Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01392378
First received: July 8, 2011
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: January 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Pneumococcal Vaccines
Interventions: Biological: 13-valent pneumococcal conjugate vaccine
Biological: INFANRIX hexa
Drug: Paracetamol
Drug: Ibuprofen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
13vPnC + INFANRIX Hexa Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.

Participant Flow for 3 periods

Period 1:   Infant Series
    13vPnC + INFANRIX Hexa + Paracetamol Twice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily     13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily     13vPnC + INFANRIX Hexa  
STARTED     173     176     172     177     210  
Vaccinated Dose 1     173     176     172     177     210  
Vaccinated Dose 2     171     174     172     177     210  
Vaccinated Dose 3     170     174     172     176     210  
COMPLETED     169     174     172     175     210  
NOT COMPLETED     4     2     0     2     0  
Adverse Event                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 1                 0  
Protocol Violation                 0                 1                 0                 0                 0  
Withdrawal by Parent                 4                 1                 0                 0                 0  

Period 2:   After Infant Series
    13vPnC + INFANRIX Hexa + Paracetamol Twice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily     13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily     13vPnC + INFANRIX Hexa  
STARTED     169     174     172     175     210  
COMPLETED     169     173     170     175     209  
NOT COMPLETED     0     1     2     0     1  
Lost to Follow-up                 0                 0                 1                 0                 0  
Withdrawal by Parent                 0                 1                 1                 0                 1  

Period 3:   Toddler Dose
    13vPnC + INFANRIX Hexa + Paracetamol Twice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily     13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily     13vPnC + INFANRIX Hexa  
STARTED     169     173     170     175     209  
COMPLETED     169     172     170     173     208  
NOT COMPLETED     0     1     0     2     1  
Lost to Follow-up                 0                 0                 0                 1                 0  
Withdrawal by Parent                 0                 1                 0                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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 + INFANRIX Hexa + Paracetamol Twice Daily Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
13vPnC + INFANRIX Hexa Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
Total Total of all reporting groups

Baseline Measures
    13vPnC + INFANRIX Hexa + Paracetamol Twice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily     13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily     13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily     13vPnC + INFANRIX Hexa     Total  
Number of Participants  
[units: participants]
  173     176     172     177     210     908  
Age  
[units: days]
Mean ± Standard Deviation
  65.1  ± 9.5     66.5  ± 10.1     65.6  ± 9.7     66.4  ± 10.3     65.6  ± 9.4     65.8  ± 9.8  
Gender  
[units: participants]
           
Female     87     89     75     79     98     428  
Male     86     87     97     98     112     480  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

2.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

3.  Secondary:   Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

4.  Secondary:   Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

5.  Secondary:   Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

6.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

7.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

8.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

9.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

10.  Secondary:   Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

11.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

12.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

13.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

14.  Secondary:   Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

15.  Secondary:   Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

16.  Secondary:   Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series   [ Time Frame: 1 month after the infant series ]

17.  Secondary:   Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose   [ Time Frame: 1 month after the toddler dose ]

18.  Secondary:   Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1   [ Time Frame: Within 4 days after infant series Dose 1 ]

19.  Secondary:   Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2   [ Time Frame: Within 4 days after infant series Dose 2 ]

20.  Secondary:   Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3   [ Time Frame: Within 4 days after infant series Dose 3 ]

21.  Secondary:   Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose   [ Time Frame: Within 4 days after toddler dose ]

22.  Secondary:   Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series   [ Time Frame: Baseline up to 1 Month (28 to 42 days) after infant series ]

23.  Secondary:   Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series   [ Time Frame: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose ]

24.  Secondary:   Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose   [ Time Frame: Toddler dose up to 1 Month (28 to 42 days) after toddler dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01392378     History of Changes
Other Study ID Numbers: B1851047, 6096A1-4027
Study First Received: July 8, 2011
Results First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: Poland: Ministry of Health and Social Welfare. Poland: Research Ethics Committee.