224 (0%) | ||||||||
| Paronychia | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Pharyngotonsillitis | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Pneumonia | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Respiratory tract infection viral | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Roseola | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Viral skin infection | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Viral upper respiratory tract infection | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Acarodermatitis | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Injection site abscess | 0/218 (0%) | 0/225 (0%) | 1/218 (0.5%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Oral herpes | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Fungal skin infection | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Lice infestation | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Viral rash | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Head injury | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Burns third degree | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Arthropod bite | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 2/209 (1%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Cow's milk intolerance | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 1/225 (0.4%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Anorexia | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Failure to thrive | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Benign neoplasm | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Somnolence | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Restlessness | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Cough | 4/218 (1.8%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Rhinorrhoea | 1/218 (0.5%) | 5/225 (2.2%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Wheezing | 3/218 (1.4%) | 3/225 (1.3%) | 1/218 (0.5%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Bronchial hyperreactivity | 1/218 (0.5%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Asphyxia | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Asthma | 1/218 (0.5%) | 0/225 (0%) | 1/218 (0.5%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 1/224 (0.4%) | ||||||||
| Bronchospasm | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Throat irritation | 1/218 (0.5%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Infantile asthma | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 1/218 (0.5%) | 0/224 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Dermatitis atopic | 3/218 (1.4%) | 3/225 (1.3%) | 1/218 (0.5%) | 2/225 (0.9%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Rash | 0/218 (0%) | 6/225 (2.7%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Dermatitis | 3/218 (1.4%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Urticaria | 1/218 (0.5%) | 2/225 (0.9%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 1/218 (0.5%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Angioedema | 0/218 (0%) | 1/225 (0.4%) | 0/218 (0%) | 0/225 (0%) | 0/209 (0%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Dermatitis diaper | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Petechiae | 0/218 (0%) | 0/225 (0%) | 0/218 (0%) | 0/225 (0%) | 1/209 (0.5%) | 0/218 (0%) | 0/218 (0%) | 0/224 (0%) | ||||||||
| Tenderness (any) | 199/218 (91.3%) | 205/225 (91.1%) | 0/0 (NaN) | 0/0 (NaN) | 164/209 (78.5%) | 172/218 (78.9%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Tenderness (any) | 182/218 (83.5%) | 180/225 (80%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Tenderness (any) | 170/218 (78%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Tenderness (significant) | 199/218 (91.3%) | 200/225 (88.9%) | 0/0 (NaN) | 0/0 (NaN) | 154/209 (73.7%) | 160/218 (73.4%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Tenderness (significant) | 177/218 (81.2%) | 177/225 (78.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Tenderness (significant) | 167/218 (76.6%) | 169/225 (75.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (any) | 196/218 (89.9%) | 200/225 (88.9%) | 0/0 (NaN) | 0/0 (NaN) | 169/209 (80.9%) | 168/218 (77.1%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (any) | 182/218 (83.5%) | 177/225 (78.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (any) | 171/218 (78.4%) | 170/225 (75.6%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (mild) | 196/218 (89.9%) | 200/225 (88.9%) | 0/0 (NaN) | 0/0 (NaN) | 166/209 (79.4%) | 163/218 (74.8%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (mild) | 182/218 (83.5%) | 177/225 (78.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (mild) | 171/218 (78.4%) | 170/225 (75.6%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (moderate) | 196/218 (89.9%) | 196/225 (87.1%) | 0/0 (NaN) | 0/0 (NaN) | 156/209 (74.6%) | 163/218 (74.8%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (moderate) | 177/218 (81.2%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (moderate) | 166/218 (76.1%) | 168/225 (74.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (severe) | 196/218 (89.9%) | 196/225 (87.1%) | 0/0 (NaN) | 0/0 (NaN) | 152/209 (72.7%) | 156/218 (71.6%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (severe) | 177/218 (81.2%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Induration (severe) | 166/218 (76.1%) | 168/225 (74.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (any) | 197/218 (90.4%) | 199/225 (88.4%) | 0/0 (NaN) | 0/0 (NaN) | 170/209 (81.3%) | 169/218 (77.5%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (any) | 181/218 (83%) | 180/225 (80%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (any) | 172/218 (78.9%) | 172/225 (76.4%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (mild) | 197/218 (90.4%) | 198/225 (88%) | 0/0 (NaN) | 0/0 (NaN) | 167/209 (79.9%) | 165/218 (75.7%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (mild) | 180/218 (82.6%) | 180/225 (80%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (mild) | 172/218 (78.9%) | 171/225 (76%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (moderate) | 196/218 (89.9%) | 197/225 (87.6%) | 0/0 (NaN) | 0/0 (NaN) | 157/209 (75.1%) | 163/218 (74.8%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (moderate) | 178/218 (81.7%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (moderate) | 166/218 (76.1%) | 169/225 (75.1%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (severe) | 196/218 (89.9%) | 196/225 (87.1%) | 0/0 (NaN) | 0/0 (NaN) | 152/209 (72.7%) | 156/218 (71.6%) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (severe) | 177/218 (81.2%) | 175/225 (77.8%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
| Erythema (severe) | 166/218 (76.1%) | 168/225 (74.7%) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||||||
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 | |
| clintrialresults@wyeth.com |
Responsible Party:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00474539
Other Study ID Numbers:
- 6096A1-3007
First Posted:
May 17, 2007
Last Update Posted:
Mar 5, 2013
Last Verified:
Jan 1, 2013