Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously Vaccinated (AB PERSISTENCE)
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ClinicalTrials.gov Identifier: NCT01025336 |
Recruitment Status :
Completed
First Posted : December 3, 2009
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Healthy |
Intervention |
Other: Blood draw |
Enrollment | 962 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Only participants who completed Parent Study 6115A1-3010 (NCT00574548) or Parent Study 6115A1-3005 (NCT00546572) were enrolled in this follow-up study 6115A1-3018 (NCT01025336). |
Arm/Group Title | 13vPnC/13vPnC Group (23vPS Naïve) | 13vPnC/23vPS Group (23vPS Naïve) | 23vPS/13vPnC Group (23vPS Naïve) | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) |
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Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) |
Period Title: Overall Study | |||||
Started | 130 | 210 | 179 | 221 | 222 |
Completed | 130 | 210 | 179 | 219 | 222 |
Not Completed | 0 | 0 | 0 | 2 | 0 |
Reason Not Completed | |||||
Protocol Violation | 0 | 0 | 0 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | 13vPnC/13vPnC Group (23vPS Naïve) | 13vPnC/23vPS Group (23vPS Naïve) | 23vPS/13vPnC Group (23vPS Naïve) | 13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | 23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior) | Total | |
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Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2) | Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) | Total of all reporting groups | |
Overall Number of Baseline Participants | 130 | 210 | 179 | 221 | 222 | 962 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 130 participants | 210 participants | 179 participants | 221 participants | 222 participants | 962 participants | |
64.0 (1.4) | 64.1 (1.4) | 64.2 (1.4) | 78.3 (4.5) | 77.8 (4.1) | 70.5 (7.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 130 participants | 210 participants | 179 participants | 221 participants | 222 participants | 962 participants | |
Female |
76 58.5%
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125 59.5%
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102 57.0%
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114 51.6%
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115 51.8%
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532 55.3%
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Male |
54 41.5%
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85 40.5%
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77 43.0%
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107 48.4%
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107 48.2%
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430 44.7%
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