Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00743652
First received: August 27, 2008
Last updated: March 13, 2012
Last verified: March 2012
Results First Received: September 9, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Pneumococcal Disease
13-valent Pneumococcal Vaccine
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine

  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
Blood sample was optional for subjects living in the Bethel area. Active vaccination stopped when 13-valent pneumococcal conjugate vaccine (13vPnC) was commercially available in Alaska. Study ended after a 6-month follow-up for safety following the last vaccination.

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 Group 1 (3 Doses Infant Series and 1 Toddler Dose) Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 4 (2 Catch-Up Doses) Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
13vPnC Group 5 (1 Catch-Up Dose) Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.

Participant Flow:   Overall Study
    13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)     13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)     13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)     13vPnC Group 4 (2 Catch-Up Doses)     13vPnC Group 5 (1 Catch-Up Dose)  
STARTED     151     51     25     67     79  
Vaccinated Dose 1     151     51     25     66     79  
Vaccinated Dose 2     112     41     0     49     0  
Vaccinated Dose 3     74     0     0     0     0  
Toddler Dose     15     23     16     0     0  
COMPLETED     141     48     23     63     79  
NOT COMPLETED     10     3     2     4     0  
Parent/Legal Guardian Request                 3                 2                 2                 2                 0  
Adverse Event                 3                 0                 0                 0                 0  
Death                 2                 0                 0                 0                 0  
Investigator Request                 0                 0                 0                 2                 0  
Unspecified                 1                 1                 0                 0                 0  
Lost to Follow-up                 1                 0                 0                 0                 0  



  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 Group 1 (3 Doses Infant Series and 1 Toddler Dose) Participants 6 weeks to less than (<) 10 months of age with 0 prior doses of Prevnar received 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at greater than (>) 12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose) Participants <12 months of age with 1 prior dose of Prevnar received 2 single IM 0.5 mL doses of 13vPnC at least 28 days apart (infant series), and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose) Participants <12 months of age with 2 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series) and a single IM 0.5 mL dose of 13vPnC at >12 months of age (toddler dose), at least 60 days after last infant dose.
13vPnC Group 4 (2 Catch-Up Doses) Participants greater than or equal to (≥) 12 months to <2 years of age received 2 single IM 0.5 mL doses of 13vPnC at least 60 days apart.
13vPnC Group 5 (1 Catch-Up Dose) Participants ≥2 years to <5 years of age received a single IM 0.5 mL dose of 13vPnC.
Total Total of all reporting groups

Baseline Measures
    13vPnC Group 1 (3 Doses Infant Series and 1 Toddler Dose)     13vPnC Group 2 (2 Doses Infant Series and 1 Toddler Dose)     13vPnC Group 3 (1 Dose Infant Series and 1 Toddler Dose)     13vPnC Group 4 (2 Catch-Up Doses)     13vPnC Group 5 (1 Catch-Up Dose)     Total  
Number of Participants  
[units: participants]
  151     51     25     67     79     373  
Age, Customized  
[units: Months]
Mean ± Standard Deviation
  1.4  ± 0.6     4.4  ± 0.8     7.1  ± 1.6     15.2  ± 3.4     40.1  ± 11.1     12.9  ± 15.9  
Gender  
[units: Participants]
           
Female     73     23     11     36     47     190  
Male     78     28     14     31     32     183  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Level ≥0.35 Micrograms Per Milliliter (Mcg/mL) 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

2.  Primary:   Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ]

3.  Primary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 Mcg/mL 1 Month After the Relevant Catch-Up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

4.  Secondary:   Percentage of Participants Achieving Serum IgG Antibody Level ≥0.35 Mcg/mL Prior to Vaccination With 13vPnC (Groups 4 and 5 Only)   [ Time Frame: 28 to 56 days before vaccination 2 for Group 4, and before the single vaccination in Group 5. ]

5.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

6.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ]

7.  Secondary:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥1.0 Mcg/mL 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

8.  Secondary:   Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1   [ Time Frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. ]

9.  Secondary:   Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2   [ Time Frame: Day 1 through Day 7 after vaccination 2 for Group 4 ]

10.  Secondary:   Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 1   [ Time Frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. ]

11.  Secondary:   Percentage of Participants Reporting Pre-Specified Systemic Events: Catch-up Dose 2   [ Time Frame: Day 1 through Day 7 after vaccination 2 for Group 4 ]

12.  Other Pre-specified:   Number of Cases of Invasive Pneumococcal Disease (IPD) in Participants Less Than 5 Years of Age Due to Any Serotype Contained in 13vPnC   [ Time Frame: Baseline to 6 months after last vaccination ]

13.  Other Pre-specified:   Percentage of Participants Achieving Serotype-Specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

14.  Other Pre-specified:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ]

15.  Other Pre-specified:   Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.15 Mcg/mL 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

16.  Other Pre-specified:   Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

17.  Other Pre-specified:   GMC for Serotype-Specific Pneumococcal IgG Antibodies 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. ]

18.  Other Pre-specified:   GMC for Serotype-specific Pneumococcal IgG Antibodies 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

19.  Other Pre-specified:   Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥Lower Limit of Quantitation (LLOQ) Measured 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

20.  Other Pre-specified:   Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ]

21.  Other Pre-specified:   Percentage of Participants Achieving OPA Titers ≥LLOQ Measured 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

22.  Other Pre-specified:   Pneumococcal OPA Geometric Mean Titers (GMTs) 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

23.  Other Pre-specified:   Pneumococcal OPA GMTs 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, after vaccination 2 for Group 3. ]

24.  Other Pre-specified:   Pneumococcal OPA GMTs 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]

25.  Other Pre-specified:   Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Infant Series   [ Time Frame: 28 to 56 days after vaccination 3 for Group 1, after vaccination 2 for Group 2, and after vaccination 1 for Group 3. ]

26.  Other Pre-specified:   Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Toddler Dose   [ Time Frame: 28 to 56 days after vaccination 4 for Group 1, after vaccination 3 for Group 2, and after vaccination 2 for Group 3. ]

27.  Other Pre-specified:   Correlation of OPA and IgG Values for Each 13vPnC Serotype 1 Month After the Relevant Catch-up Dose   [ Time Frame: 28 to 56 days after vaccination 2 for Group 4, and after the single vaccination in Group 5. ]


  Serious Adverse Events


  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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  More Information
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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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00743652     History of Changes
Other Study ID Numbers: 6096A1-3010, B1851009
Study First Received: August 27, 2008
Results First Received: September 9, 2011
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration