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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.
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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  
Number of Participants  
[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
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Additional Description No text entered.

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).

Serious 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, serious adverse events              
# participants affected / at risk     9/120 (7.50%)     9/126 (7.14%)     1/86 (1.16%)     0/103 (0.00%)     4/86 (4.65%)     1/103 (0.97%)  
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%)  
Lymphadenitis *            
# 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%)  
Congenital, familial and genetic disorders              
Chairi I malformation *            
# 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              
Gastroenteritis *            
# 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%)  
Rotaviral diarrhea *            
# 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%)  
Vomiting *            
# 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%)  
General disorders              
Irritability *            
# 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%)  
Infections and infestations              
Bilateral otitis media *            
# 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%)  
Bronchiolitis *            
# participants affected / at risk     3/120 (2.50%)     3/126 (2.38%)     0/86 (0.00%)     0/103 (0.00%)     1/86 (1.16%)     0/103 (0.00%)  
Bronchiolitis RSV *            
# 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%)  
Cystitis *            
# 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%)  
Febrile illness (fever) *            
# 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%)  
Fever of unknown origin *            
# 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%)  
Otitis media *            
# 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%)  
Pneumococcal meningitis *            
# 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%)  
Staphylococcal infection (hand) *            
# 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%)  
Urinary tract 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%)  
Viral URI *            
# 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%)  
Viral conjunctivitis *            
# 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%)  
Viral respiratory infection *            
# 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%)  
Metabolism and nutrition disorders              
Dehydration *            
# 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%)  
Hypoglycemia *            
# 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%)  
Nervous system disorders              
Complex febrile seizure *            
# 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%)  
Febrile seizure *            
# 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%)  
Seizure *            
# 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%)  
Sensory integration 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%)  
Tethered cord syndrome *            
# 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, thoracic and mediastinal disorders              
Asthma exacerbation *            
# participants affected / at risk     0/120 (0.00%)     0/126 (0.00%)     0/86 (0.00%)     0/103 (0.00%)     1/86 (1.16%)     1/103 (0.97%)  
Pneumonia right middle lobe *            
# 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%)  
RSV positive bronchiolitis *            
# participants affected / at risk     0/120 (0.00%)     1/126 (0.79%)     0/86 (0.00%)     0/103 (0.00%)     1/86 (1.16%)     0/103 (0.00%)  
Right upper and left lower lobe pneumonia *            
# 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%)  
Status asthmaticus *            
# participants affected / at risk     0/120 (0.00%)     0/126 (0.00%)     1/86 (1.16%)     0/103 (0.00%)     2/86 (2.33%)     0/103 (0.00%)  
* Events were collected by non-systematic assessment




  Other Adverse Events


  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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