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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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ClinicalTrials.gov Identifier: NCT00452452
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pneumococcal Infections
Intervention Biological: 13-valent Pneumococcal Conjugate Vaccine
Enrollment 355
Recruitment Details Participants were recruited in Poland from July 2007 to September 2007.
Pre-assignment Details Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Arm/Group Title 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Hide Arm/Group Description Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
Period Title: Overall Study
Started 90 112 153
Vaccinated Dose 1 90 112 152
Vaccinated Dose 2 90 112 0
Vaccinated Dose 3 89 0 0
Completed 88 112 152
Not Completed 2 0 1
Reason Not Completed
Protocol Violation             0             0             1
Withdrawal by Subject             1             0             0
Lost to Follow-up             1             0             0
Arm/Group Title 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age Total
Hide Arm/Group Description Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. Total of all reporting groups
Overall Number of Baseline Participants 90 112 153 355
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 90 participants 112 participants 153 participants 355 participants
8.7  (1.6) 17.6  (3.5) 42.0  (13.1) 25.9  (17.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 112 participants 153 participants 355 participants
Female
47
  52.2%
58
  51.8%
74
  48.4%
179
  50.4%
Male
43
  47.8%
54
  48.2%
79
  51.6%
176
  49.6%
1.Primary Outcome
Title Percentage of Participants Achieving Antibody Level ≥0.35μg/mL After Vaccination
Hide 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 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
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Hide 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 immunoglobulin G (IgG) antibody concentration to the given serotype.
Arm/Group Title 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Hide Arm/Group Description:
Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
Overall Number of Participants Analyzed 84 110 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4 (n= 84,110,151)
100.0
(95.7 to 100.0)
100.0
(96.7 to 100.0)
99.3
(96.4 to 100.0)
Common Serotypes - Serotype 6B (n=83,110,150)
98.8
(93.5 to 100.0)
100.0
(96.7 to 100.0)
99.3
(96.3 to 100.0)
Common Serotypes - Serotype 9V (n= 83,104,148)
98.8
(93.5 to 100.0)
99.0
(94.8 to 100.0)
98.6
(95.2 to 99.8)
Common Serotypes - Serotype 14 (n= 84,108,135)
100.0
(95.7 to 100.0)
100.0
(96.6 to 100.0)
88.1
(81.5 to 93.1)
Common Serotypes - Serotype 18C (n= 83,109,151)
100.0
(95.7 to 100.0)
100.0
(96.7 to 100.0)
98.7
(95.3 to 99.8)
Common Serotypes - Serotype 19F (n=84,110,147)
97.6
(91.7 to 99.7)
100.0
(96.7 to 100.0)
98.0
(94.2 to 99.6)
Common Serotypes - Serotype 23F (n= 84,110,151)
98.8
(93.5 to 100.0)
92.7
(86.2 to 96.8)
93.4
(88.2 to 96.8)
Additional Serotypes - Serotype 1 (n= 83,108,149)
100.0
(95.7 to 100.0)
100.0
(96.6 to 100.0)
96.6
(92.3 to 98.9)
Additional Serotypes - Serotype 3 (n= 83,108,149)
98.8
(93.5 to 100.0)
100.0
(96.6 to 100.0)
97.3
(93.3 to 99.3)
Additional Serotypes - Serotype 5 (n= 84,107,152)
97.6
(91.7 to 99.7)
99.1
(94.9 to 100.0)
98.7
(95.3 to 99.8)
Additional Serotypes - Serotype 6A (n= 84,110,150)
100.0
(95.7 to 100.0)
98.2
(93.6 to 99.8)
100.0
(97.6 to 100.0)
Additional Serotypes - Serotype 7F (n= 84,108,142)
100.0
(95.7 to 100.0)
100.0
(96.6 to 100.0)
99.3
(96.1 to 100.0)
Additional Serotypes - Serotype 19A (n=84,110,150
100.0
(95.7 to 100.0)
100.0
(96.7 to 100.0)
100.0
(97.6 to 100.0)
2.Primary Outcome
Title Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups
Hide 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.
Time Frame 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age).
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Hide 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 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Hide Arm/Group Description:
Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
Overall Number of Participants Analyzed 84 110 152
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Common Serotypes - Serotype 4
3.63
(3.11 to 4.23)
4.28
(3.78 to 4.86)
3.37
(2.95 to 3.85)
Common Serotypes - Serotype 6B
4.77
(3.90 to 5.84)
3.38
(2.81 to 4.06)
3.41
(2.80 to 4.16)
Common Serotypes - Serotype 9V
2.56
(2.21 to 2.96)
3.08
(2.69 to 3.53)
2.67
(2.32 to 3.07)
Common Serotypes - Serotype 14
8.04
(6.95 to 9.30)
6.45
(5.48 to 7.59)
2.24
(1.71 to 2.93)
Common Serotypes - Serotype 18C
2.77
(2.39 to 3.23)
3.71
(3.29 to 4.19)
2.56
(2.17 to 3.03)
Common Serotypes - Serotype 19F
2.88
(2.35 to 3.54)
3.07
(2.68 to 3.51)
2.53
(2.14 to 2.99)
Common Serotypes - Serotype 23F
2.16
(1.82 to 2.55)
1.98
(1.64 to 2.39)
1.55
(1.31 to 1.85)
Additional Serotypes - Serotype 1
2.88
(2.44 to 3.39)
2.74
(2.37 to 3.16)
1.78
(1.52 to 2.08)
Additional Serotypes - Serotype 3
1.94
(1.68 to 2.24)
1.86
(1.60 to 2.15)
1.42
(1.23 to 1.64)
Additional Serotypes - Serotype 5
2.85
(2.34 to 3.46)
2.16
(1.89 to 2.47)
2.33
(2.05 to 2.64)
Additional Serotypes - Serotype 6A
3.72
(3.12 to 4.45)
2.62
(2.25 to 3.06)
2.96
(2.52 to 3.47)
Additional Serotypes - Serotype 7F
5.30
(4.54 to 6.18)
5.99
(5.40 to 6.65)
4.92
(4.26 to 5.68)
Additional Serotypes - Serotype 19A
4.77
(4.28 to 5.33)
4.94
(4.31 to 5.65)
6.03
(5.22 to 6.97)
3.Secondary Outcome
Title Percentage of Participants Reporting Pre-Specified Local Reactions
Hide 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
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Hide Analysis Population Description
The safety population included all participants who received at least 1 dose of vaccine.
Arm/Group Title 13vPnC Group 1 - Dose 1 13vPnC Group 2 - Dose 1 13vPnC Group 3 - Dose 1 13vPnC Group 1 - Dose 2 13vPnC Group 2 - Dose 2 13vPnC Group 1 - Dose 3
Hide Arm/Group Description:
Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
Overall Number of Participants Analyzed 90 112 152 90 112 89
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness - Any 15.1 33.3 42.3 15.1 43.7 15.2
Tenderness - Significant 1.2 0.0 4.1 3.5 4.1 6.4
Swelling - Any 36.0 44.5 36.9 32.2 41.0 25.0
Swelling - Mild 32.6 36.7 28.2 28.7 36.2 20.5
Swelling - Moderate 11.6 24.8 20.3 14.0 12.1 11.3
Swelling - Severe 0.0 0.0 0.0 0.0 0.0 0.0
Redness - Any 48.8 70.0 50.0 46.0 54.7 37.8
Redness - Mild 41.9 55.5 37.4 40.2 44.7 31.3
Redness - Moderate 16.3 38.2 25.7 9.3 25.5 12.5
Redness - Severe 0.0 0.0 0.0 0.0 0.0 0.0
4.Secondary Outcome
Title Percentage of Participants Reporting Pre-Specified Systemic Events
Hide 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all subjects who received at least 1 dose of vaccine.
Arm/Group Title 13vPnC Group 1 - Dose 1 13vPnC Group 2 - Dose 1 13vPnC Group 3 - Dose 1 13vPnC Group 1 - Dose 2 13vPnC Group 2 - Dose 2 13vPnC Group 1 - Dose 3
Hide Arm/Group Description:
Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
Overall Number of Participants Analyzed 90 112 152 90 112 89
Measure Type: Number
Unit of Measure: percentage of participants
Fever ≥38°C but ≤39°C 3.4 3.7 0.7 8.1 5.1 5.1
Fever >39°C but ≤40°C 1.2 0.9 0.7 2.3 0.0 1.3
Fever >40°C 0.0 0.0 0.0 0.0 0.0 0.0
Decreased appetite 19.5 22.2 16.3 17.2 25.5 17.5
Irritability 24.1 30.6 14.3 34.5 34.0 24.7
Increased sleep 9.2 13.0 11.6 9.3 10.1 2.6
Decreased sleep 24.1 19.4 6.8 18.4 20.4 15.0
Use of antipyretic medication to treat symptoms 9.2 10.1 2.7 9.3 13.3 7.6
Use of antipyretic medication to prevent symptoms 8.0 13.8 4.8 4.7 14.3 5.1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Hide Arm/Group Description Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
All-Cause Mortality
13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/90 (5.56%)   2/112 (1.79%)   2/152 (1.32%) 
Gastrointestinal disorders       
Dyspepsia * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Stomatitis * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Vomiting * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
General disorders       
Diarrhoea * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Infections and infestations       
Exanthema subitum * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Gastrointestinal infection * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Otitis media * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Pharyngitis * 1  0/90 (0.00%)  1/112 (0.89%)  1/152 (0.66%) 
Pneumonia * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Injury, poisoning and procedural complications       
Thermal burn * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Nervous system disorders       
Febrile convulsion * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
13vPnC 7 to <12 Months of Age 13vPnC 12 to <24 Months of Age 13vPnC 24 to < 72 Months of Age
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   55/90 (61.11%)   77/112 (68.75%)   74/152 (48.68%) 
Eye disorders       
Chalazion * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Conjunctivitis * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  6/90 (6.67%)  8/112 (7.14%)  1/152 (0.66%) 
Dyspepsia * 1  2/90 (2.22%)  2/112 (1.79%)  1/152 (0.66%) 
Teething * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Vomiting * 1  1/90 (1.11%)  1/112 (0.89%)  1/152 (0.66%) 
Constipation * 1  0/90 (0.00%)  2/112 (1.79%)  0/152 (0.00%) 
Stomatitis * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
General disorders       
Pyrexia * 1  4/90 (4.44%)  2/112 (1.79%)  1/152 (0.66%) 
Injection site nodule * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Injection site erythema * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Injection site pain * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Fever ≥38°C but ≤39°C  3 [1]  3/87 (3.45%)  4/108 (3.70%)  1/147 (0.68%) 
Fever ≥38°C but ≤39°C  3 [2]  7/86 (8.14%)  5/98 (5.10%)  0/0 
Fever ≥38°C but ≤39°C  3 [3]  4/78 (5.13%)  0/0  0/0 
Fever >39°C but ≤40°C  3 [4]  1/86 (1.16%)  1/108 (0.93%)  1/147 (0.68%) 
Fever >39°C but ≤40°C  3 [5]  2/86 (2.33%)  0/98 (0.00%)  0/0 
Fever >39°C but ≤40°C  3 [6]  1/79 (1.27%)  0/0  0/0 
Fever >40°C  3 [7]  0/86 (0.00%)  0/108 (0.00%)  0/147 (0.00%) 
Fever >40°C  3 [8]  0/86 (0.00%)  0/98 (0.00%)  0/0 
Fever >40°C  3 [9]  0/78 (0.00%)  0/0  0/0 
Decreased appetite  3 [10]  17/87 (19.54%)  24/108 (22.22%)  24/147 (16.33%) 
Decreased appetite  3 [11]  15/87 (17.24%)  25/98 (25.51%)  0/0 
Decreased appetite  3 [12]  14/80 (17.50%)  0/0  0/0 
Irritability  3 [13]  21/87 (24.14%)  33/108 (30.56%)  21/147 (14.29%) 
Irritability  3 [14]  30/87 (34.48%)  34/100 (34.00%)  0/0 
Irritability  3 [15]  20/81 (24.69%)  0/0  0/0 
Increased sleep  3 [16]  8/87 (9.20%)  14/108 (12.96%)  17/147 (11.56%) 
Increased sleep  3 [17]  8/86 (9.30%)  10/99 (10.10%)  0/0 
Increased sleep  3 [18]  2/78 (2.56%)  0/0  0/0 
Decreased sleep  3 [19]  21/87 (24.14%)  21/108 (19.44%)  10/148 (6.76%) 
Decreased sleep  3 [20]  16/87 (18.39%)  20/98 (20.41%)  0/0 
Decreased sleep  3 [21]  12/80 (15.00%)  0/0  0/0 
Immune system disorders       
Allergy to animal * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Allergy to arthropod sting * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Infections and infestations       
Pharyngitis * 1  12/90 (13.33%)  13/112 (11.61%)  5/152 (3.29%) 
Nasopharyngitis * 1  11/90 (12.22%)  12/112 (10.71%)  5/152 (3.29%) 
Upper respiratory tract infection * 1  8/90 (8.89%)  16/112 (14.29%)  4/152 (2.63%) 
Bronchitis * 1  6/90 (6.67%)  9/112 (8.04%)  1/152 (0.66%) 
Respiratory tract infection * 1  6/90 (6.67%)  0/112 (0.00%)  1/152 (0.66%) 
Rhinitis * 1  6/90 (6.67%)  9/112 (8.04%)  4/152 (2.63%) 
Exanthema subitum * 1  4/90 (4.44%)  2/112 (1.79%)  0/152 (0.00%) 
Viral infection * 1  4/90 (4.44%)  2/112 (1.79%)  0/152 (0.00%) 
Otitis media * 1  1/90 (1.11%)  1/112 (0.89%)  0/152 (0.00%) 
Acute tonsillitis * 1  1/90 (1.11%)  0/112 (0.00%)  1/152 (0.66%) 
Ear infection * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Gastroenteritis * 1  1/90 (1.11%)  4/112 (3.57%)  2/152 (1.32%) 
Pneumonia * 1  1/90 (1.11%)  1/112 (0.89%)  0/152 (0.00%) 
Tonsillitis * 1  1/90 (1.11%)  0/112 (0.00%)  1/152 (0.66%) 
Laryngitis * 1  0/90 (0.00%)  4/112 (3.57%)  1/152 (0.66%) 
Varicella * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Injury, poisoning and procedural complications       
Head injury * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Upper limb fracture * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Investigations       
Urological examination abnormal * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Nervous system disorders       
Syncope * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Respiratory, thoracic and mediastinal disorders       
Rhinitis allergic * 1  1/90 (1.11%)  0/112 (0.00%)  0/152 (0.00%) 
Asthma * 1  1/90 (1.11%)  2/112 (1.79%)  1/152 (0.66%) 
Cough * 1  0/90 (0.00%)  1/112 (0.89%)  0/152 (0.00%) 
Dysphonia * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Skin and subcutaneous tissue disorders       
Dermatitis allergic * 1  2/90 (2.22%)  1/112 (0.89%)  0/152 (0.00%) 
Dermatitis diaper * 1  2/90 (2.22%)  1/112 (0.89%)  0/152 (0.00%) 
Rash * 1  1/90 (1.11%)  1/112 (0.89%)  1/152 (0.66%) 
Heat rash * 1  0/90 (0.00%)  0/112 (0.00%)  2/152 (1.32%) 
Dermatitis * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Swelling face * 1  0/90 (0.00%)  0/112 (0.00%)  1/152 (0.66%) 
Tenderness (any)  2 [22]  13/86 (15.12%)  36/108 (33.33%)  63/149 (42.28%) 
Tenderness (any)  2 [23]  13/86 (15.12%)  45/103 (43.69%)  0/0 
Tenderness (any)  2 [24]  12/79 (15.19%)  0/0  0/0 
Tenderness (significant)  2 [25]  1/86 (1.16%)  0/108 (0.00%)  6/147 (4.08%) 
Tenderness (significant)  2 [26]  3/86 (3.49%)  4/98 (4.08%)  0/0 
Tenderness (significant)  2 [27]  5/78 (6.41%)  0/0  0/0 
Induration (Any)  2 [28]  31/86 (36.05%)  49/110 (44.55%)  55/149 (36.91%) 
Induration (Any)  2 [29]  28/87 (32.18%)  43/105 (40.95%)  0/0 
Induration (Any)  2 [30]  20/80 (25.00%)  0/0  0/0 
Induration (mild)  2 [31]  28/86 (32.56%)  40/109 (36.70%)  42/149 (28.19%) 
Induration (mild)  2 [32]  25/87 (28.74%)  38/105 (36.19%)  0/0 
Induration (mild)  2 [33]  16/78 (20.51%)  0/0  0/0 
Induration (moderate)  2 [34]  10/86 (11.63%)  27/109 (24.77%)  30/148 (20.27%) 
Induration (moderate)  2 [35]  12/86 (13.95%)  12/99 (12.12%)  0/0 
Induration (moderate)  2 [36]  9/80 (11.25%)  0/0  0/0 
Induration (severe)  2 [37]  0/86 (0.00%)  0/108 (0.00%)  0/147 (0.00%) 
Induration (severe)  2 [38]  0/86 (0.00%)  0/98 (0.00%)  0/0 
Induration (severe)  2 [39]  0/78 (0.00%)  0/0  0/0 
Erythema (any)  2 [40]  42/86 (48.84%)  77/110 (70.00%)  74/148 (50.00%) 
Erythema (any)  2 [41]  40/87 (45.98%)  58/106 (54.72%)  0/0 
Erythema (any)  2 [42]  31/82 (37.80%)  0/0  0/0 
Erythema (Mild)  2 [43]  36/86 (41.86%)  61/110 (55.45%)  55/147 (37.41%) 
Erythema (Mild)  2 [44]  35/87 (40.23%)  46/103 (44.66%)  0/0 
Erythema (Mild)  2 [45]  25/80 (31.25%)  0/0  0/0 
Erythema (Moderate)  2 [46]  14/86 (16.28%)  42/110 (38.18%)  38/148 (25.68%) 
Erythema (Moderate)  2 [47]  8/86 (9.30%)  26/102 (25.49%)  0/0 
Erythema (Moderate)  2 [48]  10/80 (12.50%)  0/0  0/0 
Erythema (Severe)  2 [49]  0/86 (0.00%)  0/108 (0.00%)  0/147 (0.00%) 
Erythema (Severe)  2 [50]  0/86 (0.00%)  0/98 (0.00%)  0/0 
Erythema (Severe)  2 [51]  0/78 (0.00%)  0/0  0/0 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, Local Reactions
3
Term from vocabulary, Systemic Events
[1]
Infant Series Dose 1; Fever ≥38°C but ≤39°C
[2]
Infant Series Dose 2; Fever ≥38°C but ≤39°C
[3]
Infant Series Dose 3; Fever ≥38°C but ≤39°C
[4]
Infant Series Dose 1; Fever >39°C but ≤40°C
[5]
Infant Series Dose 2; Fever >39°C but ≤40°C
[6]
Infant Series Dose 3; Fever >39°C but ≤40°C
[7]
Infant Series Dose 1; Fever >40°C
[8]
Infant Series Dose 2; Fever >40°C
[9]
Infant Series Dose 3; Fever >40°C
[10]
Infant Series Dose 1; Decreased appetite
[11]
Infant Series Dose 2; Decreased appetite
[12]
Infant Series Dose 3; Decreased appetite
[13]
Infant Series Dose 1; Irritability
[14]
Infant Series Dose 2; Irritability
[15]
Infant Series Dose 3; Irritability
[16]
Infant Series Dose 1; Increased sleep
[17]
Infant Series Dose 2; Increased sleep
[18]
Infant Series Dose 3; Increased sleep
[19]
Infant Series Dose 1; Decreased sleep
[20]
Infant Series Dose 2; Decreased sleep
[21]
Infant Series Dose 3; Decreased sleep
[22]
Infant Series Dose 1; Tenderness (any)=present at site of vaccination.
[23]
Infant Series Dose 2; Tenderness (any)
[24]
Infant Series Dose 3; Tenderness (any)
[25]
Infant Series Dose 1; Tenderness (significant)=present and interfered with limb movement.
[26]
Infant Series Dose 2; Tenderness (significant)
[27]
Infant Series Dose 3; Tenderness (significant)
[28]
Infant Series Dose 1; Induration (any)=present at site of vaccination.
[29]
Infant Series Dose 2; Induration (Any)
[30]
Infant Series Dose 3; Induration (Any)
[31]
Infant Series Dose 1; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
[32]
Infant Series Dose 2; Induration (mild)
[33]
Infant Series Dose 3; Induration (mild)
[34]
Infant Series Dose 1; Induration (moderate)=2.5 cm to 7.0 cm.
[35]
Infant Series Dose 2; Induration (moderate)
[36]
Infant Series Dose 3; Induration (moderate)
[37]
Infant Series Dose 1; Induration (severe) >7.0 cm.
[38]
Infant Series Dose 2; Induration (severe)
[39]
Infant Series Dose 3; Induration (severe)
[40]
Infant Series Dose 1; Erythema (any)=present at site of vaccination.
[41]
Infant Series Dose 2; Erythema (any)
[42]
Infant Series Dose 3; Erythema (any)
[43]
Infant Series Dose 1; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm.
[44]
Infant Series Dose 2; Erythema (Mild)
[45]
Infant Series Dose 3; Erythema (Mild)
[46]
Infant Series Dose 1; Erythema(moderate)=2.5 cm to 7.0 cm.
[47]
Infant Series Dose 2; Erythema (Moderate)
[48]
Infant Series Dose 3; Erythema (Moderate)
[49]
Infant Series Dose 1; Erythema (severe) >7.0 cm.
[50]
Infant Series Dose 2; Erythema (Severe)
[51]
Infant Series Dose 3; Erythema (Severe)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00452452    
Other Study ID Numbers: 6096A1-3002
First Submitted: March 23, 2007
First Posted: March 27, 2007
Results First Submitted: March 26, 2010
Results First Posted: August 15, 2012
Last Update Posted: August 15, 2012