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Study Evaluating Pneumococcal Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00205803
First received: September 19, 2005
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: March 26, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Conditions: Healthy Subjects
Pneumococcal Infections
Interventions: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in the United States from September 2004 to September 2005.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were enrolled into the study according to the inclusion/exclusion criteria without a screening period.

Reporting Groups
  Description
13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Participant Flow for 3 periods

Period 1:   Infant Series
    13vPnC   7vPnC
STARTED   122   127 
Vaccinated Dose 1   121   126 
Vaccinated Dose 2   115   122 
Vaccinated Dose 3   110   118 
COMPLETED   104   116 
NOT COMPLETED   18   11 
Lost to Follow-up                10                4 
Withdrawal by Subject                2                5 
Physician Decision                3                1 
Protocol Violation                1                0 
Lost Kaiser coverage                0                1 
Non-compliant                1                0 
Sponsor request                1                0 

Period 2:   After Infant Series
    13vPnC   7vPnC
STARTED   104   116 
COMPLETED   86   103 
NOT COMPLETED   18   13 
Adverse Event                1                1 
Protocol Violation                1                1 
Lost to Follow-up                2                1 
Physician Decision                3                2 
Withdrawal by Subject                1                4 
Unspecified                10                4 

Period 3:   Toddler Dose
    13vPnC   7vPnC
STARTED   86   103 
COMPLETED   84   100 
NOT COMPLETED   2   3 
Lost to Follow-up                2                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
13vPnC Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
7vPnC Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
Total Total of all reporting groups

Baseline Measures
   13vPnC   7vPnC   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   126   247 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 9.2  (1.4)   9.1  (1.2)   9.2  (1.3) 
Gender 
[Units: Patients]
     
Female   58   59   117 
Male   63   67   130 


  Outcome Measures
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1.  Primary:   Percentage of Participants Reporting Pre-Specified Local Reactions   [ Time Frame: Within 15 days after each dose ]

2.  Primary:   Percentage of Participants Reporting Pre-Specified Systemic Events   [ Time Frame: Within 15 days after each dose ]

3.  Primary:   Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: one month after 3-dose infant series (at 7 months of age) ]

4.  Secondary:   Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: One month after the toddler dose (at 13 to 16 months of age) ]

5.  Secondary:   Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: One month after 3-dose infant series (at 7 months of age) ]

6.  Secondary:   Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose   [ Time Frame: Immediately before (12 to 15 months of age) and one month after the toddler dose (13 to 16 months of age) ]

7.  Secondary:   Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, Polio, Pertussis, Tetanus, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: One month after the infant series (7 months of age) ]

8.  Secondary:   Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

9.  Secondary:   Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

10.  Secondary:   Geometric Mean Antibody Concentration Diphtheria Toxoid and Anti-Tetanus Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

11.  Secondary:   Geometric Mean Antibody Concentration of Polio in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

12.  Secondary:   Geometric Mean Antibody Concentration of Pertussis Antigens in 13vPnC Group Relative to 7vPnC Group After the Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

13.  Secondary:   Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series   [ Time Frame: one month after the infant series (7 months of age) ]

14.  Secondary:   Percentage of Participants Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: One month after the toddler dose (13 to 16 months of age) ]

15.  Secondary:   Geometric Mean Antibody Titer (OPA) in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose   [ Time Frame: One month after the Toddler Dose (13 to 16 months of age) ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
13vPnC Infant Series Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
7vPnC Infant Series Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
13vPnC Toddler Dose Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
7vPnC Toddler Dose Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
13vPnC 6-Month Follow-up Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
7vPnC 6-Month Follow-up Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).

Other Adverse Events
    13vPnC Infant Series   7vPnC Infant Series   13vPnC Toddler Dose   7vPnC Toddler Dose   13vPnC 6-Month Follow-up   7vPnC 6-Month Follow-up
Total, other (not including serious) adverse events             
# participants affected / at risk   104/120 (86.67%)   110/126 (87.30%)   33/86 (38.37%)   51/103 (49.51%)   20/86 (23.26%)   33/103 (32.04%) 
Blood and lymphatic system disorders             
Leukocytosis             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Anaemia             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   2/103 (1.94%)   0/86 (0.00%)   1/103 (0.97%) 
Congenital, familial and genetic disorders             
Plagiocephaly             
# participants affected / at risk   2/120 (1.67%)   3/126 (2.38%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Dacryostenosis congenital             
# participants affected / at risk   2/120 (1.67%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Ankyloglossia congenital             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Macrocephaly             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Thalassaemia alpha             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Ear and labyrinth disorders             
Ear pain             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Cerumen impaction             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Middle ear effusion             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Otorrhoea             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Eye disorders             
Conjunctivitis             
# participants affected / at risk   13/120 (10.83%)   16/126 (12.70%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   4/103 (3.88%) 
Dacryostenosis acquired             
# participants affected / at risk   3/120 (2.50%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Conjunctival haemorrhage             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Eyelid ptosis             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Strabismus             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Scleral hyperaemia             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Eye disorder             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Gastrointestinal disorders             
Diarrhoea             
# participants affected / at risk   7/120 (5.83%)   17/126 (13.49%)   2/86 (2.33%)   6/103 (5.83%)   0/86 (0.00%)   2/103 (1.94%) 
Vomiting             
# participants affected / at risk   8/120 (6.67%)   10/126 (7.94%)   1/86 (1.16%)   6/103 (5.83%)   0/86 (0.00%)   1/103 (0.97%) 
Gastrooesophageal reflux disease             
# participants affected / at risk   2/120 (1.67%)   8/126 (6.35%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Constipation             
# participants affected / at risk   2/120 (1.67%)   4/126 (3.17%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Umbilical hernia             
# participants affected / at risk   4/120 (3.33%)   2/126 (1.59%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Teething             
# participants affected / at risk   2/120 (1.67%)   2/126 (1.59%)   0/86 (0.00%)   2/103 (1.94%)   1/86 (1.16%)   0/103 (0.00%) 
Abdominal pain             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Abdominal pain upper             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Glossodynia             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Infantile spitting up             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Mouth cyst             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Oesophagitis             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Dental caries             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Enteritis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Stomatitis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
General disorders             
Pyrexia             
# participants affected / at risk   10/120 (8.33%)   12/126 (9.52%)   1/86 (1.16%)   2/103 (1.94%)   1/86 (1.16%)   3/103 (2.91%) 
Irritability             
# participants affected / at risk   3/120 (2.50%)   6/126 (4.76%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Granuloma             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Xerosis             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Fever ≥38°C but≤39°C † 2 [5]             
# participants affected / at risk   19/114 (16.67%)   20/121 (16.53%)   11/78 (14.10%)   12/94 (12.77%)   0/0   0/0 
Fever ≥38°C but≤39°C † 2 [6]             
# participants affected / at risk   22/102 (21.57%)   28/114 (24.56%)   0/0   0/0   0/0   0/0 
Fever ≥38°C but≤39°C † 2 [7]             
# participants affected / at risk   20/100 (20.00%)   23/113 (20.35%)   0/0   0/0   0/0   0/0 
Fever >39°C but≤40°C † 2 [8]             
# participants affected / at risk   3/113 (2.65%)   1/121 (0.83%)   2/77 (2.60%)   0/94 (0.00%)   0/0   0/0 
Fever >39°C but≤40°C † 2 [9]             
# participants affected / at risk   4/102 (3.92%)   4/113 (3.54%)   0/0   0/0   0/0   0/0 
Fever >39°C but≤40°C † 2 [10]             
# participants affected / at risk   2/101 (1.98%)   1/113 (0.88%)   0/0   0/0   0/0   0/0 
Fever >40°C † 2 [11]             
# participants affected / at risk   0/113 (0.00%)   0/121 (0.00%)   0/76 (0.00%)   0/94 (0.00%)   0/0   0/0 
Fever >40°C † 2 [12]             
# participants affected / at risk   0/102 (0.00%)   0/113 (0.00%)   0/0   0/0   0/0   0/0 
Fever >40°C † 2 [13]             
# participants affected / at risk   0/100 (0.00%)   0/113 (0.00%)   0/0   0/0   0/0   0/0 
Decreased appetite † 2 [14]             
# participants affected / at risk   36/118 (30.51%)   39/124 (31.45%)   19/85 (22.35%)   22/101 (21.78%)   0/0   0/0 
Decreased appetite † 2 [15]             
# participants affected / at risk   25/110 (22.73%)   27/118 (22.88%)   0/0   0/0   0/0   0/0 
Decreased appetite † 2 [16]             
# participants affected / at risk   29/107 (27.10%)   36/117 (30.77%)   0/0   0/0   0/0   0/0 
Decreased sleep † 2 [17]             
# participants affected / at risk   22/118 (18.64%)   22/124 (17.74%)   11/84 (13.10%)   15/101 (14.85%)   0/0   0/0 
Decreased sleep † 2 [18]             
# participants affected / at risk   27/110 (24.55%)   23/118 (19.49%)   0/0   0/0   0/0   0/0 
Decreased sleep † 2 [19]             
# participants affected / at risk   23/107 (21.50%)   22/117 (18.80%)   0/0   0/0   0/0   0/0 
Increased sleep † 2 [20]             
# participants affected / at risk   67/119 (56.30%)   67/124 (54.03%)   24/86 (27.91%)   44/101 (43.56%)   0/0   0/0 
Increased sleep † 2 [21]             
# participants affected / at risk   47/111 (42.34%)   55/118 (46.61%)   0/0   0/0   0/0   0/0 
Increased sleep † 2 [22]             
# participants affected / at risk   37/107 (34.58%)   48/117 (41.03%)   0/0   0/0   0/0   0/0 
Irritability † 2 [17]             
# participants affected / at risk   79/118 (66.95%)   88/124 (70.97%)   33/85 (38.82%)   48/101 (47.52%)   0/0   0/0 
Irritability † 2 [18]             
# participants affected / at risk   69/110 (62.73%)   67/118 (56.78%)   0/0   0/0   0/0   0/0 
Irritability † 2 [19]             
# participants affected / at risk   55/107 (51.40%)   63/117 (53.85%)   0/0   0/0   0/0   0/0 
Immune system disorders             
Allergy to chemicals             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Drug hypersensitivity             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Hypersensitivity             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Seasonal allergy             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Food allergy             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   1/86 (1.16%)   0/103 (0.00%) 
Cellulitis orbital             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Infections and infestations             
Upper respiratory tract infection             
# participants affected / at risk   57/120 (47.50%)   65/126 (51.59%)   8/86 (9.30%)   10/103 (9.71%)   5/86 (5.81%)   12/103 (11.65%) 
Otitis media             
# participants affected / at risk   40/120 (33.33%)   37/126 (29.37%)   1/86 (1.16%)   10/103 (9.71%)   9/86 (10.47%)   14/103 (13.59%) 
Bronchiolitis             
# participants affected / at risk   13/120 (10.83%)   13/126 (10.32%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   2/103 (1.94%) 
Otitis media acute             
# participants affected / at risk   7/120 (5.83%)   16/126 (12.70%)   1/86 (1.16%)   2/103 (1.94%)   2/86 (2.33%)   2/103 (1.94%) 
Viral infection             
# participants affected / at risk   9/120 (7.50%)   12/126 (9.52%)   1/86 (1.16%)   3/103 (2.91%)   1/86 (1.16%)   2/103 (1.94%) 
Candida nappy rash             
# participants affected / at risk   8/120 (6.67%)   7/126 (5.56%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Viral upper respiratory tract infection             
# participants affected / at risk   6/120 (5.00%)   8/126 (6.35%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Gastroenteritis             
# participants affected / at risk   7/120 (5.83%)   4/126 (3.17%)   0/86 (0.00%)   0/103 (0.00%)   2/86 (2.33%)   4/103 (3.88%) 
Oral candidiasis             
# participants affected / at risk   8/120 (6.67%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   2/86 (2.33%)   0/103 (0.00%) 
Croup infectious             
# participants affected / at risk   3/120 (2.50%)   6/126 (4.76%)   3/86 (3.49%)   1/103 (0.97%)   1/86 (1.16%)   4/103 (3.88%) 
Nasopharyngitis             
# participants affected / at risk   4/120 (3.33%)   5/126 (3.97%)   1/86 (1.16%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Pneumonia             
# participants affected / at risk   4/120 (3.33%)   5/126 (3.97%)   0/86 (0.00%)   0/103 (0.00%)   2/86 (2.33%)   2/103 (1.94%) 
Gastroenteritis viral             
# participants affected / at risk   4/120 (3.33%)   3/126 (2.38%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Viral pharyngitis             
# participants affected / at risk   3/120 (2.50%)   4/126 (3.17%)   1/86 (1.16%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Candidiasis             
# participants affected / at risk   1/120 (0.83%)   5/126 (3.97%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Sinusitis             
# participants affected / at risk   2/120 (1.67%)   4/126 (3.17%)   1/86 (1.16%)   0/103 (0.00%)   1/86 (1.16%)   2/103 (1.94%) 
Bronchitis             
# participants affected / at risk   2/120 (1.67%)   3/126 (2.38%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   2/103 (1.94%) 
Pharyngitis             
# participants affected / at risk   4/120 (3.33%)   1/126 (0.79%)   0/86 (0.00%)   1/103 (0.97%)   1/86 (1.16%)   2/103 (1.94%) 
Viral rash             
# participants affected / at risk   3/120 (2.50%)   2/126 (1.59%)   1/86 (1.16%)   2/103 (1.94%)   2/86 (2.33%)   0/103 (0.00%) 
Respiratory syncytial virus bronchiolitis             
# participants affected / at risk   2/120 (1.67%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Skin candida             
# participants affected / at risk   1/120 (0.83%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Acarodermatitis             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Body tinea             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Roseola             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Tinea infection             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Varicella             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   2/103 (1.94%)   0/86 (0.00%)   2/103 (1.94%) 
Acute tonsillitis             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Dacryocystitis             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Eczema infected             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Erythema infectiosum             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Exanthema subitum             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Fungal skin infection             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Herpangina             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   2/103 (1.94%)   0/86 (0.00%)   0/103 (0.00%) 
Infection             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Localised infection             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Nail infection             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Paronychia             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   1/86 (1.16%)   0/103 (0.00%) 
Pneumonia primary atypical             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash pustular             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Respiratory syncytial virus infection             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rhinitis             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   1/103 (0.97%)   4/86 (4.65%)   1/103 (0.97%) 
Staphylococcal infection             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Tinea versicolour             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Folliculitis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Influenza             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Pharyngitis streptococcal             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   1/86 (1.16%)   0/103 (0.00%) 
Tinea capitis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   2/103 (1.94%)   0/86 (0.00%)   0/103 (0.00%) 
Tonsillitis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Conjunctivitis infective             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Oral herpes             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   1/86 (1.16%)   0/103 (0.00%) 
Rotavirus infection             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Injury, poisoning and procedural complications             
Fall             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Arthropod bite             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   2/86 (2.33%)   2/103 (1.94%)   0/86 (0.00%)   0/103 (0.00%) 
Injury             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   1/103 (0.97%) 
Limb injury             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Skin laceration             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Traumatic brain injury             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Arthropod sting             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Burns second degree             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Exposure to toxic agent             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Back injury             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   1/86 (1.16%)   0/103 (0.00%) 
Contusion             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Investigations             
Cardiac murmur             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Cardiac murmur functional             
# participants affected / at risk   0/120 (0.00%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite             
# participants affected / at risk   4/120 (3.33%)   3/126 (2.38%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Dehydration             
# participants affected / at risk   1/120 (0.83%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   2/103 (1.94%) 
Food intolerance             
# participants affected / at risk   2/120 (1.67%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Anorexia             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Failure to thrive             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Hypervitaminosis a             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Lactose intolerance             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Weight gain poor             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Musculoskeletal and connective tissue disorders             
Torticollis             
# participants affected / at risk   0/120 (0.00%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Weight bearing difficulty             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Haemangioma             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Melanocytic naevus             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Nervous system disorders             
Hypersomnia             
# participants affected / at risk   1/120 (0.83%)   3/126 (2.38%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Hypertonia             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Hypotonia             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Somnolence             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Speech disorder developmental             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Febrile convulsion             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Psychiatric disorders             
Insomnia             
# participants affected / at risk   2/120 (1.67%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Renal and urinary disorders             
Vesicoureteric reflux             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Haematuria             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Penile adhesion             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Reproductive system and breast disorders             
Penile blister             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Vaginal discharge             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough             
# participants affected / at risk   9/120 (7.50%)   16/126 (12.70%)   1/86 (1.16%)   1/103 (0.97%)   1/86 (1.16%)   3/103 (2.91%) 
Nasal congestion             
# participants affected / at risk   8/120 (6.67%)   17/126 (13.49%)   1/86 (1.16%)   3/103 (2.91%)   0/86 (0.00%)   0/103 (0.00%) 
Rhinorrhoea             
# participants affected / at risk   11/120 (9.17%)   8/126 (6.35%)   3/86 (3.49%)   3/103 (2.91%)   0/86 (0.00%)   0/103 (0.00%) 
Wheezing             
# participants affected / at risk   5/120 (4.17%)   7/126 (5.56%)   1/86 (1.16%)   2/103 (1.94%)   0/86 (0.00%)   0/103 (0.00%) 
Asthma             
# participants affected / at risk   3/120 (2.50%)   2/126 (1.59%)   1/86 (1.16%)   0/103 (0.00%)   1/86 (1.16%)   2/103 (1.94%) 
Bronchial hyperreactivity             
# participants affected / at risk   3/120 (2.50%)   2/126 (1.59%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Rhinitis allergic             
# participants affected / at risk   2/120 (1.67%)   0/126 (0.00%)   0/86 (0.00%)   2/103 (1.94%)   0/86 (0.00%)   0/103 (0.00%) 
Tracheomalacia             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Choking             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Hypoxia             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Macleod's syndrome             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Sinus congestion             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Sneezing             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis diaper             
# participants affected / at risk   7/120 (5.83%)   10/126 (7.94%)   1/86 (1.16%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Eczema             
# participants affected / at risk   10/120 (8.33%)   6/126 (4.76%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash             
# participants affected / at risk   2/120 (1.67%)   7/126 (5.56%)   1/86 (1.16%)   3/103 (2.91%)   0/86 (0.00%)   0/103 (0.00%) 
Dry skin             
# participants affected / at risk   2/120 (1.67%)   4/126 (3.17%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Seborrhoeic dermatitis             
# participants affected / at risk   3/120 (2.50%)   2/126 (1.59%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash macular             
# participants affected / at risk   2/120 (1.67%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Dermatitis atopic             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash papular             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Urticaria             
# participants affected / at risk   1/120 (0.83%)   1/126 (0.79%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Dermatitis contact             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Erythema multiforme             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Heat rash             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Ingrowing nail             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Petechiae             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash erythematous             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Rash maculo-papular             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Skin irritation             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Acne infantile             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Dermatitis             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Dermatitis allergic             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   1/86 (1.16%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Keratosis pilaris             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   1/103 (0.97%)   0/86 (0.00%)   0/103 (0.00%) 
Blister             
# participants affected / at risk   0/120 (0.00%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   1/103 (0.97%) 
Tenderness (Any) † 1 [23]             
# participants affected / at risk   41/119 (34.45%)   54/124 (43.55%)   19/85 (22.35%)   30/101 (29.70%)   0/0   0/0 
Tenderness (Any) † 1 [24]             
# participants affected / at risk   31/110 (28.18%)   43/118 (36.44%)   0/0   0/0   0/0   0/0 
Tenderness (Any) † 1 [25]             
# participants affected / at risk   26/107 (24.30%)   30/117 (25.64%)   0/0   0/0   0/0   0/0 
Tenderness (Significant) † 1 [26]             
# participants affected / at risk   10/119 (8.40%)   7/124 (5.65%)   2/85 (2.35%)   4/101 (3.96%)   0/0   0/0 
Tenderness (Significant) † 1 [27]             
# participants affected / at risk   2/110 (1.82%)   10/118 (8.47%)   0/0   0/0   0/0   0/0 
Tenderness (Significant) † 1 [28]             
# participants affected / at risk   5/107 (4.67%)   7/117 (5.98%)   0/0   0/0   0/0   0/0 
Induration (Any) † 1 [29]             
# participants affected / at risk   26/119 (21.85%)   24/124 (19.35%)   16/85 (18.82%)   17/100 (17.00%)   0/0   0/0 
Induration (Any) † 1 [30]             
# participants affected / at risk   18/110 (16.36%)   23/118 (19.49%)   0/0   0/0   0/0   0/0 
Induration (Any) † 1 [31]             
# participants affected / at risk   18/107 (16.82%)   22/117 (18.80%)   0/0   0/0   0/0   0/0 
Induration (Mild) † 1 [32]             
# participants affected / at risk   24/119 (20.17%)   22/123 (17.89%)   16/85 (18.82%)   17/100 (17.00%)   0/0   0/0 
Induration (Mild) † 1 [33]             
# participants affected / at risk   18/110 (16.36%)   20/117 (17.09%)   0/0   0/0   0/0   0/0 
Induration (Mild) † 1 [34]             
# participants affected / at risk   18/107 (16.82%)   20/116 (17.24%)   0/0   0/0   0/0   0/0 
Induration (Moderate) † 1 [35]             
# participants affected / at risk   4/119 (3.36%)   3/123 (2.44%)   2/85 (2.35%)   3/100 (3.00%)   0/0   0/0 
Induration (Moderate) † 1 [36]             
# participants affected / at risk   4/110 (3.64%)   4/117 (3.42%)   0/0   0/0   0/0   0/0 
Induration (Moderate) † 1 [37]             
# participants affected / at risk   0/107 (0.00%)   5/116 (4.31%)   0/0   0/0   0/0   0/0 
Induration (Severe) † 1 [38]             
# participants affected / at risk   0/119 (0.00%)   0/123 (0.00%)   0/85 (0.00%)   0/100 (0.00%)   0/0   0/0 
Induration (Severe) † 1 [39]             
# participants affected / at risk   0/110 (0.00%)   0/117 (0.00%)   0/0   0/0   0/0   0/0 
Induration (Severe) † 1 [40]             
# participants affected / at risk   0/107 (0.00%)   0/116 (0.00%)   0/0   0/0   0/0   0/0 
Erythema (Any) † 1 [41]             
# participants affected / at risk   25/119 (21.01%)   24/124 (19.35%)   21/85 (24.71%)   19/100 (19.00%)   0/0   0/0 
Erythema (Any) † 1 [42]             
# participants affected / at risk   18/111 (16.22%)   21/118 (17.80%)   0/0   0/0   0/0   0/0 
Erythema (Any) † 1 [43]             
# participants affected / at risk   19/107 (17.76%)   23/117 (19.66%)   0/0   0/0   0/0   0/0 
Erythema (Mild) † 1 [44]             
# participants affected / at risk   24/119 (20.17%)   24/124 (19.35%)   21/85 (24.71%)   16/99 (16.16%)   0/0   0/0 
Erythema (Mild) † 1 [45]             
# participants affected / at risk   15/110 (13.64%)   20/117 (17.09%)   0/0   0/0   0/0   0/0 
Erythema (Mild) † 1 [46]             
# participants affected / at risk   17/106 (16.04%)   21/116 (18.10%)   0/0   0/0   0/0   0/0 
Erythema (Moderate) † 1 [47]             
# participants affected / at risk   3/119 (2.52%)   0/124 (0.00%)   3/85 (3.53%)   5/99 (5.05%)   0/0   0/0 
Erythema (Moderate) † 1 [48]             
# participants affected / at risk   3/108 (2.78%)   0/117 (0.00%)   0/0   0/0   0/0   0/0 
Erythema (Moderate) † 1 [49]             
# participants affected / at risk   1/106 (0.94%)   3/116 (2.59%)   0/0   0/0   0/0   0/0 
Erythema (Severe) † 1 [50]             
# participants affected / at risk   0/119 (0.00%)   0/124 (0.00%)   0/85 (0.00%)   0/99 (0.00%)   0/0   0/0 
Erythema (Severe) † 1 [51]             
# participants affected / at risk   0/108 (0.00%)   0/117 (0.00%)   0/0   0/0   0/0   0/0 
Erythema (Severe) † 1 [52]             
# participants affected / at risk   0/106 (0.00%)   0/116 (0.00%)   0/0   0/0   0/0   0/0 
Social circumstances             
Corrective lens user             
# participants affected / at risk   0/120 (0.00%)   1/126 (0.79%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Exposure to communicable disease             
# participants affected / at risk   1/120 (0.83%)   0/126 (0.00%)   0/86 (0.00%)   0/103 (0.00%)   0/86 (0.00%)   0/103 (0.00%) 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, Local reactions
2 Term from vocabulary, Systemic Events
[5] Infant Series Dose 1 and Toddler Dose; Fever ≥38 degrees C but ≤39 degrees C
[6] Infant Series Dose 2; Fever ≥38 degrees C but ≤39 degrees C
[7] Infant Series Dose 3; Fever ≥38 degrees C but ≤39 degrees C
[8] Infant Series Dose 1 and Toddler Dose; Fever >39 degrees C but ≤40 degrees C
[9] Infant Series Dose 2; Fever >39 degrees C but ≤40 degrees C
[10] Infant Series Dose 3; Fever >39 degrees C but ≤40 degrees C
[11] Infant Series Dose 1 and Toddler Dose; Fever >40 degrees C
[12] Infant Series Dose 2; Fever >40 degrees C
[13] Infant Series Dose 3; Fever >40 degrees C
[14] Infant Series Dose 1 and Toddler Dose; Decreased appetite
[15] Infant Series Dose 2; Decreased appetite
[16] Infant Series Dose 3; Decreased appetite
[17] Infant Series Dose 1 and Toddler Dose; Irritability
[18] Infant Series Dose 2; Irritability
[19] Infant Series Dose 3; Irritability
[20] Infant Series Dose 1 and Toddler Dose; Increased sleep
[21] Infant Series Dose 2; Increased sleep
[22] Infant Series Dose 3; Increased sleep
[23] Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination.
[24] Infant Series Dose 2; Tenderness (any)
[25] Infant Series Dose 3; Tenderness (any)
[26] Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement.
[27] Infant Series Dose 2; Tenderness (significant)
[28] Infant Series Dose 3; Tenderness (significant)
[29] Infant Series Dose 1 and Toddler Dose; Induration (any)=present at site of vaccination.
[30] Infant Series Dose 2; Induration (any)
[31] Infant Series Dose 3; Induration (any)
[32] Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm.
[33] Infant Series Dose 2; Induration (mild)
[34] Infant Series Dose 3; Induration (mild)
[35] Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm.
[36] Infant Series Dose 2; Induration (moderate)
[37] Infant Series Dose 3; Induration (moderate)
[38] Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm.
[39] Infant Series Dose 2; Induration (severe)
[40] Infant Series Dose 3; Induration (severe)
[41] Infant Series Dose 1 and Toddler Dose; Erythema (any)=present at site of vaccination.
[42] Infant Series Dose 2; Erythema (any)
[43] Infant Series Dose 3; Erythema (any)
[44] Infant Series Dose 1 and Toddler Dose; Erythema (mild)=0.5 cm to 2.0 cm.
[45] Infant Series Dose 2; Erythema (mild)
[46] Infant Series Dose 3; Erythema (mild)
[47] Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm.
[48] Infant Series Dose 2; Erythema (moderate)
[49] Infant Series Dose 3; Erythema (moderate)
[50] Infant Series Dose 1 and Toddler Dose; Erythema (severe) >7.0 cm.
[51] Infant Series Dose 2; Erythema (severe)
[52] Infant Series Dose 3; Erythema (severe)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00205803     History of Changes
Other Study ID Numbers: 6096A1-003
Study First Received: September 19, 2005
Results First Received: March 26, 2010
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration